[ad_1]
Last week, the company released preliminary clinical trial data showing its vaccine is over 90% effective and said it waits to go to the FDA until it has collected enough vaccine safety data.
“I think the questions about security as a whole have also been answered,” Bourla said in an interview with The New York Times on Tuesday. “Our security milestone has already been met and we are now preparing for submissions.”
Moderna, another pharmaceutical company, announced Monday that the first results of its clinical trials show that its vaccine is 94.5% effective. The company plans to seek clearance from the FDA soon after it accumulates more safety data later this month.
Dr Anthony Fauci, the country’s leading infectious disease physician, told CNN this week Americans would likely start getting vaccinated “around the end of December.”
The FDA has scheduled a meeting of its Vaccines and Related Biologics Advisory Committee, a group of outside experts, for Dec. 8, 9 and 10, a source familiar with the process told CNN on Tuesday.
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.
“It will make sense that, in all likelihood, the FDA considers the two applications together,” the source said, considering that the two vaccines use the same technology and appear to have very similar safety and efficacy results from their clinical trials. large-scale phase 3.
What happens after an EUA
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 to ACIP, we should be very flexible with our schedules as it is likely that there will not be a lot of advance notice for this meeting. It will be done very, very quickly. “said Dr. William Schaffner, a member of the committee.
Once ACIP has issued its recommendations, vaccinations can be administered.
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.
[ad_2]
Source link