Newsman: The independent panel of experts voted to recommend Pfizer’s Covid-19 vaccine for emergency use in people ages 16 and older. This vote doesn’t mean the vaccine will be authorized immediately. But the authority has signaled that it will issue the EUA for the vaccine though Today’s Expert’s recommendation is now waits to get the final approval by the Food and Drug Administration. This recommendation now will go through the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) whether it recommends that the vaccine be deployed for use. ACIP has a meeting scheduled for Friday, and expects to vote during another meeting, scheduled for Sunday. Operation Warp Speed officials say they will start shipping the vaccine within 24 hours of FDA authorization.
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee spent 9 hours in virtual discussion and Q& A session before the recommendation vote. The 23 committee members including temporary members were in this process. Acting Chair Arnold Mondo chaired the voting session where the vote was split 17 in favor of the authorization, four against, with one person abstaining from the vote.
The FDA’s advisory panel is scheduled to meet again virtually Dec. 17 to consider a similar Covid-19 vaccine, made by Moderna. In November, the company released preliminary results from its Phase 3 trial, which showed the vaccine is nearly 95 percent at preventing symptomatic illness.
Additional details from Moderna are expected to be released publicly before next week’s meeting.
Elsewhere in the pipeline, vaccines from AstraZeneca and Johnson & Johnson are continuing with Phase 3 trials, with results likely after the New Year.
The United States would be the fourth country to move forward with Pfizer’s vaccine. Canada approved the vaccine Wednesday, and the United Kingdom began administering the shots this week. Bahrain has also granted access to the vaccine.
Data so far indicate the vaccine is safe and 95 percent effective across a variety of age and racial groups and ethnicities, when given in two doses, about three weeks apart.
The shots are known to come with some side effects, including fever, fatigue, headache and muscle and joint pain. Two people in the U.K. were reported to have severe allergic reactions after receiving the shot.
During Thursday’s meeting, Dr. Nancy Messonnier, director for the National Center for Immunization and Respiratory Diseases at the CDC and head of the agency’s work on Covid-19 vaccines, outlined the various tracking platforms and databases that will watch for any potential adverse events or problems possibly related to the vaccine.
“On Day One of the Covid-19 vaccine program, systems will be in place to monitor the safety of vaccine recipients,” she said. Those systems will include tried-and-true monitoring databases, such as the vaccine adverse event reporting system as well as a new CDC database called V-SAFE, which uses text messaging and online surveys to check in with people who have received the vaccine to identify potential safety issues. What’s more, experts say, additional information on the vaccine’s effects on pregnant women, young children and those who are severely immunocompromised will be needed moving forward
