FDA calls for fall boosters against BA.4/5 as subvariants take over US

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021, in Washington, DC.

Enlarge / Dr. Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration, testifies during a Senate Health, Education, Labor, and Pensions Committee hearing on the federal coronavirus response on Capitol Hill on March 18, 2021, in Washington, DC. (credit: Getty | Pool)

On Thursday, the US Food and Drug Administration advised vaccine makers to reformulate COVID-19 booster shots for this fall. The boosters would target both the original strain of the pandemic coronavirus plus two new omicron subvariants—BA.4 and BA.5—which became the dominant versions of the virus circulating in the United States this week.

The FDA’s announcement comes two days after its independent expert advisors voted overwhelmingly in favor of updating boosters to include an omicron component. The vote—19 in favor, two against—was simply in favor of including an omicron component generally. But, in their afternoon-long discussion, experts offered opinions that led to the FDA’s more specific guidance.

Specifically, much of the committee expressed support for combination shots—aka bivalent boosters—that would target both the original virus and a version of omicron. There was also broad support for targeting the omicron subvariants BA.4 and BA.5 specifically, rather than earlier subvariants, such as the first, BA.1, which is no longer in circulation.

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Moderna, Pfizer vaccines for under 5s overwhelmingly endorsed by FDA advisors

A woman in protective gear leans over a toddler in a bed.

Enlarge / Boston Medical Center Child Life Specialist Karlie Bittrich sees to a baby while in a pediatrics tent set up outside of Boston Medical Center in Boston on April 29, 2020. (credit: Getty | Boston Globe)

A committee of experts advising the Food and Drug Administration voiced unanimous support Wednesday for the authorization of two COVID-19 vaccines for children under the age of 5. If the FDA authorizes the vaccines, it will mark the first time during the more than two-year pandemic that vaccines against COVID-19 will be available for this age group—the last group yet to be eligible for vaccination.

Although children in this young age group have a relatively lower risk of severe disease and death from COVID-19 compared with older groups, they can and do become severely ill and die from the infection. As of last month, 45,000 children under 5 have been hospitalized for COVID-19 during the pandemic; roughly 50 percent of those hospitalizations occurred during the omicron wave. Of the children who land in the hospital, about 63 percent have no underlying medical conditions that put them at greater risk of severe COVID-19. And about a quarter of those hospitalized require intensive care.

So far, 475 children under the age of 5 have died from COVID-19 during the pandemic, making COVID-19 far deadlier than other diseases we routinely vaccinate young children against, including influenza, measles, chickenpox, hepatitis A, and rotavirus.

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Moderna’s omicron-combo booster outcompetes current booster

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

A combination COVID-19 booster dose that targets the ancestral strain of SARS-CoV-2 and the initial omicron variant, BA.1, appears to outperform the current booster against both of those versions of the virus, Moderna reported Wednesday.

Specifically, Moderna says the combination booster increased neutralizing antibodies against omicron 8-fold, while the original booster only increased antibody levels around 4.4-fold.

The vaccine maker is angling to have this bivalent shot—dubbed mRNA-1273.214—be the go-to booster for seasonal shots this fall. The company will be submitting its data to the Food and Drug Administration in the coming weeks and says it hopes to have the bivalent booster available by late summer, if not early fall.

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Switch to Moderna booster after Pfizer shots better against omicron in 60+

The Comirnaty (Pfizer/BioNTech) and Moderna COVID-19 vaccines.

Enlarge / The Comirnaty (Pfizer/BioNTech) and Moderna COVID-19 vaccines. (credit: Getty | Marcos del Mazo)

People ages 60 and older who were initially vaccinated with two Pfizer-BioNTech COVID-19 vaccine doses were better protected from the omicron coronavirus variant after being boosted with a Moderna vaccine rather than another dose of the Pfizer-BioNTech vaccine.

Those results are according to interim data from a small but randomized controlled clinical trial in Singapore and published this week in the journal Clinical Infectious Diseases.

The study—involving 98 healthy adults—can’t determine if the Moderna booster is simply superior to a Pfizer-BioNTech booster for older adults or if a mix-and-match booster strategy is inherently better. It also focused solely on antibody levels, which may or may not translate to significant differences in infection rates and other clinical differences. It also only followed people for 28 days after a booster, so it’s unclear if the Moderna booster’s edge will hold up over time.

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Moderna requests FDA authorization for COVID vaccine for kids under 6

Moderna requests FDA authorization for COVID vaccine for kids under 6

Enlarge (credit: Getty | Bloomberg)

In a move highly anticipated by parents the country over, Moderna announced Thursday that it has requested FDA authorization for its two-dose COVID-19 vaccines for children 6 months to 2 years, and 2 years to under 6 years.

If the Food and Drug Administration issues an emergency use authorization (EUA) for the vaccines, they will be the first such vaccines available to the age groups in the now nearly two-and-a-half-year-long pandemic. Parents of young, vaccine-ineligible children have been anxiously awaiting the availability of such vaccines, particularly as much of the country tries to move on from the pandemic even as the number of cases of the extremely contagious omicron subvariants continue to tick upward.

“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” Moderna CEO Stéphane Bancel said in a statement Thursday morning. “We believe mRNA-1273 [the COVID-19 vaccine] will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”

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Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5

Fauci confirms parents’ nightmare: FDA may delay COVID vaccines for kids under 5

Enlarge (credit: Getty | Congressional Quarterly)

The Food and Drug Administration is considering holding off on reviewing Moderna’s COVID-19 vaccine for children under age 5 until it has data from Pfizer and BioNTech on their vaccine for young children. The plan would push back the earliest possible authorization for a vaccine in the age group from May to June—yet another blow to parents who are anxious to protect their young children as the rest of the country ditches pandemic precautions, despite recent upticks in cases.

The FDA’s plan to delay the review was first reported by Politico Thursday morning, with sources telling the outlet that FDA officials worry about green-lighting Moderna’s vaccine, only to find out just a few weeks later that Pfizer’s offers superior protection.

In an interview with CNN’s Kasie Hunt later in the day Thursday, top infectious disease expert Anthony Fauci confirmed that the regulator is considering waiting until summer, likely June, to authorize vaccines for kids under 5. Fauci said the delay was intended to avoid confusion about the vaccines, but he emphasized that he was not involved in the regulators’ decisions and couldn’t explain their thinking further.

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Combo COVID booster is the way to go this fall, Moderna data suggests

A tray of prepared syringes for booster vaccinations with Moderna's vaccine.

