Dr. Archana Chatterjee declares her no on the FDA panel to the Pfizer Covid vaccine
Dr. Archana Chatterjee, a member of the FDA advisory panel who voted against the recommendation of Pfizer’s Covid-19 emergency vaccine, told CNBC on Friday that her opposition was due to her disagreeing that 16- and 17 -Year-olds should be included right now.
In a “Squawk Box” interview, Chatterjee said she would have voted “yes” if the question before her had been different. “Let me be very clear that I fully support the emergency use approval for the use of this vaccine from Pfizer and BioNTech for adults 18 and older,” said Chatterjee, a pediatric infectious disease specialist who serves as the dean of Chicago Medical school.
The FDA committee recommended emergency approval of the vaccine for people aged 16 and over.
In addition to Chatterjee, three other members of an advisory committee of the Food and Drug Administration voted against the recommendation of the vaccine from Pfizer in the USA and the German partner BioNTech for the emergency. One member abstained and 17 voted for a recommendation.
The decision of the group of external experts is not binding, but FDA Commissioner Stephen Hahn said in a statement on Friday that the agency was “working fast” on completing the emergency approval.
Pfizer and BioNTech’s vaccine would be the first to receive regulatory approval in the US. It has already been approved by health authorities in the UK and Canada.
Chatterjee noted that the vaccine was 95% effective in preventing clinical trials of Covid-19 while showing a “really good overall safety profile.” She added, “I think we were pleasantly surprised to see that this vaccine performed so well in the tens of thousands of people who took part in the study.”
While commending Pfizer and BioNTech for including people under the age of 18 in the studies, she stressed that she would have liked to see more data before recommending more people in the group to receive it.