Top Mayo researcher calls Pfizer approval 'a spectacular human accomplishment'

The FDA granted full approval to Pfizer’s Covid-19 vaccine for those 16+ on Monday — a milestone in the fight against the virus as the first Covid-19 vaccine to move past emergency use authorization.

“This is a spectacular human accomplishment,” said Dr. Gregory Poland, an infectious diseases expert and head of Mayo Clinic’s Vaccine Research Group. “Think of this from 18 months ago when this was identified, to (now) having hundreds of millions, billions worldwide, that have received a vaccine and the speed at which science has been able to move. Amazing.”

Dr. Poland believes the FDA’s decision could soon lead to full approval for Pfizer booster shots — which have already been granted emergency use authorization for individuals who are moderately to severely immunocompromised. 

Full FDA approval requires stringent review of manufacturing processes, follow-up of clinical trial participants for a minimum of six months and intensive review of efficacy. 

While emergency use authorization follows similar guidelines — following half of clinical trial participants two months out — Dr. James Watson, chair of Mayo Clinic’s Covid-19 Vaccine Allocation and Distribution Work Group, hopes the FDA’s decision will provide greater assurance to people who so far have been hesitant to get vaccinated.

“Full FDA approval requires a rigorous review of data for safety, effectiveness and manufacturing processes, which I hope removes a barrier to vaccination for many individuals," said Dr. Watson.

The FDA’s decision comes at a significant time as the delta variant causes a surge in Covid cases around the country. Olmsted County is currently reporting the highest seven-day rolling average in cases since early 2021. 

Dr. Melanie Swift, co-chair of Mayo’s Covid-19 vaccine work group, spoke of the importance of vaccinating now before the delta variant spreads further and new variants are formed — noting that states with the lowest vaccination rates are experiencing the worst delta outbreaks. 

“Now is the time for people to get vaccinated,” said Dr. Swift. “That's really the only way that we're going to stave off what could be a really devastating next wave of this pandemic.”

Haley Handelman is a summer news intern for Med City Beat. A graduate of Mayo High School, she now studies at Northwestern University.

Cover photo licensed via Getty