Enlarge / A tray of prepared syringes for booster vaccinations with Moderna’s vaccine. (credit: Getty | Picture alliance)

A COVID-19 booster targeting two versions of the coronavirus in one shot offered stronger and broader protection than the current booster, which targets only one version, according to clinical trial results released this week by vaccine maker Moderna.

The results are preliminary and have not been peer reviewed or published in a scientific journal. But Moderna touted the findings as evidence that bivalent or multivalent vaccines—those that target two or more versions of the virus in a single shot—are the way forward for COVID-19 boosters.

Moderna and other vaccine makers are on a mission to develop boosters that could restore the once extraordinarily high levels of protection that mRNA-based COVID-19 vaccines initially provided, while also protecting against future variants. The first-generation mRNA vaccines were all designed to target the ancestral version of SARS-CoV-2 isolated in Wuhan, China—and they did so quite effectively, showing efficacy against symptomatic disease in the ballpark of 95 percent. But the virus has evolved into variants that can evade vaccine-derived protections. The latest variant, omicron, significantly reduced vaccine effectiveness against symptomatic disease, though protection against severe disease remains strong. Booster doses of the current vaccine design buoy protection but don’t restore the high levels seen previously. And the virus continues to evolve.

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NIH begins trial of COVID boosters to fight future variants

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Mild or not, more SARS-CoV-2 variants are inevitable. To avoid any blips in our pandemic endgame, researchers at the National Institutes of Health on Thursday announced the start of a complex Phase II clinical trial to find the best COVID-19 booster regimen to protect against variants that emerge in the wake of omicron.

“We are looking beyond the omicron variant to determine the best strategy to protect against future variants,” Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, said in a statement. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

Evidence so far suggests that the current vaccines—which are based on an early version of SARS-CoV-2 isolated in Wuhan, China—can muster protection against most of the variants that have swept across the globe so far. However, current vaccines have struggled against omicron, an ultratransmissible variant that is the most divergent variant yet. As such, researchers are wary that an omicron-specific vaccine alone will not generate broad protection against any future variant that may be more closely related to past variants—such as beta, a variant first detected in South Africa in 2020 suspected of being more severe than past variants, and delta, a highly transmissible variant that swept through the US before the emergence of omicron.

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Pfizer, Moderna vaccines aren’t the same; study finds antibody differences

A vial of COMIRNATY (Pfizer/BioNTech) and a vial of Moderna COVID-19 vaccines.

Enlarge / A vial of COMIRNATY (Pfizer/BioNTech) and a vial of Moderna COVID-19 vaccines. (credit: Getty | Marcos del Mazo)

The mRNA-based COVID-19 vaccines made by Pfizer/BioNTech and Moderna have proven highly effective at priming our immune systems to fight the pandemic coronavirus—preventing substantial amounts of infection, severe disease, and death throughout several waves of variants. But, despite their similar design and efficacy, the two vaccines are not exactly the same—and our immune systems don’t respond to them in the same way.

An early hint of this was some real-world data that found startling differences in the effectiveness of the two vaccines, despite both shots performing nearly identically in Phase III clinical trials—95 percent and 94 percent. Amid last year’s delta wave, a Mayo Clinic study found that Pfizer’s effectiveness against infection dipped to 42 percent while Moderna’s only fell to 76 percent.

According to a new study in Science Translational Medicine, such differences might be explained by evidence that the two vaccines spur the immune system to produce slightly different antibodies against SARS-CoV-2.

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With a second booster now authorized for some, the question is when to get it

A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021.

Enlarge / A health worker administers a third dose of the Pfizer-BioNTech COVID-19 vaccine to an elderly resident at Ichilov medical center in Tel Aviv, Israel, on Monday, Aug. 2, 2021. (credit: Getty | Bloomberg)

The US Food and Drug Administration on Tuesday announced the authorization of second booster doses of both the Pfizer/BioNTech and Moderna COVID-19 vaccines for people ages 50 and above, as well as certain immunocompromised people.

The FDA’s decision, which was made without consulting its panel of independent expert advisers, was expected this week.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Peter Marks, the FDA’s top vaccine regulator, said in a statement. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”

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Moderna reports good COVID vaccine results for kids

Avery, 6, and Aidan, 11, got their second Moderna COVID-19 vaccine doses at Kaiser Permanente Los Angeles Medical Center on Friday, June 25, 2021, as part of the KidCOVE study evaluating the safety and efficacy of the Moderna vaccine in young children.

Enlarge / Avery, 6, and Aidan, 11, got their second Moderna COVID-19 vaccine doses at Kaiser Permanente Los Angeles Medical Center on Friday, June 25, 2021, as part of the KidCOVE study evaluating the safety and efficacy of the Moderna vaccine in young children. (credit: Getty | MediaNews Group)

Wednesday brought some potentially positive news for the parents and caregivers of young children who have endured an agonizing wait for an effective COVID-19 vaccine. Moderna announced Wednesday that its two-dose vaccine for children ages 6 months to under 6 years appeared safe and produced strong antibody levels that correlate with effectiveness in adults. The company plans to ask the Food and Drug Administration to authorize the vaccine in the coming weeks.

The trial, a randomized, observer-blind, placebo-controlled study called KidCOVE, involved 6,700 children under 6 years old (4,200 children six months to 2 years and 2,500 children 2 years to under 6 years). Vaccinated children received two 25-microgram doses of vaccine—a quarter of the adult dose—which were given 28 days apart. Neutralizing antibody levels in the vaccinated children met or exceeded those seen in adults ages 18 to 25, for which vaccine is already approved.

Omicron hit

Though the primary objective of the trial was to reach those antibody levels seen in adults—a process called an immunobridging study—the trial also looked at efficacy against infection and severe disease amid the wave of omicron coronavirus variant infections. Phase III trial data indicated that the vaccine was about 44 percent effective at preventing an omicron infection in children ages 6 months to 2 years and 37.5 percent effective against an omicron infection in children ages 2 years to under 6 years.

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Murky case for fourth doses now with FDA as protection wanes, BA.2 looms

The US Food and Drug Administration in Silver Spring, Maryland.

Enlarge / The US Food and Drug Administration in Silver Spring, Maryland. (credit: Getty | Xinhua News Agency)

Vaccine-makers Moderna and Pfizer have now both submitted requests for the US Food and Drug Administration to authorize fourth doses—second boosters—of their COVID-19 vaccines.

Pfizer, along with vaccine partner BioNTech, announced Tuesday that they had asked the FDA to authorize fourth doses for adults age 65 and above. The move followed days of Pfizer CEO Albert Bourla saying in press interviews that a fourth shot is “necessary” for everyone.

