The FDA committee will vote favorably for the Moderna COVID-19 EUA vaccine

The safety and efficacy of the mRNA-1273 vaccine candidate was a focus at the Dec. 17 meeting of the Advisory Committee on Vaccines and Related Biological Results (VRBPAC), which advises the FDA’s Center for Biological Assessment and Research. The same committee signed the Pfizer-BioNTech BNT162b2 vaccine last week, which the EUA received two days later.

Moderna submitted its EUA application for mRNA-1273 on 30 November. Information documents provided by the company prior to the meeting supported a vaccine efficacy of 94.1% and a satisfactory safety profile. Data from all three stages of clinical trials were presented in the documentation.

At its meeting on 17 December, VRBPAC committee members were asked to vote on the following question:

“Based on the available scientific evidence, do the benefits of the Moderna COVID-19 vaccine outweigh the risks for its use in individuals 18 years of age and older?”

Based on the discussion from the previous meeting, Moderna was able to better anticipate the committee ‘s questions and provide some additional data to have meaningful discussions about the safety and effectiveness of the vaccine candidate. In fact, the company submitted preliminary data suggesting that the vaccine may protect against asymptomatic infection.

In addition, both the FDA and support agents supported cases of anaphylactic reactions to mRNA-1273. Investigations into these cases were carried out quickly. Dr. Doran Fink, PhD, deputy director of FDA, explained that the monitoring systems set up to monitor this exact situation were working as expected.

The VRBPAC committee spent a lot of time discussing how placebo participants in the trial should be treated moving forward in the clinical trial: whether they should remain blind (ignorant whether they received the placebo or vaccine) or crossover (another branch of the trial where they were the placebo group is able to get the vaccine). The committee was strongly divided on the subject. Committee members do not have the final say on this issue, however, as the FDA and the supporter take the views of the committee into account.

VRBPAC members expressed interest in the transparency of data and future data released by the company related to the question of whether the vaccine protects against asymptomatic disease. Moderna said during the discussion that they plan to continue collecting data for this destination and release data in support of a future biological permit application.

After deliberation, the committee voted on the potential benefits of mRNA-1273 in inhibiting COVID-19 in individuals 18 years of age and older. With 20 votes in favor and one vote, the committee recommended favorably to the FDA for issuing the EUA. Similar to the previous VRBPAC meeting, the group is expected to make a final decision on the EUA within a few days.

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