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Moderna CEO says Covid vaccines will evolve like 'an iPhone' On Wednesday, January 12, 2021, in Edmonton, Alberta, Canada. The advisers said there are three main reasons why it matters that the infection data was not presented to them.Īn illustrative image of a person holding a medical syringe and a Covid-19 vaccine vial in front of the Moderna logo displayed on a screen. Kristen Nordlund, a CDC spokeswoman, said that “due to the many limitations involving this clinical data, it was not featured” in the CDC’s advisory committee discussion. He added that “throughout the pandemic, the FDA has remained as transparent as possible regarding its processes and decision-making regarding the COVID-19 vaccines” and that Moderna could have chosen to present the data at the FDA advisory committee meeting.

“Numerous studies support the finding that the COVID-19 vaccines remain the best defense against the most devastating consequences of COVID-19 such as hospitalization and death, and that the updated vaccines may help provide better protection against the currently circulating variants,” Felberbaum wrote. Michael Felberbaum, an FDA spokesman, told CNN in an email that “the FDA received the preprint less than a day prior to the advisory committee meeting,” and “the information was therefore not provided in an adequate timeframe for it to be included in the agency’s meeting materials, and generally the FDA only discusses data at advisory committee meetings that the agency has had the opportunity to substantively review.” That study preprint was posted online June 25, three days before the FDA advisers met.

#Possible side effects of covid vaccine fda update#

Moderna spokesman Christopher Ridley said in an email to CNN that the company shared the infection data with the FDA and posted the study manuscript before the agency’s panel meeting in June “in response to requests that we share an update from the ongoing study.”

The advisers then make their recommendations to the agencies, and the agencies decide whether to authorize the shots and recommend them to the public. At last year’s meetings, Moderna executives made presentations, as well. The FDA and the CDC convene their advisory board meetings and make presentations to the advisers. Pablo Sanchez, a member of the CDC’s panel, called the Advisory Committee on Immunization Practices, said that if the data “was looked at as part of the study, it should have been presented to the advisers prior to their decision.” They are early, but they indicate that we need to look at them and see what their value is.”ĭr. Arnold Monto, a professor of epidemiology at the University of Michigan School of Public Health and acting chair of the FDA advisers’ group.

#Possible side effects of covid vaccine fda full#

“There should always be full transparency,” said Dr. The six FDA and CDC advisers interviewed by CNN said that this infection data wouldn’t have changed how they voted, because the data had such limitations, but it still should have been presented to them. Eric Rubin, a member of the FDA vaccine advisory committee.

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We understand how to interpret these results,” said Dr. HHS debuts ads for updated Covid-19 booster, focusing on adults 50 and older US Department of Health and Human Services