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

1:35 a.m.

The U.S. plans to send 6.4 million doses of Pfizer's COVID-19 vaccine across the U.S. within 24 hours of the vaccine getting emergency use authorization from the Food and Drug Administration, officials said Tuesday. The goal is to distribute 40 million doses of vaccines from Pfizer and Moderna by the end of the year, enough to vaccinate 20 million people. States were informed of their allocations on Friday, and they will probably be advised to inoculate front-line health care workers first, said Gen. Gustave Perna, the logistics chief of the U.S. vaccination effort.

The FDA will get a recommendation on whether to approve the Pfizer-BioNTech shots after a Dec. 10 vaccine advisory committee meeting, and final say over emergency approval will go to FDA Commissioner Stephen Hahn. "While we cannot predict how long the FDA's review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner," Hahn said in a statement. Health and Human Services Secretary Alex Azar predicted approval would come "soon after" the Dec. 10 meeting.

Within two days of FDA approval, an independent advisory board to the Centers for Disease Control and Prevention will meet publicly to finalize recommendations on who should get the first shots. Then it will be up to the governors of each state, Perna said, describing the federal government as the "air traffic controller" of vaccine distribution.

Getting frozen vials of vaccine — Pfizer's needs to be stored -94 degrees Fahrenheit — to hospitals and other distribution centers across the U.S., then tracking that the right people get two doses of the same vaccine weeks apart will be a massive logistical challenge, as The Washington Post explains.

The CDC's Advisory Committee on Immunization Practices says it will recommend that 20 million health care workers and 3 million people in long-term care facilities get first priority, then about 87 million other essential workers, 100 million adults with high-risk medical conditions, and 53 million senior citizens 65 and older. The general public will probably start getting vaccinated in April. Peter Weber

November 24, 2020

Essential workers — including people who work in meat-packing plants, waste management operations, and the transportation sectors, as well as police officers, firefighters, and teachers — are expected to have earlier access to coronavirus vaccines than any group save for health care workers, Stat News reports. That means those workers would move ahead of people 65 and older and those with high-risk medical conditions.

The Advisory Committee on Immunization Practices, the group of experts tasked with making recommendations to the Centers for Disease Control and Prevention on vaccine use, has not yet had a formal vote on the matter, but members expressed support for the proposal, writes Stat.

The intention is reportedly to ensure people of color, who have been disproportionately affected by the pandemic and make up a high percentage of essential workers, are at the front of the priority line, should they choose to get vaccinated.

"These essential workers are out there putting themselves at risk to allow the rest of us to socially distance," said Beth Bell, a global health expert from the University of Washington who is on the ACIP and chairs its COVID-19 work group. "And they come from disadvantaged situations, they come from disadvantaged communities." Read more at Stat News. Tim O'Donnell

November 23, 2020

The coronavirus almost certainly originated in another species before jumping to humans (perhaps infecting a third party species in between), but new research is suggesting that humans could also play the role of vector, National Geographic reports.

A new study led by Harris Lewin, a professor of ecology and evolution at University of California, Davis, found that humans could potentially spread the virus to wild animals, and they probably already have among animals in captivity. For example, Lewin said it's likely lions and tigers that contracted the virus at the Bronx Zoo in New York were infected by human zookeepers.

That could put endangered species — especially close human relatives like the western lowland gorilla, the Sumatran orangutan, chimpanzees, and bonobos — at high risk of a COVID-19 outbreak, especially in places where wild animals are more likely to come into close contact with humans, Lewin told Nat Geo.

Lewin's co-author Klaus-Peter Koepfli singled out Africa's eastern gorilla as another high-risk species because the fewer than 5,000 remaining individuals live in close-knit family groups, making them more vulnerable to their own pandemic.

The good news is there's no evidence the virus is spreading among wild animal populations, and the animals that have been infected in experimental settings have mostly exhibited mild cases. But the risk remains, so Koepfli and Lewin are calling for a focus on preventative methods such as national park staffers getting regularly tested to mitigate the threat. Read more at National Geographic. Tim O'Donnell

November 23, 2020

An interim trial analysis for Oxford-AstraZeneca's COVID-19 vaccine found the candidate's average efficacy to be 70 percent. While considered encouraging, it falls short of the rates shown by Pfizer/BioNTech and Moderna, whose vaccines appear to be more than 90 percent effective.

Still, the Oxford-AstraZeneca candidate has a few key advantages — it can be stored at regular refrigerators temperatures for a long period of time, and it's much cheaper than the other candidates, which means it could be particularly crucial for developing nations and rural communities around the world.

The vaccine costs just $3 to $4 per dose. In comparison, the Pfizer and Moderna candidates cost around $20 and $30, respectively. AstraZeneca has also made a "no-profit" pledge, and the more-established technology used by Oxford means it will be easier to mass produce cheaply, BBC News notes. Read more at BBC and The Financial Times. Tim O'Donnell

November 23, 2020

Oxford University and drugmaker AstraZeneca announced Monday morning that their COVID-19 vaccine candidate had proved to be 70 percent effective in its Phase Three trial of 20,000 volunteers in Britain and Brazil. And Oxford Vaccine Group director Andrew Pollard told BBC Radio 4 Today that the vaccine appeared to be 90 percent effective when people were given a half-dose of the vaccine followed by a full dose.

