Solving COVID
December 4, 2020

Promising results from Moderna, Pfizer, and AstraZeneca's coronavirus vaccines have raised hopes that an end to the pandemic may be in sight. But distribution issues aside, a study from the Massachusetts Institute of Technology out last week is raising further concerns about those vaccines' effectiveness.

After initial human trials, Moderna reported its vaccine to be 94 percent effective in preventing coronavirus transmission, while Pfizer's was 95 percent effective and AstraZeneca's 90 percent. But these vaccines, along with many others still in development, share a potential weakness, MIT researchers report. Researchers used artificial intelligence and machine learning to examine a vaccine similar to these big developers', and found that while less than 0.5 percent of white trial participants didn't respond strongly to the vaccine, nearly 10 percent of Asian participants didn't. This could mean "people of Black or Asian ancestry could have a slightly increased risk of vaccine ineffectiveness," the study's senior author David Gifford said in an article accompanying the study.

A lack of diversity in the vaccine trial pools may have led developers to calibrate the vaccine to a specific version of human genes — white people's genes in particular. But MIT researchers did offer a potential solution: "adding a small number of additional COVID-19 peptides" — strings of amino acids that make up proteins, which in turn make up a coronavirus — "to a given dose of the vaccine," MIT's Computer Science and Artificial Intelligence lab writes.

"The study's results highlight longstanding trends in health care" and clinical trials, Health IT Analytics notes. Minority groups are often underrepresented in trials, making it less certain how effective vaccines and drugs will be for them and potentially leading to the formulation of vaccines that are tailored for white people. That's especially troubling amid the coronavirus pandemic, as Black and brown people have disproportionately been hospitalized with and died of the virus. Kathryn Krawczyk

December 3, 2020

Pfizer Inc. will only be able to deliver half the COVID-19 vaccine doses it promised to ship by the end of the year, the company said Thursday.

Pfizer and its German partner BioNTech SE projected it would distribute 100 million vaccines worldwide in 2020, but has cut that to 50 million. "Scaling up the raw material supply chain took longer than expected," a spokesperson told The Wall Street Journal, and the vaccine's clinical trial finished "somewhat later than the initial projection" as well. A person directly involved in the vaccine's development meanwhile said "some early batch of raw material failed to meet the standards," leading Pfizer to miss this year's projections.

The U.K. on Wednesday granted an emergency-use authorization for Pfizer's two-shot vaccine, making it the first Western country to do so. The U.S. Food and Drug Administration is reviewing Pfizer's vaccine for a similar authorization after it proved safe and effective at stopping the transmission of COVID-19. Kathryn Krawczyk

December 2, 2020

Britain will start vaccinating its elderly and health care workers next week against COVID-19, and the U.S. is expected to approve two vaccines for emergency use in the next few weeks, but it's going to be a "slow walk to normalcy," Renuka Rayasam writes at Politico. With vaccines in hand, "the first phase of the global pandemic will be over by New Year's Eve," but "2021 should be a year of small victories, each one inching us back toward pre-pandemic life." After speaking with vaccine experts Mark Slifka and Peter Hotez, Rayasam came up with a sketch of how 2021 may play out.

The first two vaccines expected to get FDA approval, from Pfizer-BioNTech and Moderna, both require two doses administered three to four weeks apart. The federal government will likely recommend that front-line health care workers and long-term care residents be given first access to the vaccine, but the first group won't be fully vaccinated until January.

There will be milestones throughout 2021, and "if everything goes as planned — the vaccines are safe, they provide lasting immunity, there are enough doses, and they get distributed properly — the second phase of the global pandemic will end a year from now," Politico reports. But most adults will likely have access to the vaccine by the end of May, according to Dr. Anthony Fauci, the top U.S. infectious disease expert. By that point, more vaccines will likely be approved, as will new treatments to reduce COVID-19 deaths, and we'll have more safety data.

The tipping-point month may end up being October, however, when "Goldman Sachs analysts are predicting that vaccinations will be available to kids," Rayasam writes. "Right now drug companies have not yet tested COVID vaccines on children under the age of 12 (or pregnant women), saying they want to wait until there's more safety data available for adults." But by October, she adds, "schools will close because of snow storms and not COVID outbreaks and kids can go trick-or-treating." Read more at Politico. Peter Weber

December 2, 2020

Britain's medicine and health-care regulator, the MHRA, gave emergency approval Wednesday for the COVID-19 vaccine made by Pfizer and BioNTech, making the U.K. the first country to green-light the promising vaccine for mass rollout. Britain has already ordered 40 million doses of the vaccine, or enough to inoculate 20 million people, and the first doses should arrive in the coming days. "Help is on its way," Health Secretary Matt Hancock tweeted: "The NHS stands ready to start vaccinating early next week."

