Pfizer’s COVID-19 vaccine set for final review, could become first authorized by FDA for US use as early as Thursday – USA TODAY

0
50

The safety and effectiveness of the nation’s first COVID-19 vaccine is taking center stage Thursday as a critical committee spends the day vetting and then voting on whether to recommend its general use by the American public.   

The 17-member independent Vaccines and Related Biological Products Advisory Committee is reviewing and discussing data from Pfizer and German startup BioNTech on their vaccine, called BNT162b2. 

The daylong, live-streamed meeting comes a day after the nation set a new daily record for COVID-19 deaths, topping 3,000, according to Johns Hopkins University data.

Such meetings are always accessible to the public but Thursday’s is likely to be one of the most-watched ever. 

The U.S. Food and Drug Administration published briefing documents in advance, and the public has an opportunity to submit questions. A one-hour public comment period also will be held during the meeting, said Norman Baylor,CEO of Biologics Consulting and the former director of FDA’s Office of Vaccines Research and Review.

“It’s a very transparent process,” he said.

That process will end around 5:15 p.m. when VRBPAC (pronounced verb-pack) is expected to vote to recommend the FDA authorize the Pfizer vaccine, which could come anytime after VRBPAC’s decision.

A vial of the COVID-19 candidate vaccine developed by BioNTech and Pfizer is displayed at the headquarters in Puurs, Belgium.

It’s not possible to predict with certainty what that vote will be, Baylor said. But judging from FDA’s overview of the vaccine’s safety and effectiveness published Tuesday and the fact that Pfizer and BioNTech have met all the criteria the FDA established for an authorized vaccine, the outlook is good. 

“Based on that information, one could predict that if there are no untoward scenarios that come up, authorization could be relatively soon,” he said.  

The companies are requesting an “emergency use authorization,” a more rapid overview just shy of a full vaccine approval. While they have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed and it’s not clear how long the vaccine will continue to be effective. 

Trading COVID-19 vaccines. Regular deliveries. Tracking doses: What we know about Operation Warp Speed distribution process.

If the committee recommends authorization, the FDA is expected to sign off on the vaccine, possibly as soon as Thursday night, setting the stage for the first doses to be distributed and administered across all 50 states.

Monitoring for post-vaccination problems

Watching for any adverse reactions among people who’ve gotten the vaccine is a major concern. During the morning portion of the meeting, the U.S. Centers for Disease Control and Prevention Dr. Nancy Messonnier outlined the multiple systems that will be monitoring possible problems. 

New to the vaccine world is V-SAFE, a smartphone-based after-vaccination health checker that people who get COVID-19 vaccine can sign up for if they choose.

It will send text messages and web surveys to those who do, and feed information about any health problems directly back to CDC. Anyone who reports a medically significant adverse event will get a telephone call from a CDC staffer to find out more.

Another monitoring system is VAERS, the Vaccine Adverse Event Reporting System. This is a joint CDC and FDA system established in 1990. It collects reports about adverse events from vaccines from health care professionals, vaccine manufacturers and the public.

Any adverse events that are unexpected, appear to happen more often than expected or have unusual patterns are followed up with specific studies.

The Department of Defense also has its own system for following adverse events among its personnel, as does the Indian Health Service.

Finally, there’s the Vaccine Safety Datalink, a network of nine large integrated health care organizations across the United States that conduct active surveillance and research on vaccine side effects. Because these health systems have access to their members’ medical records, they can often see patterns that might not immediately be visible to other networks.

Ethical considerations

The group spent the last session before lunch discussing the ethics of how to deal with trial participants who received a placebo rather than an active vaccine.

So far, all the COVID-19 vaccine trials have provided half of their participants an active vaccine and half a placebo or a vaccine against another condition.

When people signed onto the Pfizer trial, they agreed to remain “blinded” for two years, not knowing whether they received the active vaccine or placebo.

But once there is a safe, effective vaccine reaching the public, experts are concerned about the ethics of leaving half the volunteers unprotected. They also are worried that many participants, who believe they got the placebo because they did not react to their shots, will drop out of the trial, compromising its longer-term results.

To avoid that, Dr. Steven Goodman, an associate dean and professor of medicine at the Stanford University School of Medicine, urged the group to consider changing the trial design.

He suggested that companies not tell trial participants whether they received vaccine or placebo earlier in the trial, but give them whichever they didn’t get before they would normally become eligible for the vaccine.

That way, they would remain “blinded” to which arm of the study they were in, maintaining the integrity of the scientific study, Goodman said.

He also suggested putting them at the head of the line among their peers, so that a healthy young person, who would typically not be eligible to get a vaccine until April or May, would not jump ahead of an older person at high risk of serious COVID-19 disease. Instead, they would be among the first of the young, healthy people to be offered a vaccine.

That would remove the incentive they would otherwise have to drop out of the trial, Goodman said, and provide them a reward of sorts for volunteering to help with the research.

This “deferred randomization” design, he argued, requires ethical and scientific compromise, but is fair and justifiable.

At a certain point, he said, maybe in about a year when vaccines are widely available, trials will no longer be ethically able to justify including a placebo group but will have to compare vaccines against each other.

Afternoon program

After a lunch break and a public comment period, Pfizer/BioNTech will present their vaccine, BNT162b2. The FDA will follow with its findings.

The New England Journal of Medicine Thursday published a peer-reviewed version of the data from the late-stage Pfizer/BioNTech trial. The study confirmed numbers that the companies and the FDA have already made public and found that the vaccine was safe and highly effective.

“The results demonstrate that Covid-19 can be prevented by immunization, provide proof of concept that RNA-based vaccines are a promising new approach for protecting humans against infectious diseases, and demonstrate the speed with which an RNA-based vaccine can be developed with a sufficient investment of resources,” the study concluded.

Once the presentations are completed, the committee has two hours scheduled for discussion before it votes. 

This is a developing story. Check back for updates.

LEAVE A REPLY

Please enter your comment!
Please enter your name here