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
(Reuters) – Pfizer Inc PFE.N said on Friday it could file in late November for U.S. authorization of the COVID-19 vaccine it is developing, suggesting that a vaccine could potentially be available in the United States by the end of the year.
That timeline makes it unlikely, however, that a vaccine will be available before the U.S. election, as President Donald Trump has promised. Pfizer, which is developing the vaccine with German partner BioNTech 22UAy.F, said that it may confirm if the vaccine is effective as soon as this month but that it also needs safety data from a 44,000-person clinical trial that will not be available until next month.
The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares fell slightly of rival vaccine maker Moderna Inc MRNA.O, which is close to Pfizer in its vaccine development.
“So 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,” Pfizer Chief Executive Albert Bourla said, noting that he published the letter to provide greater clarity on the timeline for the vaccine.
People around the world are counting on a vaccine to control the spread of the coronavirus, which has killed more than a million people and ravaged the global economy.
Fears of delays were raised after trials for two rival vaccines were put on hold in the United States in recent weeks.
Trump has said repeatedly that there would be a vaccine available before the Nov. 3 election.
When asked about the Pfizer news, White House spokesman Judd Deere said, “The president continues to be optimistic that we will have one or more vaccines very soon, before the end of the year.”
The U.S. government’s Operation Warp Speed program has spent billions of dollars on development of vaccines and treatments. It has signed a deal to buy Pfizer vaccine shots if they work.
But the rush to develop a vaccine has raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review.
U.S. health officials have sought to assuage those concerns. Earlier this month, the FDA formalized a requirement that the vaccine-makers collect two months of safety data on one-half of trial participants.
Pfizer has been trying to demonstrate that its decision-making is being driven by science rather than politics, Mizuho analyst Vamil Divan said.
“Just getting it to the market is only a small part of it,” Divan said. “People should actually be willing to take it.”
Rival vaccine-maker Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as