We have another highly effective COVID vaccine, based on different tech

Image of a man receiving an injection.

Enlarge / A participant gets his second dose of the Novavax vaccine during the clinical trial. (credit: Karen Ducey / Getty Images)

Today, a company called Novavax announced that it had completed a large efficacy trial of its COVID-19 vaccine, and the news was good. The vaccine is highly effective, it blocked severe disease entirely, and it appeared to work against some of the more recently evolved virus variants. The company says it can produce 150 million doses per month by the end of the year, and the vaccine is stable when stored in a normal freezer, so it could play a big part in the effort to administer vaccines outside of industrialized nations.

Different tech

So far, US citizens have had the choice of RNA-based vaccines, like the offerings from Moderna and Pfizer/BioNTech, or a vaccine based on a harmless virus engineered to carry the coronavirus spike protein, as used in the Johnson & Johnson vaccine. (The AstraZeneca and Sputnik vaccines are similar to J&J’s.) Outside the US, many countries have used vaccines based on an inactivated coronavirus, although these have turned out not to be very effective.

The Novavax vaccine uses an entirely different technology. Vaccine production starts by identifying a key gene from the pathogen of interest—the SARS-CoV-2 spike protein, in this case—and inserting it into a virus that infects insect cells. Insect cells can easily be grown in culture, and they process any proteins they make in the same way that human cells do. (This processing can involve chemically linking sugars or cleaving off superfluous parts of the protein.) The activity ensures that the purified protein will be chemically identical to the spike protein found on the surface of the SARS-CoV-2 virus itself.

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#biology, #medicine, #novavax, #science, #vaccines, #virology

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Hospital suspends 178 health care workers for failing to get COVID vaccine

Multistory glass-and-steel hospital.

Enlarge / An American flag flies outside the Houston Methodist Hospital at the Texas Medical Center (TMC) campus in Houston, Texas, on Wednesday, June 24, 2020. (credit: Getty | Bloomberg)

As of Tuesday, 178 health care workers employed by a Houston-based hospital system are on a two-week unpaid suspension after failing to meet the hospital system’s mandate to be fully vaccinated against COVID-19 by Monday, June 7.

Houston Methodist CEO Marc Boom announced the mandate in April, telling hospital staffers that if they failed to get vaccinated, they would be fired. The 178 suspended employees now have the two unpaid weeks to become fully vaccinated before termination. They can do so by getting the one-shot COVID-19 vaccine by Johnson & Johnson or a second dose of either of the two mRNA vaccines. Boom noted in a letter to employees sent Tuesday that 27 of the 178 suspended employees have received one dose of vaccine.

The Texas hospital system stood out in issuing the vaccination mandate. Many employers have shied away from mandates, though more employers have followed Houston Methodist’s lead in recent weeks. Overall, the mandate appears successful: about 97 percent of the hospital’s nearly 26,000 employees are fully vaccinated. Boom reported that 24,947 staffers were fully vaccinated, while 285 received a medical or religious exemption, and 332 were granted deferrals for pregnancy and other reasons.

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#covid-19, #healthcare-workers, #hospital, #houston, #infectious-disease, #public-health, #science, #vaccine-mandates, #vaccines

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CDC loosened mask guidance to encourage vaccination—it failed spectacularly

A thrown-away surgical mask lays on the ground.

Enlarge / A thrown-away surgical mask lays on the ground. (credit: Getty | David Gannon)

The Centers for Disease Control and Prevention stunned health officials and experts May 13 with the abrupt announcement that people fully vaccinated against COVID-19 could forgo masking in most settings—indoor, outdoor, uncrowded, and crowded alike. The guidance was a stark reversal from the health agency’s previous stance, issued just two weeks earlier, that still recommended vaccinated people wear masks among crowds and in many indoor, uncrowded settings.

The CDC said at the time that it was merely following the science for masking. The agency and its director, Rochelle Walensky, highlighted fresh, real-world studies demonstrating COVID-19 vaccines’ high efficacy and ability to lower transmission risks. But the update was also part of an overt effort to encourage vaccination among the vaccine hesitant by emphasizing the perks of being vaccinated—like not needing to wear masks anymore and reclaiming other bits of normal life.

That messaging shift came as states across the country started to see their pace of vaccination slow despite a glut of vaccine doses. Numerous polls have indicated that most of the people eager to get vaccinated already have. Now, with just 62 percent of the US adult population vaccinated, much of the remaining unvaccinated portion is either hesitant or resistant to being vaccinated. It’s that group of people the CDC was trying to reach with the new mask guidance.

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#cdc, #fda, #masks, #public-health, #science, #vaccines

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Ohio lawmakers want to abolish vaccine requirements—all vaccine requirements

A child with measles.

Enlarge / A child with measles. (credit: Greene, Charles Lyman)

Ohio Gov. Mike DeWine’s “Vax-a-Million” program began Wednesday, running the first of five $1-million weekly lottery drawings open to residents who have been vaccinated. The effort is one of many incentive programs across the country aimed at getting vaccine-hesitant groups to roll up their sleeves, get vaccinated against the deadly coronavirus, and help end the pandemic.

But, while the lottery has already been hailed as a success in boosting vaccination numbers, conservative lawmakers in the Buckeye State appear to be diligently working toward reversing that trend.

Lawmakers are working on legislation to call off the lottery immediately. They’re also trying to head off any plans for “vaccine passports.” And last month, they introduced a sweeping antivaccination bill that would essentially demolish public health and vaccination requirements in the state—and not just requirements for COVID-19 vaccines, requirements for any vaccine.

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#covid-19, #infectious-diseases, #measles, #public-health, #science, #vaccine-preventable, #vaccines

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COVID cases after vaccination are still very rare—variants aren’t changing that

On Tuesday, the Centers for Disease Control and Prevention released the latest data on breakthrough COVID-19 infections, which are infections among people who have been fully vaccinated against the disease. Yet again, the data suggests that the vaccines are highly effective against infection, as well as severe disease and death. The data breakdown also hints that vaccines are winning the race against variants, which don’t seem to be breaking through at higher rates than expected.

Among approximately 101 million vaccinated people in the US as of April 30, the CDC collected reports of 10,262 breakthrough cases from 46 states and territories. That works out to about 0.01% breakthrough cases among the fully vaccinated. This number is almost certainly a significant undercounting, the CDC acknowledges.

Breakthrough monitoring is passive and voluntary; vaccinated people who had asymptomatic or mild COVID-19 infections may not have gotten tested or reported their cases. Only about 27 percent of the 2,725 cases tallied by the CDC were considered asymptomatic. Transmission of COVID-19 was also very high during the monitoring period reported, with about 355,000 COVID-19 cases reported nationally in the week ending on April 30.

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Need for annual COVID shots hinges on how many people get vaccinated now

A masked man rolls up his sleeve to receive an injection.

Enlarge / Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, receives the Moderna Inc. COVID-19 vaccine during an event at the NIH Clinical Center Masur Auditorium in Bethesda, Maryland, on Tuesday, Dec. 22, 2020. (credit: Getty | Bloomberg)

As COVID-19 vaccination efforts continue across the United States, many are wondering how long protection from the shots might last. And if protection is relatively short-lived, what does that mean for the years ahead? Will we need boosters? Will COVID-19 vaccines become an annual jab like the seasonal flu shot?

In back-to-back public interviews, top infectious disease expert Anthony Fauci provided the current outlook based on the latest data. Boosters are looking likely, but it’s still unclear when we’ll need them, with current speculation landing in the range of a year or so after the previous vaccination. Whether we’ll need them every year seems, for now, dependent on how many people get vaccinated this year.

Boosters

Speaking at an Axios virtual event Wednesday, Dr. Fauci emphasized that “we don’t know exactly when” a booster will be required. We know that the current vaccines remain protective for at least six months—“and likely considerably more,” Fauci added.

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Before ruining millions of vaccines, Emergent failed inspections, raked in cash

A flatscreen TV shows a serious man in a business suit.

Enlarge / Robert Kramer, President and Chief Executive Officer of Emergent BioSolutions, speaks via videoconference during a House Select Subcommittee on the Coronavirus Crisis hearing in the Rayburn House Office Building on Capitol Hill on May 19, 2021, in Washington, DC. (credit: Stefani Reynolds-Pool / Getty Images)

When contract-manufacturer Emergent BioSolutions contaminated at least 15 million doses of Johnson & Johnson’s COVID-19 vaccine and millions more doses of AstraZeneca’s vaccine at its Baltimore facility earlier this year, the company had been collecting monthly payments of $27 million from the US government—payments intended to help Emergent avoid just such a manufacturing disaster.

