Solving COVID
November 16, 2020

Moderna announced early Monday that, according to preliminary phase-three trial data reviewed by an independent monitoring board, its coronavirus vaccine candidate was more than 94 percent effective. CEO Stéphane Bancel called the results a "game-changer." Among the trial's 30,000 participants, 90 COVID-19 cases were found among those getting placebo shots, and only five cases occurred among those who got the two-dose vaccine. Moderna also said doses of its vaccine, once thawed, could last at refrigerated temperatures for a longer-than-expected 30 days.

The vaccine's preliminary 94.5 percent efficacy is a "really important milestone," Moderna president Dr. Stephen Hoge told The Associated Press. But more importantly, the fact that both it and Pfizer's vaccine had similar results "should give us all hope that actually a vaccine is going to be able to stop this pandemic and hopefully get us back to our lives." The company said it expects to seek emergency authorization use from the Food and Drug Administration by early December, once more data has come in.

Pfizer announced last week that its COVID-19 vaccine, developed with BioNTech, was 90 percent effective in phase three trials. The better-than-expected vaccine data arrived as the total number of U.S. infections surpassed 11 million. Michigan and Washington state on Sunday became the latest states to announce broad new restrictions on private gatherings and many businesses to fight the latest wave in the pandemic. Peter Weber

May 8, 2021

The Centers for Disease Control and Prevention on Friday updated its public COVID-19 guidance to explicitly state that the coronavirus can be transmitted via aerosols — smaller respiratory particles that can float — that are inhaled at a distance greater than six feet from an infected person. The risk is higher while indoors, bringing ventilation practices to the forefront. The new language marks a change from the federal health agency's previous stance that transmission of the virus typically occurs through "close contact, not airborne transmission."

Infectious disease experts have warned that the CDC and the World Health Organization (which has also updated its guidance) were overlooking evidence of airborne transmission during the pandemic, The New York Times notes, and some have stressed the need for the CDC to strengthen its recommendations for preventing exposure to aerosolized virus, especially in indoor workplaces like meatpacking plants.

Good ventilation should be one of the primary things to focus on, Dr. David Michaels, an epidemiologist at George Washington School of Public Health and the head of the Occupation and Safety Health Administration during the Obama administration, told the Times. Dr. Linsey Marr, an aerosol expert at Virginia Tech, explained that "if you're in a poorly ventilated environment, virus is going to build up in the air, and everyone who's in that room is going to be exposed."

Sociologist Zeynep Tufekci, who has long been pushing for such a change, called it "one of the most crucial scientific advancements of the pandemic" that should provide a lot of clarity about what is and isn't safe going forward. Read her Twitter thread on the issue here and learn more at The New York Times. Tim O'Donnell

May 7, 2021

The COVID-19 vaccine from Pfizer and BioNTech could become the first in the United States to receive full FDA approval.

The companies announced Friday they have initiated an application seeking full approval of the vaccine for people 16 and over from the Food and Drug Administration, CNN reports. The vaccine is now being administered under an emergency use authorization, a "mechanism to facilitate the availability and use of" vaccines "during public health emergencies," per the FDA.

Receiving full FDA approval requires six months of safety and efficacy data, as opposed the two months required for the emergency use authorization, according to NBC News. CNN chief medical correspondent Sanjay Gupta stressed Friday this isn't to suggest that data didn't already show the vaccine to be safe and effective or that the process to get the emergency authorization wasn't rigorous, but the "bar of data that you now have to show" to get full approval is even higher, he said on New Day.

With that in mind, experts have said full FDA approval could help reduce vaccine hesitancy and further demonstrate that the vaccines are safe. Former U.S. Surgeon General Jerome Adams wrote in The Washington Post that "many people who are lower risk" have expressed uncertainty over whether the "benefits justify taking a medication that has not received the full and traditional FDA stamp of approval." So full approval might provide a "boost of confidence to people who were on the fence about getting vaccinated," Brown University School of Public Health dean Ashish Jha said.

If the vaccine is fully approved, Pfizer can also start marketing and distributing it. Another key difference, CNN writes, is that full approval could "have an impact on vaccine mandates," as "some organizations say they expect to require the vaccine, but have opted not to while it's authorized and not yet fully approved." ABC News reports it's likely to take "several months" for the FDA to make a decision. Brendan Morrow

May 6, 2021

Early data indicates Moderna's COVID-19 vaccine is highly effective in adolescents between the ages of 12 and 17, the company says.

Moderna released this data on Thursday along with its first-quarter earnings, CNBC reported. An initial analysis of a study of its COVID-19 vaccine in adolescents between 12 and 17 years old "showed a vaccine efficacy rate of 96 percent," the company said. The vaccine was also "generally well tolerated," and the "majority of adverse events were mild or moderate in severity." Like Pfizer, Moderna also said Thursday it plans to apply for full FDA approval of the vaccine this month.

The Food and Drug Administration is reportedly on the verge of authorizing the Pfizer-BioNTech COVID-19 vaccine for children between 12 and 15 years old, allowing the vaccine to expand to this key age group ahead of the next school year. In March, Pfizer said a trial showed its vaccine was 100 percent effective in adolescents aged 12 to 15, demonstrating "robust antibody responses." President Biden earlier this week said his administration's COVID-19 vaccination efforts are set to enter a "new phase," which includes vaccinating kids between 12 and 15 pending FDA approval of the Pfizer vaccine.

