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FDA Panel Backs Moderna COVID-19 Vaccine; EUA Expected Next


After a daylong meeting, an FDA advisory panel agreed that the second vaccine in the United States to prevent coronavirus disease 2019 (COVID-19) should be put forward for use.

This story has been updated.

An FDA advisory panel Thursday agreed that use of the second vaccine to prevent coronavirus disease 2019 (COVID-19) is warranted in individuals 18 years and older.

As with the Pfizer-BioNTech vaccine granted an Emergency Use Authorization (EUA) last week by the FDA, the first Moderna doses will go to health care workers and individuals in nursing homes.

The FDA is not obligated to follow the recommendation of the Vaccines and Related Biological Products Advisory Committee, but it usually follows the lead of its outside panels; the EUA for the new vaccine could come by Friday, if not later Thursday.

The vote was 20-0, with 1 abstention.

As with the first vaccine, the Moderna vaccine is given in 2 doses and uses mRNA technology. Both use different lipid nanoparticles. The Moderna vaccine is given 28 days apart; the Pfizer-BioNtech one, 21 days apart.

The Moderna vaccine does not require ultra-cold storage and transportation temperatures, making it easier than the Pfizer vaccine to supply rural and remote areas.

The panel of outside experts agreed that the benefits outweighed the risks for individuals 18 years and older (the Pfizer vaccine is approved for those 16 years and older).

During the daylong presentations and discussions, panel members were concerned about a number of issues, including the balance between the scientific integrity of the information collected in the clinical trials and continued follow-up of volunteers who may have received a placebo, and the ethics and safety of preventing future severe illness and death.

One person in the Moderna trial who did receive a placebo died of COVID-19 later.

The company submitted plans to unblind and cross over those who received placebo, and in addition to voting on the benefit vs risk question, the panel was also tasked with discussing, but not voting on, what other information should be collected in ongoing and future studies, as well as if they agreed with unblinding the trial.

Some panel members wanted to keep the placebo recipients blinded, but endorsed the crossover idea.

Others supported an open-label and unblinding crossover, noting that reports are suggesting that since the vaccinations are likely to cause temporary, short-term fatigue and other effects, volunteers are likely to figure out anyway whether they were actively vaccinated.

Under an EUA, the benefits of the vaccine are considered to outweigh any risks and it is still considered unapproved while it is further analyzed under an Investigational New Drug Application until it is licensed under a Biologics License Application (BLA).

The 1 abstention came from Michael G. Kurilla, MD, PhD, director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences at the National Institutes of Health. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risk. And I would prefer to see it more targeted towards people at high risk of serious and life threatening COVID disease,” he said, citing a limited supply of available vaccine doses.

He also said that rather than an EUA, he would have preferred an expanded access program, saying it would have provided more opportunity to keep collecting data.

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