Efficacy of Chinese vaccines is “not high”—officials back 3rd dose

A vial and boxes of the Sinopharm Group Co Ltd. Covid-19 vaccine.

Enlarge / A vial and boxes of the Sinopharm Group Co Ltd. Covid-19 vaccine. (credit: Getty | Bloomberg)

Officials in Beijing are reportedly planning to roll out third doses of China’s COVID-19 vaccines. These shots have long been dogged by doubts of their efficacy.

According to a report by The Washington Post, health experts in China say that protection from the vaccines may not last after six months and that people who are at high risk of COVID-19 should get a third dose. Now, state-run media outlets suggest Beijing is on board with the suggestion and is preparing to offer the third doses.

Last week, both the United Arab Emirates and Bahrain said they would offer third doses of China’s Sinopharm vaccine to try to boost protection. UAE is offering the extra shots to anyone who was vaccinated six or more months ago. Bahrain is offering third doses to high-risk groups.

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#boosters, #china, #coronavirus, #covid-19, #inactivated-virus-vaccine, #public-health, #sars-cov-2, #science, #sinopharm, #sinovac, #vaccine, #vaccine-efficacy

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Researchers show neutralizing antibodies correlate with COVID protection

Cartoon of a virus surrounded by small, Y-shaped molecules.

Enlarge / Illustration of antibodies (red and blue) responding to an infection with the new coronavirus SARS-CoV-2 (purple). (credit: Getty Images)

From the start of the COVID-19 pandemic, many of researchers’ nagging questions involved trying to understand what constitutes immunity to future infections. People who had been infected by the virus produced varying amounts of antibodies, and it wasn’t clear what levels were needed to provide protection. Similar issues applied to figuring out how long protection lasted, given that antibody levels appeared to decline over time. Those questions have implications for whether we will eventually need booster shots to maintain our immunity.

The most common way of looking at immunity at the beginning of the pandemic was to check for neutralizing antibodies, which could block the virus’s ability to infect new cells. But we’ve gone through much of the pandemic without knowing exactly how levels of these antibodies relate to protection.

Evidence has been building that neutralizing antibodies directly correlate with protection, and a new paper provides some of the most decisive evidence yet. The authors also provide some hints about the sort of decline in immunity we might expect.

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#antibodies, #biology, #covid-19, #immunology, #medicine, #pandemic, #sars-cov-2, #science

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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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In evolving to infect mink, SARS-CoV-2’s risk for humans changes

Computer generated graphical representation of the coronavirus.

Enlarge / The coronavirus spike protein that mediates coronavirus entry into host cell. (credit: Design Cells / Getty Images)

We’ve always needed to limit the total SARS-CoV-2 infections for reasons beyond the immediate risk they pose to the infected. Each new infected individual is a chance for the virus to evolve in a way that makes it more dangerous—more infective or more lethal. This is true even when an individual has a completely symptom-free infection. The more the virus replicates, the more mutations it will experience and the greater chance that something threatening will evolve.

One of the disturbing discoveries of the past year has been that it’s not just the human population we have to worry about. SARS-CoV-2 has been found in a number of species, notably cats and mink, that we spend a lot of time around. It has even spread from there to the wild mink population, and the virus has jumped back and forth between humans and farmed mink. These animal reservoirs provide added opportunities for COVID to evolve in ways that make it more dangerous to us—perhaps via mutations that allow it to adapt to the new species.

A group of German researchers has now tested some of the mutations that have appeared in viruses circulating in mink populations, and the news is mixed. One specific mutation makes the virus somewhat less infectious to humans but reduces the probability that antibodies raised against the virus will recognize it.

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#biology, #covid-19, #sars-cov-2, #science, #virology, #zoonotic

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More J&J troubles: Vaccine manufacturing halted and more possible clot cases

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)

The US Food and Drug Administration last week asked Emergent BioSolutions to stop making Johnson & Johnson’s COVID-19 vaccine at its troubled facility in Baltimore, according to a regulatory filing Emergent released Monday.

The FDA had begun an inspection of the contract manufacturer’s facility on April 12 but requested on April 16 that production be halted “pending completion of the inspection and remediation of any resulting findings,” the filing reads. Any vaccine materials already made at the plant will be held in quarantine.

The production halt follows news last month that a mishap at the plant led to the ruin of 15 million doses of Johnson & Johnson’s one-shot COVID-19 vaccine. The ruined doses had reportedly been contaminated with ingredients from AstraZeneca’s COVID-19 vaccine, which was also being manufactured at the plant at the time.

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SARS-CoV-2 variant found in Brazil: More infectious, may limit immunity

Aerial view of a large section of a cemetery.

Enlarge / COVID-19 has taken a terrible toll on Brazil. (credit: Michael Dantas / Getty Images)

Almost from the moment it made the jump to humans, the SARS-CoV-2 virus has been picking up mutations and creating new lineages as it expands into different populations. In practical terms, the vast majority of these mutations makes absolutely no difference; the resulting virus has the same properties as the unmutated form it’s derived from.

But there have been a number of cases where variants surge in frequency. Early on in the pandemic, this was often the product of the variant moving into a previously unexposed population—a matter of chance rather than a feature of the virus. Separating out these cases from instances where mutations make the virus more dangerous is a serious challenge. But this week, an international team of researchers has published evidence showing that a variant first characterized in Brazil is likely to represent a significant additional threat.

There’s a lot of uncertainty about the details, but the virus appears to be more infectious and more likely to infect those who have immunity to other viral strains, and it might even be more lethal. And, as of when the paper was written, the lineage had been detected in over 35 countries.

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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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Variant hunters race to find new strains where variant testing lags

Variant hunters race to find new strains where variant testing lags

Enlarge (credit: Marina Dekhnik | Getty Images)

In mid-February, three travelers were stopped at the airport in Luanda, Angola. Even during the pandemic, the country, a hub for the oil industry, had seen plenty of passengers from Europe and South Africa, where two concerning variants of the virus that causes Covid-19 hold sway. But the strains weren’t yet circulating widely in Angola, so this winter, health officials battened down the hatches. Before any passports get stamped, travelers receive a rapid antigen test and wait 30 minutes for a result. A negative test means self-quarantine, followed by another test a few days later. A positive test means a two-week stay at a quarantine hotel. For the three travelers, it was option two.