Pfizer and fellow drugmaker Moderna have reported a 95 percent effectiveness rate for their vaccines from large human clinical trials. Both vaccines use a new approach, relying on messenger RNA, or mRNA, to teach the body how to fight off the new coronavirus. Moderna has also applied for emergency use authorization in Britain and the U.S., and the U.S. Food and Drug Administration is expected to approve both vaccines in the next two or three weeks. White House Chief of Staff Mark Meadows summoned FDA Commissioner Stephen Hahn to the West Wing on Tuesday to explain why the FDA hasn't already approved Pfizer's vaccine, Axios reports. Peter Weber

December 1, 2020

The Centers for Disease Control and Prevention will advise that health-care workers and long-term care facility residents receive COVID-19 vaccinations first, if and when Food and Drug Administration approval is granted.

The decision was reached by the Advisory Committee on Immunization Practices, which is advising the CDC on vaccine distribution practices. As vaccine approval for emergency use becomes increasingly likely in the coming weeks, the panel voted 13-1 in favor of a motion elevating two groups to the front of the line. Health-care workers are frequently exposed to the virus and are essential to keeping hospitals running throughout the pandemic, while nursing homes have faced some of the deadliest COVID-19 outbreaks across the country.

The lone vote against the priority recommendation came from Dr. Helen Kiepp Talbot, who clarified that she has no reservations about health-care workers receiving the vaccines, but is concerned there is not enough data on the safety and efficacy of the vaccine candidates nearing approval in older adults, who are more likely to live in long-term care facilities. Tim O'Donnell

November 30, 2020

In Moderna's COVID-19 vaccine trial, all but 11 of the 196 participants who contracted the virus were in the placebo group, good for a 94 percent efficacy rate. But perhaps even more crucially, none of the people who received the vaccine developed a severe infection, the company said. There were 30 severe cases in the trial — including one death — but they all occurred in the placebo group.

Experts have previously highlighted the importance of separating out worst the cases. Back in September, Drs. Peter Doshi and Eric Topol, in an op-ed for The New York Times, expressed concern that companies developing vaccines, including Moderna and Pfizer, which are on track to receive emergency approval from the Food and Drug Administration in the coming weeks, wouldn't specify the severity of the infections in their trial. But Moderna did just that Monday (Pfizer has also provided data on the matter), and the news is encouraging. Tim O'Donnell

November 30, 2020

Moderna has announced plans to seek emergency authorization for its COVID-19 vaccine after data showed it to be 94.1 percent effective.

The company said it will apply for emergency use authorization from the Food and Drug Administration for its COVID-19 vaccine on Monday. This announcement comes after Moderna earlier this month revealed that preliminary phase-three trial data showed its vaccine candidate was almost 95 percent effective.

On Monday, Moderna said an analysis of 196 cases "confirms the high efficacy observed at the first interim analysis," and additionally, data also showed the vaccine was 100 percent effective at preventing severe COVID-19 cases.

Moderna is the second company to seek emergency authorization for a vaccine against COVID-19. Pfizer previously announced it would also be submitting a request for FDA emergency authorization for its vaccine candidate, which data showed was about 95 percent effective.

When COVID-19 vaccines begin to roll out, those at the highest risk are expected to receive them first. Moderna CEO Stéphane Bancel told The New York Times that should the company's vaccine receive emergency approval, the first doses could potentially be given by Dec. 21, and the company expects to produce 20 million doses in the United States by the end of the year. Brendan Morrow

November 28, 2020

United Airlines on Friday began operating charter flights carrying the COVID-19 vaccine developed by Pfizer and BioNTech to expedite its distribution should it receive approval from the Food and Drug Administration in the coming weeks, two people familiar with the matter told The Wall Street Journal.

The Journal reviewed a letter from the Federal Aviation Administration detailing United's plans to fly chartered flights between Brussels International Airport — Pfizer has a final-assembly center in Puurs, Belgium — and Chicago O'Hare International Airport, and the FAA said in a statement Friday it was supporting the "first mass air shipment of a vaccine."

The agency said it will also allow United to carry 15,000 pounds of dry ice per flight, five times more than what is normally permitted, to ensure the low storage temperature required for Pfizer's vaccine is maintained throughout the flights. The dry ice will be packed inside suitcase-sized boxes containing the vaccine. Per The Hill, the FAA said air traffic services will prioritize flights carrying vaccine cargo.

The flights are just one aspect of Pfizer's distribution, the Journal notes. The company also includes refrigerated storage sites in Puurs and Kalamazoo, Michigan, as well as expanded storage capacity at distribution sites in Pleasant Prairie, Wisconsin, and Karlsruhe, Germany. There will reportedly be dozens of cargo flights and hundreds of truck trips each day. Read more at The Wall Street Journal. Tim O'Donnell

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