Late Thursday, Moderna announced that it, too, had asked the FDA to authorize fourth doses—for all adults. Moderna addressed the broader request in its announcement, saying it’s intended to “provide flexibility” for the FDA and the Centers for Disease Control and Prevention to decide for themselves who should get a fourth dose—whether it’s specific age groups and/or groups with higher risks of disease.

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Vaccine makers announce slowdowns for omicron-specific booster

Rows of small glass vials.

Enlarge / Vials of undiluted Pfizer COVID-19 vaccine. (credit: Getty | BRENDAN SMIALOWSKI )

Vaccine makers are pushing back when omicron-specific COVID-19 vaccines could be ready for use. The shots were initially expected in March.

Delays in the vaccines’ development come as cases of omicron have been dropping rapidly, and several animal studies have suggested the variant-specific formulations will not offer an advantage over the current vaccines.

BioNTech CEO Uğur Şahin on Wednesday said that his company’s omicron-specific vaccine had been delayed by several weeks due to unexpectedly slow data gathering, according to Reuters. BioNTech and its COVID-19 vaccine partner, Pfizer, had announced last month that they had begun a clinical trial with the omicron-specific shot.

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Monkey study casts doubt on need for an omicron-specific booster

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

In a small group of monkeys, an omicron-specific version of Moderna’s COVID-19 vaccine did not protect against the omicron variant better than Moderna’s current, highly effective booster. This finding casts doubt on whether a switch to variant-specific doses is necessary.

The study was led by researchers at the National Institutes of Health and posted on a preprint server last Friday. The study has not been peer-reviewed or published in a scientific journal. It also has all the limitations of an animal study and only involved eight monkeys. The study’s findings will have to be verified in human trials, which are currently underway.

Still, there’s good reason to think the finding will hold up. As the authors of the study note, this isn’t Moderna’s first variant-specific booster. The company had previously developed a booster against the concerning variant beta. As with the omicron-specific booster, the beta-booster didn’t outperform the original vaccine at protecting primates from beta. And that finding later held up in human trials.

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Third dose of Moderna COVID-19 vaccine leads to 37-fold jump in antibodies

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

Enlarge (credit: JOSEPH PREZIOSO / Getty Images)

Moderna announced Monday that its booster provides protection against COVID-19 variant omicron. In its testing, Moderna found a 50-microgram dose resulted in a 37-fold increase of antibodies compared to vaccinated, unboosted individuals. 

A 100 µg dose, which is the same amount used in the first two vaccine doses, provided even more protection, increasing antibody levels 83-fold. But that increased immune response was paired with slightly worse side effects than with the smaller dose. 

Moderna’s data is preliminary and has not been reviewed, but CEO Stéphane Bancel said the results are “reassuring” all the same and touted the company’s work on a booster targeted specifically at omicron. “To respond to this highly transmissible variant, Moderna will continue to rapidly advance an Omicron-specific booster candidate into clinical testing in case it becomes necessary in the future. We will also continue to generate and share data across our booster strategies with public health authorities to help them make evidence-based decisions on the best vaccination strategies against SARS-CoV-2.”

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FDA authorizes Pfizer and Moderna COVID boosters for all adults

19 November 2021, Hamburg: A tray of prepared syringes for booster vaccinations with Moderna's vaccine.

Enlarge / 19 November 2021, Hamburg: A tray of prepared syringes for booster vaccinations with Moderna’s vaccine. (credit: Getty | Picture alliance)

The Food and Drug Administration has authorized booster doses of both the Pfizer-BioNTech and Moderna COVID-19 vaccines for all people ages 18 and up, the companies announced separately this morning.

The boosters are to be given at least six months after a person’s second dose and, according to Moderna, can be used for mix-and-match boosting. That is, people who received two Pfizer-BioNTech vaccine doses earlier this year could get a Moderna booster and vice versa.

Preliminary data released last month from a mix-and-match booster trial run by the National Institutes of Health found that Moderna boosters appeared to generate the highest antibody levels overall, including in people who had previously received two doses of the Pfizer-BioNTech vaccine. However, the trial used a full dose of the Moderna vaccine (100 micrograms) for a booster, whereas the FDA has authorized a half-dose shot (50 micrograms) for boosters. It’s unclear if the half dose offers the same edge over boosting with a third Pfizer-BioNTech shot, which is given at the same dosage as the first two shots (30 micrograms).

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FDA advisors unanimously green-light Moderna boosters for people 65+, high-risk

Words and symbols adorn a large outdoor sign.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

As expected, a committee of independent advisors for the Food and Drug Administration voted unanimously (19-to-0) Thursday afternoon in favor of authorizing a booster dose of Moderna’s COVID-19 vaccine for certain groups.

The groups flagged for boosting are individuals aged 65 and older, people ages 18 to 64 who are at risk of severe COVID-19 due to health concerns, and those 18 to 64 who are at risk of COVID-19 due to frequent institutional or occupational exposures, such as health care and essential workers. These are the same groups that were previously authorized to get a Pfizer/BioNTech booster.

As with the Pfizer/BioNTech boosters, the Moderna boosters are to be given six months or longer after the first two doses of Moderna’s mRNA vaccine.

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Mix-and-match COVID boosters are as good—if not better than—all the same shots

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Mixing and matching COVID-19 vaccines for booster doses appears safe and as effective—if not more effective—than sticking with the same vaccine for a booster dose. That’s according to preliminary data posted online Wednesday from a clinical trial run by the National Institutes of Health.

The trial bolsters what some have long hoped: that mixing and matching vaccines could provide stronger, broader protection against the pandemic virus and all its variants.

The trial was not large enough to definitively indicate which combination of vaccines offers the best protection. And the early results, available on a preprint server, have not yet been peer-reviewed. But the preliminary trial findings do hint that Moderna’s mRNA vaccine may offer the strongest protection all around—backing up similar findings from earlier vaccine-effectiveness studies. The data also suggests that people who received the one-shot Johnson & Johnson vaccine may want to get a boost with one of the two mRNA vaccines, either Moderna’s or Pfizer/BioNTech’s.

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Biden administration expects J&J boosters in the next few weeks

Boxes of Johnson & Johnson's Janssen COVID-19 vaccine at a vaccination site in Florida.

Enlarge / Boxes of Johnson & Johnson’s Janssen COVID-19 vaccine at a vaccination site in Florida. (credit: Getty | Paul Hennessy)

Johnson & Johnson plans to seek authorization for a booster dose for its one-shot COVID-19 vaccine early this week, according to a report by The New York Times.