A few weeks later, samples taken from their noses arrived 2,000 miles south in South Africa, at the lab of Tulio de Oliveira, a geneticist at the University of KwaZulu-Natal. He was in for a surprise. The virus that had infected these three travelers didn’t resemble the strains circulating in most other places, including those labeled as “variants of concern” for their ability to spread faster and evade certain types of immunity. If those variants are like siblings, this one was more like a forgotten second cousin. It came from a lineage of the virus that emerged in the early days of the pandemic but had disappeared soon thereafter, apparently outcompeted by other variants. And yet here it was, a year later. And it had been busy. The virus had since accumulated dozens of mutations, including many of the same ones that made those other strains worrisome because of increased transmissibility and immune evasion. It had arrived at a similar genetic conclusion all on its own.

A scarcity of data

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US COVID cases “disturbingly high” as Michigan sees dire spike

An A frame sign tells diners in a downtown patio how to behave.

Enlarge / A sign requiring protective face masks in Detroit, Michigan, on Sunday, March 21, 2021. (credit: Getty | Bloomberg)

Even as the pace of vaccination in the US nears a heartening 3 million per day, the country hovers on the brink of a fourth surge, with current cases lingering at a “disturbingly high level,” according to top infectious disease expert Anthony Fauci.

The current seven-day average of new daily cases is now over 63,000—levels seen at the base of the record winter surge. “When you’re at that level, there is the risk of getting a surge back up,” Fauci said in an interview with CNN.

Adding to the precarious situation is the highly transmissible B.1.1.7 coronavirus variant, first identified in the UK. It is now the predominant strain of SARS-CoV-2 in the US, Rochelle Walensky (director of the Centers for Disease Control and Prevention) said in a White House Press Briefing Wednesday.

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Coronavirus variant that spreads easily doesn’t do so by surviving in air better

People practice social distancing in white circles in Domino Park in Williamsburg during the coronavirus pandemic on May 17, 2020, in New York City.

Enlarge / People practice social distancing in white circles in Domino Park in Williamsburg during the coronavirus pandemic on May 17, 2020, in New York City. (credit: Getty | Noam Galai)

The B.1.1.7 coronavirus variant is estimated to spread about 50 percent more than previous versions—but it doesn’t seem to manage that higher transmissibility by surviving in the air better than other versions of the virus, according to a new study.

In lab experiments looking at virus survival in artificially produced aerosolized particles, a B.1.1.7 lineage virus had about the same survival rate as a strain of the virus that was circulating in Wuhan, China in January 2020, according to the study, which published recently in The Journal of Infectious Diseases.

For the study, government researchers created aerosolized particles that mimic those spewed from deep in a person’s lungs, then tested how well the viruses survived in those particles under different temperature, humidity, and light conditions.

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Real-world data shows vaccines kicking butt—including against scary variant

A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021.

Enlarge / A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021. (credit: Getty | Bloomberg)

In a small trial, the Pfizer/BioNtech vaccine fully protected people from symptomatic COVID-19 caused by the worrisome B.1.351 coronavirus variant widely circulating in South Africa, the companies announced in a press release.

Though researchers will need more data to confirm the result, it is just the latest bit of positive news to come out this week about how the vaccines are performing with real-world conditions and in real-world settings.

On Monday, the Centers for Disease Control and Prevention released real-world data showing that the Pfizer/BioNTech mRNA vaccine and Moderna mRNA vaccine were, collectively, 90 percent effective at preventing infections in fully vaccinated health care, frontline, and essential workers.

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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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“Are schools safe?” is the wrong question to be asking

Image of mask-wearing students in a classroom.

Enlarge (credit: MediaNews Group/Reading Eagle via Getty Images )

Is it safe to open schools? From the moment it became clear that the COVID-19 pandemic had set up shop in the US, answers to that question have been scrutinized, analyzed, and even politicized. Lost in all of this is the realization that it’s a terrible question—because there’s no single answer to it.

Instead, any answer to that question only applies to individual communities and, in many cases, individual schools. It’s also subject to change with the evolving dynamics of the pandemic, including the appearance of new variants. Fortunately, a detailed understanding of why the question is bad can help people understand which questions they should be asking instead.

Schools are part of a community

A couple things that are relevant to school safety have become clear over the course of the pandemic. One is that school-aged children are the least likely to be hospitalized or die of any age group tracked by the Centers for Disease Control and Prevention. Out of the over half-million COVID-19 deaths in the US, only a few hundred have been kids under the age of 17. In addition, in a few cases where new infections were tracked in detail, schools that adopted adequate safety measures saw lower infection rates than the surrounding community.

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#cdc, #covid-19, #health, #medicine, #pandemic, #sars-cov-2, #schools, #science

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Former Trump advisor joins company that makes hazardous air cleaners

An older man in a business suit listens to a woman in a business suit.

Enlarge / US President Donald Trump, right, listens to Deborah Birx, coronavirus response coordinator, as she speaks during a news conference in the White House in Washington, DC, on Thursday, April 23, 2020. (credit: Getty | Bloomberg)

One of the most indelible moments of Deborah Birx’s controversial time as White House coronavirus response coordinator for the Trump administration came on April 23, 2020. That’s when she sat quietly to the side of the former president while he recklessly suggested that people could rid themselves of the pandemic virus by taking in or injecting themselves with hazardous disinfectants.

Since leaving the administration, Birx has spoken about how “extraordinarily uncomfortable” she was in the moment, telling ABC News recently: “I still think about it every day.”

But, at the same time she was expressing that regret, Birx was also in the process of joining ActivePure—an air-cleaning company that makes products that could lead to people inhaling hazardous disinfectants or byproducts, all in the name of getting rid of the pandemic coronavirus.