That’s according to a preliminary report from a Congressional investigation, conducted by two House committees—the Select Subcommittee on the Coronavirus Crisis and the Committee on Oversight and Reform. The report was released today and includes a number of troubling new details about the ongoing Emergent scandal.

The monthly “reservation fees” Emergent received were paid out of a questionable $628 million contract from May 2020. The money was intended to help Emergent maintain a state of “cleanliness and readiness” to produce vaccine under proper manufacturing standards and practices. But, as Ars previously reported, an inspection by the Food and Drug Administration in April found that to be far from the case.

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#covid-19, #emergent, #fda, #johnson-johnson, #science, #vaccines

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Biden pledges to share 20 million COVID-19 vaccine doses with the world

An older man in a suit speaks casually from behind a podium.

Enlarge / President Joe Biden speaks to a member of the media after delivering remarks in the East Room of the White House with Vice President Kamala Harris, left, in Washington, DC, on Monday, May 17, 2021. Biden plans to send an additional 20 million doses of vaccines abroad by the end of June. (credit: Getty | Bloomberg)

President Joe Biden announced on Monday that the United States will share at least 20 million doses of Pfizer-BioNTech, Moderna, and Johnson & Johnson COVID-19 vaccines with other countries over the next six weeks.

The pledged doses will be in addition to 60 million stockpiled doses of AstraZeneca’s vaccine the administration has previously said it will donate after they’re cleared by the Food and Drug Administration.

The announcement comes amid mounting pressure for the US and other rich nations to share doses with low- and middle-income countries, some of which are struggling with COVID-19 surges amid a dearth of doses. It also comes as the US has a glut of vaccine doses and is now struggling to convince a vaccine-hesitant portion of the population to take the available shots.

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#biden, #covax, #covid-19, #public-health, #science, #unicef, #vaccine-equity, #vaccines, #who

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It’s not enough to trust science on vaccines—others have to as well

Image of a woman receiving a vaccine.

Enlarge (credit: Luis Alvarez)

Before the COVID-19 pandemic, it was possible to believe that the US public’s skepticism of scientific information had some limits. Once a crisis hit a critical point—when things became a matter of life and death—people would come around, the thinking went.

Obviously, that hasn’t been the case. The US public’s skepticism toward science is extending toward one of its most important developments: vaccines. The COVID-19 vaccines offer both the prospect of a return to normal life and limits on the risk of dangerous coronavirus variants evolving—but only if enough people are vaccinated. And that “but” is looming larger as states are having to experiment with various inducements to get more people to take the vaccine.

Given this situation, any data that helps us understand why people might be hesitant to get vaccinated could be valuable. Some researchers have now found a hint that trust in science is more complicated than an individual belief. The societal consensus on trust in science matters, too.

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#behavioral-science, #human-behavior, #science, #vaccines

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Vaccinated people can now go maskless in most indoor locations

A masked woman walks along a treelined city street.

Enlarge / If you’ve been vaccinated, the CDC now says you can skip the mask and spacing. (credit: Luis Alvarez / Getty Images)

As part of an ongoing press conference, the Centers for Disease Control and Prevention responded to recent data on the effectiveness of vaccines and updated its guidance on mask use and physical distancing. Under the new guidance, anyone who is fully vaccinated (meaning two weeks after the final dose of their vaccine) can now skip mask use and social distancing both indoors and outdoors.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities—large or small—without wearing a mask or physical distancing,” said CDC Director Rochelle Walensky. There are some exceptions; vaccinated people should still mask up in places like hospitals, airplanes, and other forms of public transport. But for the most part, people who have been vaccinated can return to normal activities.

The press conference is ongoing, and we’ll update this story once it’s over.

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CDC advisory committee recommends COVID vaccine for 12- to 15-year-olds

A masked child watches a healthcare worker perform an injection.

Enlarge / With new data, we’re able to expand vaccinations to ever-younger populations. (credit: Roberto Jimenez Mejias / Getty Images)

On Wednesday, the CDC’s Advisory Committee on Immunization Practices recommended that the CDC approve the use of the Pfizer/BioNTech COVID-19 vaccine for the 12- to 15-year age group. The decision comes two days after the FDA granted an emergency use authorization for the same age group and will help the US further limit the pool of people who can spread infections or foster the evolution of new viral variants. Formal CDC approval could come quickly, given recent history.

Given the FDA’s earlier decision, the move might seem anticlimactic. But having the FDA and CDC officially on the same page is reassuring, and several state-run vaccination programs are awaiting the CDC’s OK before expanding into that age group. Private providers and insurance companies were also varied in their response to the FDA’s decision and were waiting for the CDC.

The data that supported the approval was pretty decisive, as a small Phase III clinical trial of 2,260 adolescents saw 16 cases of COVID-19, with every single one occurring in the placebo group. Side effects were similar to those experienced by older people, with a brief period of flu-like symptoms. The committee was tasked with considering whether the benefits outweighed the risks; given the minor side effects and the increasingly obvious benefits of vaccination, it’s not a surprise that the vote in favor of approval by the committee was 14 in favor, none opposing, and a single recusal. The CDC director, Rochelle Walensky, is overwhelmingly likely to follow the committee’s recommendation, most likely before the day is over. (We’ll update this story if and when this occurs.)

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Biden backs plan to accelerate vaccine production by waiving patents

Tiny bottles with plastic lids crowd a conveyor belt.

Enlarge / Pharmaceutical bottles on a conveyor belt in South Africa. (credit: Westend61 / Getty Images)

The Biden administration has thrown its weight behind an international effort to loosen patent and other legal protections for COVID vaccines.

“The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” wrote US Trade Representative Katherine Tai in a Wednesday statement.

If successful, that effort might open up the vaccine market to independent drug makers, speeding production and distribution and ending the pandemic more quickly. Or it might not.

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#covid-19-vaccine, #patents, #policy, #science, #trips, #vaccines, #wto

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Biden shifts strategy as national vaccination rate continues to slow

An older man in a suit gestures while addressing an unseen crowd.

Enlarge / US President Joe Biden speaks in the State Dining Room of the White House in Washington, DC, on Tuesday, May 4, 2021. (credit: Getty | Bloomberg)

By July 4—two months from today—the Biden administration wants to have 70 percent of American adults vaccinated with at least one dose of a COVID-19 vaccine and 160 million adults fully vaccinated.

Currently, over 147.5 million people have received at least one shot, which is 44 percent of the overall population and includes 56 percent of adults (people ages 18 and up). Over 105 million people are fully vaccinated, which is nearly 32 percent of the overall population and includes nearly 41 percent of adults.

The administration’s new goal would mean that close to 100 million shots would have to go out in the next 60 days or so, President Joe Biden said in an address Tuesday afternoon.

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Contractor that ruined 15M doses of J&J vaccine hiked price of another by 800%

The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson's COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021.

Enlarge / The Emergent BioSolutions plant, a manufacturing partner for Johnson & Johnson’s COVID-19 vaccine, in Baltimore, Maryland, on April 9, 2021. (credit: Getty | Saul Loeb)

Things are not looking good for Emergent BioSolutions, the contract manufacturer that ruined 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine and millions more doses of AstraZeneca’s COVID-19 vaccine at its production facility in Baltimore.

The Food and Drug Administration on Wednesday released a searing inspection report of the facility, finding a slew of significant violations and failings.

Meanwhile, federal lawmakers have opened a multi-pronged investigation into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts, inadequately training staff, persistent quality-control issues, and an “unjustified” 800% price increase for an anthrax vaccine.

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At 38.5% vaccinated, US may be running low on people eager for a shot

Residents wear protective masks while waiting to be vaccinated at a West Virginia United Health System Covid-19 vaccine clinic in Morgantown, West Virginia, U.S., on Thursday, March 11, 2021.

Enlarge / Residents wear protective masks while waiting to be vaccinated at a West Virginia United Health System Covid-19 vaccine clinic in Morgantown, West Virginia, U.S., on Thursday, March 11, 2021. (credit: Getty | Bloomberg)

The US logged another 4 million or so vaccinations Friday, bringing the total doses administered in the country over 200 million at the time of writing. Over 127 million adults—38.5 percent of the US population—have received at least one shot. Over 80 million adults—24 percent of the US population—are now fully vaccinated.

