With Covid-19 cases soaring and hospitals strained in many states, federal regulators on Thursday morning began the first public review of a vaccine that could end the pandemic.
A committee of outside experts will spend the day examining the safety and efficacy of the vaccine developed by
Pfizer
(ticker: PFE) and BioNTech (BNTX). The advisers will hear evidence from a clinical trial of 44,000 people that the vaccine developers and reviewers at the U.S. Food and Drug Administration believe has shown that the shots are safe and highly effective.
At day’s end, the panel will vote on whether the agency should authorize the shots for use in Americans aged 16 and older.
The agency would grant an emergency use authorization for the vaccine, during the Covid pandemic, but not a full marketing approval. A few treatments for Covid have become available under emergency use authorizations, but not a vaccine that could end the spread of the SARS-CoV-2 coronavirus, said the FDA’s deputy director of vaccine trials, Doran Fink, as the hearings got under way.
In early Thursday trading, Pfizer stock was roughly flat, at $41.95, while BioNTech was up 3%, to $126.64. The companies will be able to sell the shots, under the authorization, and their 2021 revenues from the products are expected to be huge.
“Today we will be considering whether to make available to millions of Americans an as-yet investigational vaccine that has been developed, tested and reviewed in record time,” Fink said. “The American public demands and deserves a rigorous, comprehensive and independent review of the data.”
“We expect a high bar for efficacy,” he added.
In the first presentation, the dire trend of Covid cases was described by Aron Hall, Covid response chief at the Centers for Disease Control and Prevention. Hall noted that total U.S. deaths had reached 282,785 by Dec. 8, among more than 14.8 million cases. Those are only the reported cases, he cautioned, and the actual toll may be much higher.
Hospitalization rates are at their highest point since the pandemic began, especially among the elderly and residents of long-term care facilities. It is worst among Latinx, Native Americans, and Blacks, Hall said. Other groups at heightened risk are those suffering from obesity, kidney disease and diabetes.
Health-care workers are also at a higher risk of Covid, the CDC epidemiologist said, with nurses making up more than a third of medical personnel who end up in the hospital.
Even after treatments and vaccines become available, Hall warned, Americans will need to continue use of masks, social distancing, and hand washing.
Briefing papers filed earlier this week by Pfizer/BioNTech and the FDA detailed the clinical trial findings, and argued for authorization. In a presentation to the advisory committee on Thursday, FDA vaccine reviewer Susan Wollersheim reviewed the strong efficacy findings. No serious safety problems were tied to vaccination—but she noted that four cases of a temporary facial paralysis called Bell’s palsy occurred among those vaccinated and will be watched in follow-up surveillance.
The pandemic has accelerated the usual timetable for development, testing and review of vaccines like the Pfizer/BioNtech shots—and another vaccine from
Moderna
(MRNA) set for an advisory committee review on Dec. 17. Wollersheim and other witnesses acknowledged that speeding a vaccine to stem the outbreak will require a trade-off that abbreviates the safety monitoring that typically proceeds vaccine approvals. Pregnant women were excluded from the clinical trial.
To monitor safety after authorization, the government has set up networks to watch particular populations, Nancy Messonnier of the Centers for Disease Control and Prevention, says in her presentation. Health-care workers and nursing home residents will get the first allocations of vaccines and will be followed first. Later on, surveys will check Department of Veterans Affairs patients and Medicare recipients.
In a presentation recapitulating the vaccine’s development and testing, Pfizer’s head of vaccine research Kathrin Jansen will assert that the shots satisfy the requirements for an emergency use authorization. Enough trial participants had been watched for enough time to support its safety, and it 95% efficacy at preventing Covid was well above the FDA’s 50% threshold, according to Jansen’s presentation. Pfizer can reliably manufacture the vaccine, she says, and will actively monitor its use for any safety problems.
The Pfizer VP for vaccine clinical trials, Bill Gruber, will review the vaccine’s safety and efficacy tests. The developers’ pivotal controlled trial started on July 27 and has analyzed 43,448 participants of a planned 44,000 enrollees—across ethnic groups and ages that ranged from 16 to 75 and older. More than 9,000 were older than 65.
Nearly 38,000 have had at least a month of safety follow-up after their two vaccine shots, according to Gruber’s presentation, while over 19,000 have had two months of safety follow-up. Starting seven days after the second shot, the study measured efficacy by lab testing any participant that showed Covid symptoms. Reactions to the shots were also recorded for at least 6,000 subjects, and all participants are being watched for adverse events for one month, and for serious adverse events for two years.
So far, the only issues seen in the study are those common to many vaccines: some pain at the injection site, in most participants; and mild to moderate fatigue, headache, chills, and aches in a third to half.
In the final analysis, Pfizer found the vaccine showed 95% efficacy at preventing Covid, with greater than 93% efficacy across demographic groups. Participants seemed to gain protection against developing a severe case of Covid, after just the first does.
The impressive clinical trial results on the Pfizer/BioNTech vaccine were published Thursday in the New England Journal of Medicine. Less-impressive interim efficacy results from several of
AstraZeneca’s
(AZN) vaccine trials appeared earlier this week in The Lancet.
Authorization under emergency use rules is a balance of benefits and risks. The Pfizer/BioNTech vaccine raised no serious safety concerns in its trial, the company says, and showed high efficacy at reducing the risk of Covid.
Write to Bill Alpert at [email protected]