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Under pressure, CDC drops school spacing to 3 ft in many classrooms

Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), adjusts her protective mask during a Senate Health, Education, Labor, and Pensions Committee hearing in Washington, DC. Susan Walsh/AP/Bloomberg via Getty Images

Enlarge / Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), adjusts her protective mask during a Senate Health, Education, Labor, and Pensions Committee hearing in Washington, DC. Susan Walsh/AP/Bloomberg via Getty Images (credit: Getty | Bloomberg)

With universal masking, just 3 feet of distancing is safe for students in many classrooms, the Centers for Disease Control and Prevention announced in updated guidance released on Friday.

According to the new recommendations, elementary schools with universal masking policies are advised to maintain at least 3 feet of distancing between students in classrooms, regardless of the current level of community transmission of SARS-CoV-2.

Middle and high schools with universal masking are also advised to maintain at least 3 feet of distancing between students in classrooms if community transmission is currently low, moderate, or substantial. If the community transmission is high and student cohorting/podding is not possible, then distancing of at least 6 feet should be maintained in middle and high school classrooms.

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Study finds 3-ft distancing in schools is enough—but debate is far from over

Spring Township, PA - August 21: A first grade classroom where the desks are spaced out for social distancing.

Enlarge / Spring Township, PA – August 21: A first grade classroom where the desks are spaced out for social distancing. (credit: Getty | Ben Hasty)

The most sensitive and heated topic of the entire pandemic is—without a doubt—the welfare of our children. How can we best protect them from this devastating virus? What role do they play in spreading it? How can we even come close to meeting all their health, developmental, educational, and social needs as we try to navigate our topsy-turvy reality?

The path to daycare and school might as well be rerouted through a minefield. And the hazards don’t end when you reach the front doors. This nightmare has only been exacerbated by media reports of single studies that yanked parents, educators, and caretakers from one extreme to the other: Don’t worry, children are completely unaffected by the virus and don’t spread it! No, wait, they’re actually superspreaders, who can develop a deadly multisystem inflammatory syndrome!

More than a year into the pandemic, it’s very clear that the inflammatory syndrome (MIS-C) is rare. And although children can certainly catch and spread the virus, mounting studies continue to find that children generally have less severe disease than adults. Also, a consensus has emerged that schools do not tend to be hotbeds of virus transmission. While having schools open has been linked to higher community spread, studies have found basic precautions can be effective at limiting spread within schools.

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The moments we realized the pandemic would change everything

The moments we realized the pandemic would change everything

Enlarge

We’re roughly at the one-year point of the global COVID-2 pandemic—Ars’ initial explainer on the virus first published on March 8, the World Health Organization declared a pandemic on March 11, and the US declared a national emergency on March 13. As we all grapple with the realization 12 months have passed, various anniversaries are being marked. There are lots of major mileposts to mark; moments that made the severity and global scale of the pandemic clear, or were the first signs of the new reality of social isolation, remote schooling, and offices created out of any available spare space.

For many of us at Ars, the big mileposts were abstract—things that happened to other people or society as a whole as we continued to work from home. But as we talked about the experience of last March, each of us seemed to come up with a different moment when the severity of the pandemic really clicked.

What follows is a collection of the experiences that drove home the severity of COVID-19 to each of us—the moments we knew things weren’t going to be the same. Feel free to add your own in the comments.

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COVID-19 could become a persistent, seasonal plague, experts warn

Empty vials of the Pfizer COVID-19 vaccine are seen at a first-come, first-serve drive-thru vaccination site operated by the Lake County Health Department on January 28, 2021 in Groveland, Florida. Seniors 65 and older waited in line for hours to be vaccinated.

Enlarge / Empty vials of the Pfizer COVID-19 vaccine are seen at a first-come, first-serve drive-thru vaccination site operated by the Lake County Health Department on January 28, 2021 in Groveland, Florida. Seniors 65 and older waited in line for hours to be vaccinated. (credit: Getty | NurPhoto)

Some experts speculate that the pandemic coronavirus will one day cause nothing more than a common cold, mostly in children, where it will be an indistinguishable drip in the steady stream of snotty kid germs. Such is the reality for four other coronaviruses that have long stalked school yards and commonly circulate among us every cold and flu season, to little noticeable effect.

But that sanguine—if not slightly slimier—future is shaky. And the road to get there will almost certainly be rocky. For the pandemic coronavirus to turn from terror to trifle, we have to build up high levels of immunity against it. At the population level, this will be difficult—even with vaccines. And with the uncertainty of how we’ll pull it off, some experts are cautioning that we should prepare for the possibility that the pandemic coronavirus, SARS-CoV-2, will stick with us for the near future, possibly becoming a seasonal surge during the winter months when we’re largely indoors.

“The prospect of persistent and seasonal COVID-19 is real,” write public health expert Christopher Murray of the University of Washington and infectious disease expert Peter Piot of the London School of Hygiene and Tropical Medicine. In a recent commentary in the Journal of the American Medical Association, the two warn that if that happens, it “could require both health system change and profound cultural adjustment for the life of high-risk individuals in the winter months. There is an urgent need to prepare for such a scenario.”

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Under intense pressure, WHO skips summary report on coronavirus origin

Liang Wannian (2nd L) and Peter Ben Embarek (3rd R) both members of the WHO-China joint study team, shake hands after the WHO-China joint study press conference in Wuhan, central China's Hubei Province, on Feb. 9, 2021.

Enlarge / Liang Wannian (2nd L) and Peter Ben Embarek (3rd R) both members of the WHO-China joint study team, shake hands after the WHO-China joint study press conference in Wuhan, central China’s Hubei Province, on Feb. 9, 2021. (credit: Getty | Xinhua News Agency )

Facing intense international pressure and criticism, the World Health Organization has abandoned plans to release a summary report of its investigation into the possible origin of the pandemic coronavirus, SARS-CoV-2.

Instead, the health agency of the United Nations is skipping the summary report and plans to release a full report the week of March 15. The WHO had previously said it would release a summary report in mid-February.

“By definition, a summary report does not have all the details,” Dr. Ben Embarek, a WHO expert who led the investigation, told The Wall Street Journal. “So since there [is] so much interest in this report, a summary only would not satisfy the curiosity of the readers.”

