A panel of experts that advises the FDA on vaccine decisions voted unanimously Thursday to approve booster doses of Moderna’s COVID-19 vaccine.
/webmd/consumer_assets/site_images/article_thumbnails/video/covid19-images/Topol_092821_1800x1200b.jpg“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief ofPatrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.
Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the CDC’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet next Thursday to take up questions of exactly how these boosters should be used.
Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.Overall, data shows that two doses of the Modernaremains highly effective at preventing hospitalization and death.
Data presented by Moderna today showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their
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