Pressure to create a coronavirus vaccine is increasing by the day, but for a safe vaccine to enter the market, it takes time.
An open letter from the frontrunner COVID-19 vaccine producer published Friday ends any expectations a vaccine might be available before Election Day.
Pfizer Inc. CEO Albert Bourla’s letter says the earliest the company could apply for authorization for its COVID-19 vaccine is the third week of November.
The CEO of the other frontrunner, Moderna’s Stéphane Bancel , said at a biotechnology conference on Sept. 30 that it would not have enough safety data to apply for Food and Drug Administration authorization of its vaccine until Nov. 25.
The other two COVID-19 vaccine candidates in final stage clinical trials in the United States, Johnson & Johnson and AstraZeneca, are both on hold as possible adverse events are investigated.
That means there is now no chance any COVID-19 vaccine could be approved before the Presidential election on Nov. 3.
The news lays to rest a concern brewing in the public health community for months that a vaccine might be rushed through to provide a political win for President Donald Trump. He has said multiple times over the past six months he anticipated a COVID-19 vaccine would be available prior to the election.
That stance shifted on Oct. 6 when the White House embraced guidelines published by the Food and Drug Administration that likely would slow approval of a coronavirus vaccine by requiring drug makers to conduct trials for two months before requesting approval.
After that shift, the only way a vaccine could have come about prior to Nov. 3 would have been if absolutely everything went right in the Pfizer vaccine trials, which are the furthest along.
The timing would have been tight. The Pfizer vaccine requires two doses given 28 days apart and it launched its U.S. Phase 3 trials on July 27. The second shots would have begun on Aug. 24. Two months of follow-up after that second shot would be Oct. 23.
Bourla’s letter makes clear it will take longer than that. Based on the company’s current trial enrollment and dosing pace, “we estimate we will reach this milestone in the third week of November,” he wrote.
The company is “operating at the speed of science,” with safety as its No. 1 priority, he said.
Even then, there will be several important safety and oversight steps after the company applies for an Emergency Use Authorization for its vaccine.
“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,” he said.
The news is an important step in earning back the public’s trust and confidence in the vaccine evaluation and approval process, said Dr. Kelly Moore, associate director of Immunization Education, Immunization Action Coalition.
According to a poll from Informa Pharma Intelligence, a business intelligence provider, and research firm YouGov, 35% of Americans don’t trust how quickly the COVID-19 vaccine clinical trials are moving, and 23% say they don’t think pharmaceutical companies have consumers’ best interests in mind.
It also will give breathing space for state and local COVID-19 vaccination program planners who have been racing to prepare for the day a vaccine or vaccines becomes available. Having a national distribution infrastructure ready to roll out smoothly within the next three weeks would have been next to impossible.
“This bit of specificity about the real vaccine approval timeline will give states essential time to prepare for a better start to the national vaccination program,” Mooresaid.
Contact Elizabeth Weise at [email protected]
It takes a lot of people to develop a COVID-19 vaccine. Volunteers may be one of the most important.
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