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#coronavirus, #epidemiology, #infectious-disease, #origin, #outbreak, #pandemic, #sars-cov-2, #science, #who

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B.1.1.7 variant now 10% of US cases—and cases are once again ticking up

President Joe Biden, first lady Jill Biden, Vice President Kamala Harris, and second gentleman Doug Emhoff participate in a moment of silence and candle light ceremony at sundown with 500 candles for the 500,000 dead from the COVID-19 pandemic, at the South Portico at the White House on Monday, Feb. 22, 2021 in Washington, DC.

Enlarge / President Joe Biden, first lady Jill Biden, Vice President Kamala Harris, and second gentleman Doug Emhoff participate in a moment of silence and candle light ceremony at sundown with 500 candles for the 500,000 dead from the COVID-19 pandemic, at the South Portico at the White House on Monday, Feb. 22, 2021 in Washington, DC. (credit: Getty | The Washington Post)

After weeks of dramatic decline, COVID-19 cases in the US have hit a plateau—and in some places are ticking up. Officials are sounding the alarm in hopes of averting a fourth surge in the devastating pandemic.

“We at CDC consider this a very concerning shift in the trajectory,” Rochelle Walensky, director of the Centers for Disease Control and Prevention, said in a press briefing last week. Though cases are down from their astronomical peak in early to mid January, the overall numbers are still quite high, matching averages seen in late October, at the base of the holiday surge.

“Things are tenuous,” she noted. “Now is not the time to relax restrictions.”

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We’ll likely have a 3rd COVID vaccine soon; J&J vaccine clears last hurdle

A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California.

Enlarge / A sign at the Johnson & Johnson campus on August 26, 2019 in Irvine, California. (credit: Getty | Mario Tama)

After a day-long meeting Friday, an advisory panel for the US Food and Drug Administration voted 22 to 0 to recommend issuing an Emergency Use Authorization for Johnson & Johnson’s single-shot, refrigerator-stable COVID-19 vaccine.

If the FDA accepts the panel’s recommendation and grants the EUA—which it likely will—the country will have a third COVID-19 vaccine authorized for use. Earlier this week, FDA scientists released their review of the vaccine, endorsing authorization.

Agency watchers expect the FDA to move quickly on the decision, possibly granting the EUA as early as tomorrow, February 27. The FDA moved that fast in granting EUAs for the two previously authorized vaccines, the Moderna and Pfizer/BioNTech mRNA vaccines.

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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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Garden-variety germs may explode in COVID’s wake, study suggests

Masked girls in matching uniforms wait for school to begin.

Enlarge / Young children go back to kindergarten following COVID-19 lockdown. (credit: Getty | TPG)

In our cushy COVID bubbles, our immune systems may be getting soft.

Physical distancing, lockdowns, masking, and spirited sanitizing all mean we are coming into contact with fewer garden-variety germs than normal. This year’s flu season was basically cancelled.

While that may seem like a welcome reprieve from seasonal ailments and pesky sniffles, experts fear that our immune systems may be losing their defensive edge in the lull. And with the usual microscopic suspects lying in wait for our return to some sense of normalcy, it could mean that nasty bursts of common colds and flu-like illnesses are in our post-COVID futures—ones that may not be avoidable even if we carry on with some of our COVID precautions.

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#common-cold, #immunity, #infectious-disease, #influenza, #pandemic, #rhinovirus, #sars-cov-2, #school-children, #science

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CDC releases updated “science based” school guidelines

Image of a woman wearing a face mask.

Enlarge / Rochelle Walensky during the announcement of her nomination to head the CDC. (credit: Jim Watson, Getty Images)

As the US approached the start of the school year in 2020, the guidance it received from the federal government was a mess. The Centers for Disease Control (CDC) issued a series of documents in late July that was a mix of evidence-based risk analysis and full-throated endorsement of having children back in school, with no consideration of risk at all.

Now, with a new administration in charge and promoting evidence-based policymaking, the CDC has revisited its advice on pandemic safety in schools. The result is a set of documents that are far more coherent in their approach to managing risk. Several documents all promote a single approach to keeping schools open, focused on mask use and distancing, and back that up with an analysis of the latest research on the pandemic’s spread in children. And, in introducing them, CDC Director Rochelle Walensky announced “I can assure you this is free from political meddling.”

Science-focused

In a press conference announcing the release of the new documents, the count of Walensky’s use of the term “science based” probably reached double digits. Backing that up is one of the three documents released by the CDC on Friday, which focuses entirely on the evidence that was used to formulate the new guidelines. The document makes clear that a lot of the information we now have has come from analyses of what happened after schools were reopened in the autumn, both in the US and overseas. This makes it clear that, even if it weren’t for the change in administration, we were due to revisit our thinking about school safety.

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China refused to hand over key data to WHO team probing pandemic’s origin

Liang Wannian (2nd L) and Peter Ben Embarek (3rd R) both members of the WHO-China joint study team, shake hands after the WHO-China joint study press conference in Wuhan, central China's Hubei Province, Feb. 9, 2021.

Enlarge / Liang Wannian (2nd L) and Peter Ben Embarek (3rd R) both members of the WHO-China joint study team, shake hands after the WHO-China joint study press conference in Wuhan, central China’s Hubei Province, Feb. 9, 2021. (credit: Getty | Xinhua News Agency )

The Chinese government failed to share key data on early COVID-19 cases with a team of international scientists investigating how the pandemic began.

The researchers had requested raw data on 174 of the very first COVID-19 cases identified in Wuhan, China during December 2019, as well as other cases. But the team—assembled by the World Health Organization—was only given a summary of those early cases, according to multiple media reports.

Having such detailed patient data from the start of an outbreak is “standard practice for an outbreak investigation,” Dominic Dwyer, an Australian infectious diseases expert and WHO team member, told Reuters in an interview Saturday. Dwyer emphasized that data on those 174 cases is particularly key because only half of them were connected to the Huanan seafood market, which was initially thought to be the source of the outbreak.

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#china, #coronavirus, #outbreak, #pandemic, #sars-cov-2, #science, #who, #wuhan

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Past coronavirus infections don’t seem to help with SARS-CoV-2

Image of small blue spheres above a larger yellow surface.

