Pfizer says earliest U.S. filing for COVID-19 vaccine would be late November

(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.”

FILE PHOTO: The logo of U.S. pharmaceutical corporation Pfizer Inc. is seen at a branch in Zurich, Switzerland October 2, 2018. REUTERS/Arnd Wiegmann

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

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Pfizer says it will not have a coronavirus vaccine until late November, allaying fears of a rush for approval before Election Day

Chief executive Albert Bourla wrote in the letter that while the company projects it may have enough data to determine whether the vaccine is effective in October, there will not be sufficient safety follow-up to satisfy criteria laid out by the Food and Drug Administration until late November.

“A key point that I’d like to make clear is that effectiveness would satisfy only one of the three requirements and, alone, would not be enough for us to apply for approval for public use,” Bourla said. “Safety is, and will remain, our number one priority.”

The letter was welcomed by Eric Topol, a physician-scientist at Scripps Research Translational Institute who joined other experts in writing to Bourla in late September, asking the company not to seek authorization for a vaccine before late November. Topol recently had a virtual meeting with company executives to express his concerns and said he was frustrated they would not answer directly whether they would seek broader use of a vaccine before Nov. 3.

Bourla’s emphasis on having data in October “is what got many of us concerned, whether it was inadvertently playing into the political pressure or just because the incentives were aligned,” Topol said. “I thought [the letter] was very good. I wish it had been done potentially even earlier.”

Bourla made clear that while the company won’t seek approval until reaching the safety threshold, it could announce data on whether the vaccine candidate works before the election.

Pfizer’s trial will ultimately include 44,000 study subjects, with half receiving two shots of its experimental vaccine and the other half receiving placebo inoculations. Neither participants, study investigators nor company executives know who received a vaccine and who did not. But periodically throughout the trial, an independent committee is examining the data to see whether the vaccine is protecting participants from infection, as demonstrated by far fewer cases of covid-19, the disease caused by the virus, in those getting the shots than those receiving a placebo.

“In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us,” Bourla wrote.

The FDA in October issued guidance explaining the criteria for an emergency use authorization, saying a vaccine given to healthy people will be held to a higher standard than the typically low threshold that a medical product “may be effective” for emergency use. The agency put forth a requirement — despite White House objections — that vaccine candidates must have a minimum of two months of follow-up data on half of the participants in the study.

Pfizer will not have such data until the third week of November. Moderna, a biotechnology company, will not have enough safety data to apply for regulatory authorization until two days before Thanksgiving, according to spokesman Ray Jordan. Two other late-stage vaccine trials, from AstraZeneca and Johnson & Johnson, are paused because of potential safety concerns and have previously predicted readouts from their

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Pfizer says COVID-19 vaccine could be ready by late November

Pfizer CEO Albert Bourla said in an open letter on Friday that his company could apply for emergency federal approval of its coronavirus vaccine as soon as late November, noting that the drugmaker expects to have enough data on the treatment’s safety and efficacy by then. That marks the first time a vaccine developer has specified when a vaccine might be available.

“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 wrote in the letter. The Food and Drug Administration is in charge of reviewing and approving requests for emergency use.

He added, “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.”


COVID-19 treatment trials halted over safety …

02:17

Thirty-seven states are seeing a rise in average new coronavirus cases; only one state — South Carolina — is down. At the same time, two vaccine developers have paused their trials due to safety concerns, with drugmaker Eli Lilly halting human testing and Johnson & Johnson pausing its trial this week due to a sick participant. 

Pfizer’s guidance that it could apply for emergency use authorization by the end of November is a setback to President Donald Trump, who has asserted that a vaccine could be ready by election day on November 3.

“There is a great deal of confusion regarding exactly what it will take to ensure its development and approval,” Bourla said in the letter. 

Pfizer, which is developing the vaccine with BioNTech, must demonstrate that the treatment is effective in preventing COVID-19 in “at least a majority of vaccinated patients,” he noted. Next, the vaccine must be shown to be safe. Lastly, the company must demonstrate it can manufacture the vaccine consistently “at the highest quality standards,” Bourla said.

Pfizer earlier this year signed a $1.9 billion pact to provide the U.S. government with 100 million doses of a COVID-19 vaccine. Americans would receive the vaccine for free, the pharmaceutical company said. The deal for the vaccine includes the right to purchase up to an additional 500 million doses.

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