J&J is the last to apply for booster authorization among the makers of the three COVID-19 vaccines used in the US. Yet, it is the booster that many health officials are most eager to see. The vaccine, which uses a viral vector strategy rather than an mRNA-based design, is the only available COVID-19 vaccine given as just one shot. Its efficacy has lagged behind the other vaccines throughout the pandemic.

Still, Moderna and Pfizer-BioNTech, both mRNA-based vaccine, have already submitted booster applications to US regulators. On September 22, the Food and Drug Administration granted authorization for a booster dose of the Pfizer-BioNTech vaccine for certain groups of people. The decision was tense, with experts torn over whether a booster for the highly effective vaccine was widely needed.

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Following expert advice, FDA authorizes boosters for people 65+, high risk

Words and symbols adorn a large outdoor sign.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

The US Food and Drug Administration late Wednesday authorized booster doses of the Pfizer/BioNTech COVID-19 vaccine for people ages 65 and up. Also eligible for boosters will be those ages 18 to 64 who are at high risk of severe COVID-19 or at high risk from frequent occupational or institutional exposures to SARS-CoV-2, such as healthcare workers and teachers.

The single booster dose should only be given at least six months after the two initial doses. The approval comes an amendment to an Emergency Use Authorization.

The FDA’s authorization largely follows the recommendations from a committee of independent experts that advises the agency, known as the Vaccines and Related Biological Products Advisory Committee or VRBPAC. The committee met all day Friday to review and deliberate over the data surrounding boosters. The meeting concluded with an 18-0 vote in favor of recommending boosters for people over 65 and high-risk groups. But, prior to that, the committee voted 16-2 against recommending boosters for everyone ages 16 and up, rejecting the Biden administration’s plans to rollout additional doses to nearly all vaccinated people.

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Vaccine mandates work, especially when they’re done right

Vaccine mandates work, especially when they’re done right

Enlarge (credit: Mario Tama | Getty Images)

On Monday, the US Food and Drug Administration gave formal, full approval to the Covid-19 vaccine made by the drug companies Pfizer and BioNTech. You might’ve already gotten a dose of it, of course; millions of Americans have, thanks to an “emergency use authorizationawarded in December 2020. But the new designation was more than just a formality. “If you’re one of the millions of Americans who said they will not get the shot until it has full and final approval from the FDA, it has now happened,” President Joe Biden said when he announced the approval. And, in the same speech: “If you’re a business leader, a non-profit leader, a state or local leader who has been waiting for full FDA approval to require vaccinations, I call on you now to do that—require it.”

Pretty much right away, a lot of places did. Vaccines are safe, effective, and free, but somewhere around 30 percent of Americans haven’t got their shots. Carrots didn’t work; here come the sticks. And they might be able to crush the fourth wave of the Covid pandemic in the US—if they’re done right.

Like the other vaccines still available under EUA, the Pfizer drug is extraordinarily good at keeping people from getting really sick or dying from Covid. But with more than 100,000 people in the hospital with Covid in the US—the most since January—and with the vast majority of them unvaccinated, it’s clear that alone isn’t enough. States, localities, and businesses have tried inducements like prizes, cash, or lotteries, little tricks designed to corral people into doing what’s good for them. In the language of behavioral economics, that’s called a nudge. But in states with low vaccine uptake, those nudges didn’t change the momentum. So now, it’s time for mandates. If you’re one of the 30 percent or so of Americans who haven’t gotten vaccinated yet, get ready for a good hard shove.

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What to know about the US COVID booster plan—and why WHO hates it

 A health professional holds a vial of the Moderna vaccine against Covid-19

Enlarge / A health professional holds a vial of the Moderna vaccine against Covid-19 (credit: Europa Press News)

US officials on Wednesday formally announced plans to offer COVID-19 vaccine booster shots to Americans—and the plans are already under fire from experts at the World Health Organization.

US officials are recommending that all Americans vaccinated with two doses of an mRNA vaccine (either the Moderna or Pfizer/BioNTech vaccine) get a third booster dose of the same vaccine eight months after receiving their second dose. As such, boosters will be rolled out based on the order in which people were initially offered vaccines, i.e., with frontline health workers, nursing home residents, and other seniors at the front of the line.

US officials are prepared to begin offering booster shots the week of September 20. However, the timing of the boosters is pending authorization from the Food and Drug Administration and the recommendation of the Advisory Committee on Immunization Practices, an independent committee of experts that advises the Centers for Disease Control and Prevention.

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Here’s who can get a 3rd vaccine dose now—and who may be next

Hypodermic needles lined up in a tray.

Enlarge / COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021. (credit: Getty | NurPhoto)

Pfizer and BioNTech submitted new COVID-19 vaccine-booster data to the Food and Drug Administration Monday as US officials continue to consider whether to recommend third doses for more Americans.

For now, officials have only recommended that some people with weakened immune systems get a third dose of a COVID-19 vaccine. While officials continue to say that there is not enough evidence to support third-dose boosters for other vaccinated groups at this point, many officials say boosters will likely be in our futures. The lingering questions are when exactly shots will be needed and who will be next in line.

On Sunday, Director of the National Institutes of Health Francis Collins told the Associated Press that, with the delta variant raging and immune responses possibly waning, officials could be making decisions on boosters for this fall or winter within the coming weeks.

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#biontech, #boosters, #breakthrough, #covid-19, #infection, #johnson-johnson, #moderna, #mrna, #pfizer, #science, #vaccine-efficacy, #vaccines

FDA expected to authorize 3rd COVID vaccine dose for immunocompromised

Extreme close-up photograph of gloved hand holding frost-covered glass vial.

Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

The Food and Drug Administration is expected to announce Thursday (or soon after) that it is authorizing a third COVID-19 vaccine dose for some people with compromised immune systems, according to people familiar with the FDA’s plans.

The plans were first reported by NBC News and confirmed by CNN and Politico.

The FDA is expected to give a green light for a third dose of both the Moderna and Pfizer/BioNTech mRNA vaccines. The authorization for the third shots would come by way of updates to the vaccines’ emergency use authorizations.

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#biontech, #cancer, #cdc, #covid-19, #fda, #hiv, #immunocompromised, #moderna, #organ-transplant, #pfizer, #science, #vaccine

mRNA vaccine technology moves to flu: Moderna says trial has begun

Grubb's Pharmacy on Capitol Hill is pictured on Monday, April 12, 2021.