Enlarge / False color image of viruses attached to a cell’s surface. (credit: NIAID)

While the SARS-CoV-2 virus is new to humans, coronaviruses in general aren’t. There have been earlier members of this group of viruses that have raised pandemic fears, while another group regularly circulates widely in humans, causing symptoms of the common cold.

Early on, there were some indications that prior exposure to cold-causing viruses could produce a degree of protection against COVID-19. But back in December, researchers published results indicating that any cross-reactivity against related viruses by T cells was likely to be ineffective. Now, additional results have been published that indicate antibodies raised against cold viruses fail to neutralize SARS-CoV-2.

Memories

The SARS-CoV-2 virus has a number of features that distinguish it from other coronaviruses that have circulated within humans. But it also has plenty of things in common, like its use of RNA as a genetic material and the general layout of its genome. Some of its genes have also picked up very few changes over the course of evolution. As a result, there are some stretches of genes that are identical in cold viruses and SARS-CoV-2.

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New details emerge of how pandemic began: WHO team still eyes animal source

Peter Ben Embarek (R) talks with Liang Wannian (L) during a press conference following a visit by the international team of experts from the World Health Organization (WHO) in the city of Wuhan, in China's Hubei province on February 9, 2021.

Enlarge / Peter Ben Embarek (R) talks with Liang Wannian (L) during a press conference following a visit by the international team of experts from the World Health Organization (WHO) in the city of Wuhan, in China’s Hubei province on February 9, 2021. (credit: Getty | Hector Retamal)

After 12 days of field work in Wuhan, China, an international team of scientists assembled by the World Health Organization have wrapped up its investigation into the origins of the SARS-CoV-2 virus that mushroomed out of the city in December of 2019.

The team’s findings support researchers’ previous leading hypothesis of how the pandemic began—that the virus used a still-elusive intermediate animal host as a bridge to infect humans from a distant reservoir host, such as horseshoe bats. But the team did fill in new, intriguing details of the pandemic’s first, crucial month—and ruled out sensational theories that the pandemic was born from a laboratory incident.

“Our initial findings suggest that the introduction [to humans] through an intermediary host species is the most likely pathway,” Peter Ben Embarek, WHO International Team Lead, said in a 3-hour press conference on the team’s findings, livestreamed from Wuhan on February 9. Though researchers in China have already surveyed 11,000 animals around the country in search of that host, all have tested negative for SARS-CoV-2 so far, the team noted. Identifying the intermediary host “will require more studies and more specific, targeted research,” Embarek added.

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Tweaking COVID vaccines to fight variants won’t require big trials, FDA says

Tweaking COVID vaccines to fight variants won’t require big trials, FDA says

Enlarge (credit: Getty | Congressional Quarterly)

With concerning coronavirus variants erupting around the world, the US Food and Drug Administration is ironing out how to rapidly review vaccine tweaks that better protect against the mutants—and the regulatory agency is turning to its experience with annual flu shots to do so.

In a statement late Thursday, the regulatory agency said it is actively hashing out what kind of “streamlined” clinical data makers of authorized COVID-19 vaccines could submit. The agency expects to have a draft of its guidance in the next few weeks.

The announcement suggests that makers of authorized vaccines will not be required to submit reams of data from large, months-long clinical trials, as they did for their initial authorizations. Still, data on any altered vaccine—however pared down—would still have to be enough to convince FDA scientists that a next-generation shot is safe and effective against variants. Vaccine alterations may include changes to the initial vaccine design or additions of new vaccine components, the FDA said.

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Signs that SARS-CoV-2 is evolving to avoid immune responses

Ribbon diagram of the structure of the coronavirus spike protein.

Enlarge / The structure of the SARS-CoV-2 spike protein. (credit: University of Arkansas)

Over the summer, you could almost hear a sigh of relief rising from the portion of the research community that was tracking the evolution of the SARS-CoV-2 virus. Viruses, especially those new to their hosts, often pick up mutations that help them adapt to their new habitat, or they evade drugs or immune attacks. But SARS-CoV-2 seemed to be picking up mutations at a relatively sedate pace, in part because its virus-copying enzymes had a feature that lets them correct some errors.

But suddenly, new variants appear to be everywhere, and a number of them appear to increase the threat posed by the virus. A new study helps explain the apparent difference: while new base changes in the virus’ genetic material remain rare, some deletions of several bases appear to have evolved multiple times, indicating that evolution was selecting for them. The research team behind this new work found evidence that these changes alter how the immune system can respond to the virus.

This looks familiar

The researchers’ interest in deletions started with their involvement with an immunocompromised cancer patient, who held off the infection for over two months without being able to clear the virus. Samples obtained from late in the infection revealed two different virus strains that each had a deletion in the gene encoding the spike protein that SARS-CoV-2 uses to attach to and enter cells.

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#antibodies, #biology, #covid-19, #immunology, #medicine, #sars-cov-2, #science, #vaccine, #virology

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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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GSK eyes next-gen COVID vaccine as it inks deal to help boost current supply

A needle is inserted into a vial held by a gloved hand.

Enlarge / A vaccine syringe and vial in front of the GSK (GlaxoSmithKline) logo. (credit: Getty | Anadolu Agency)

After its own COVID-19 vaccine setback, GlaxoSmithKline has inked a $180 million deal to help German biotech company CureVac manufacture 100 million doses of its mRNA vaccine, which is currently under development. The deal also lays the groundwork for the two to cook up a next-generation vaccine that would protect against several concerning coronavirus variants at the same time.

The partnership is the latest example of a pharmaceutical giant teaming up with a peer—in some cases a rival—to help address the global shortage of desperately needed COVID-19 vaccines.

On January 27, Sanofi—one of the world’s leading vaccine makers—announced that it would use its manufacturing prowess to produce the vaccine developed by rivals Pfizer and BioNTech, which has already been authorized for use in the US and the EU. Sanofi will begin producing over 125 million doses of the Pfizer/BioNTech vaccine from its plant in Frankfurt, Germany, later this year.

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#covid-19, #gsk, #novartis, #pfizer, #sanofi, #sars-cov-2, #science, #vaccine

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New COVID cases dropping, but worrying signs on the horizon

Image of an orange dirt lot with a tractor digging near the edge of a grid of individual coffins.

