Story at a glance
- CEO Albert Bourla said the drug maker could know if its vaccine is effective by the end of this month.
- But safety data required by the U.S. Food and Drug Administration would not be available until the end of November.
- The move makes it highly unlikely a vaccine candidate would be proven to be safe and effective before the presidential election.
Pharmaceutical giant Pfizer will not apply for emergency authorization for its COVID-19 vaccine candidates until at least the third week of November, throwing cold water on President Trump’s push to secure a safe and effective vaccine by Election Day.
In a statement posted to Pfizer’s website Friday, CEO Albert Bourla said the drug maker could know if its vaccine is effective by the end of this month. To do so, Pfizer must obtain a certain number of COVID-19 cases in its trial to compare the effectiveness of the vaccine in vaccinated individuals to those who have been given a placebo.
But knowing the vaccine is effective is only one of three requirements, Bourla said. The second condition — proving the vaccine is safe — is contingent upon safety data required by the U.S. Food and Drug Administration (FDA). And that safety data would not be available until the end of November.
“We are operating at the speed of science,” Bourla said in an open letter.
“Let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla said.
The FDA earlier this month released guidance on emergency authorizations that requires vaccine developers to monitor patients for at least two months to assess potential negative effects from their candidates before applying for emergency approval. The more stringent requirements were issued amid rising concerns about political pressure on the agency to approve a vaccine before the presidential election.
President Trump called the additional safety steps a “political move” that would surely mean a vaccine is not approved before Nov. 3.
There are several COVID-19 vaccine candidates currently in the third stage of clinical trials., including those from Moderna, Johnson & Johnson and AstraZeneca. Moderna has also said it won’t be ready to file for an emergency use authorization before the election.
AstraZeneca started its phase three trial last month but paused it shortly after a patient became ill. The trial has yet to continue in the U.S. Johnson & Johnson also temporarily paused its clinical trial this after a patient fell ill. Clinical trials are often resumed quickly after the illness is found not to be a serious health risk.
Public health officials estimate a vaccine could be ready for FDA review late this year or by early 2021. A vaccine could become widely available as early as March 2021.
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