The seven-day rolling average of US vaccinations per day is now around 3.35 million and the Biden administration is on track to make its latest goal of 200 million vaccinations within the first 100 days in office.

Even with a current pause in use of Johnson & Johnson’s vaccine, Biden officials expect availability of vaccine to remain strong.

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#cdc, #covid-19, #immunity, #infectious-disease, #public-health, #science, #vaccination, #vaccines

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99.992% of fully vaccinated people have dodged COVID, CDC data shows

Residents wait in an observation area after receiving Covid-19 vaccines at a vaccination site in Richmond, California on Thursday, April 15, 2021.

Enlarge / Residents wait in an observation area after receiving Covid-19 vaccines at a vaccination site in Richmond, California on Thursday, April 15, 2021. (credit: Getty | Bloomberg)

Cases of COVID-19 are extremely rare among people who are fully vaccinated, according to a new data analysis by the Centers for Disease Control and Prevention.

Among more than 75 million fully vaccinated people in the US, just around 5,800 people reported a “breakthrough” infection, in which they became infected with the pandemic coronavirus despite being fully vaccinated.

The numbers suggest that breakthroughs occur at the teeny rate of less than 0.008 percent of fully vaccinated people—and that over 99.992 percent of those vaccinated have not contracted a SARS-CoV-2 infection.

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#breakthrough, #cdc, #covid-19, #infection, #infectious-disease, #public-health, #sars-cov-2, #science, #vaccines

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The very common vaccine ingredient at the center of J&J, AstraZeneca drama

Adenoviruses seen via transmission electron microscopy.

Enlarge / Adenoviruses seen via transmission electron microscopy. (credit: Getty | BSIP)

Out of an abundance of caution, US officials on Tuesday recommended pausing use of Johnson & Johnson’s COVID-19 vaccine. Officials linked the vaccine to six peculiar illnesses in which people developed life-threatening blood clots in combination with low levels of blood platelets, the cell fragments in blood that form clots. One person died from their condition and another is in critical condition.

It’s unclear if the vaccine caused the illnesses. Even if it did, the illnesses would represent an exceedingly rare side effect. The six cases occurred among more than 6.8 million people in the US who received the Johnson & Johnson vaccine. That would make it a side effect seen in fewer than one in a million. The risk of hospitalization and death from COVID-19, which the vaccine protects against, easily exceeds those odds. Without question, the benefits of the vaccine outweigh the potential risks.

Still, with robust supplies of vaccine from Moderna and Pfizer-BioNtech—neither of which have been linked to these unusual cases—US officials took the cautious route of pausing Johnson & Johnson’s vaccine while they investigate the cases further and inform clinicians about how to spot and treat any others that may arise. This latter point is critical because if doctors try to use standard blood clot treatments in these vaccine-linked cases, the outcomes can be fatal.

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#adenovirus, #astrazeneca, #cdc, #covid-19, #fda, #features, #infectious-disease, #johnson-johnson, #science, #vaccine-development, #vaccines, #viral-vector

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Former Trump vaccine czar fired over substantiated sexual harassment claim

Two men in suits stand by a podium.

Enlarge / President Donald Trump listens as Moncef Slaoui, the former head of GlaxoSmithKlines vaccines division, speaks about coronavirus vaccine development in the Rose Garden of the White House on May 15, 2020, in Washington, DC. (credit: Drew Angerer | Getty Images)

Moncef Slaoui, the former head scientist for the Trump administration’s Operation Warp Speed, has been fired from his position as chair of a biomedical company’s board of directors after an internal investigation substantiated allegations of sexual harassment against him.

Slaoui was chair of the board directors for Galvani Bioelectronics, a company formed through a partnership between pharmaceutical giant GlaxoSmithKline and Verily Life Sciences (formerly Google Life Sciences). GSK is the majority shareholder of Galvani.

According to an announcement by GSK, the company received a letter from one of its employees containing allegations of sexual harassment and “inappropriate conduct” by Slaoui, which occurred several years ago while he was working there.

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#gsk, #operation-warp-speed, #science, #sexual-harassment, #slaoui, #trump, #vaccines

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Russia’s Sputnik V vaccine looks good in early analysis

Image of two medical vials.

Enlarge / Picture of vials of Russia’s Sputnik V vaccine against the novel coronavirus disease, COVID-19, seen at the Cotahuma Hospital in La Paz, Bolivia. (credit: Jorge Bernal/Getty Images)

Yesterday, the people behind Russia’s leading vaccine, termed Sputnik V, issued a preliminary analysis of its function. The news was quite good: while the trial is ongoing and final results will have to wait, the interim data suggests that the vaccine could be over 90 percent effective.

Sputnik V is based on similar technology to the vaccines being developed by Johnson & Johnson and the Oxford/AstraZeneca collaboration. Strikingly, however, the preliminary efficiency is quite a bit higher than those vaccines are showing, and it’s not clear how the Sputnik-specific features could account for the difference.

Sounds great!

The results come out of a Phase III clinical trial involving roughly 21,000 participants being run in Moscow. Participants were all over the age of 18, hadn’t received other vaccinations recently, weren’t pregnant or drug users, and met a number of other criteria. PCR-based SARS-CoV-2 tests were performed at enrollment, and participants were also tested for the presence of antibodies against the virus.

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#biology, #covid-19, #medicine, #russia, #sars-cov-2, #science, #sputnik-v, #vaccines, #virology

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B.1.1.7 coronavirus variant is picking up a worrisome new mutation

Cartoon representation of coronaviruses.

Enlarge (credit: CDC.gov)

As the world races to get vaccines into arms, one of the most concerning coronavirus variants appears to be getting a little more concerning.

Researchers in the UK have detected at least 15 cases of B.1.1.7 variants carrying an additional mutation: E484K, a mutation already seen in other concerning variants and one that may make current vaccines less effective at preventing infection. The B.1.1.7 variant, first identified in the United Kingdom, is already known to spread more easily among people than earlier strains of the pandemic coronavirus SARS-CoV-2. And according to some preliminary evidence, it may cause more severe disease.

So far, B.1.1.7 variants carrying E484K appear rare. On Monday, Public Health England reported in a technical briefing that it had detected E484K in just 11 B.1.1.7 variants among more than 200,000 viruses examined. For now, it’s unclear if the augmented mutants will take off and become dominant in the population or fizzle out. It’s also not entirely clear what the addition of E484K means for B.1.1.7 in people. Preliminary laboratory experiments suggest the mutation alone, and its presence in B.1.1.7 specifically, may help the virus evade immune responses. But more studies and clinical data are necessary to understand the full effect of the new addition.

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#antibodies, #b-1-1-7, #coronavirus, #mutation, #sars-cov-2, #science, #spike, #vaccines, #variants

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Why kids matter in the quest to stamp out COVID-19

Masked school children work at desks separated by clear barriers.

Enlarge (credit: Getty Images)

Last December, when Caleb Chung, a 12-year-old in Durham, North Carolina, first heard from his dad that he might be eligible for a local clinical trial of a COVID-19 vaccine, his reaction was a little muted. He was “interested,” he tells me over Zoom. Not excited, exactly, not jumping for joy at the thought of joining the rarefied ranks of the immune. Interested. He had heard about side effects, for one thing, while watching the news with his parents. But mostly he just wasn’t sure what to make of the idea.

So Caleb and his dad, a pediatrician who works with adolescents, started talking. They covered the science of creating vaccines and testing them and how trials had helped bring vaccines to vulnerable people in the past. Plus, Caleb missed seeing his friends indoors, and seventh-grade Zoom school was slow. Getting shots to more people would bring a quicker end to the tedium. So he signed up. In late December, he got his first shot of what was either the Pfizer-BioNTech vaccine or a placebo. Then, three weeks later, he received his second. Both times, he kept a daily log of how he was feeling, recording a slight fever and soreness in his arm on day two. He took it in stride. “I hope this means I got the vaccine,” he says.