Enlarge / Grubb’s Pharmacy on Capitol Hill is pictured on Monday, April 12, 2021. (credit: Getty | Tom Williams)

Moderna has given out the first doses of an mRNA-based influenza vaccine to participants in an early-phase clinical trial, the company announced Wednesday.

Moderna ultimately plans to test the vaccine on about 180 people in the Phase 1/2 randomized, stratified, observer-blind trial. The trial will look at safety, different doses, and immune responses.

The vaccine, called mRNA-1010, is designed to target four lineages of influenza viruses that circulate seasonally each year, just like the current quadrivalent flu vaccines on the market. The four virus lineages are those identified by the World Health Organization as the ones to target for disease prevention each year—seasonal influenza type A lineages H1N1 and H3N2 as well as influenza type B lineages Yamagata and Victoria. If mRNA-1010 is shown to be effective against the yearly plague in later-stage trials, Moderna aims to eventually bundle it with three other mRNA-based vaccines to create a yearly, one-stop shot.

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#covid-19, #flu, #infectious-disease, #moderna, #mrna, #rsv, #sars-cov-2, #science, #vaccines

What does Uber and birth control have in common?

Hello and welcome back to Equity, TechCrunch’s venture capital-focused podcast where we unpack the numbers behind the headlines.

This is Equity Monday, our morning coffee chat with you that is all about the weekend, what to expect this week, and some funding rounds you may have missed. I’m subbing in for Alex Wilhelm today, who is deservedly out on vacation. You can find me on Twitter @nmasc_, and Equity on Twitter (turn on those notifications!) @equitypod. 

Biden and world leaders are congregating at the NATO summit, which kicks off this week. Also, the Dublin Tech Summit is happening on Thursday with yours truly, other TC folks, and many entrepreneurs making a virtual appearance.

Now, onto the news!

  •  The weekend: The seat next to Jeff Bezos as he launches into space just got filled for $28 million. Also, Elon Musk tweeted about how Tesla might start accepting Bitcoin as a payment once at least half of it can be mined using clean energy. The comment sent Bitcoin up more than a few percentage points, hovering at $39,173 at the time of the recording.
  • This morning: The FT reports that Flagship Pioneering, which is responsible for incubating and launching Moderna, has raised a new venture capital fund at $3.4 billion. Flagship isn’t your traditional VC. It forms teams around problem areas and brainstorms solutions, incubates the most promising ones, and then eventually spins out and finances those companies.
  •  Funding rounds: Byju’s got a check from UBS and Zoom founder Eric Yuan, making it the most valuable startup in India. The company is now valued at $16.5 billion post-money. Plus, The Pill Club has raised an extension Series B round with former Uber exec Liz Meyerdirk newly at the helm of the company.
  • Finally, please take the Equity Listener Survey. We want to make the show better for you, so spending a few seconds filling out our survey and we will be very grateful.

And that’s all. Be kind with yourself this week, and take more than a 5-minute lunch because true glamour is being present and chewing slowly.

Equity drops every Monday at 7:00 a.m. PST, Wednesday, and Friday at 6:00 AM PST, so subscribe to us on Apple PodcastsOvercastSpotify and all the casts!

#bitcoin, #byjus, #edtech, #elon-musk, #equity, #equity-pod, #eric-yuan, #flagship-pioneering, #health-tech, #jeff-bezos, #moderna, #space, #tc, #tesla, #the-pill-club, #truepill, #uber, #zoom

Trial started for vaccine against one of the scariest coronavirus variants

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Researchers have given out the first jabs of a tweaked version of Moderna’s COVID-19 vaccine, one aimed at fighting one of the most concerning coronavirus variants—the B.1.351 variant, first identified in South Africa.

The jabs are part of an early trial of the tweaked vaccine, which is being run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The agency aims to enroll around 210 healthy adults in the trial by the end of April.

“The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States,” NIAID Director Anthony Fauci said in an announcement. “Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”

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#clinical-trial, #covid-19, #infectious-disease, #moderna, #nih, #public-health, #sars-cov-2, #science, #vaccine, #variant

Could Valo Health become one of Flagship Pioneering’s biggest companies yet?

The investment firm Flagship Pioneering has incubated a lot of life sciences companies since it was founded in 2000. In fact, while a general partner with Flagship Pioneering over the last 15 years, David Berry has started more than 30 companies, five of which trade publicly right now: Seres Therapeutics, Sensen Bio, Evelo Biosciences, T2 Biosystems, and Axcella Health.

Berry is often a company’s first CEO, then transitions out of the company within 18 months. But he has no plans to leave his post as CEO of Valo Health, a three-year-old, Boston-based, 110-person drug discovery company that Berry and Flagship seem to think could become one of the firm’s most important companies yet. That’s notable, considering that Flagship incubated 11-year-old Moderna, which currently boasts a $50 billion market cap thanks in large part its coronavirus vaccine.

Perhaps it’s no surprise, given Berry’s and Flagship’s track record that Valo has attracted believers. Notably, today it is announcing a fresh $110 million in extended Series B financing from Koch Disruptive Industries that brings the round total to $300 million and the overall amount the young company has raised to more than $450 million.

Still, given that there are hundreds of drug discovery companies in the world seizing on the latest advancements in AI, machine learning and computation, it’s easy to wonder what’s so special about this one. We got Berry’s take during a chat with him yesterday, parts of which we are featuring below edited for length and clarity.

TC: Valo is trying to accelerate the creation of drugs, and it has a computational platform called Opal to do it faster and more effectively than many rivals. Is there a way to make it clearer to outsiders why this platform is so unique? 

DB: First, from day one, we were operating on a different scale [than past Flagship Pioneering companies]. Typically, when you look at Flagship companies, there’s an [exclusive] initial commitment by Flagship of plus or minus $50 million. But because of the scale of the opportunity that we saw ahead of us with Valo, we actually started out by bringing in external financing partners as part of a Series A that was right around $100 million.

[Also unique is the] breadth of what we’re trying to achieve through our systematic approach to R&D, as opposed to a targeted approach to thinking about it. There’s been an historical challenge in life sciences in that companies are primarily viewed based on what their lead therapeutic asset looks like. But if you have the potential to change the scope, the scale, the potential, the speed, the probability of success, [and] the cost of developing drugs, you’re not going to look like a typical therapeutics company.

TC: So your focus on multiple therapeutic areas at once — oncology, neurodegenerative, and cardiovascular diseases — is a distinguishing element of the company. How are you tackling so much simultaneously?

DB: The legacy biopharma model is basically this point-to-point system [where up to 15 groups] do some work, and then they basically take the result of it and they throw it over a wall to another group that has its own framework. The model is intrinsically disintegrated. They use mice. They use cell lines. They use extracted organs. And those just don’t represent what a full, intact living human actually looks like, and they don’t reflect what the disease looks like in the context of that human.

