Dr. Scott Gottlieb told CNBC on Monday that he expected U.S. drug regulators to clear the Pfizer BioNTech Covid-19 vaccine in late fall or early winter this year for emergencies in children ages 5-11.
The Pfizer board member said data from the company’s vaccine trials for children in this age group “should be available in September,” and was then presented to the Food and Drug Administration that month.
“The application will probably not be made until October,” said Gottlieb, who headed the FDA during the Trump administration from 2017 to 2019.
“If the FDA sticks to its normal schedule in reviewing these applications, you would expect this review to be a four to six week review for a potential emergency clearance ‘are late fall, early winter,” added Gottlieb in a Squawk Box interview added.
Gottlieb’s expectations are in line with recent remarks by White House Chief Medical Officer Dr. Anthony Fauci, on the NBC show “Today”.
The Pfizer BioNTech two-shot Covid vaccine is currently the only one to have received full FDA approval, which happened on Aug. 23. However, this designation only applies to people aged 16 and over. Children aged 12 to 15 can still receive Pfizer, but only in an emergency.
The Johnson & Johnson single vaccine and the two-dose Moderna vaccine, both used in the United States in an emergency, are approved for people aged 18 and over. Moderna has applied for full FDA approval for this age group. J&J has not yet applied for full approval. In June, Moderna applied to extend its emergency permit to children between the ages of 12 and 17.
Young children who can be vaccinated are an important step in fighting the pandemic in the United States, especially when children go back to school in the fall. Last week, Covid pediatric hospital admissions reached their highest level since records by U.S. health officials began about a year ago. While the coronavirus poses a lower risk to children than, say, people over 65, some studies suggest that children who become infected can still pass the virus on to other people.
Delta variant could “put pressure” on FDA
Gottlieb said his prediction that children ages 5-11 would be eligible for the Pfizer vaccine in late fall or early winter is a “streamlined scenario, if everything goes right and this is an expedited review, like the one with the.” other requests was the case “.
The former FDA chief left the possibility open that the schedule could change. It is possible that this could be delayed if the drug agency decides that it wants a “median follow-up of children of three to six months in clinical trials,” said Gottlieb, which would “provide a longer-term view of their performance” in Time . “
On the flip side, Gottlieb said the highly transmissible Delta variant, which has sparked a resurgence of coronavirus cases, hospitalizations, and deaths in Americans, could impact the vaccine review process in younger children.
“If we continue to see these increasing infection rates in children, especially as the Delta variant migrates to the northeast, there could be more pressure to try to get an earlier approval for a vaccine,” said Gottlieb.
Pfizer’s study data on children under the age of 5 are not expected to be released until November, Gottlieb said. “So that’s further back.” He added, “This is a lower dose than the vaccine used in children ages 5-11.”
Disclosure: Scott Gottlieb is a CNBC employee and a member of the board of directors of Pfizer, genetic testing startup Tempus, health technology company Aetion, and biotechnology company Illumina. He is also co-chair of the Healthy Sail Panel of Norwegian Cruise Line Holdings and Royal Caribbean.