The pressure to create a coronavirus vaccine increases during the day, but for a safe vaccine to enter the market, it takes time.
An open letter from the COVID-19 vaccine provider published on Friday concludes any expectations that a vaccine may be available before Election Day.
The letter from the CEO of Pfizer Inc. that Albert Bourla said the earliest the company could apply for approval for this COVID-19 vaccine was the third week of November.
The CEO of another frontrunner, Moderna Stéphane Bancel, said at a biotechnology conference on September 30 that it did not have enough safety data to apply for Food and Drug Administration approval for its vaccine until November 25.
The other two candidates for the COVID-19 vaccine in the final stages of clinical trials in the United States, Johnson & Johnson and AstraZeneca, are both awaiting as much as possible bad events under investigation.
That means there is no chance that any COVID-19 vaccine could be approved before the November 3 Presidential election.
The news raises a concern that has existed in the public health community for months that a vaccine could be expedited to give President Donald Trump a political victory. He has said several times over the past six months that he expects a COVID-19 vaccine to be available before the election.
That stance was changed on October 6 when the White House adopted guidelines published by the Food and Drug Administration that may slow down the approval of a coronavirus vaccine by asking drug manufacturers to make trial for two months before requesting approval.
After that transfer, the only way a vaccine can be had before November 3 is if everything is completely correct in the Pfizer vaccine tests, which are the farthest included.
The timing would have been tight. The Pfizer vaccine requires two doses given 28 days apart and it launched the US Phase 3 test on July 27. The second shot will start on August 24. Two months of follow-up after the second shot is October 23.
Bourla’s letter clarified that it would take longer than that. Based on the company’s current enrollment and dosage rate, “we expect to reach this milestone by the third week of November,” he wrote.
The company is “running at the speed of science,” with safety as the number one priority, he said.
Although, there will be many important safety and administrative steps even if the company applies for an Emergency Use Authorization for this vaccine.
“All data contained in our application in the US will be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held agency meeting,” he said.
The news is an important step in restoring public confidence and confidence in the vaccine testing and approval process, Drs. 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 do not trust how fast clinical trials COVID-19 moves, and 23% said they do not think of drug companies. keeping in mind the best interests of consumers.
It will also provide breathing space for state-of-the-art COVID-19 vaccination program planners to prepare for the day a vaccine or vaccine will be available. Having a national distribution infrastructure ready to roll smoothly over the next three weeks would be next to impossible.
“This little specification about the real vaccine approval timeline will give states valuable time to prepare for a better start in the national vaccination program,” he said.
Contact Elizabeth Weise at [email protected]
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