What we’re doing is what I would call that next transformation . . enabled by high-quality human-centric data [that we analyze] in an end-to-end, but componentized manner. What I mean by that is we’ve created a single underlying architecture so that we’re using the same species, we’re using the same decision-making criteria. we’re using the same KPIs throughout the entirety of the R&D cascade, [and] we’re using the same bases of the core computation. We’re using the same self-reinforcing model to learn as we go. We have a local expression, because we have to perform a certain set of tasks in order to comply with the regulatory environment. But by doing it in this way as we do those tasks, we’re learning a lot more and we’re keeping that human centricity, so when we uncover for example, a new target in cardiovascular disease or neurodegenerative disease, it’s based on our human data. It’s not based on a dog model or mouse model or something along those lines. It’s not based on cells adapted to plastic in a lab.

TC: Where is that human data coming from? Is the data you’re feeing into Opal somehow better or different than what others are using?

DB: We haven’t we haven’t yet disclosed where our datasets are coming from, but we have reason to believe that the scale and quality of the data sets are substantially high. We have not seen data sets that compare in scope and size. We have announced one subset of our data lake, but I would call it a small subset through a data partnership we announced earlier. [Editor’s note: this is with a company called Global Genomics Group, which gives Valo access to a cardio-metabolic dataset.]

TC: You’ve been at this for a few years. Have you had any major breakthroughs?

DB: I believe what we’ve done over the last two years is build an incredibly strong technology basis and foundation [for] transformation. We’ve announced four therapeutic programs that we’ve launched thus far, and each represents not only something where we’ve been able to develop a therapeutic candidate in very short periods of time, but we’ve also been able to overcome issues that were historical barriers things that made developing those sorts of candidates much more difficult, and we were able to overcome those barriers in weeks.

TC: Can you elaborate on one of those therapies to underscore your point?

DB: One of the programs we announced is called NAMPT. What was really interesting about it is it’s a very powerful cancer target. The downside of it is it’s known to cause a very particular toxicological effect — it causes retinal toxicity — and what we wanted to figure out was whether we could get the benefit of the molecule by targeting the target but avoiding getting that molecule into the retina, which required a very specific design. Long story short, in a couple of weeks, we were able to achieve a molecule that had enough differentiation between the blood in the eye that it shouldn’t have any substantial effects.

TC: Are any of these four candidates heading into the market any time soon?

DB: I would love them to be in the market soon but they’re not yet there. We are expecting that with the financing in hand, we should ultimately have molecules in clinical trials, and ultimately we’re very excited to be able to transition some of the drugs that we’re developing into [viable offerings in the market].

TC: Would you sell then sell these to a big pharma company, or would Valo be marketing these itself?

DB: Both are viable potential paths. Because we’re developing a number of different therapeutics, it gives us flexibility in the way we think about our ultimate business model.

#biotech, #drug-discovery, #flagship-pioneering, #machine-learning, #medicine, #moderna, #recent-funding, #startups, #tc, #venture-capital

A 3rd shot? A new booster? Vaccine makers race to trials to beat variants

COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021.

Enlarge / COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021. (credit: Getty | NurPhoto)

With worrisome coronavirus variants seemingly emerging and spreading everywhere, lead vaccine makers are wasting no time in trying to get ahead of the growing threat.

This week, Moderna and partners Pfizer and BioNTech announced they have kicked off new vaccine clinical trials aimed at boosting the effectiveness of their authorized vaccines against new, concerning SARS-CoV-2 variants—primarily B.1.351, a variant first identified in South Africa.

In a set of studies published last week in the New England Journal of Medicine, both the Moderna mRNA vaccine and Pfizer/BioNTech mRNA vaccine spurred antibodies in vaccinated people that could neutralize the B.1.351 variant. But the levels of those neutralizing antibodies were significantly lower than what was seen against past versions of the virus. (Both vaccines performed well against the B.1.1.7 variant, first identified in the UK, which is expected to become the dominant strain in the US next month.)

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#biontech, #covid-19, #infectious-disease, #moderna, #mutation, #pandemic, #pfizer, #sars-cov-2, #science, #vaccine, #variant

Pfizer-BioNTech’s COVID-19 vaccine just got a lot easier to transport and distribute

The COVID-19 vaccine developed by Pfizer and BioNTech now has less stringent and extreme transportation requirements than it debuted with. Originally, the mRNA-based vaccine had to be maintained at ultra-low temperatures throughout the transportation chain in order to remain viable – between -76°F and -112°F. New stability data collected by Pfizer and BioNTech, which has been submitted to the U.S. Food and Drug Administration (FDA) for review, allow it to be stored at temps between 5°F and -13°F – ranges available in standard medical freezers found in most clinics and care facilities.

The vaccine should remain stable for up to two weeks at that temperature, which vastly improves the flexibility of its options for transportation, and last-mile storage in preparation for administration to patients. To date, the vaccine has relied largely on existing “cold-chain” infrastructure to be in place in order for it to be able to reach the areas where it’s being used to inoculate patients. That limitation hasn’t been in place for Moderna’s vaccine, which is stable at even higher, standard refrigerator temperatures for up to a month.

This development is just one example of how work continues on the vaccines that are already being deployed under emergency approvals by health regulators across the U.S. and elsewhere in the world. Pfizer and BioNTech say they’re working on bringing those storage temp requirements down even further, so they could potentially approach the standard set by the Moderna jab.

Taken together with another fresh development, study results from Israeli researchers that found just one shot of the ordinarily two-shot Pfizer-BioNTech vaccine could be as high as 85 percent effective on its own, this is a major development for global inoculation programs. The new requirements open up participation to a whole host of potential new players in supporting delivery and distribution – including ride-hailing and on-demand delivery players with large networks like Amazon, which has offered the President Biden’s administration its support, and Uber, which is already teamed up with Moderna on vaccine education programs.

This also opens the door for participation from a range of startups and smaller companies in both the logistics and the care delivery space that don’t have the scale or the specialized equipment to be able to offer extreme ‘cold-chain’ storage. Technical barriers have been a blocker for some who have been looking for ways to assist, but lacked the necessary hardware and expertise to do so effectively.

