FDA panel member says she voted against vaccine authorization because of limited data on ‘younger participants’

A member of a federal panel that voted Thursday to move forward with an emergency use authorization for Pfizer’s coronavirus vaccine said that she voted against the candidate citing a lack of data on younger participants. 

Archana Chatterjee, Dean of the Chicago Medical School, told CNN anchor Erin Burnett during a panel segment on “OutFront” that she is for the use of a coronavirus vaccine in legal adults. 

“I want to make it very clear that I am fully supportive of the emergency use authorization of this vaccine for use in adults 18 years and older. I think we are facing a deadly pandemic, and the vaccine, in addition to all the countermeasures, are needed to try to control the pandemic,” said Chatterjee. 

“The issue I had was with regard to the data as Dr. Thomas mentioned in those younger patients excusing those younger participants, where I felt like the data were limited,” she added. “And since they are not a high risk category, at this point in time they’re not high priority for vaccination.”

A 21-person Food and Drug Administration (FDA) panel composed of outside experts, including Chatterjee, on Thursday voted 17-4 to move forward with an emergency authorization from the agency. 

Chatterjee was one of four who voted against recommending the vaccine.

“For those reasons, I thought it would be important to vote no and bring that to the attention to the FDA,” Chatterjee continued. 

Stephen Thomas, who was also part of Burnett’s panel Thursday night, is the principal investigator for the Pfizer coronavirus vaccine.

Thomas responded to Chatterjee’s comments saying, “I know that, you know, the majority of children who do get infected don’t — many of them are asymptomatic and another large group or just have mild illness but the fact is, they can get infected, they can transmit to other higher risk people.”

Chatterjee replied, once again citing the lack of data on young participants and expressed her concern that minors would be made to participate on the orders of someone else and not of their own volition.

But Burnett pressed Chatterjee, pointing out that experts have warned the vaccine will only be effective if enough people are immunized to the coronavirus.

Chatterjee said, “It’s a matter of timing I think Erin, you’re absolutely correct that we need — it’s estimated somewhere around 60 or 70 percent of the population to be vaccinated for the vaccine to have an impact on controlling the pandemic That is true.”

But Chatterjee reasoned that that percentage of the population would not be receiving the vaccine for quite some time, so there was time and reason to collect further data while that number is reached.

Pfizer vaccine trials on children as young as 12 began in October. One hundred children were vaccinated by a team at Cincinnati Children’s Hospital.

Pharmaceutical company Moderna announced last week that it would begin coronavirus vaccine trials on adolescents aged 12 to 17.

Following the panel’s vote Thursday, the FDA has to give the official green light on Pfizer’s vaccine. From there, the Trump administration will begin to ship millions of doses of the vaccine across the country. 

The final step before shots go into arms, however, is a Centers for Disease Control and Prevention panel, which will have to “OK” the vaccine.  

Tags Archana Chatterjee BioNTech COVID-19 vaccine Moderna Pfizer Vaccination Vaccine

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