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

10:02 a.m.

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

8:28 a.m.

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

November 27, 2020

Thomas Cueni, the director-general of the International Federation of Pharmaceutical Manufacturers and Associations, said Friday that as many as 10 COVID-19 vaccines could be available by the middle of next year, as long as they are granted approval by regulatory agencies.

Cueni noted that the vaccine developers that have already released info from late-stage trials — Pfizer and BioNTech, Moderna, and the University of Oxford and AstraZeneca — have all showed promising results. Moderna and Pfizer both reported higher than 90 percent efficacy rates, while the Oxford-AstraZeneca trial has sparked some confusion after the accidental discovery that a lower dosing regimen proved more effective than the full one. The trial is being amended, but even the study's lower 62 percent efficacy rate for the full dosing regimen would meet the United States' 50 percent threshold, and the European Union is not setting a minimum efficacy level, so if it passes the regulatory observation the U.K. government is moving forward with, it will likely be gearing up for global deployment.

Beyond that trio, Cueni suggested Johnson & Johnson, Novavax, Sanofi Pasteur, GSK, and Merck have a good chance of following suit in the coming months. "But all of them need to be submitted by rigorous scientific scrutiny by the regulators," he said. Read more at Reuters. Tim O'Donnell

November 25, 2020

The Food and Drug Administration on Wednesday approved a "new generation" COVID-19 antibody test which is designed to tell how well people are protected against subsequent infection.

Most antibody tests are able to determine whether a person has contracted the virus or not, and some can estimate the level of neutralizing antibodies someone has, CNBC notes. But the newly-authorized COVID-SeroKlir developed by Kantaro BioSciences measures specific levels.

The catch is that scientists aren't sure if high levels of antibody guarantee COVID-19 immunity, so the test won't necessarily serve as proof that someone is protected against re-infection just yet. What it will do, however, is allow researchers to gain a better understanding about the correlation between antibody levels and immunity, which will come in handy both for people who have been exposed to the virus already and for vaccine development.

"It's going to broadly enable studies of immunity and the relationship between immunity and the level of antibodies that an individual has," said Erik Lium, the commercial innovation officer for the Mount Sinai Health System, which joined up with diagnostic startup Renalytix to form Kantaro. Read more at CNBC. Tim O'Donnell

November 25, 2020

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

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