FDA hears case for Pfizer booster shots

Booster shots are at the center of a debate between Pfizer and federal health officials, and Monday the vaccine maker made its case to U.S. scientists for needing a third COVID-19 shot

Pfizer-BioNTech says it’s time to start thinking about booster shots, especially with new variants circulating, but the FDA and CDC said Americans don’t need a booster shot right now. In a briefing to federal officials Monday, the vaccine maker presented their argument for the third shot.

"I think it's really important to see what they say when they come out the other end," said Dr. Thomas Unnasch, an epidemiologist with USF Health. "I really hope that they approve the idea of giving us a third booster so that it's going to be available and ready to go if we need it."

Dr. Unnasch said Pfizer is trying to plan ahead. He said there are concerns more breakthrough infections will show up in already vaccinated Americans. Studies show the new variants are slipping past roadblocks.

"With Pfizer's initial data, if you give a boost, you get a tenfold increase in the amount of antibodies that are there. So that's going to more than overcome the effect of these variants," said Unnasch.

Vaccine makers are tuned in to the virus mutations, so they can develop new defenses beyond a booster. Dr. Unnasch said scientists are revamping the two-dose shot.

"My impression is that Pfizer is going to be going ahead to start to run clinical trials on that. And if it's successful, we'll probably ask for another emergency use authorization for that new enhanced version of the vaccine later on this year, probably in November or December," he said.

Scientists said federal health officials are right that vaccinated people don’t need a booster at this time, but they say Pfizer is also right to plan.

"Probably there's not a crying need right now, but there probably is going to be a need in three to six months, I would guess," said Unnasch about the booster shots.

Public health scientists said Pfizer representatives are thinking people who got vaccinated first back in December 2020, and how a booster shot could help them be even more protected against variants. The company plans to go for emergency use authorization for their third dose in the coming weeks, so it will be ready if needed later this year.