FDA Sets Meeting to Discuss COVID-19 Vaccine
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The U.S. Food and Drug Administration (FDA) confirmed a meeting date has been set to discuss the approval of a COVID-19 vaccine from Pfizer, Inc. and their partnering company BioNTech Manufacturing.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Dec. 10 to examine and evaluate the data submitted in an Emergency Use Authorization request that was submitted by Pfizer on Nov. 20.
On Nov. 18, Pfizer released a statement announcing the conclusion of a phase 3 clinical study of their COVID-19 vaccine which they say has a 95% efficacy rate.
Phase 3 of the clinical study began on July 27 with 43,661 participants spread over 150 clinical trial sites scattered throughout the United States, Germany, Turkey, South Africa, Brazil and Argentina. According to the studies from the phase 3 trials, two doses are required for the vaccine to have the efficacy reported.
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
Following the announcement of a meeting date being set, the FDA posted new information regarding the vaccine development and review process.
The newly posted information outlines the research, testing process and the data requirements that vaccines must meet before being approved by an FDA team. This team is typically made up of “physicians, chemists, statisticians, pharmacologists/toxicologists, microbiologists, experts in post marketing safety, clinical study site inspectors, manufacturing and facility inspectors, and labeling and communications experts.”
According to Pfizer’s distribution fact sheet the company intends to work with governments to support distribution to what that government may consider a priority.
“We anticipate that points of vaccination will vary but may include hospitals, outpatient clinics, community vaccination locations and pharmacies.”
The company plans on using existing distribution centers located in Michigan and Wisconsin and will also be utilizing many modes of transportation as a means to deliver their product.
Pfizer Inc. CEO, Albert Bourla, released a video saying the COVID-19 vaccine is now in the hands of the FDA.
“We will continue the work already underway to make sure we can begin shipping immediately after authorization and approval.” Bourla says, “Based on current projections we expect to produce up to 50 million doses globally in 2020, and up to 1.3 billion by the end of 2021.”
There are still currently no COVID-19 vaccines approved by the U.S. FDA.