Analysis of interim data for Pfizer Inc.'s coronavirus vaccine candidate has not yet begun, setting the timeline for data to be submitted to U.S. regulators back to around the third week of November, according to CEO Albert Bourla.
The New York-based company is developing a vaccine to guard against the coronavirus with Germany's BioNTech SE in multiple clinical trials including more than 42,000 participants so far. The companies in July released preliminary data and a timeline suggesting the vaccine would be up for U.S. Food and Drug Administration review in October.
Bourla has previously been criticized for promising phase 3 vaccine data for the highly anticipated vaccine before the end of October. But the Pfizer chief walked back that timeline during an Oct. 27 third-quarter earnings call.
"For us, the election is an artificial milestone. This is going to be not a Republican vaccine or a Democratic vaccine," Bourla said. "[This] will be the vaccine for the cities of the world, and this is how we see it."
Bourla said Pfizer expects to file for emergency use authorization in the U.S. in the third week of November.
"I can say today that the data monitoring committee has not been unblinded to efficacy data, nor has it conducted any efficacy analysis today," Bourla said. "In case of a conclusive readout — positive or negative — we will inform the public as soon as we complete the necessary administrative work, which we estimate to be completed within one week from the time we know."
In a blinded trial, very few people have access to information regarding who has received the vaccine or the placebo. Bourla said only a small group of Pfizer employees have access to that information, and none has been shared with the broader company or the independent monitoring committee as of this time.
Bourla said no further efficacy data will be shared with the public until a conclusive readout from the committee is available.
The FDA set strict standards for obtaining an emergency use authorization for a COVID-19 vaccine in early October. Companies will be required to provide two months of safety data from the ongoing phase 3 clinical trials in order to receive authorization. Bourla said the independent committee that will receive the trial data has not changed its mandate in any way in response to the new FDA requirements.
"Let's all be very patient. I know how much the stress levels are growing. I know how much a vaccine is needed for the world," Bourla said. "We are working very diligently, very carefully to make sure that we will bring this project through the finish line."
Pfizer expects the data analysis to take about a week to release once available. The trial design requires 32 patients out of the 44,000 possible enrollees to become infected with COVID-19, the disease caused by the novel coronavirus, before a first look at the data is available. Bourla acknowledged that the 32-case threshold has not yet been reached.
Bourla expressed confidence in the quality of the interim data and dismissed a suggestion that regulatory filing will have to wait for a final readout from the trials. The CEO said the vaccine has shown a strong immune response in patients who have received it in earlier trials, but said "you never know until you have a study readout."
"We have reached the last mile here," Bourla said. "I'm not bullish that the vaccine will work. I am cautiously optimistic that it will work."
Pfizer is prepared to roll out the vaccine upon authorization from the FDA, but Bourla said the regulator should take "as much time as they need" to review the candidate.
The CEO said the company "feels good" about meeting a goal of distributing 100 million doses to the U.S. by March under a contract signed with the federal government. He acknowledged that providing 30 million doses by the end of the year would only be enough for about 15 million Americans, meaning the vaccine will be distributed with "targeted" availability.
Bourla noted that public skepticism of a safe vaccine has grown due to "politicization" of the vaccine development process. Pfizer has therefore taken unprecedented measures to bolster support for immunization, including publishing real-time phase 1 trial data and committing with other pharmaceutical companies to ethically developing a quality vaccine. He also noted that the company is developing the vaccine at a financial risk.
Pfizer expects to ramp up education efforts on the vaccine's safety for the public once a label for the vaccine is in hand, including a campaign for minority communities that have been disproportionately affected by COVID-19.