Enlarge / Aerial view showing a tractor digging graves in a new area of the Nossa Senhora Aparecida, where COVID-19 victims are buried, in Manaus, Brazil. (credit: Marcio James / Getty Images)

While attention has been focused on the worrying new variants of SARS-CoV-2, there has been some good news: despite the evolution of a number of strains that appear to spread more readily, total COVID-19 cases have been dropping, both in the United States and globally. While there are a number of nations that are still seeing an increase in infections, a combination of reduced post-holiday spread and increased social interventions appear to be getting the surges seen in January under control.

That said, there are worrying signs that, at least in the US, a number of states are making the same mistakes that ensured that the virus never really went away after the first surge in cases. And the spread of many new variants drives home the need to avoid complacency.

Going down

The general fall in cases came up at a recent press briefing from the World Health Organization. “For the third week in a row, the number of new cases of COVID-19 reported globally fell last week,” said WHO Director-General Tedros Adhanom Ghebreyesus. “There are still many countries with increasing numbers of cases, but at the global level, this is encouraging news.”

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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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Media frenzy, skepticism engulf virus origin probe—and WHO is over it

A frustrated man speaks in front of World Health Organization logo.

Enlarge / World Health Organization (WHO) Health Emergencies Programme Director Michael Ryan talks during a daily press briefing on COVID-19 virus at the WHO headquaters in Geneva on March 11, 2020. (credit: Getty | Fabrice Coffrini)

An international team of scientific experts is on the ground in Wuhan, China, finally making progress in its long-sought attempt to understand how the pandemic coronavirus first jumped from animals to humans. But the tedious scientific investigation has become a media frenzy there, and it continues to be plagued by conspiracy theories and thorny international politics.

On Monday, a top official with the World Health Organization had clearly had enough, scolding skeptics and essentially telling conspiracy theorists to show hard evidence or be quiet.

Members of the 15-person team arrived in Wuhan last month and finished their mandatory two-week quarantine last Thursday. Since then, they have made several trips around Wuhan—swarmed by media—including a visit to the hospital that treated the first known COVID-19 cases and the Huanan seafood market, where authorities linked many of the earliest cases. The team also plans to meet with COVID-19 survivors and visit the Wuhan Institute of Virology, which is the center of much speculation and many conspiracy theories that the pandemic virus was engineered and/or accidentally released from a laboratory.

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#infectious-disease, #pandemic, #public-health, #sars-cov-2, #science, #who, #wuhan

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COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%

COVID variants throw J&J vaccine a curveball, lowering efficacy to 66%

Enlarge (credit: Getty | SOPA Images)

Johnson & Johnson’s experimental COVID-19 vaccine was 72 percent effective at preventing moderate and severe disease in the United States and 85 percent effective at preventing severe disease globally. But the one-shot vaccine struggled to fight off emerging virus variants in other countries, lowering its overall efficacy to 66 percent.

The topline results from Johnson & Johnson’s Phase III ENSEMBLE trial, announced Friday, suggest the vaccine will be yet another much-needed weapon against the pandemic virus, which has now infected over 100 million worldwide and killed nearly 2.2 million.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, global head of research and development at Janssen Pharmaceutical (owned by J&J). “The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

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Coronavirus variants: What they do and how worried you should be

Coronaviruses

Enlarge / Coronaviruses (credit: Getty | BSIP)

Ever since the novel coronavirus, SARS-CoV-2, began jumping from human to human, it’s been mutating. The molecular machinery the virus uses to read and make copies of its genetic code isn’t great at proofreading; minor typos made in the copying process can go uncorrected. Each time the virus lands in a new human victim, it infects a cell and makes an army of clones, some carrying genetic errors. Those error-bearing clones then continue on, infecting more cells, more people. Each cycle, each infection offers more opportunity for errors. And, over time, those errors, those mutations, accumulate.

Some of these changes are meaningless. Some are lost in the frenetic viral manufacturing. But some become permanent fixtures, passed on from virus to virus, human to human. Maybe it happens by chance; maybe it’s because the change helps the virus survive in some small way. But in aggregate, viral strains carrying one notable mutation can start carrying others. Collections of notable mutations start popping up in viral lineages, and sometimes they seem to have an edge over their relatives. That’s when these distinct viruses—these variants—get concerning.

Scientists around the world have been closely tracking mutations and variants since the pandemic began, watching some rise and fall without much ado. But in recent months, they have become disquieted by at least three variants. These variants of concern, or VOCs, have raised critical questions—and alarm—over whether they can spread more easily than previous viral varieties, whether they can evade therapies and vaccines, or even whether they’re deadlier.

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#covid-19, #features, #genetics, #infectious-disease, #pandemic, #sars-cov-2, #science, #spike-protein, #variants, #who

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Basic pandemic safety limits spread in schools

Image of a classroom with widely spread desks.

Enlarge / Masks and distancing work in the classrooms, too. (credit: MediaNews Group/Reading Eagle via Getty Images)

Can schools be kept open safely even as the COVID-19 pandemic continues largely unchecked? So far, the data has been mixed. Studies of spread in schools seem to suggest they’re not a major source of infections. But when countries that shut their schools as part of a package of pandemic restrictions were compared to those that didn’t, the ones that had schools shut down had a lower overall rate of infection. So, the record on opening schools seems a bit mixed.

Yesterday, the CDC released a detailed look at the spread of SARS-CoV-2 within a single school system in rural Wisconsin. While the results come from a time before the new, more easily spread strains had evolved, they show that some of the measures laid out in guidelines on how to safely reopen schools work. Thanks to those precautions, infections in the school were down by 37 percent compared to infections in the community at large, and there were very few infections that occurred within the school. But it also raises an obvious question: if these measures work, why aren’t we all using them?

Appropriate cautions

The study started at the end of August 2020 and continued on through to the end of November. It focused on the schools of Wood County, Wisconsin, and tracked infections that took place among its faculty and staff as well as comparing those to the spread of the pandemic in the county as a whole. Overall, there were 4,876 students and 654 staff members included in the data.