#amazon, #articles, #biden, #biontech, #biotech, #clinical-trials, #covid-19, #covid-19-vaccine, #health, #medical-research, #medicine, #moderna, #pfizer, #president, #tc, #uber, #united-states, #vaccine

Johnson & Johnson’s COVID-19 vaccine is 85% effective against severe cases, and 66% effective overall per trial data

Another COVID-19 vaccine is almost ready to begin being distributed – a single-shot inoculation made by Johnson & Johnson’s Janssen pharmaceutical subsidiary. The company just released an efficacy report based on data from its Phase 3 trial, which found that the new vaccine is 66% effective overall in preventing moderate to severe incarnations of COVID-19 in those who received the jab, and 85% effective in preventing sever disease.

Those numbers aren’t as impressive as the reported figures for the Moderna and Pfizer/BioNTech vaccines that are already being distributed via emergency FDA approval, both of which reported 90+% efficacy. But Johnson & Johnson’s vaccine is a single shot rather than a two-course treatment, which should make it much easier to distribute much more quickly. The vaccine also showed 100% efficacy in preventing hospitalization or death among participants in the trial, 28 days after vaccination, which is a key measure when considering the broader impact of COVID-19 on healthcare resources, and efficacy varied by region, with the jab proving 72% effective in the U.S. across moderate and severe cases vs. 66% globally.

It’s also important to note that Johnson & Johnson’s Phase 3 trial is happening amid the emergence of new strains of the virus, including much more contagious versions like the UK and South African variants. At the time that both Moderna and BioNTech released their trial data, these variants hadn’t yet emerged or been confirmed by pandemic researchers.

Johnson & Johnson’s vaccine uses a modified version of a common cold virus to deliver DNA that provides a person’s body with instructions on building a replica of the spike protein that SARS-CoV-2 uses to attach to cells. The modified adenovirus can’t replicate in human cells, however, meaning it won’t lead to illness – only an immune response that can later be employed to combat contracting the virus that leads to COVID-19. This adenovirus method is much more proven in terms of use in human patients vs. the mRNA method that the other vaccines currently in use employ.

All of which is to say, despite headline numbers that appear to fall short relative to the data we’ve seen from Moderna and Pfizer, this Johnson & Johnson report is actually very encouraging. The company says it expects to file a request for an Emergency Use Approval (EUA) from the FDA in February, which could see it begin to be distributed next month, adding yet another weapon in the arsenal to combat the global pandemic.

#articles, #biontech, #biotech, #clinical-trials, #disease, #fda, #health, #illness, #johnson-johnson, #medical-research, #medicine, #moderna, #pfizer, #tc, #united-kingdom, #united-states, #vaccination, #vaccine

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

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

“Shkreli Award” goes to Moderna for “blatantly greedy” COVID vaccine prices

COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left).

Enlarge / COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left). (credit: Drew Angerer / Florian Gaertner / Getty Images)

One of the leading developers of COVID-19 vaccines has now been placed in the ranks of people like Martin Shkreli—the disgraced pharmaceutical executive infamous for jacking up the price of an old, life-saving drug by more than 5,000 percent. He is now serving an 84-month prison sentence from a 2017 conviction on fraud counts unrelated to the drug pricing.

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. The awards, announced annually for four years now, go to “perpetrators of the ten most egregious examples of profiteering and dysfunction in health care.”

Award judges cited Moderna’s pricing of its COVID-19 vaccine, which was developed with $1 billion in federal funding. Still, despite the tax-payer backing, Moderna set the estimated prices for its vaccine significantly higher than other vaccine developers.

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#covid-19, #funding, #moderna, #science, #vaccine

Experts debate fiddling with vaccine doses as virus rages out of control

Vials of undiluted Pfizer COVID-19 vaccine are prepared to administer to staff and residents at the Goodwin House Bailey's Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020.

Enlarge / Vials of undiluted Pfizer COVID-19 vaccine are prepared to administer to staff and residents at the Goodwin House Bailey’s Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020. (credit: Getty | BRENDAN SMIALOWSKI )

With the pandemic continuing to surge to new heights, debate has erupted among experts about how to get the most protection as quickly as possible from the limited supply of COVID-19 vaccines currently available.

Suggestions floated so far include delaying the second of a two-dose regimen for maybe three to four months rather than doling them out in the planned three-to-four-week intervals evaluated in large clinical trials. With this change, more people can get a first dose now, offering ­some protection. Another possibility is simply cutting doses by half, which would immediately double the number of people who can be vaccinated now. And regulators in the United Kingdom have introduced the idea of mixing regimens—with some people getting their first dose of a vaccine by one manufacturer and then getting a second dose of vaccine from a different manufacturer based on availability at the time.

Evidence supporting these suggested tweaks in the vaccine rollout are shaky at best. But some experts argue that the dire state of the pandemic warrants a new, perhaps riskier approach.

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#astrazeneca, #covid-19, #fauci, #fda, #immunity, #moderna, #pfizer, #science, #vaccine

Second COVID vaccine approved for use in the US

Image of a syringe in front of a Moderna company logo.

Enlarge (credit: DeFodi Images )

Late Friday, the Food and Drug Administration issued an emergency authorization to a COVID-19 vaccine from a company called Moderna. The move follows an enthusiastic endorsement of the vaccine following an evaluation of clinical trial data by the FDA’s Vaccines and Related Biological Products Advisory Committee. Moderna already has millions of doses prepared, and the federal government has pre-issued a large order for more, which will enable more extensive vaccinations than would be possible previously, where the agency had only issued an authorization to the Pfizer/BioNTech vaccine.

The authorization was considered to be a matter of time following the release of safety and efficacy data from a large clinical trial that had enrolled over 30,000 people. Emergency Use Authorizations require that a product or treatment meet a number of criteria, including the declaration of a medical emergency, which was done earlier this year, and the lack of an FDA approved alternative. (FDA approval is distinct from an Emergency Use Authorization, so the authorization of the Pfizer/BioNTech vaccine isn’t a barrier to further authorizations.)

Beyond that, the product must be considered likely to be effective, and its potential benefits need to outweigh its potential risks. The votes from the members of the Vaccine Advisory Committee were unanimous that the benefits outweighed the risks, a conclusion that was well supported by the clinical trial data. That cleared the way for Friday’s Authorization, which took place on a similar schedule to the authorization of the Pfizer/BioNTech vaccine the week prior.

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

FDA authorizes Moderna’s COVID-19 vaccine for emergency use

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, as expected after an independent panel commissioned by the administration recommended its approval earlier this week. This is the second vaccine now authorized for use in the U.S. under EUA, after the Pfizer -BioNTech vaccine was approved last week.

