Panel recommends vaccine approval
A committee of leading U.S. vaccine scientists recommended Thursday that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans.
The endorsement paves the way for a final decision by the FDA and mass vaccinations to begin within days in thousands of front-line heath care workers and nursing homes residents.
After an eight-hour public hearing, the independent Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention to recommend the vaccine made by Pfizer and its partner BioNTech called BNT162b2.
Members found the benefits of the vaccine outweighed the risks for most people 16 years old and older.
The companies are requesting an “emergency use authorization,” a more rapid review 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.
Committee members also brought up other knowledge gaps they hope are filled in coming months, including how safe and effective the vaccine will be in pregnant and nursing women, in people with severe allergies, and in those who are immunocompromised from conditions such as HIV.
With the vote made, the committee’s recommendation now goes to the FDA, which could authorize the vaccine for emergency use as early as Friday. Once it’s authorized, vials of the vaccine will begin shipping to all 50 states.
One last important meeting will take place Sunday, when an advisory committee to the Centers for Disease Control and Prevention meets to make a final recommendation on who should get the vaccine first when it is in very short supply.
While the Advisory Committee on Immunization Practices doesn’t have regulatory power, providers receiving COVID-19 vaccine sign agreements to comply with committee guidelines. If that committee gives its thumbs up, mass vaccination could start Monday.
Thursday’s meeting of VRBPAC (pronounced verb-pack) came a day after the U.S. set a new daily record for
COVID-19 deaths, topping 3,000 – nearly as many as died on 9/11.
Overall, the committee was satisfied with the safety and effectives data provided by Pfizer/BioNTech.
But Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, raised concerns about the allergic reactions in two British people who got the vaccine when it first became available there on Tuesday and had a strong allergic reaction.
He said he is not personally concerned about the safety of the vaccine and supports authorization but wants the companies to run a separate study of people with egg or peanut allergies to reassure them that the vaccine is safe. “This issue is not going to die until we have better data,” Offit said.
He also pointed out that it will be difficult for people with severe allergies to know if they are allergic to the ingredients in the vaccine. People who are allergic to any of its ingredients have been told to avoid vaccination, he said, but “if you look at the components of that vaccine, which has probably the longest chemical name of any vaccine I’ve ever seen, nobody’s going to look at that name and say “I’m allergic to that.”
Dr. Arnold Monto, the committee’s chair and an epidemiologist at the University of Michigan’s School of Public Health agreed that more information on allergic reactions is warranted.
“Facts may be important, but perception drives a lot of decisions,” he said.
Layers of monitoring for 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 monitor possible problems.
New to the vaccine world is V-SAFE, a smartphonebased after-vaccination health checkerpeople 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.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.