Dr. Scott Gottlieb told CNBC Monday that he expects U.S. drug regulators to remove the Pfizer-BioNTech Covid vaccine for emergency use in children ages 5 to 11 in late fall or early winter of this year.
The Pfizer board member said data from the company’s vaccine trials for children in this age group “should be available in September” and should then be submitted to the Food and Drug Administration this month.
“The application will probably not be filed until sometime in October,” said Gottlieb, who led the FDA from 2017 to 2019 during the Trump administration.
“If the FDA adheres to its normal timeline, in terms of how it reviews these applications, this review is expected to be a four- to six-week review for a potentially emergency use authorization. , so it will put you on a schedule where It’s late fall, early winter, “Gottlieb added in an interview with” Squawk Box. “
Gottlieb’s expectations coincide with recent statements by White House chief medical adviser Dr. Anthony Fauci, on NBC’s “Today.”
The Pfizer-BioNTech double-shot Covf vaccine is currently the only one that has received full FDA approval, which happened on August 23rd. However, this designation is only for people 16 years of age or older. Children 12 to 15 years old can still get Pfizer but in case of an emergency.
The unique feature of Johnson & Johnson and the modern two-dose vaccine, both under emergency use in the U.S., have been eliminated for those over 18 years of age. Modern has applied for full FDA approval for this age range. J&J has not yet sought full approval. In June, Moderna applied to extend its emergency use permit to cover children ages 12-17.
Young children with the ability to be vaccinated are an important step in the fight against the pandemic in the US, especially when children return to school in the fall. Last week, Covid pediatric hospitalizations reached their highest level since U.S. health officials began recording them about a year ago. Although coronavirus presents a lower risk for children than people over 65, for example, some studies suggest that children who become infected can transmit the virus to other people.
The Delta variant could “pressure” the FDA
Gottlieb said his projection that children aged 5 to 11 would be eligible to receive the Pfizer vaccine in late fall or early winter represents an “optimized scenario, if all goes well and this is a review accelerated as other applications have been “.
The former FDA chief left open the possibility that the timeline could change. It may be delayed if the drug regulator decides it wants an “average three- to six-month follow-up of children in clinical trials,” said Gottlieb, who would offer “a long-term view of their time performance.”
On the other hand, Gottlieb said the highly transmissible delta variant, which has led to a resurgence of coronavirus cases, hospitalizations and deaths among Americans, could affect the vaccine review process in younger children.
“If we continue to see these accelerated rates of infections in children, especially when the delta variant moves to the northeast, I think there would be more pressure to try to get prior authorization for a vaccine,” Gottlieb said.
Pfizer test data on children under 5 will not be presented until likely November, Gottlieb said. “So it’s further back.” He added: “It is a lower dose than the vaccine that will be used in children aged 5 to 11.”
Outreach: Scott Gottlieb is a CNBC contributor and board member of Pfizer, initial genetic testing company Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co – chair of Norway Cruise Line Holdings‘i Royal Caribbean“Healthy Candle Panel”.