Moderna’s vaccine could begin being administered to Americans by “Monday or Tuesday” next week, according to Dr. Anthony Fauci speaking to NBC’s Today show in a new interview. That’s in keeping with the timelines between the Pfizer EUA and the first patients actually receiving the vaccine last week.

Like Pfizer’s vaccine, Moderna’s is an mRNA therapy. That means that it contains no actual virus — just genetic instructions that tell a person’s body to create a specific protein. That protein is more or less identical to the one that SARS-CoV-2, the virus which causes COVID-19, uses to attach to a host’s cells and replicate. Moderna’s vaccine causes a person to create just the protein, which on its own is harmless, and then their natural defenses via their immune system react to that and develop a method for fighting it off. That defense system is “remembered” by the body, while the vaccine itself naturally dissolves after a brief time, leaving a person with immunity but nothing else.

The Oxford-AstraZeneca vaccine, which has yet to be approved for use in the U.S., uses a weakened and modified common cold virus that doesn’t spread in humans to create the spike protein in recipients, resulting in the body generating its own immune response. That’s a much more tried-and-tested method for creating a vaccine, but both Moderna and Pfizer’s mRNA therapies have shown to be very effective in preliminary data from their large Phase 3 clinical trials.

#astrazeneca, #biontech, #biotech, #health, #medical-research, #medicine, #moderna, #oxford, #pfizer, #science, #tc, #united-states, #vaccine

Finger-pointing abounds as states get fewer vaccines than planned

Fake highway sign showing the USS Enterprise hitting a speed bump

Enlarge / Operation Warp Speed hits a speed bump. (credit: Aurich Lawson / Getty Images)

As we’re waiting for word on the authorization of a second vaccine for use in the US, glitches have been striking the distribution of the first through the federal government’s “Operation Warp Speed.” This week, the US saw the first use of the vaccine developed by a Pfizer/BioNTech collaboration. But immediately afterward, many states started saying that orders for shipments in the ensuing weeks were being cut. After some in the federal government had indicated that the problem might be in production, Pfizer issued a statement indicating that it had doses in its warehouse ready to ship out but no indication of where to ship them to.

All in all, it’s about what you’d expect in the first weeks of a massive undertaking like this.

State of denial

One of the first states to report problems was Illinois, where its governor, J.B. Pritzker, said that it had indications it would only be receiving half the expected doses of the Pfizer/BioNTech vaccine next week. Since then, over a dozen states have indicated that they’ll be receiving fewer doses than planned in the second week (this article seems to have a fairly comprehensive list).

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#moderna, #operation-warp-speed, #pfizer, #policy, #science, #us-government, #vaccine

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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FDA releases data on Moderna’s COVID vaccine: It looks good

Image of a syringe in front of a Moderna company logo.

Enlarge (credit: DeFodi Images )

As the first doses of the Pfizer/BioNTech vaccine were administered yesterday, most of the US public began a potentially long waiting game, as the vaccine will be in short supply for many months and is being administered to healthcare workers and the elderly first. For most of the US, that means waiting until manufacturing can catch up with our needs.

One thing that could significantly speed vaccinations is the approval of additional vaccines, and here the news is also good: today, the Food and Drug Administration released detailed data on Moderna’s RNA-based vaccine, finding it well over 90 percent effective. These numbers make it highly likely that the FDA will issue an Emergency Use Authorization when it considers the issue on Thursday.

Looking good

The previous data on the vaccine’s efficacy had been delivered by press release in mid-November. The FDA’s documentation is, as you’d expect, far more detailed. We’ll provide a summary of it here and will update the story as we get a chance to look through all 54 pages the FDA has released.

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FDA grants emergency use authorization for Pfizer’s COVID-19 vaccine, distribution to begin within days

The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the COVID-19 vaccine developed by Pfizer and its partner BioNTech, the New York Times first reported on Friday night, and later supported by The Wall Street Journal. This EUA follows a recommendation by an independent panel of experts commissioned by the FDA to review Pfizer’s application and provide a recommendation, which the panel unanimously supported earlier this week.

Following this authorization, shipment of the vaccine are expected to begin immediately, with 2.9 million doses in the initial shipment order. Patients in the category of highly vulnerable individuals, which include healthcare workers and senior citizens in long-term care facilities, are expected to begin receiving doses within just a few days not was the EUA is granted.

This approval isn’t a full certification by the U.S. therapeutics regulator, but it is an emergency measure that still requires a comprehensive review of the available information supplied by Pfizer based on its Phase 3 clinical trial, which covered a group of 44,000 volunteer participants. Pfizer found that its vaccine, which is an mRNA-based treatment, was 95% effective in its final analysis of the data resulting form the trial to date – and also found that safety data indicated no significant safety issues in patients who received the vaccine.

On top of the initial 2.9 million dose order, the U.S. intends to distribute around 25 million doses by the end of 2020, which could result in far fewer people actually vaccinated since the Pfizer course requires two innoculations for maximum efficacy. Most American shouldn’t expect the vaccine to be available until at least late Q1 or Q2 2021, given the pace of Pfizer’s production and the U.S. order volume.

Still, this is a promising first step, and a monumental achievement in terms of vaccine development turnaround time, since it’s been roughly eight months since work began on the Pfizer vaccine candidate. Moderna has also submitted an EUA for its vaccine candidate, which is also an mRNA treatment (which provides instructions to a person’s cells to produce effective countermeasures to the virus). That could follow shortly, meaning two vaccines might be available under EUA within the U.S. before the end of the year.

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Trump to hold “Vaccine Summit” today—no vaccine-makers agreed to come

US President Donald Trump in the Oval Office of the White House in Washington, DC on December 7, 2020.

Enlarge / US President Donald Trump in the Oval Office of the White House in Washington, DC on December 7, 2020. (credit: Getty | Saul Loeb)

The Trump administration will host a “Vaccine Summit” today at the White House. But notably absent from the vaccine-centered event will be any companies that actually make vaccines—including the companies leading the race for a COVID-19 vaccine, Moderna, Pfizer, and Pfizer’s partner BioNTech.

The companies reportedly declined to attend or withdrew, which is seen as a snub to lame-duck President Trump. Senior officials for the Trump administration, meanwhile, said the administration decided to go “in a different direction.”

The Trump administration has pitched the unusual event as a way to educate the public about vaccine development, regulatory approval, and distribution processes and to congratulate the many players helping to develop COVID-19 vaccine candidates. The event includes a “fire-side chat” with top vaccine regulator Peter Marks from the Food and Drug Administration. There will also be talks with representatives from FedEx, UPS, McKesson, CVS, and Walgreens, who will all help get any FDA-approved vaccines to people’s arms.

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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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