At the moment, two COVID-19 vaccines have been greenlit for emergency use by the US Food and Drug Administration, but both are only available to people older than Caleb. The Moderna vaccine is authorized for people over 18, while Pfizer’s is allowed for people as young as 16 because people that age were included earlier in its trials. But that could be changing. Last week, Pfizer officials announced they had finished enrolling more than 2,200 people in an expanded vaccine trial that includes kids as young as 12, and Moderna is currently in the process of signing up teens. That likely sets the stage for the companies to include teens in their requests for FDA approval, expected later this spring.

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#children, #covid-19, #policy, #vaccines

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“We’re failing”: Ex-Warp Speed leader proud, deflects blame on vaccines

President Donald Trump listens as Moncef Slaoui, the former head of GlaxoSmithKlines vaccines division, speaks about coronavirus vaccine development in the Rose Garden of the White House on May 15, 2020 in Washington, DC.

Enlarge / President Donald Trump listens as Moncef Slaoui, the former head of GlaxoSmithKlines vaccines division, speaks about coronavirus vaccine development in the Rose Garden of the White House on May 15, 2020 in Washington, DC. (credit: Drew Angerer | Getty Images)

Moncef Slaoui, the former head scientist for the Trump Administration’s Operation Warp Speed, is proud of his team’s work in helping to develop and distribute vaccine in an unprecedented timeframe amid the devastating COVID-19 pandemic. But when it comes to immunizing the population, “overall, we’re failing,” he says.

The immunologist and former head of vaccines for GlaxoSmithKline resigned from his role on Warp Speed at the request of the Biden Administration nearly two weeks ago. Though the Administration also quickly scrubbed away the “Warp Speed” name—which was repeatedly criticized for giving the impression that vaccines would be hastily developed without proper testing—Slaoui agreed to stay on into February to help with the transition. With his time in the federal position dwindling, he sat down for an interview with Science magazine to review how things have gone.

Overall, Slaoui is proud of his work, his team, and the monumental tasks they accomplished, he said. “Between May [2020] and now, we’ve moved five vaccines into Phase III trials, two have been authorized, two are completing Phase III—and one of those could be approved imminently… By all standards, this is absolutely exceptional,” he said.

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#covid-19, #infectious-disease, #operation-warp-speed, #pandemic, #public-health, #science, #slaoui, #trump, #vaccines

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“Complete incompetence:” Biden team slams Trump’s COVID work

A man in a suit holds up a laminated binder while speaking at a microphone.

Enlarge / US President Joe Biden releases his strategic COVID-19 plan at the White House on Thursday, Jan. 21, 2021. (credit: Getty | Bloomberg)

Just a day into office, President Joe Biden and his administration have unveiled a comprehensive, 200-page strategic plan and over a dozen executive orders and actions to tackle the COVID-19 pandemic currently rampaging across the country.

With the running start, the administration hopes to finally get control over the virus, which has already taken the lives of more than 408,000 Americans. The number of deaths is expected to top 500,000 next month, Biden said in an appearance Thursday to unveil his strategic plan.

“Things are going to continue to get worse before they get better,” he said, calling his approach to the pandemic a “full-scale wartime effort.”

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First task for Biden’s CDC director: Fix everything Trump broke

Dr. Rochelle Walensky, President-elect Joe Biden’s pick to head the Centers for Disease Control.

Enlarge / Dr. Rochelle Walensky, President-elect Joe Biden’s pick to head the Centers for Disease Control. (credit: Getty | Chip Somodevilla)

Midday today, January 20, Dr. Rochelle Walensky will take over as director of the Centers for Disease Control and Prevention—and one of her top priorities will be to try to undo all the harms done to the agency by the Trump administration.

“How is it that I make sure that the people who are there—these incredible scientists, these incredible civil servants for their entire career—understand and feel the value that we should be giving them? They have been diminished. I think they’ve been muzzled, that science hasn’t been heard,” Walensky said in a brief, but wide-ranging interview with JAMA Tuesday. “This top-tier agency—world renowned—hasn’t really been appreciated over the last four years and really markedly over the last year. So, I have to fix that.”

Part of her plan to do that is unmuzzling those scientists and getting their science out to the public where it can make a difference. And that blends into the next challenge: “We obviously need to get this country out of COVID and the current pandemic crisis,” she said. And that will also entail increasing communication with the public, as well as state and local health authorities and members of Congress.

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#biden, #cdc, #covid-19, #infectious-disease, #public-health, #science, #vaccines, #variants, #walensky

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EMA warns over doctored COVID-19 vaccine data hacked and leaked online

The European Medical Agency (EMA) has warned that information on COVID-19-related medicines and vaccines, which was stolen in a cyber attack last December and leaked online earlier this week, includes correspondence that’s been manipulated prior to publication “in a way which could undermine trust in vaccines”.

It’s not clear exactly how the information — which includes schematics of drug structures and correspondence relating to evaluation processes for COVID-19 vaccines — has been doctored.

We’ve reached out to the agency with questions.

One security researcher, Lukasz Olejnik, who has raised concerns about the leak via Twitter suggested the doctored data will be “perfect for sowing distrust” because the biotechnical language involved in the leaked correspondence will not be widely accessible.

Equally, it also seems possible that the high bar of expertise required to properly parse the data could limit how much damage the manipulated versions can do by limiting their viral appeal.

But it’s notable the EMA has raised concerns over the risk to trust in coronavirus vaccines.

“Two EU marketing authorisations for COVID-19 vaccines have been granted at the end of December/beginning of January following an independent scientific assessment,” the EMA writes in the latest update on the hack.

“Amid the high infection rate in the EU, there is an urgent public health need to make vaccines available to EU citizens as soon as possible. Despite this urgency, there has always been consensus across the EU not to compromise the high-quality standards and to base any recommendation on the strength of the scientific evidence on a vaccine’s safety, quality and efficacy, and nothing else.

“EMA is in constant dialogue with the EC, and other regulators across the network and internationally. Authorisations are granted when the evidence shows convincingly that the benefits of vaccination are greater than any risks of the vaccine. Full details of the scientific assessments are publicly available in the European Public Assessment Reports on EMA’s website,” it adds.

At the time of writing a criminal investigation into the cyber attack remains ongoing.

The attack has not been attributed to a specific hacking group or state actor and there’s no confirmation of who is responsible for trying to sew coronavirus-related disinformation by seeding doctored medical documents online.

However, last November Microsoft warned that hackers backed by Russia and North Korea had targeted pharmaceutical companies involved in the COVID-19 vaccine development efforts.

Back in June, the European Commission also raised concerns about the risks of coronavirus vaccine disinformation spreading in the coming months — simultaneously name-checking China and Russia as foreign entities it said it had confirmed as being behind state-backed disinformation campaigns targeting the region.

So suspicion seems likely to fall on the usual ‘hostile suspect’ states.

We’ve seen similar ‘doctored leak’ tactics attributed to Russia before — typically related to attempts to interfere with elections by smearing candidates for high political office.

Researchers have suggested that the hackers responsible for the 2015-16 breaches of the Democratic National Committee’s network snuck doctored data into the leaked emails — an attack that was subsequently attributed to Russia.

While, more recently, there was the infamous ‘Hunter Biden’ laptop incident — which supporters of president Trump sought to leverage against his challenger for the White House (now president-elect) in last year’s presidential race.

In that case, any disinformation punch fizzled out amid a raft of dubious claims around the finding and timing of the claimed data cache (along with much greater general awareness about the risk of digital fake smear tactics in political campaigns in the wake of revelations about the scale of Russia’s social media influence disops in the 2016 US presidential election).

In an earlier incident, from 2017, emails linked to the French president Emmanuel Macron’s election campaign also leaked online shortly before the vote — coinciding with a document dump on an Internet forum that suggested the presidential frontrunner had a secret bank account in the Cayman Islands. A claim Macron’s political movement said was fake.

While in 2019 Reddit also linked account activity involving the leak and amplification of sensitive UK-US trade talks on its platform during the UK election campaign to a suspected Russian political influence operation.

It’s not clear whether that leaked trade dossier had been doctored or not (it was heavily redacted). And it certainly did not deliver a landslide election win to Jeremy Corbyn’s Labour Party — which used the leaked data in its campaign. But a similar, earlier operation which was also attributed to Russia had involved the leak of fake documents on multiple online platforms. (That disinformation operation was identified and taken down by Facebook in May 2019.)

The emergence of leaks of doctored medical data linked to COVID-19 vaccines and treatments looks like a troubling evolution of hostile cyber disops which seek to weaponize false data to generate unhelpful outcomes for others — as there’s a direct risk to public health if trust in vaccine programs are undermined.

