Pfizer and BioNTech vaccine emergency use would not mean approval

Friday, November 20, 2020

If emergency use approval is given to the Pfizer and BioNTech coronavirus vaccine by the US Food and Drug Administration, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.

That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.

There will be a lot of unknowns. For example, the 95 percent protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?

That’s why the 44,000-person study needs to keep running -- something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.

And at least for now, pregnant women will not qualify because they were not studied. Pfizer only recently began testing the vaccine in children aged 12 years.

A decision on Pfizer’s vaccine won’t affect other vaccine candidates in the pipeline, which will be judged separately.-AP