Member of the advisory panel at Food and Drug Administration, Dr. Archana Chatterjee announced her reasons for voting against the authorization of Pfizer’s Covid-19 vaccine for emergency use. She says that she does not believe that children of 16 and 17 years should be included in the vaccination drive as the vaccine has been cleared for use in adults of 18 years and above.
On Friday, Chatterjee, a pediatric infectious disease specialist and dean of the Chicago Medical School, told CNBC that her opposition was based on her belief that the currently 16- and- 17-year-old should be exempted from the emergency use drive.
In a “Squawk Box” interview, Chatterjee said she would have cast a positive vote if the question had been different. “I want to be very clear that I am fully supportive of the emergency use authorization for the use of this vaccine from Pfizer and BioNTech for adults 18 years and older,” said Chatterjee.
The FDA committee has recommended emergency authorization for people of 16 and above.
Reports say that three other members of the FDA advisory panel also voted against recommending Pfizer’s COVID-19 vaccine for emergency use. It is said that one member refrained from casting the vote, but the remaining 17 were in favor of a recommendation.
The vaccine developed by from Pfizer and BioNTech would be the first to obtain regulatory clearance in the United States. The vaccine has been approved by health officials in Canada and the United Kingdom.
Chatterjee noted that the vaccine has shown “really good safety profile overall” as it has proven to be 95% effective in the clinical trials. She added, “I think that we were pleasantly surprised to see that this vaccine has such good efficacy in tens of thousands of participants that were included in the trial.” She commended Pfizer and BioNTech for their efforts and good intentions behind including people under 18 in the trials.
Chatterjee feels that there needs to be additional data and definitive results before the under-18 recommendation by the companies.
Director of the Precision Vaccines Program at Boston Children’s Hospital, Dr. Ofer Levy, had voted in favor of recommending the vaccine. He told CNBC a “rigorous” safety review process took place, including for 16- and 17-year-olds.
“There was no particularly different safety signal for them as the older individuals, so the majority of the committee members felt comfortable voting ‘yes,’” Levy said Friday on “Worldwide Exchange.”
“Yesterday was a milestone but there is a long road ahead” in the effort to end the coronavirus pandemic, Levy added.
As the doses of the vaccine are likely to be limited in the early days, concerns have been raised regarding its administration to the younger individuals, says Dr. Scott Gottlieb, a Pfizer board member and former FDA chief. “This vaccine isn’t going to be eligible for 16- and-17-year-olds for quite some time … and probably until it gets fully licensed at some point, hopefully if everything goes well, in the spring and summertime,” Gottlieb said on “Squawk Box”.
Source: CNBC
