An open letter from the market-leading COVID-19 vaccine producer published on Friday ends any wait for a vaccine to be available before polling day.
The letter from Pfizer Inc. CEO Albert Bourla indicates that in the first week of November, the company may seek approval for its COVID-19 vaccine.
The CEO of the other frontrunner, Stéphane Bancel of Moderna, told a biotechnology conference on September 30 that he would not have enough safety data to seek clearance from the Food and Drug Administration. of his vaccine before November 25.
The other two COVID-19 vaccine candidates in late-stage clinical trials in the United States, Johnson & Johnson and AstraZeneca, are both on hold as possible adverse events are being investigated.
This means that there is now no chance that a COVID-19 vaccine could be approved before the presidential election on November 3.
The news puts an end to the public health community’s worry for months that a vaccine could be rushed to provide a political victory for President Donald Trump. He has said repeatedly over the past six months that he expects a COVID-19 vaccine to be available before the election.
That position changed on October 6 when the White House passed guidelines released by the Food and Drug Administration that would likely slow approval of a coronavirus vaccine by forcing drugmakers to conduct trials for two months before to seek approval.
After this change, the only way for a vaccine to have seen the light of day before November 3 would have been for all to go well in Pfizer’s vaccine trials, which are the most advanced.
The timing would have been tight. The Pfizer vaccine requires two doses given 28 days apart and it launched its Phase 3 trials in the United States on July 27. The second injections are said to have started on August 24. Two months of follow-up after this second injection would be October 23.
Bourla’s letter makes it clear that it will take longer than that. Based on the company’s current trial registrations and dosing pace, “we estimate that we will reach this milestone in the third week of November,” he wrote.
The company “operates at the speed of science,” with safety as the No.1 priority, he said.
Even so, there will be several important safety and surveillance steps after the company applies for emergency use authorization for its vaccine.
“All data in our US application would be reviewed not only by the FDA’s own scientists, but also by an external panel of independent experts at a public meeting called by the agency,” he said. .
This news is an important step in regaining public confidence in the vaccine review and approval process, said Dr. Kelly Moore, Associate Director of Immunization Education, Immunization Action Coalition.
According to a survey by Informa Pharma Intelligence, a market intelligence provider and research firm YouGov, 35% of Americans don’t trust how quickly clinical trials of the COVID-19 vaccine are progressing and 23% say they don’t think of drug companies with the best interests of consumers in mind.
It will also give a breathing space to national and local COVID-19 immunization program planners who have been racing to prepare for the day a vaccine or vaccines become available. Having a nationwide distribution infrastructure ready for smooth deployment within the next three weeks would have been next to impossible.
“This little specificity on the actual vaccine approval schedule will give states the time needed to prepare for a better start to the national immunization program,” Moores said.
Contact Elizabeth Weise at [email protected]