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 group of external experts’ decision is non-binding, but FDA Commissioner Stephen Hahn said in a statement on Friday that the agency was “working quickly” towards finalizing 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 Covid-19 in clinical trials while also having 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 additional data before recommending more people in the group to receive it.
Dr. Ofer Levy, director of the Precision Vaccine Program at Boston Children’s Hospital, was among 17 outside experts who voted in favor of recommending the emergency vaccine. He told CNBC that there was a “strict” security clearance process in place, including for 16- and 17-year-olds.
“There wasn’t a particularly different safety signal for them than for the elderly, so the majority of committee members felt comfortable when they voted ‘yes’,” said Levy on Friday at Worldwide Exchange.
“Yesterday was a milestone, but there is still a long way to go,” added Levy to end the coronavirus pandemic. He pointed out the need for a large supply of Covid-19 vaccines so that more people have the opportunity to get vaccinated both in the US and abroad.
Since the doses of the Pfizer BioNTech vaccine will initially be limited, concerns about younger people currently receiving it are “controversial,” claimed Dr. Scott Gottlieb, Pfizer board member and former FDA chief. Healthcare workers and residents of long-term care facilities will come first to get the right results.
“This vaccine will not be an option for 16- and 17-year-olds for some time … and probably until it is fully licensed sometime in the spring and summer, hopefully if all goes well.” Gottlieb said on “Squawk Box”.
The FDA advisory panel will meet next week on whether to recommend the emergency use of Moderna’s Covid vaccine, which, like Pfizer’s, requires two shots and uses a new approach to vaccination that uses genetic material to trigger an immune response.
Disclosure: Scott Gottlieb is a CNBC employee and a member of the boards of directors of Pfizer, the genetic testing startup Tempus, and the biotech company Illumina. Gottlieb is also co-chair of Norwegian Cruise Line Holdings and Royal Caribbean’s Healthy Sail Panel.