Wed. Nov 25th, 2020

Americans are beginning to see light at the end of this year-long pandemic tunnel with Friday’s announcement Pfizer and its partner BioNTech are submitting its candidate vaccine, BNT162b2, to the Food and Drug Administration for emergency authorization.

The companies revealed earlier this week the vaccine was 95% effective. If it is authorized as swiftly as is expected, frontline health care workers could receive the first doses of the vaccine before the end of December.

While some people have shown enthusiasm at the prospect of a quick turnaround, others are more skeptical. How is it possible a vaccine that under normal circumstances would take years to approve could be ready to roll out in a couple of weeks and still be safe?

Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, stressed to the USA TODAY Editorial Board last week public confidence in the COVID-19 vaccine approval process is key to beating the pandemic.

Before a vaccine is submitted for FDA authorization, an independent Data Monitoring Committee (DMC) reviews clinical trial data to confirm it is safe. The committee is made up of career scientists who have experience serving in a DMC, have relevant expertise and experience in clinical trials, according to FDA guidance. 

Throughout the trials, the committee members monitor effectiveness, safety and study conduct, and even consider interim changes depending on new data that may emerge from other studies. 

About half the trial participants must be two months past their second shot as severe adverse effects are more likely to happen within six weeks. The DMC for the Pfizer/BioNTech vaccine study “has not reported any serious safety concerns related to the vaccine,” the companies said in a statement. Fauci said he looked at the study data Sunday afternoon.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will advise the FDA whether it should issue an emergency use authorization for the vaccine. VRBPAC is a group of outside experts who advise FDA on whether or not to approve drugs, therapeutics and vaccines after they have gone through FDA’s rigorous approval process. The group plans to meet Dec. 10 to evaluate the Pfizer vaccine candidate.

Then Pfizer submits the data to the FDA.

The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.

A few days before the meeting, the FDA will release its own internal analysis, which will set the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict. They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom.

It’s important to note even if the candidate vaccine gets authorized and is distributed by the millions, it’s still considered “investigational.” The 44,000-person study will keep going until it becomes unethical to keep giving trial participants placebo shots, in which case, scientists will have concluded that the vaccine is safe and effective. 

Until then, anyone offered the authorized vaccine must get a “fact sheet” describing potential benefits and risks before going through with it, Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.

Fauci stressed the importance of instilling vaccine confidence in the American public when it’s available to the general population starting April through July. If most of the country gets vaccinated within that time frame, he estimates the U.S. can return to pre-pandemic normalcy by fall 2021. 

No matter how well the vaccine works in preventing the coronavirus, it won’t end the pandemic if not enough people take it.

Vaccine efficacy is how well the vaccine works in a vaccinated group compared to a placebo group in a controlled trial. Vaccine effectiveness is the impact of the vaccine on the community and the dynamics of the disease, Fauci said. 

If 30% to 50% of the population don’t get vaccinated, Fauci says the efficacious vaccine has no chance of becoming effective in the community. 

Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT. 

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.

Source

By Editor

Leave a Reply

Your email address will not be published. Required fields are marked *