A volunteer received a Covid-19 vaccine during clinical trials in Hollywood, Fla., in August.

Photo: chandan khanna/Agence France-Presse/Getty Images

A Food and Drug Administration panel began its review of the Covid-19 vaccine Thursday, a process that is expected to culminate in approval of a second weapon against the pandemic later this week.

At the end of Thursday’s meeting, the federal vaccine-advisory committee is likely to recommend that the FDA grant an emergency use authorization for the new Covid-19 vaccine from Moderna Inc., MRNA 4.25% the panel’s chairman said earlier.

“I have no serious doubts that there will be a likely approval” for broad U.S. use of the vaccine, said Arnold Monto, a professor of public health and epidemiology at the University of Michigan who chairs the FDA’s Vaccines and Related Biological Products Advisory Committee.

Dr. Monto said he based that assessment on his own view of the strength of the Moderna test data, which showed the vaccine was 94.1% effective in thwarting Covid-19, and wasn’t speaking for the full committee.

The FDA said earlier this week that the vaccine is “highly effective,” and seems certain to do so soon after the committee’s recommendation.

With a favorable recommendation, the FDA is expected to act Friday to grant an emergency use authorization, as it did with the vaccine from Pfizer Inc. and BioNTech vaccine last week.

Moderna has millions of manufactured doses ready to ship, a spokesman said, and federal officials say distribution could start within 24 hours of an authorization of the vaccine, arriving at hospitals and other vaccination sites by Monday. Immunizations would start soon after.

The Moderna vaccine, however, is likely to be approved only for people 18 and older. The Pfizer product was more extensively tested in younger patients and can be used in people 16 and older.

At Thursday’s hearing, an FDA vaccine official said the agency is studying two cases of serious allergic reactions in people who got the Covid-19 vaccine from Pfizer and BioNTech in Alaska, stressing that vaccination sites will be able to handle such reactions.

Doran L. Fink, deputy clinical director of the agency’s division of vaccines, Thursday asked an advisory panel to evaluate the side effects and other issues related to the vaccines. FDA officials said such allergic reactions are a known phenomenon with vaccines in general.

Dr. Fink said the agency has “robust safety and reporting systems” to monitor such issues, including the fact that vaccine recipients are asked to participate in an electronic safety reporting network.

The panel Thursday is considering whether to recommend the FDA authorize use of a vaccine from Moderna Inc. Last week it authorized the use of a vaccine from Pfizer Inc. and BioNTech which has been used in patients since early this week in the U.S.

Dr. Fink said the FDA was working with Pfizer to revise the written prescribing information and fact sheets distributed with Pfizer’s vaccine to underscore the need for post-vaccination monitoring and how to manage an immediate allergic reaction.

The Moderna vaccine, developed in collaboration with the National Institutes of Health, was tested in about 30,000 patients and found to be 94.1% effective at preventing Covid-19 with certain symptoms, including severe disease. The Pfizer vaccine was found to be 95% effective.

Moderna also presented preliminary data suggesting that the first dose of its vaccine could reduce coronavirus infections that have no symptoms. A member of the FDA panel, Patrick Moore, said this would be “important for control of the epidemic” because it could be a sign the vaccine reduces viral transmission.

The Moderna study found that the most common side effects included injection-site pain, fatigue, headache and chills. Severe adverse reactions were rare but occurred more frequently after the second dose than after the first dose.

Moderna’s vaccine “offers the potential to address the public health crisis of Covid-19,” Jacqueline Miller, a Moderna senior vice president and therapeutic area head for infectious diseases, told the FDA committee members Thursday.

Hospitals across the U.S. have started receiving the Pfizer-BioNTech Covid-19 vaccine. WSJ visits a hospital in New York City to see what potential hurdles are ahead as vaccinations begin. Photo: Mount Sinai Queens

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Moderna said there was one anaphylactic reaction in a vaccine recipient in the study, but it occurred two months after the second dose in a person with a history of asthma and allergy to shellfish. The company plans to continue to monitor for such events.

The Moderna vaccine would be the first of several after Pfizer’s vaccine that are expected to build up the nation’s vaccine supply against the coronavirus pandemic, which has killed more than 305,000 Americans and 1.6 million people world-wide, according to Johns Hopkins University.

One thorny issue the panel will confront is whether placebo patients in the Moderna and Pfizer studies will automatically now get vaccine. Ethical considerations suggest that they should, having sacrificed for the public. But a countervailing force is that researchers need to follow those patients as long as possible to be a comparison group to assess side effects of the vaccines.

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More on the Covid-19 Vaccines

Moderna is exploring changing the design of its large study to offer its vaccine to people who previously received the placebo, to encourage them to remain in the study, the FDA said in a briefing document released earlier this week. This would allow Moderna to continue to collect safety and effectiveness data over a longer time frame than if placebo recipients were to drop out of the trial and take Pfizer’s vaccine or any other vaccine that may be authorized in the future, according to the document.

Write to Thomas M. Burton at [email protected] and Peter Loftus at [email protected]

Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

This post first appeared on wsj.com

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