FDA Commissioner Stephen Hahn, M.D., was fresh off a controversy over the emergency use authorization for convalescent plasma to treat COVID-19 when he made waves again, this time promising on Twitter that the agency would review coronavirus vaccines before the November election. And Pfizer executives appear to be in sync with that timeline, as they race to complete a phase 3 trial of their vaccine candidate.
Nicholas Kitchin, M.D., a senior director in Pfizer's vaccine R&D group, told the Centers for Disease Control on Wednesday that the clinical trial of the company’s BioNTech-partnered COVID vaccine, BNT162b2, is more than 50% enrolled.
The news followed several public comments from Pfizer’s CEO Albert Bourla regarding the company’s plan to seek FDA approval of the vaccine in October.
Hahn took to Twitter saying the agency’s reviewers are “encouraged by the rapid rate of enrollment” in clinical trials of COVID-19 vaccines.
They are looking forward to the completion of the trials so that they can evaluate data and decide whether to approve or authorize its use.— Dr. Stephen M. Hahn (@SteveFDA) August 26, 2020
Hahn also noted that the vaccine 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 vaccine 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 figured, the company should “reach full enrollment by end of next month,” Divan wrote in a note sent to investors Thursday. That means the first dataset should be released in mid-September, potentially at an investor event the company has scheduled for that time.
All of the data from the trial could be ready by mid-October, Divan added, just in time for the FDA committee meeting. “While difficult to predict, this does set the stage for potential … review and FDA Emergency Use Authorization in that same time period,” he wrote.
Pfizer did not immediately respond to a request for comment.
Divan estimates that Pfizer’s COVID vaccine could launch late this year and reach peak sales of about $1.7 billion in 2021. Sales will fall to $850 million in 2023, after which the vaccine will bring in annual sales between $500 million and $600 million, assuming “a flu-like scenario with annual vaccinations,” he predicted.
Pfizer is facing competition, notably from Moderna, which is also working on an mRNA vaccine to prevent COVID-19. But SVB Leerink analysts pointed out in a note earlier this week that Pfizer has some key advantages: Its vaccine is the only candidate to have 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, SVB Leerink analysts added.
There's also AstraZeneca and its Oxford University-partnered shot. Earlier this week, the Financial Times reported that the Trump administration was weighing a potential OK for that vaccine before the election. AstraZeneca said Tuesday it had not discussed an emergency authorization with U.S. officials. The shot is in phase 2/3 testing in the U.K., Brazil and South Africa, and the company doesn’t “anticipate efficacy results until later this year," a spokeswoman said via email.
Several other COVID vaccine contenders will also be vying for market share, some of which have developed their candidates using technology that’s already proven, unlike mRNA. They include Johnson & Johnson, which plans to enroll 60,000 people in a trial of its vaccine, Ad26.COV2.S. J&J developed the vaccine using the same technology behind an Ebola vaccine that’s been given to more than 60,000 people.
SVB Leerink tempered its predictions for Moderna after speaking with three specialists who suggested that protein subunit vaccines might be more attractive than the mRNA candidates. Sanofi and GlaxoSmithKline are working on a protein subunit vaccine, as is Novavax, which is gearing up for its phase 3 trial now.
Given Moderna is not going to complete enrollment until September, which means all participants in the trial won’t have their booster until October, why have a meeting on 10/22?— Joanna Turner Bisgrove, MD, FAAFP (@JoTBizMD) August 26, 2020
Oh, I get it. It’s before the election.
Try not to be so blatantly obvious next time.
The FDA's Hahn, who took some heat for incorrectly stating that convalescent plasma is associated with a 35% improvement in survival in COVID-19 patients, was quick to tweet that the October 22 review of vaccine candidates would hinge on "good scientific data." But that didn't stop some critics from pointing out that said meeting would be happening just days before the presidential election.
As for Pfizer, it continues to rack up supply deals for its vaccine. In late July, it locked down a $1.95 billion order from the U.S. government for 100 million doses. It also has supply deals with the U.K. and Japan.