There have been state level hacks targeting medical data before too — albeit without the pandemic-related backdrop of an ongoing public health emergency.

Back in 2016, for example, the World Anti-Doping Agency confirmed that confidential medical data related to the Olympic drug tests of a number of athletes had been leaked by the Russia-linked cyber hacking group, ‘Fancy Bear’. In that case there were no reports of the data being doctored.

#covid-19, #disinformation, #europe, #european-medical-agency, #hack, #security, #vaccines

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Trump tries to claw back billions from COVID vaccine distributor

A picture taken on January 15, 2021, shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

Enlarge / A picture taken on January 15, 2021, shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

With mere days left in office, President Donald Trump has proposed $27.4 billion in brutal budget cuts—including clawing back 5.1 billion from global public health amid a raging pandemic. Of the proposed health cuts, $4 billion would be slashed from a vaccine alliance playing a central role in helping to distribute COVID-19 vaccines to low-income countries.

The proposed cuts are part of a recession request, which has no chance of being enacted by Congress, as Politico reports. However, the proposed cuts—particularly to the vaccine alliance—are likely to add insult to injury to the global public health community, which continues to battle the out-of-control pandemic.

Worldwide, the total number of COVID-19 cases is over 93 million, and deaths are approaching 2 million. In the US alone, the seven-day rolling average of daily new cases is over 235,000, with 129,000 people currently hospitalized. Around 4,000 people have died each day for the past three days, bringing the US death toll to around 380,000.

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#covid-19, #gavi, #global-public-health, #infectious-vaccine, #public-health, #science, #trump, #vaccines, #who

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Uber and Moderna partner on COVID-19 vaccine access and information

Uber and pharmaceutical company Moderna have announced a partnership around COVID-19 vaccination, which will include a number of different initiatives. To start, it’s only confirmed component is to provide users with credible, factual information about COVID-19 vaccine safety through Uber’s consumer app, but the companies have also discussed additional “options” including building ride scheduling via Uber directly into the immunization appointment booking process.

Still in its early days, the U.S. COVID-19 vaccination program is already beset with challenges, including providing timely access to vaccines to swaths of the population who need it most. The inoculation program also has to contend with significant misinformation proliferating on social media about vaccine safety, and any app with the surface area of something like Uber has a chance to get positive messages and accurate information in front of a lot of people, so that’s good news on its own.

But one of the very real challenges to an effective vaccination campaign remains logistical, and getting people to make their initial and follow-up appointments for the first round of the Moderna vaccine, and its second shot booster, is a bigger challenge than many might suspect. I spoke to Healthvana CEO Ramin Bastani about their work with  LA County on creating an immunization record that integrates with Apple Wallet to provide patients with timely info and reminders about vaccination appointments, but integrating a ride-booking service or appointment reminder directly in the Uber app that most users already have on their phone anyway could be another very effective way to increase success rates for first and follow-up inoculation visits.

Uber has already offered up free and discounted rides to help lower the friction of actually going out and getting a vaccine, but a product-level integration could do a lot more than that by providing easy, user-friendly access. As noted, this is still just one of the options being discussed, but if Uber and Moderna are willing to commit it to print, that at least means they’re serious about trying to find a way. We’re holding them to account, too, so rest assured we’ll follow up on their progress as this collaboration develops.

#apps, #ceo, #health, #healthvana, #medicine, #moderna, #pharmaceutical, #social-media, #tc, #transportation, #uber, #united-states, #vaccination, #vaccine, #vaccines

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Moderna is developing three new mRNA-based vaccines for seasonal flu, HIV and Nipah virus

Moderna, the biotech company behind one of the two mRNA-based vaccines currently being rolled out globally to stem the tide of COVID-19, has announced that it will purse development programs around three new vaccine candidates in 2021. These include potential vaccines for HIV, seasonal flu and the Nipah virus. Moderna’s development and clinical trial of its COVID-19 vaccine is among the fastest in history, and thus far its results have been very promising, buoying hopes for the efficacy of other preventative treatments being generated using this technology which is new to human clinical use.

An mRNA vaccine differs from typical, historical vaccines because it involves providing a person with just a set of instructions on how to build specific proteins that will trigger a body’s natural defenses. The mRNA instructions, which are temporary and do not affect a person’s actual DNA, simply prompt the body’s cells to produce proteins that mirror those used by a virus to attach to and infect cells. The independent proteins are then fought off by a person’s natural immune response, which provides a lasting lesson in how to fight off any future proteins that match that profile, including those which help viruses attach to and infect people.

Moderna’s new programs will target not only seasonal flu, but also a combinatory vaccine that could target both the regular flu and SARS-CoV-2, the virus that leads to COVID-19. The HIV candidate, which is developed in collaboration with both the AIDS Vaccine Initiative and the Bill and Melinda Gates Foundation, is expected to enter into Phase 1 trials this year, as will the flue face. Nipah virus is a highly lethal illness that can cause respiratory and neurological symptoms, and which is particularly a threat in India, Bangladesh, Malaysia and Singapore.

mRNA-based vaccines have long held potential for future vaccine development, in part because of their flexibility and programmability, and in part because they don’t use any active or dormant virus, which reduces their risks in terms of causing any direct infections up front. The COVID-19 pandemic spurred significant investment and regulatory/health and safety investment into the technology, paving the way for its use in other areas, including these new vaccine candidate trials by Moderna.

#aids, #bangladesh, #biotech, #health, #hiv, #india, #malaysia, #medical-research, #medicine, #moderna, #singapore, #tc, #vaccination, #vaccine, #vaccines, #virus

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At risk of extinction, black-footed ferrets get vaccinated for COVID-19

A curious pair of black-footed ferret kits survey the shortgrass prairie from their outdoor enclosures at the National Black-footed Ferret Conservation Center in Colorado.

Enlarge / A curious pair of black-footed ferret kits survey the shortgrass prairie from their outdoor enclosures at the National Black-footed Ferret Conservation Center in Colorado. (credit: Ryan Moehring | US Fish and Wildlife Service (CC BY-2.0))

In late summer, as researchers accelerated the first clinical trials of COVID-19 vaccines for humans, a group of scientists in Colorado worked to inoculate a far more fragile species.

About 120 black-footed ferrets, among the most endangered mammals in North America, were injected with an experimental COVID vaccine aimed at protecting the small, weasel-like creatures rescued from the brink of extinction four decades ago.

The effort came months before US Department of Agriculture officials began accepting applications from veterinary drugmakers for a commercial vaccine for minks, a close cousin of the ferrets. Farmed minks, raised for their valuable fur, have died by the tens of thousands in the US and been culled by the millions in Europe after catching the COVID virus from infected humans.

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#black-footed-ferret, #covid-19, #endangered-species, #ferrets, #mink, #science, #vaccines

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New virus variant found in Colorado while UK struggles to limit it

Image of a man with goggles and a face mask, holding a vial.

Enlarge / UK Prime Minister Boris Johnson poses for a photograph with a vial of the AstraZeneca/Oxford University COVID-19 candidate vaccine. (credit: WPA Pool/Getty Images)

This week, the UK released more data on the newly evolved strain of SARS-CoV-2, providing further evidence that it spreads more readily than previously circulating strains of the virus. Despite efforts to keep it limited to the UK, most public health experts expected it was already too late—a fear confirmed by the discovery of cases in Colorado. There is some good news, however, as the UK’s data indicates the new strain doesn’t appear to be more dangerous to people once they become infected.

In another bit of good news, health authorities in the UK approved the use of another vaccine, this one from a collaboration between Oxford University and the pharmaceutical company AstraZeneca. While the vaccine doesn’t appear to be as effective as the two others already in wide use, the addition of another supplier ensures that the UK should now have enough vaccine for its entire population early next year.

New, but decidedly not improved

Because the coronavirus accumulates mutations over time, there are now many distinct strains of SARS-CoV-2 circulating. The one that’s now causing concern first drew the attention of medical authorities in the UK because it drove a wave of new infections at a time where targeted lockdown policies were reducing the levels of other strains. By the middle of December, the strain had a name (B.1.1.7), was circulating widely within the UK, and had already been spotted elsewhere in Europe. But nearly everything else about the strain was an open question, including whether it was actually more infectious, or had simply ended up circulating within groups that were more likely to pass it on to others.

