Effectiveness and safety of Moderna COVID-19 vaccine confirmed, path cleared for expected authorization this week

By Karen Weintraub | USA Today

Vaccine maker Moderna is poised to win authorization for its COVID-19 vaccine days after Pfizer-BioNTech did the same.

Data released Tuesday by the U.S. Food and Drug Administration confirmed that Moderna’s vaccine appeared safe and highly effective in a study of more than 30,000 volunteers.

Unlike Pfizer-BioNTech’s vaccine, Moderna’s will be given only to adults. The company has begun testing in teenagers but has not accumulated enough data to include in its authorization request to the FDA. 

An independent advisory committee to the FDA will review the data in an all-day meeting Thursday. If the Vaccines and Related Biological Products Advisory Committee decides that the vaccine’s benefits outweigh its risks, the vaccine is likely to be authorized this week by the FDA commissioner.

An independent advisory committee to the U.S. Centers for Disease Control and Prevention will review the data this weekend and will vote on whether to add the vaccine to the nation’s vaccine schedule for adults.

Then, as with Pfizer-BioNTech’s vaccine, it will be distributed across the country, probably starting Monday.

The FDA will “authorize” the vaccine but stop short of a full approval. The companies have met requirements for so-called emergency use authorization but do not have the longer-term data required for full approval. Both are likely to apply for full approval once they collect this data.

There are no major differences in safety or effectiveness identified between these first two vaccines, although the two Moderna vaccine doses should be given 28 days apart, and Pfizer-BioNTech’s second shot should be given after 21 days. 

Read more >> http://ow.ly/3rIe50COoSZ

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