FDA Commissioner Stephen Hahn, MD, was fresh from a controversy over the authorization for emergency use of restorative plasma to treat COVID-19 when he made waves again, this time promising on Twitter that the agency would review coronavirus vaccines for the elections of November. And Pfizer executives seem to be in sync with that timeline as they race to complete a Phase 3 trial of their vaccine candidate.
Nicholas Kitchin, MD, senior director at Pfizer’s vaccine R & D group, told the Centers for Disease Control on Wednesday that the clinical trial of the company’s BioNTech partner COVID vaccine, BNT162b2, is more than 50% registered.
The news followed several public comments from Pfizer’s CEO Albert Bourla regarding the company’s plan to seek FDA approval for the vaccine in October.
Hahn took to Twitter and said the agency’s reviewers “are encouraged by the rapid rate of enrollment” in clinical trials of COVID-19 vaccines.
They look forward to completing the trials so that they can evaluate data and decide whether to approve or authorize the use.
– Dr. Stephen M. Hahn (@SteveFDA) August 26, 2020
Hahn also determined that the fax advisory committee would meet on October 22. The comments were noteworthy, given that the FDA’s website does not list that committee meeting on its calendar.
Mizuho Securities analyst Vamil Divan figures that fax timeline can only benefit Pfizer. If the company is already halfway to its goal of recruiting 30,000 patients in the mRNA vaccine trial, he thought the company should “reach full enrollment by the end of next month,” Divan wrote in a note sent to investors on Thursday . That means the first dataset should be released by mid-September, potentially at an investor event the company has planned for that time.
All data from the trial could be ready by mid-October, Divan added, just in time for the FDA commission meeting. “While difficult to predict, this sets the stage for potential … assessment and FDA Authorization for emergency use in the same time period,” he wrote.
Pfizer did not immediately respond to a request for comment.
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Divan estimates that Pfizer’s COVID vaccine could launch later this year and reach a peak sales of about $ 1.7 billion in 2021. Sales will fall to $ 850 million in 2023, after which the fax brings annual sales between $ 500 million and $ 600 million, based on “a flu-like scenario with annual vaccinations,” he predicted.
Pfizer faces competition, especially from Moderna, which is also working on an mRNA vaccine to prevent COVID-19. But SVB Leerink analysts pointed out earlier this week in a note that Pfizer has some significant advantages: The vaccine is the only candidate that has produced confirmed responses in CD4 + and CD8 + T cells in human trials – a sign of strong immune protection – the analysts said, And Pfizer has a strong infrastructure and commercial expertise that the much younger Moderna lacks, added analysts from SVB Leerink.
There’s also AstraZeneca and her shot with Oxford University partner. Earlier this week, the Financial Times reported that the Trump administration was weighing a potential OK for that fax before the election. AstraZeneca said Tuesday it had not discussed emergency authorization with U.S. officials. The shot is in phase 2/3 testing in the UK, Brazil and South Africa, and the company “does not expect any impact results until later this year,” a spokeswoman said via email.
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Several other candidates for vaccine against COVID will also compete for market share, some of which their candidates have developed with technology already proven, other than mRNA. They include Johnson & Johnson, which plans to enroll 60,000 people for a trial of its vaccine, Ad26.COV2.S. J&J developed the vaccine using the same technology behind an Ebola vaccine given to more than 60,000 people.
SVB Leerink tempered its predictions for Moderna after speaking with three specialists who suggested that vaccines for protein subunit would be more attractive than the mRNA candidates. Sanofi and GlaxoSmithKline are working on a protein subunit vaccine, such as Novavax, which is currently preparing for its Phase 3 trial.
In view of Moderna, the registration will not be completed until September, which means that all participants in the trial will not have their booster until October, why have a meeting on 10/22?
Oh, I get it. It’s for the election.
Try not to be so obvious next time.
– Joanna Turner Bisgrove, MD, FAAFP (@JoTBizMD) August 26, 2020
The FDA’s Hahn, who took some caution to incorrectly state that restorative plasma is associated with a 35% improvement in survival in COVID-19 patients, was quick to tweet that the October 22 review would depend on vaccine candidates on “good scientific data.” But that did not stop some critics from pointing out that the meeting would take place just days before the presidential election.
As far as Pfizer is concerned, it continues to provide offers for its fax machine. At the end of July, it blocked a $ 1.95 billion order from the U.S. government for 100 million doses. It also has supply agreements with the United Kingdom and Japan.
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