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#biology, #covid-19, #medicine, #sars-cov-2, #science, #uk, #vaccines, #virology

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Trump admin. agrees to pay Pfizer $1.95B for 100M more vaccine doses

Extreme close-up photograph of fingers holding a tiny glass jar.

Enlarge / A nurse in the UK holds a vial of the Pfizer-BioNTech COVID-19 vaccine on December 22, 2020. (credit: Lindsey Parnaby | AFP | Getty Images)

The Federal government has reached a deal with drugmaker Pfizer to secure an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine before the end of July, the company said today.

Under the terms of the new agreement, the government will pay $1.95 billion for the additional doses. Of the new vaccine doses, 70 million are due by June 30, with the remaining 30 million to be delivered no later than July 31. The agreement also provides US authorities with the option to order up to 400 million additional doses of the vaccine later.

Health and Human Services Secretary Alex Azar said in a statement that the additional Pfizer vaccine “can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021,” when added to the 100 million doses the US government has already agreed to purchase from Pfizer, as well as the recently approved Moderna vaccine.

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#biontech, #coronavirus, #covid-19, #deals, #pfizer, #policy, #science, #vaccines

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Moderna vaccine gets the thumbs-up for emergency use

Image of a building with the Moderna logo behind a security fence.

Enlarge / This unassuming building in Massachusetts has taken on remarkable significance in recent weeks. (credit: JOSEPH PREZIOSO / Getty Images)

Earlier this week, the FDA released documents that summarized the data on a second SARS-CoV-2 vaccine candidate, this one from a company called Moderna. That document was the background for a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, which would consider whether the benefits of the vaccine outweigh its potential risks. That question is one of the key considerations for the agency as it decides whether to grant an emergency use authorization similar to the one it gave the Pfizer/BioNTech vaccine.

After an all-day meeting that frequently focused on other topics, the committee was near unanimous: 20 votes for approval, none against, and one abstention.

Emergency use authorizations have a number of requirements once a health emergency has been declared. There must be no alternatives that have achieved full FDA approval, there must be reasons to think that the treatment will be effective, and its benefits are considered likely to outweigh its risks. It’s that final question—the risk versus benefit balance—that the advisory committee was called to address.

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#covid-19, #fda, #medicine, #moderna, #policy, #sars-cov-2, #science, #vaccines

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Google to add Covid-19 vaccine information panels to Search

Google announced today it’s introducing a new search feature that will surface a list of authorized vaccines in users’ location, as well as informational panels about each individual vaccine. The feature is first being launched in the U.K., which earlier this month gave emergency authorization to the BioNTech/Pfizer coronavirus vaccine.  The company says the feature will roll out to other countries as their local health authorities authorize vaccines.

The feature itself will appear at the top of Google.com searches for Covid-19 vaccines and will present the authoritative information in a box above the search results, linking to the health authority as the source. The panel will also have two tabs. One will be the overview of the vaccine, which appears above Top Stories and links to Local and National resources, like government websites. The other will organize news related to the vaccine under a separate section.

Image Credits: Google

Google positioned the new search panels as one way it’s helping to address vaccine misinformation and hesitance at scale.

However, another arm of the company, YouTube, allowed Covid-19 misinformation and conspiracies to spread during the pandemic. While YouTube in April banned “medically unsubstantiated” content after earlier banning conspiracies that linked Covid-19 to 5G networks, it didn’t ban misinformation about Covid-19 vaccines until October. In other words, it didn’t proactively create a policy to ban all aspects of Covid-19 misinformation, but waited to address the spread of Covid-19 antivax content until vaccine approvals appeared imminent. This meant that any clips making false claims — like saying vaccines would kill their recipients, cause infertility, or implant microchips –were not officially covered by YouTube’s policies until October.

And even after the ban, YouTube’s moderation policies were found to miss many anti-vaccination videos, studies found.

This is not a new challenge for the video platform. YouTube has struggled to address antivax content for years, even allowing videos with prohibited antivax content to be monetized, at times.

Image Credits: Google

Today, Google downplayed YouTube’s issues in its fight against misinformation, saying that its Covid-19 information panels on YouTube which offer authoritative information have been viewed over 400 billion times.

However, this figure provides provides at look into the scale at which YouTube creators are publishing videos about the pandemic, often with just their opinions.

Google said, to date, it has removed over 700,000 videos related to dangerous or misleading Covid-19 health information. If the platform was regulated, however, it would not be entirely up to Google to decide when a video with dangerous information should be removed, what constitutes misinformation, or what the penalty against the creator should be.

The company also noted that it’s now helping YouTube creators by connecting them with health experts to make engaging and accurate content for their viewers, and donated $250 million in Ad Grants to help over 100 government agencies run PSAs about Covid-19 on the video platform. In April, Google donated $6.5 million to support COVID-19 related fact-checking initiatives, as well, and is now donating $1.5 million more to fund the creation of a COVID-19 Vaccine Media Hub.

#coronavirus, #covid, #covid-19, #google, #health, #vaccines, #youtube

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The NIH’s top vaccine maker wants Warp Speed to be the new normal

The NIH’s top vaccine maker wants Warp Speed to be the new normal

Enlarge (credit: Krisana Antharith | Getty Images)

If the first vaccines against COVID-19 really do start coming online in a couple of weeks, that’ll be a blazingly fast scientific achievement—from new virus to new vaccine in just about 12 months, faster than ever before, and using a new vaccine technology, too. Amazing! And also only sort of true, because the path of the two vaccines likeliest to become available first, one from the pharmaceutical companies Pfizer and BioNTech and one from Moderna, began long before people started getting sick in Wuhan in December 2019.

Like all scientific discoveries, that path has many trailheads. One of them is the lab of John Mascola, director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. He didn’t come up with the idea of using genetic material to make vaccines, but he and collaborators around the US spent years trying to direct those efforts against coronaviruses, the family that includes SARS-CoV-2, the cause of COVID-19. Most vaccines against the disease clue the immune system into seeing a specific protein on the surface of the virus; it was Mascola’s VRC that brought the mRNA for that “spike protein” to Moderna.

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#covid-19, #moderna, #science, #vaccines, #warp-speed

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AstraZeneca says it will likely do another study of COVID-19 vaccine after accidental lower dose shows higher efficacy

AstraZeneca’s CEO told Bloomberg that the pharmaceutical company will likely conduct another global trial of the effectiveness of its COVID-19 vaccine trial, following the disclosure that the more effective dosage in the existing Phase 3 clinical trial was actually administered by accident. AstraZeneca and its partner the University of Oxford reported interim results that showed 62% efficacy for a full two-dose regimen, and a 90% efficacy rate for a half-dose followed by a full dose – which the scientists developing the drug later acknowledged was actually just an accidental administration of what was supposed to be two full doses.

To be clear, this shouldn’t dampen anyone’s optimism about the Oxford/AstraZeneca vaccine. The results are still very promising, and an additional trial is being done only to ensure that what was seen as a result of the accidental half-dosage is actually borne out when the vaccine is administered that way intentionally. That said, this could extend the amount of time that it takes for the Oxford vaccine to be approved in the U.S., since this will proceed ahead of a planned U.S. trial that would be required for the FDA to approve it for use domestically.

The Oxford vaccine’s rollout to the rest of the world likely won’t be affected, according to AstraZeneca’s CEO, since the studies that have been conducted, including safety data, are already in place from participants around the world outside of the U.S.

While vaccine candidates from Moderna and Pfizer have also shown very strong efficacy in early Phase 3 data, hopes are riding high on the AstraZeneca version because it relies on a different technology, can be stored and transported at standard refrigerator temperatures rather than frozen, and costs just a fraction per dose compared to the other two leading vaccines in development.

That makes it an incredibly valuable resource for global inoculation programs, including distribution where cost and transportation infrastructures are major concerns.

#astrazeneca, #biotech, #ceo, #coronavirus, #covid-19, #fda, #health, #medical-research, #moderna, #oxford, #pfizer, #pharmaceutical, #tc, #united-states, #vaccine, #vaccines

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We don’t have a COVID vaccine yet, but distribution is already messy

A sign on the entrance to a pharmacy reads "Covid-19 Vaccine Not Yet Available", November 23, 2020 in Burbank, California.

