Pfizer Inc. CEO Albert Bourla said he doesn’t worry about political pressure to bring potentially the first coronavirus vaccine to market, but can’t escape feeling the weight of the world on his shoulders.
Bourla’s company is among the leaders in developing a vaccine that could ease the strain of the global pandemic that has caused hundreds of thousands of deaths and crippled economies. Pfizer’s messenger RNA (mRNA) vaccine candidate has entered Phase 3 and is expected to read out this fall.
But as worries grow that the US Food and Drug Administration may be pushed by the White House and others to approve a vaccine before the 3 November US presidential election, Bourla said that sort of pressure has not reached his office.
Political pressure “doesn’t worry me at all because I don’t feel it,” he said on 6 August during a Washington Post Live interview. “We’re not going to put out there any product that our scientists do not feel that it’s safe and effective, even before FDA speaks.”
But Bourla added that he cannot ignore that the entire planet is counting on him and his employees.
“When billions of people around the world, millions of businesses and hundreds of governments are investing their hope in the pharmaceutical industry to find a solution and you are the CEO of one of the leading companies, I can assure you … that you feel the weight on your shoulders. And I do feel it,” he said.
FDA Commissioner Stephen Hahn continues to fight concerns about inappropriate pressure on the agency to clear a vaccine, writing in a 5 August op-ed in the Washington Post that all decisions will be based only on good science and data.
Hahn also has said that a vaccine could receive an emergency use authorization rather than full approval, but the pathway employed will depend on several factors. (Also see “COVID-19 Vaccines: EUA Route Offers Advantage In Review Speed, Not Level Of Evidence” – Pink Sheet, 30 Jul, 2020.)
The agency’s guidance setting a minimum efficacy bar for a coronavirus vaccine of 50% was seen in part as an effort to avoid pressure to potentially approve a substandard product. (Also see “Coronavirus Vaccine Efficacy Rate Set At 50% Because That’s What US FDA ‘Could Tolerate’” – Pink Sheet, 8 Jul, 2020.)
KEEP POLITICS OUT OF REVIEW, DISTRIBUTION DECISIONS, BOURLA SAYS
Bourla also reiterated that health authorities and scientists should decide who receives the vaccine first. He said allowing the FDA and other global regulators to make independent decisions will help build public confidence in any product that is approved.
“We need to leave the politics out of it,” Bourla said. “I think they create a very big dangerous situation because they create the perception that maybe political reasons will advance the vaccine and not science.”
“As long as people know that the approval or not of a vaccine, it is subject to strictly scientific criteria, but only the stuff the FDA is recommending, I think that would be a very big win for creating the right sentiment,” he added.
Polls have suggested public reluctance about receiving a coronavirus vaccine, in part because it is perceived to have been rushed. (Also see “Speed Of Coronavirus Vaccine Development May Hurt Public Confidence” – Pink Sheet, 14 Jun, 2020.)
OCTOBER TARGET FOR SEEKING REGULATORY APPROVAL
Indeed, an October surprise remains a possibility for Pfizer, as well as Moderna, Inc., both of which have vaccine candidates in late-stage trials.
Bourla said more than 2,000 patients already have been vaccinated as part of the trial and that if plans are followed, enough data should be available to determine if the candidate works by the end of September or early October. He also said that the company would seek regulatory approval in October, but like several other companies is manufacturing the product at-risk to ensure that upon approval it would be available as soon as possible.
“October is coming and [in] October the truth will be revealed,” he said.
Pfizer recently signed a $1.95bn deal to provide 100 million doses of its vaccine to the US government. (Also see “Pfizer’s Go-It-Alone Approach Nets $1.95bn COVID Vaccine Order From US Government” – Pink Sheet, 22 Jul, 2020.)
Unlike other firms developing COVID-19 vaccines, Pfizer has not taken government funding as part of the process, which the firm says has allowed it greater speed and flexibility. Bourla is positioning the vaccine to investors as an eventual seasonal franchise. (Also see “Pfizer Lays Out Multi-Phase COVID-19 Vaccine Commercial Strategy” – Scrip, 28 Jul, 2020.)
Bourla’s stated timeline for seeking approval fits with indications that an FDA vaccine advisory committee meeting is preliminarily scheduled for 22 October. (Also see “Warp Speed Lives Up To Its Name: FDA Planning Late October Vaccine Advisory Committee” – Pink Sheet, 4 Aug, 2020.)
Moderna’s vaccine candidate also entered Phase III in late July, and several other firms could start pivotal trials soon as well. (Also see “AstraZeneca, Janssen, Novavax Likely To Be Next ‘Warp Speed’ Vaccines In Phase III” – Pink Sheet, 3 Aug, 2020.)
The agency is using its real-time assessment system to look at clinical data before a full application is submitted, which could allow for a quicker decision. (Also see “Moderna’s COVID-19 Vaccine To Get Real-Time Data Assessment By US FDA” – Pink Sheet, 27 Jul, 2020.)
Image: iStock/MBPROJECT_Maciej_Bledowski
This article was first published in the Pink Sheet on Aug. 6, 2020.