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#covid-19, #pandemic, #public-health, #sars-cov-2, #schools, #science

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The persistence of memory in B cells: Hints of stability in COVID immunity

Cartoon diagram of some of the cells of the immune system.

Enlarge / The immune response involves a lot of moving parts. (credit: BSIP/Getty Images)

There’s still a lot of uncertainty about how exactly the immune system responds to the SARS-CoV-2 virus. But what’s become clear is that re-infections are still very rare, despite an ever-growing population of people who were exposed in the early days of the pandemic. This suggests that, at least for most people, there is a degree of long-term memory in the immune response to the virus.

But immune memory is complicated and involves a number of distinct immune features. It would be nice to know which ones are engaged by SARS-CoV-2, since that would allow us to better judge the protection offered by vaccines and prior infections, and to better understand whether the memory is at risk of fading. The earliest studies of this sort all involved very small populations, but there are now a couple that have unearthed reasons for optimism, suggesting that immunity will last at least a year, and perhaps longer. But the picture still isn’t as simple as we might like.

Only a memory

The immune response requires the coordinated activity of a number of cell types. There’s an innate immune response that is triggered when cells sense they’re infected. Various cells present pieces of protein to immune cells to alert them to the identity of the invader. B cells produce antibodies, while different types of T cells perform functions like coordinating the response and eliminating infected cells. Throughout this all, a variety of signaling molecules modulate the strength of the immune attack and induce inflammatory responses.

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The immune system and COVID: It’s still confusing

A man in a red shirt seated in a chair, donating blood.

Enlarge / SOUTH TANGERANG, INDONESIA – JANUARY 7, 2021: A patient recovered from COVID-19 donate plasma at Indonesia Red Cross Transfusion Center in South Tangerang. (credit: Barcroft Media / Getty Images)

It’s clear that the immune system can mount a robust response to SARS-CoV-2, as the vaccine trials have made clear. Beyond that, though, there are a lot of question marks. People exposed to the virus don’t always produce much in the way of antibodies to it, and there have been a number of cases of reinfection. We’re not sure how long immunity lasts or whether it correlates with antibody levels or something else–there hasn’t even been great evidence that antibodies are helpful.

To give some sense of the challenge of sorting all of this out, we’re going to look at three recently published papers that get at the interplay between the immune system and COVID-19. One finally provides some evidence that antibodies might be protective, another indicates that tamping down the inflammatory response might help, while the third suggests that immunosuppressives don’t affect disease outcomes at all.

Antibodies good

Antibodies are a relatively easy way to track an immune response, and they’ve been used for that throughout the pandemic. But early studies found the number of antibodies produced in response to an infection varied dramatically between patients. There have also been clinical trials testing whether using antibodies obtained from those formerly infected could help treat those suffering from COVID-19 symptoms, with the FDA eventually granting this a controversial Emergency Use Authorization. President Trump also received an experimental treatment of mass produced SARS-CoV-2-specific antibodies.

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#biology, #covid-19, #immunology, #medicine, #sars-cov-2, #science

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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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Antibodies and SARS-CoV-2 infections: Tthe more the better

A woman with a face mask receives an injection.

Enlarge / Oxford University is associated with the hospital that ran this study, as well as a vaccine that is currently undergoing clinical trials. (credit: Gallo Images)

The two authorizations issued by the FDA for COVID-19 vaccines come because of clear data that they limit infections by the SARS-CoV-2 virus, and ensure that any ensuing cases are mild. Studies have also indicated that the vaccine triggers the development of antibodies specific to the virus. Oddly, however, we don’t have good data on an obvious question: is there a causal relationship between the two? In other words, we haven’t determined whether production of anti-SARS-CoV-2 antibodies is a necessary step towards providing protection, or how long that protection lasts.

The have been a few small studies that hint at answers to these key questions, but significant uncertainties have remained. Now, a massive study out of Oxford University Hospital provides a clear indication that high levels of antibodies are protective. But, even with 12,500 participants, the study doesn’t eliminate the uncertainties.

The good news

To get some good numbers, Oxford University Hospital tested its entire staff of healthcare workers, both for the presence of viral RNA, and for antibodies that indicated a past exposure to the virus. Following the initial tests, all the staff had the option of being retested for the presence of virus every two weeks, and antibodies every two months. Testing started back in April, when the first wave of infections was still happening, and continued through the end of November, when the second wave was still building. While many of the hospital staff were busy enough that they took longer than two weeks for follow-up testing, the hospital was able to track over 12,500 people.

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For Biden administration, Fauci’s in but Birx is not

Image of a woman speaking in front of charts.

Enlarge / White House Coronavirus Response Coordinator Dr. Deborah Birx speaks during a press briefing in November 2020. (credit: Tasos Katopodis / Getty Images)

On Tuesday, Coronavirus Response Coordinator Dr. Deborah Birx announced that she will end decades of government service after the Biden transition is completed. The move comes after controversy over how she spent her Thanksgiving and articles suggesting that the incoming administration was uncertain about whether to retain her. Birx was a widely respected public health official until taking over the coronavirus response, which has left her associated with the misinformation provided by Trump and many other members of his administration.

Damaged legacy

Birx’s government career started in the 1980s, when she was in the Army and Army Reserve, ultimately reaching the rank of colonel. During this time, she frequently worked at the Walter Reed Army Medical Center but also spent time in the lab of Anthony Fauci at the National Institutes of Health. But much of her reputation is based on her work fighting AIDS, first at the CDC, and later as the US Global AIDS coordinator, where her work was widely praised.

That reputation earned her a prominent place in the US’ response to the COVID-19 pandemic, with Trump naming her the Coronavirus Response coordinator and giving her an influential place on the White House’s Coronavirus Task Force. This, however, ultimately placed her in an untenable position, as Trump himself was a frequent source of misinformation about the pandemic, and much of the White House staff frequently ignored public health guidance originating elsewhere in the government. Birx was left with what turned out to be an impossible task: maintain her job and influence by not publicly contradicting Trump’s misstatements and policies while attempting to ensure that the public got quality information.