Enlarge / A sign on the entrance to a pharmacy reads “Covid-19 Vaccine Not Yet Available”, November 23, 2020 in Burbank, California. (credit: Getty | Robyn Beck)

Individual states will ultimately decide who will get the first 6.4 million doses of COVID-19 vaccine, which will be distributed based on each state’s population rather than the levels of disease spread or number of high-risk people.

The approach, announced in a press briefing Tuesday, is a departure from earlier plans and reflects the frenzied effort to vaccinate a country of nearly 330 million as quickly as possible.

Top officials for Operation Warp Speed—the federal government’s program to swiftly develop and deliver COVID-19 vaccines and therapies—said at the briefing that the current approach is intended to “keep this simple.” However, the potential for state-by-state variation in early access to vaccines could easily become complicated—and time is ticking for states to get their distribution plans clarified. There’s just a matter of weeks before the Food and Drug Administration may grant an emergency authorization for a vaccine by Pfizer and BioNTech.

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#azar, #biontech, #covid-19, #hhs, #operation-warp-speed, #pfizer, #public-health, #science, #vaccines

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Oxford University’s COVID-19 vaccine shows high efficacy, and is cheaper to make and easier to store

Oxford University’s COVID-19 vaccine, being developed in partnership with drugmaker AstraZeneca, has shown to be 70.4% effective in preliminary results from its Phase 3 clinical trial. That rate actually includes data from two different approaches to dosing, including one where two full strength does were applied, which was 62% effective, and a much more promising dosage trial which used one half-dose and one full strength dose to follow – that one was 90% effective.

Oxford’s results may not have the eye-catching high efficacy headline totals of the recent announcements from Pfizer and Moderna, but they could actually represent some of the most promising yet for a few different reasons. First, if that second dosage strategy holds true across later results and further analysis, it means that the Oxford vaccine can be administered in lower amounts and provide stronger efficacy (there’s no reason to use the full two-dose method if it’s that much less effective).

Second, the Oxford vaccine can be stored and transported at standard refrigerator temperatures – between 35° and 45°F – whereas the other two vaccine candidates require storage at lower temperatures. That helps obviate the need for more specialized equipment during transportation and on-site at clinics and hospitals where it will be administered.

Oxford’s COVID-19 vaccine also uses a different approach to either Moderna’s or Pfizer’s, which are both mRNA vaccines. That’s a relatively unproven technology when it comes to human therapeutics, which involves using messenger RNA to provide blueprints to a person’s body to build proteins effective at blocking a virus, without any virus present. The Oxford University candidate is an adenovirus vaccine, which is a much more established technology that’s already been in use for decades, and which involves genetically altering a weekend common cold virus and using that to trigger a person’s own natural immune response.

Finally, it’s also cheaper – in part because it uses tried and tested technology for which there’s already a robust and mature supply chain, and in part because it’s easier to transport and store.

The Phase 3 trial for the Oxford vaccine included 24,000 participants, and it’s expected to grow to 60,000 by the end of the year. Safety data so far shows no significant risks, and among the 131 confirmed cases in the interim analysis that produced these results, none of those who received either vaccine dosage developed a severe case, or one requiring hospitalization.

This is great news for potential vaccination programs, since it introduces variety of supply chain into an apparently effective vaccine treatment for COVID-19. We’re much better off if we have not only multiple effective vaccines, but multiple different types of effective vaccines, in terms of being able to inoculate widely as quickly as possible.

#astrazeneca, #biotech, #health, #medical-research, #medicine, #messenger, #moderna, #oxford-university, #pfizer, #tc, #unproven-technology, #vaccination, #vaccine, #vaccines

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Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today

Two of the companies behind one of the leading COVID-19 vaccine candidates will seek approval from the U.S. Food and Drug Administration for emergency use authorization (EUA) of their preventative treatment with an application to be delivered today. Pfizer and BioNTech, who revealed earlier this week that their vaccine was 95% effective based on Phase 3 clinical trial data, are submitting for the emergency authorization in the U.S., as well as in Australia, Canada, Europe, Japan and the U.K., and says that could pave the way for use of the vaccine to begin in “high-risk populations” by the end of next month.

The FDA’s EUA program allows therapeutics companies to seek early approval when mitigating circumstances are met, as is the case with the current global pandemic. EUA’s still require that supporting information and safety data are provided, but they are fast-tracked relative to the full, formal and more permanent approval process typically used for new drugs and treatments that come before they’re able to actually be administered broadly.

Pfizer and BioNTech’s vaccine candidate, which is an mRNA-based vaccine that essentially provides a recipient’s body with instructions on how to produce specific proteins to block the ability of SARS-CoV-19 (the virus that causes COVID-19) to attach to cells. The vaccine has recently been undergoing a Phase 3 clinical trial, that included 43,661 participants so far. The companies are submitting supporting information they hope will convince the FDA to grant the EUA, including data from 170 confirmed cases from among the participants, and safety information actively solicited from 8,000 participants, and supplementary data form another 38,000 who that was passively collected.

While production is ramping globally for this and other vaccines in late stage development, and EUA will potentially open up access to high-risk individuals including frontline healthcare workers, it’s worth pointing out that any wide vaccination programs likely aren’t set to begin until next year, and likely later in 2021.

#australia, #biontech, #biotech, #canada, #coronavirus, #covid-19, #europe, #health, #japan, #medical-research, #medicine, #pfizer, #tc, #united-kingdom, #united-states, #vaccination, #vaccines

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Pfizer says its COVID-19 vaccine is 95% effective in final clinical trial results analysis

Drugmaker Pfizer has provided updated analysis around its COVID-19 vaccine Phase 3 clinical trial data, saying that in the final result of its analysis of the 44,000-participant trial, its COVID-19 vaccine candidate proved 95% percent effective. This is a better efficacy rate than Pfizer reported previously, when it announced a 90% effectiveness metric based on preliminary analysis of the Phase 3 trial data.

This result also follows a preliminary data report from Moderna about their own Phase 3 trial of their vaccine candidate, which they reported showed 94.5% effectiveness. Pfizer and partner BioNTech’s vaccine is an mRNA-based preventative treatment, similar to the Moderna one, and now it looks like they should be roughly similar in efficacy – at least in the early offing, based on a limited sample of total cases and prior to peer review by the scientific community, which is yet to come.

The Pfizer data in its final analysis shows that among a total of 170 confirmed COVID-19 cases so far among the 44,000 people who took part in the study, 162 cases came from the placebo group while only eight were from the group of those who received the actual vaccine candidate. The company also reported that 9 out of 10 of the severe cases among those who were infected occurred in the placebo group, suggesting that even in the rare occasion that the vaccine didn’t prevent contraction of COVID-19, it helped reduce its severity.

This should help Pfizer make its case that it be granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to be able to provide the vaccine early pending full and final approval as an emergency measure. Earlier this week, the company reported that it has already collected two months’ worth of follow-up data about participants in its trial, which is a required component for said approval, and it’s pursuing it with hopes of seeking that EUA “within days.” The company intends to ramp production of its vaccine beginning later this year, and achieving a run rate of up to 1.3 billion doses by next year.

#biontech, #biotech, #coronavirus, #covid-19, #health, #medical-research, #medicine, #moderna, #pfizer, #tc, #vaccine, #vaccines

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Moderna reports its COVID-19 vaccine is 94.5% effective in first data from Phase 3 trial

Following fast on the heels of Pfizer’s announcement of its COVID-19 vaccine efficacy, Moderna is also sharing positive results from its Phase 3 trial on Monday. The biotech company says that its COVID-19 vaccine candidate has shown efficacy of 94.5% in its first interim data analysis, which covers 95 confirmed COVID cases among its study participants, of which 90 were given the placebo, and only 5 received Moderna’s mRNA-based vaccine. Further, of 11 severe cases of COVID-19, none were found among those who received the actual vaccine candidate.

This is another very promising sign for the potential of having effective vaccines available to the public in some kind of significant volume at some point next year. As mentioned, it’s worth pointing out that this is just a first interim report, but it is data that comes from the safety board overseeing the trial appointed by the National Institutes of Health, which is an independent body not affiliated with Moderna, so it’s a reliable result that provides hope for continued and final analysis.

