Pfizer-BioNTech vaccine gets FDA advisory committee approval

The benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh its risks in individuals 16 years and older, the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee voted on Thursday.
 
WHY THIS MATTERS

The vote, which was 17 in favor and four against, with one abstention, paves the way for the FDA to authorize the vaccine for emergency use, and, if approved, to start distribution by mid-month.

Dr. William C. Gruber, senior vice president, Vaccine Clinical Research and Development for Pfizer, said the results of the clinical trials were encouraging. There was no evidence of enhanced disease, he said. Efficacy was high across racial groups.

Pain at the vaccine site was largely mild and moderate, with comparable to reactions to other vaccines, he said.

CONCERNS

The committee met for a full 8 hours, with their decision seen as a foregone conclusion, based on an FDA briefing document released days before the meeting that showed the vaccine was safe and 95% effective.

However, committee members expressed concerns about the Pfizer trial.

An unidentified number of participants developed Bell's Palsy, a condition that causes temporary weakness or paralysis in the muscles of the face. Committee member Dr. Susan Wollersheim, medical officer, Division of Vaccines and Related Products for the FDA, said there were such small numbers of participants who developed Bell's Palsy that it would be difficult to relate the condition to the vaccine at this time.

Another issue was whether 16- and 17-year-olds should be able to get vaccinated when they weren't part of the trial. 

The incidents of severe COVID-19 at this age are not high, said member Dr. Ofer Levy, a staff physician who is part of the Precision Vaccines Program at Boston Children's Hospital and a professor at Harvard Medical School. But if you take away the 16- and 17-year-olds, you lose the effort to "climb down in age and conquer the pandemic," he said.

Others said the data on this age group was too thin, since the clinical trial did not include children. The U.S. study was made up of 19,000 adults, ages 18 to 55 and 65 to 85, who were evenly split between getting a placebo and the vaccine. 

The participants were swabbed to determine they were not infected prior to each dose. The Pfizer vaccine requires two doses.

Other committee members questioned the allergic reaction by two healthcare workers who were given the vaccine in England and the length of time of its effectiveness.

Evan Fein, a Phase I trial participant, said he believed he got the real vaccine and not a placebo, because he had fever and chills. He was called repeatedly by doctors to see if he was all right, he said. As to the question of what happens in the long term, Fein said that after five months he had no long-term effects.

RECOMMENDATIONS

Some committee members recommended that Pfizer keep the trial going, even as the vaccine is being distributed, and to make sure that participants who received the placebo do not get left out of being given an actual vaccine.

Sidney Wolfe of citizens.org asked whether the placebo subjects should be told of their status. If not, they might leave the trial to get vaccinated, he said.

All trial data needs to be made public, committee members said.

THE LARGER TREND

The advisory committee is scheduled to go through a similar review of the Moderna vaccine for EUA authorization on Thursday, December 17.

As a vaccine becomes available, more than a third of adults say they are unwilling to take it, according to the Employee Benefit Research Institute – a private, nonpartisan, nonprofit research group – and independent research firm Greenwald Research, which released their annual Consumer Engagement in Health Care Survey.

The CEHCS found that only 55% of the adult population was willing to receive a COVID-19 vaccine, and 24% said they would not get the vaccine. Nine percent said that it depends, and 12% were unsure.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com