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SARS-CoV-2’s spread to wild mink not yet a reason to panic

Image of a mink at the base of a tree.

Enlarge (credit: Eric Sonstroem / Flickr)

Did anyone have “mink farms” on their 2020 catastrophe bingo cards? It turns out that the SARS-CoV-2 virus readily spreads to mink, leading to outbreaks on mink farms in Europe and the United States. Denmark responded by culling its entire mink population, which naturally went wrong as mink bodies began resurfacing from their mass graves, forcing the country to rebury them. Because 2020 didn’t seem apocalyptic enough.

More seriously, health authorities are carefully monitoring things like mink farms because the spread of the virus to our domesticated animals raises two risks. One is that the virus will be under different evolutionary selection in these animals, producing mutant strains that then pose different risks if they transfer back to humans. So far, fortunately, that seems not to be happening. The second risk is that these animals will provide a reservoir from which the virus can spread back to humans, circumventing pandemic control focused on human interactions.

Heightening those worries, mid-December saw a report that the US Department of Agriculture had found a wild mink near a mink farm that had picked up the virus, presumably from its domesticated peers. Fortunately, so far at least, the transfer to wild populations seems very limited.

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#biology, #covid-19, #disease, #medicine, #mink, #sars-cov-2, #science, #surveillance

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What we know about the new SARS strain that’s shutting down the UK

Cartoon representation of coronaviruses.

Enlarge (credit: CDC.gov)

A variant of the pandemic coronavirus, SARS-CoV-2, is now dominating headlines and inspiring precautionary travel bans worldwide. But scientists are still trying to get a grip on what the variant can actually do differently and what it might mean for the nearly year-old pandemic.

Researchers in the United Kingdom—where the variant was identified and is now rapidly circulating—suggested it may be up to 70 percent more transmissible than other SARS-CoV-2 strains, stoking fear of surges upon surges of disease on the eve of year-end holidays. But other researchers are now rapidly working to collect data on the variant’s interactions with human cells and immune responses to see if those interactions differ from those seen by other SARS-CoV-2 strains.

What we know

While much remains to be known about the variant, dubbed B.1.1.7, there are some reassuring aspects. For one thing, it’s normal for viruses to accumulate small genetic changes, such as those that created the new UK variant (more on that below). Many other variants have been identified throughout the pandemic, and none has spawned any nightmare scenarios.

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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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Stanford hospital erupts in protest after vaccine plan leaves out residents

Images of people protesting while wearing medical garb.

Enlarge / Protests by medical staff took place both inside and out of the hospital. (credit: Ars Technica)

One of the more challenging aspects of the initial round of vaccinations is deciding who gets the first doses of a limited supply. The need to have a functional medical system in the face of an out-of-control pandemic has meant that most places have prioritized doctors and nurses who provide most face-to-face patient care. But an apparent failure to prioritize those caregivers at Stanford Medical Center has caused many of its doctors to stage protests today.

Ars received a copy of an open letter sent by the Chief Medical Residents to the Stanford administration that outlines the problems that sparked these protests.

In the US, a residency occurs after the completion of medical school, and is a requirement for the practice of medicine. Residents typically operate under the supervision of a physician in a training program at teaching hospitals, and they learn to practice a specialized branch of medicine, such as internal medicine or pediatrics. In many cases, residencies are followed by fellowships, which are used to develop further specializations. Because these positions are both temporary and required for practicing medicine, however, those occupying them have little political weight within hospitals.

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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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Looking into the genetics of severe COVID-19

A medical worker in protective gear stands beside a bedridden patient hooked into all manner of machines.

Enlarge / Researchers have looked at whether there are genetic influences on who experiences a case of severe COVID-19. (credit: ALBERTO PIZZOLI / Getty Images)

The body’s response to SARS-CoV-2 infection range from imperceptible to death, raising an obvious question: what makes the difference? If we could identify the factors that make COVID-19 so dangerous for some people, we could do our best to address these factors, and provide extra protections for those who are at highest risk. But aside from the obvious—health disparities associated with poverty and race seem to be at play here, too—we’ve had trouble identifying the factors that make a difference.

A recently published study takes a look at one potential influence: genetics. In a large study of UK COVID-19 patients, researchers have found a number of genes that appear to be associated with severe cases, most of them involved in immune function. But the results don’t clarify how immune function is linked to the disease’s progression.

All in the genes

The work took place in the UK, one of the countries involved in the GenOMICC (Genetics Of Mortality In Critical Care) project, which has already been exploring the genetics underlying hospitalization for communicable diseases. For the new study, the researchers worked with over 200 intensive care units in the UK to identify study participants. All told, they managed to get genetic data for over 2,700 critical COVID-19 patients. These were matched with people in the UK’s Biobank who had similar demographics in order to provide a control population. The one weakness of this design is that some people in the Biobank may be susceptible to severe COVID-19 but simply haven’t been infected yet, which would tend to weaken any genetic signals.

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FDA authorizes use of a nonprescription home COVID test

Image of the test hardware next to a cell phone.

Enlarge (credit: Ellume)

The FDA’s ability to issue Emergency Use Authorizations isn’t limited to treatments; the administration can also hand them out for medical equipment and tests. And today, it approved the first over-the-counter, at-home SARS-CoV-2 test kit. The kit detects the presence of a protein found on the surface of the virus and sends the results to a user’s smartphone via a Bluetooth connection. While it’s less accurate than the diagnostic approaches used by large testing centers, the FDA cited an accuracy of over 90 percent when issuing the authorization.

This isn’t the first at-home test kit given approval by the FDA. In November, the FDA issued an Emergency Use Authorization to a company called Lucira, which is offering a test that requires a prescription. Lucira’s test is based on sensing the virus’ genetic material, using a series of enzyme-catalyzed reactions that work at room temperature.

The new test comes from a company called Ellume and is based on identifying the presence of one of the virus’ proteins. Typically, these tests rely on the use of antibodies to the protein, typically linked to a chemical that can induce a color change; Ellume tags its antibodies with fluorescent quantum dots. The sample—in Ellume’s case, a swab of material from the nose—flows across the device while mixing with antibodies, producing a change in color at a specific location on the device.

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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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