Moderna says that it will be submitting for an Emergency Use Authorization of its vaccine candidate based on the results within the coming weeks, looking to get approval from the FDA to use it in emergency circumstances ahead of a full and final approval. That EUA, should it be granted, will be based on data from 151 confirmed cases among the Phase 3 participant group (which included 30,000 participants in total), and data from follow-ups extending on average over two months after case confirmation.

All final data will also be submitted to the scientific community for independent peer review, which is a standard part of the ultimate vaccine trial and approval process.

Both these and Pfizer’s vaccine candidate, which it developed in partnership with BioNTech, are mRNA-based vaccines. These are relatively new in terms of human use, and differ from traditional vaccines in that they use messenger RNA to instruct a recipient’s cells to generate effective antibodies, without actually exposing them to any virus, whereas more traditional vaccines in general use typically use either small, safe doses of active or inactive virus in order to trigger a patient’s immune system to generate their own antibodies.

#biontech, #biotech, #coronavirus, #covid-19, #fda, #health, #medical-research, #medicine, #messenger, #moderna, #pfizer, #tc, #vaccination, #vaccine, #vaccines

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We’ll need more than one vaccine to beat the pandemic

Close-up photograph of a gloved hand holding a tiny bottle of clear liquid.

Enlarge / A medical worker holds a bottle of a candidate COVID-19 vaccine developed by Oxford University that is being tested in a trial in Soweto, South Africa. (credit: Getty | Gallo Images)

On Monday, a press release from the transnational pharmaceutical company Pfizer dropped a rare spark of hope into the ongoing misery of the Covid-19 pandemic. Yes, new infections have hit an all-time high in the United States, and, yes, cities and states around the world are walking back their reopenings. But Pfizer says it has results from a massive clinical trial showing that its vaccine against the disease works, and works well. The release touted “a vaccine efficacy rate above 90 percent,” and it announced the company’s intention to seek from the US Food and Drug Administration an authorization to start giving people shots. The company’s ready to make 50 million doses this year and 1.3 billion doses in 2021.

That’s an ember of hope, but it’s sitting under a bucket of cold water, ready to pour. The Pfizer vaccine is finicky—hard to make, transport, and deliver. Because of desperate need, it’s in short supply even before it becomes available—1.3 billion doses is several billion short of what the world needs. The press release wasn’t peer-reviewed science, and it lacked critical details about how the vaccine works, and on whom. Even the simple fact of this vaccine’s existence, some analysts have argued, might jeopardize the testing and success of potentially better vaccines down the line, a case of the imperfect being the enemy of the good.

Before the ember dies out completely, here’s a theory: No. The Pfizer vaccine’s imperfections make it a perfect prime mover, because if it works as well as the company says, it’ll help people now and require research into more, better, different vaccines for later. All the things nobody knows about the Pfizer vaccine mean that the door is wide open. “Whether its effects are durable, whether it’s effective in the elderly, whether it has safety issues, the cold chain issues, the ability to have access,” says Wayne Koff, president and CEO of the nonprofit Human Vaccines Project, “all that points to the need for a number of vaccines.”

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#covid-19, #mrna, #pandemic, #science, #vaccination, #vaccines

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Vaccine czar calls on Trump to allow contact with Biden

President Donald Trump listens as Moncef Slaoui, the former head of GlaxoSmithKlines vaccines division, speaks about coronavirus vaccine development in the Rose Garden of the White House on May 15, 2020 in Washington, DC.

Enlarge / President Donald Trump listens as Moncef Slaoui, the former head of GlaxoSmithKlines vaccines division, speaks about coronavirus vaccine development in the Rose Garden of the White House on May 15, 2020 in Washington, DC. (credit: Drew Angerer | Getty Images)

The head of Donald Trump’s flagship vaccine project has called on the White House to allow Operation Warp Speed to make contact with Joe Biden’s transition team, warning that interrupting its work would put thousands of lives at risk.

Moncef Slaoui, a veteran pharmaceuticals executive who was appointed by Mr. Trump to accelerate the hunt for a vaccine, told the Financial Times he wanted to make sure his project continued operating without impediment during the transfer of power.

The comments from Mr. Slaoui, whose project is overseeing the development of five potential vaccines, come as the president faces pressure to concede defeat and allow a transition to the Biden administration to begin.

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#covid-19, #immunization, #policy, #project-warp-speed, #science, #vaccines

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Pfizer’s COVID-19 vaccine proves 90% effective in first results from Phase 3 clinical trial

The COVID-19 vaccine being developed by Pfizer and its partner BioNTech has shown to be effective blocking vaccine in 90 percent of participants in its Phase 3 clinical trial, the companies announced on Monday. That’s based on data analyzed by an external, independent committee assigned to check the results of the trial, and reflects only early results from the trial, and not the final verified result, but it’s still extremely promising news for progress towards a viable and more broadly available vaccine.

Pfizer and BioNTech’s vaccine candidate is an mRNA-based vaccine, which is a newer technology that many companies pursued for COVID-19 in part because it offers some advantages in pace of development and potential efficacy. These results from the test were based on an equable case total of 94 confirmed COVID-19 cases among study participants – passing the minimum threshold agreed to by the companies and the FDA of 62 confirmed cases for a proper, scientifically rigorous assessment.

The Phase 3 trial conducted by the companies included 43,358 participants, and Pfizer reports “no serious safety concerns have been observed” thus far in addition to the positive prevention rate. Based on this early data, individuals who receive the vaccine are protected at 28 days after first dose, and the vaccine uses a two-dose process.

There is still additional safety testing and continued studies to conduct, with the companies estimating that two full months of safety data (which is what the FDA requires for Emergency Use Authorization) will be available in the third week of this month. Participants will also be monitored for two full years after they receive their second and final dose in order to test for long-term effects. Pfizer still thinks that it can produce up to 50 million doses of its vaccine by the end of this year, and as many as 1.3 billion doses through 2021.

Full data from this trial still need to undergo peer-review by other researchers and scientific publications, but this is definitely the most promising and clearly positive news yet from the vaccine development front, and could mean that large-scale distribution of a vaccine begins even before the end of 2020 if all goes well.

#biontech, #biotech, #coronavirus, #covid-19, #fda, #health, #medical-research, #medicine, #pfizer, #tc, #vaccination, #vaccine, #vaccines

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Mink variant of coronavirus spreads to humans in Denmark; full cull planned

An adorable furry creature looks out of a cage.

Enlarge / A mink is photographed in a farm in Hjoerring, in North Jutland, Denmark, on October 8, 2020. (credit: Getty | MADS CLAUS RASMUSSEN)

A genetic variant of the pandemic coronavirus, SARS-CoV-2, found in mink has spread from the animals to at least 12 people in Denmark, the prime minister said at a press conference Wednesday. The government is now planning to cull all the mink on Danish farms, which are estimated to have between 15 and 17 million of the animals.

“It is very, very serious,” Prime Minister Mette Frederiksen said, according to the Associated Press.

It’s so far unclear how the genetic variation found in infected mink could actually affect humans. Researchers who track genetic variations in SARS-CoV-2 have not yet seen data on the mink strain and cautioned people not to be overly concerned.

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#coronavirus, #denmark, #infectious-disease, #mink, #public-health, #sars-cov-2, #science, #vaccines

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Santas scrooged by Trump admin after bizarre vaccine deal goes south

Even Santas are not safe during the pandemic.

Enlarge / Even Santas are not safe during the pandemic. (credit: Getty | Kristy O’Connor)

The Department of Health and Human Services has abandoned a deal to vaccinate Santa Claus performers as part of a $250-million taxpayer-funded public relations blitz, The Wall Street Journal reports.

According to the nixed Santa plan, performers would have received special early access to a future vaccine against the pandemic coronavirus. In exchange, the Santa Clauses, Mrs. Clauses, and accompanying elves would have promoted the vaccine to the public and participated in regional holiday events organized by the Trump administration.

Beginning to look a lot like chaos

The deal was reportedly gifted from the troubled mind of Michael Caputo, the HHS spokesperson installed by the White House in April. Caputo had no background in health when he took the position. Instead, he was reportedly placed in the department as a way for the Trump administration to assert more control over HHS Secretary Alex Azar. Caputo is a Trump loyalist, protégé of Roger Stone, and former Moscow-based political adviser who worked on public relations for Vladimir Putin.

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#alex-azar, #caputo, #cdc, #christmas, #coronavirus, #covid-19, #hhs, #public-health, #santa-claus, #science, #vaccines

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