The Food and Drug Administration published a number of documents Tuesday that appear to confirm the “safety and effectiveness” of Pfizer’s coronavirus vaccine candidate.
The documents, released ahead of an FDA meeting planned for Thursday where the vaccine is expected to receive an Emergency Use Authorization (EUA) and a Tuesday vaccine “summit” at the White House, confirm that Pfizer’s vaccine does not present any serious concerns that would prevent it from being initially approved.
“Safety data from approximately 38,000 participants ≥16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA,” the executive summary reads. (RELATED: Trump To Sign Executive Order Prioritizing Americans Over Foreign Nations For COVID-19 Vaccine)
“Based on the totality of scientific evidence available, it is reasonable to believe that the Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older, and the known and potential benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its known and potential risks for use in individuals 16 years of age and older.”
President Donald Trump and other administration officials are expected to detail the government’s specific plan for vaccine distribution Tuesday and take part in a signing ceremony for a two-part executive order that will seek to prioritize Americans in the distribution process.
Senior White House officials told the Daily Caller Monday night that the first part of the order will instruct Health and Human Services Secretary (HHS) Alex Azar to prioritize American citizens over foreign nations to receive the coronavirus vaccine, while the second part of the order will give HHS, the United States Agency for International Development (USAID) and other executive departments guidelines on how to negotiate with foreign countries for the vaccine’s international distribution.
Dr. Moncef Slaoui, Operation Warp Speed’s chief executive, said Tuesday morning, however, that he doesn’t understand what specific mechanism the order will trigger that will prioritize Americans over citizens of other countries.
This is a developing story and will be updated with new information as it becomes available.