"We are really pleased with these results," Pollard said. "What we have got is a vaccine that is able to protect against coronavirus disease and, importantly, there were no hospitalizations or severe cases in anyone who had the Oxford vaccine." Sarah Gilbert, the vaccine's architect, said "the announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by" the new coronavirus.

Britain has ordered 100 million doses of the Oxford vaccine, and if U.K. regulators approve it for emergency use, the country is ready to roll out an aggressive immunization program. Residents and staff of nursing homes are first on the list of those approved for vaccinations, followed by health care workers and people over 85, then consecutively lower age groups.

"After Pfizer and Modena both produced vaccines delivering 95 percent protection from COVID-19, a figure of 70 percent is relatively disappointing," BBC News reports. "However, anything above 50 percent would have been considered a triumph just a month ago. This vaccine can also be stored at fridge temperature, which means it can be distributed to every corner of the world, unlike the Pfizer/BioNTech and Moderna vaccines, which need to be stored at much colder temperatures." Peter Weber

November 22, 2020

Pfizer's coronavirus vaccine, which was submitted to the Food and Drug Administration for an emergency use authorization this week and could be rolled out by mid-December, must be kept in ultra-cold conditions and will initially be shipped in boxes that hold a minimum of 975 doses. Once a vial is thawed and diluted to make five shots, people receiving the vaccine (early on that is expected to be health-care workers), will then have just six hours to get inoculated, Politico reports. Whatever is left over will then spoil.

While there's great excitement about the vaccine's pending authorization, the concern about wasted shots is very real, "especially early on when it will be practically liquid gold," Douglas Hoey, CEO of the National Pharmacists Association, told Politico.

States are trying to come up with ways to mitigate the risk, but spoiled doses are inevitable. Maryland health officials told the Centers for Disease Control and Prevention that as much as 5 percent of the vaccine the state is allocated could go unused in the initial rollout, especially because rural counties may not be able to use up all 975 doses on their own. To counter, Maryland is considering creating regional clinics where people in high priority groups from different rural communities could come to get vaccinated.

Oregon is considering contracting emergency medical providers to drive around and divy up the vaccine among remote areas, Politico reports. And North Dakota wants to repackage the vaccine into smaller boxes — Pfizer says it's working on a smaller pack size that won't be ready until next year — while also identifying people in the next priority group to get a shot if there are any doses left over.

Regardless, the situation will be tricky, but Moderna's vaccine, which will also soon be up for FDA authorization, is expected to be a bit easier to distribute than Pfizer's. Read more at Politico. Tim O'Donnell

November 22, 2020

The Food and Drug Administration on Saturday issued an emergency use authorization for Regeneron's antibody cocktail, a treatment that was given to President Trump in October after he tested positive for COVID-19. Trump credited the cocktail for aiding his recovery.

For now, the authorization applies only to high-risk patients — people over the age of 65 or those who have underlying conditions — and the treatment is meant to be administered in the early stages of an infection; it has not been authorized for patients hospitalized with COVID-19 or those who require oxygen therapy.

Demand is likely to outpace supply with infections rising rapidly across the U.S., but Regeneron said it hopes to have enough doses for 80,000 patients by the end of November, 200,000 by the first week in January, and 300,000 by the end of January.

The cocktail consists of two monoclonal antibodies that target the spike protein the coronavirus uses to enter cells. A similar therapy developed by Eli Lilly was granted an emergency use by the FDA earlier this month. Read more at Bloomberg and CNN. Tim O'Donnell

November 20, 2020

Pfizer said Friday it's submitting its application to the Food and Drug Administration for emergency use authorization of its COVID-19 vaccine. If the FDA and its independent scientific advisers decide the vaccine is safe and effective after a public meeting in early December, the first shots could go out to groups of Americans, apportioned according to criteria to be determined by a separate government advisory group. Pfizer said that it may have 25 million doses of vaccine ready in December, 30 million more in January, and another 35 million doses in February and March. People will need two doses of the vaccine.

Pfizer and its German partner BioNTech announced earlier this week that its vaccine had proved safe and 95 percent effective in its large, ongoing human trial. The FDA and its advisory board will conduct their own analysis of Pfizer's data, and emergency use authorization means the FDA will continue to monitor the vaccine. Pfizer said it has also started applications for approval in Britain and Europe. Moderna, whose vaccine also showed 95 percent efficacy in human trials, is expected to submit its FDA emergency use application in the next week or two.

"Help is on the way," Dr. Anthony Fauci, the top U.S. infectious disease expert, said Thursday, adding that in the meantime, "we need to actually double down on the public health measures as we're waiting for that help to come." If the vaccines win approval and can be efficiently distributed to Americans willing to be inoculated, the pandemic could be effectively under control by mid-spring or summer. Peter Weber

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