Meanwhile, Pfizer has also said it expects to seek authorization of its vaccine for kids between 2 and 11 this September, and Moderna says a phase 2 study of its vaccine in children 6 months to 11 years old is ongoing. Brendan Morrow

May 6, 2021

The Pfizer-BioNTech COVID-19 vaccine is extremely effective against two dangerous variants of the coronavirus, the B.1.1.7 strain first found in the United Kingdom and the B.1.351 variant discovered in South Africa, researchers reported Wednesday in the New England Journal of Medicine and The Lancet.

Moderna also reported Wednesday that, according to early results from its booster shot trial, a third dose of its vaccine given six to eight months after the first two doses boosted antibodies to protect against the South African B.1.351 variant and other worrisome strain found in Brazil. Moderna is testing its original vaccine and a version modified to target the B.1.351 variant.

The new variants are more transmissible than the original strain and, some studies suggest, deadlier. The New England Journal of Medicine study examined records of more than 200,000 people from Qatar's COVID-19 database. The Pfizer vaccine was 87 to 89.5 percent effective at preventing infection from the B.1.1.7 variant among people two weeks past their second shot, 72.1 to 75 percent effective against the B.1.351 variant, and 100 percent effective at preventing severe, critical, or fatal cases of either variant, the researchers found.

The study in The Lancet was based on more than 230,000 cases from Israel. It found that the Pfizer vaccine was more than 95 percent effective against infection, hospitalization, or death in fully vaccinated people 16 and older, and 94 percent effective in people 85 and older. The vaccine efficacy numbers aren't self-evident, but Brains On!, a science podcast for kids, has a short, entertaining, and pretty effective explanation using defecating seagulls. You can watch that below. Peter Weber

May 4, 2021

Pfizer's COVID-19 vaccine appears set to be authorized for adolescents between 12 and 15, and the company aims to further expand the vaccine's use this September.

Pfizer during an earnings call on Tuesday said it expects to apply for emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine for children between 2 and 11 in September, CNN reports.

A study to examine the safety and efficacy of the vaccine among those between 6 months and 11 years old is ongoing. Additionally, Pfizer said it's expecting to seek authorization for its vaccine among children between 6 months and 2 years in the fourth quarter of 2021.

This comes after The New York Times reported on Monday that the Food and Drug Administration is set to authorize Pfizer's vaccine for adolescents between 12 and 15 by early next week, allowing this group to start getting vaccinated before the beginning of the new school year.

Pfizer also announced Tuesday it plans to file for a full FDA approval of its COVID-19 vaccine by the end of the month, which CNBC notes would mean "the company will be able to market the shot directly to consumers." Brendan Morrow

May 4, 2021

Researchers urgently want to know how long the current crop of effective COVID-19 vaccines protect against infection and also would like a quicker and more efficient way to test the efficacy of new vaccines. They are trying to check both of those boxes by studying antibody levels in people already exposed to the new coronavirus.

A study at Oxford University is deliberately exposing previously infected healthy young volunteers to the coronavirus again, using blood tests to learn what level of antibodies will protect people against getting sick again. "It may be not possible to reinfect with an antibody level above a certain amount," lead investigator Helen McShane told NPR News. When researchers find that level of antibodies — or antibody cutoff titer — they can develop blood tests to determine how long vaccines are effective.

A separate study involving the U.S. government's Biomedical Advanced Research and Development Authority (BARDA), the Fred Hutchinson Cancer Research Center, and Moderna is also trying to find the cutoff titer by examining antibodies in people who got COVID-19 symptoms after getting inoculated with Moderna's vaccine. "Because the Moderna vaccine is so very effective, it's taken a very long time to collect enough from the vaccinated individuals who became infected," BARDA's Chris Houchens tells NPR. Now that they have data from enough people, they should soon be able to calculate whether a certain level of antibodies can show that new vaccines are effective without having to test the vaccines on tens of thousands of people. You can listen to NPR's report below. Peter Weber

May 3, 2021

The Food and Drug Administration is on the verge of authorizing the Pfizer-BioNTech COVID-19 vaccine for children between 12 and 15 years old, federal officials familiar with the agency's plans told The New York Times. The announcement could come as soon as late this week or early next week.

As the Times notes, the decision is highly anticipated. It means millions of Americans would become newly eligible to get vaccinated and, more specifically, it would provide children with protection ahead of the start of the next school year.

Results from Pfizer's trial showed the vaccine is at least as effective in the age group as it is in adults. Read more at The New York Times. Tim O'Donnell

April 30, 2021

The United States has reached a significant milestone in the pandemic, according to the White House.

White House COVID-19 coordinator Jeff Zients said during a briefing on Friday that 100 million Americans have now been fully vaccinated against COVID-19, "nearly double" the 55 million Americans who had been fully vaccinated as of the end of March. He later clarified this is the number of Americans who have received both doses of a two-dose vaccine or one dose of a single-dose vaccine. A person is fully vaccinated two weeks after receiving this dose, according to the CDC.

"That's 100 million Americans with a sense of relief and peace of mind, knowing that after a long and hard year, they're protected from the virus," Zients said.

This comes after the CDC updated its guidelines earlier this week to say that those who have been fully vaccinated against COVID-19 generally no longer need to wear masks outside except when in crowded settings. The 100 million milestone, Zients said, "represents significant progress and cause for hope." Brendan Morrow

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