The U.S. Food and Drug Administration has called for a meeting of its vaccine advisory committee in three weeks to consider whether the agency should authorize two Covid-19 vaccines, according to a source familiar with the process.
The FDA contacted members of its Vaccines and Related Biologics Advisory Committee, a group of outside experts, last week, asking them to hold Dec. 8, 9 and 10 for meetings, according to the source.
The agency could make a decision at the end of the Dec. 10 meeting on whether to issue emergency use permits for the vaccines, the source said.
Two companies, Pfizer and Moderna, say they will soon seek FDA clearance for their Covid-19 vaccines, both of which were shown in initial data to be over 90% effective against Covid-19.
“It will make sense that, in all likelihood, the FDA will look at the two applications together,” the source said, considering that both vaccines use the same technology and appear to have very similar safety and efficacy results from their clinical trials. large-scale phase 3.
If the FDA clears the vaccines, then they can be immediately distributed to states, according to a presentation made last month to the U.S. Centers for Disease Control and Prevention.
However, no one can be vaccinated until a CDC advisory committee reviews the data, recommends the vaccine, and indicates which groups will receive it first.
If the FDA clears the vaccines, the CDC’s Advisory Committee on Immunization Practices, an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesperson.
At this meeting, the committee will determine whether everyone should be vaccinated or whether certain people should be excluded. He will also decide which groups should receive the vaccine first.
“We have all been alerted on ACIP, we should be very flexible with our schedules as it is likely that there will not be much advance notice for this meeting. It will be done very, very quickly, ”said Committee member Dr William Schaffner.
Once ACIP has issued its recommendations, vaccinations can be administered.
The country’s leading infectious disease physician, Dr Anthony Fauci, told CNN earlier this week that the first vaccinations in the United States could take place “around the end of December”.
States are currently working on the details of running immunization clinics. The Pfizer vaccine is particularly complicated because it needs to be stored at minus 75 degrees Celsius, and doctors’ offices and pharmacies usually don’t have freezers this low.
The first groups who should receive the vaccine are healthcare workers, the elderly, essential jobs such as police officers, and those with underlying health problems.