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Pharmaceutical company Pfizer hopes to have safety data on a potential coronavirus vaccine by the third week in November, eliminating the possibility the company could apply for emergency use authorization (EUA) before the Nov. 3 election, CEO Albert Bourla said Tuesday on Twitter.
Bourla emphasized the safety processes required to put any sort of vaccine on the market.
“We expect to have our safety data in the third week of November and the manufacturing process data before that date. Assuming positive data we will apply for EUA (emergency use authorization) in the U.S. soon after the safety milestone is achieved,” he said.
Bourla had earlier held out the possibility of quicker results, saying on the Today show that “we will have an answer by the end of October.”
That statement had boosted the hopes of President Trump, who predicted a vaccine would be available before Election Day.
In a Sept. 7 news briefing, Trump said: “So we’re going to have a vaccine very soon, maybe even before a very special date. You know what date I’m talking about.”
Bourla’s tweets echoed key points he made in a Tuesday call with investors and in an open letter posted Oct. 16 on the Pfizer website.
In the letter, Bourla said the vaccine must be proven effective and safe, and it must be able to be consistently manufactured.
“In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine,” the letter said. “Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. …
“All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”
Pfizer is one of four companies conducting third stage clinical trials on a coronavirus vaccine, along with Moderna, AstraZeneca and Johnson & Johnson. Pfizer has had the most optimistic timeline.
I continue to be #PfizerProud of all our colleagues, who delivered another strong quarter during these challenging times. The global phase 3 study for our #COVID19 vaccine candidate w/ @BioNTech_Group is ongoing at 150 sites with more than 42,000 participants enrolled. pic.twitter.com/ZCIzGMEDcJ
— AlbertBourla (@AlbertBourla) October 27, 2020
Today. “Pfizer CEO on coronavirus vaccine: ‘We will have an answer by the end of October”
The White House. “Remarks by President Trump in Press Conference | September 7, 2020”
Pfizer. “AN OPEN LETTER FROM PFIZER CHAIRMAN AND CEO ALBERT BOURLA”