The former commissioner of the U.S. Food and Drug Administration and a Pfizer board member said on Sunday that a COVID-19 vaccine for children ages 5 to 11 could be ready as soon as Halloween 2021.
Appearing on CBS News “Face the Nation,” Dr. Scott Gottlieb, said that Pfizer expects to have the necessary data before the end of this month and be ready to file “very quickly with the FDA.”
“FDA has said it’s going to be a matter of weeks, not months, in terms of their evaluation of that clinical data to make a determination whether they’re going to authorize vaccines for kids aged five to 11. I interpret that to mean perhaps four weeks, maybe six weeks. But I think in a best-case scenario, given that timeline they’ve just laid out, you could potentially have a vaccine available to children aged five to 11 by Halloween.”
Anyone over the age of 12 is currently eligible to receive the COVID-19 vaccination from Pfizer, Moderna and Johnson & Johnson. The Centers for Disease Control says that children younger than 12 should wear face masks when they are around other people to protect themselves from becoming infected.
According to CBS News, “Pfizer has been conducting clinical trials of its two-dose vaccine in children 2 years and older, and its approval could be crucial to helping combat the spread of the highly contagious Delta variant in schools. Children represent 25% of new COVID-19 infections.”
Gottlieb told “Face the Nation” that he expects the COVID-19 vaccine will be eventually be required for children in public schools.
As the Delta variant took hold this summer, the rate at which children were hospitalized for COVID-19 surged.
The Los Angeles Times reported earlier this month, “The delta variant has created a new and pressing risk to children and adolescents across this country,” the American Academy of Pediatrics wrote in an Aug. 5 letter to the FDA. The doctors exhorted the agency “to carefully consider the impact of its regulatory decisions on further delays in the availability of vaccines for this age group.”
The FDA is keenly aware of the pressure. It responded Friday with the release of an unusual public statement that acknowledged the urgency of its mission and promised to review clinical trial data “as quickly as possible, likely in a matter of weeks rather than months.”
The FDA said in a statement on Friday that, “It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population.
Children are not small adults – and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults.”
The FDA also outlined the steps it will take “to ensure the safety and efficacy of these products for children.”
The agency also said, “Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of COVID-19 vaccines in children will not cut any corners.”
“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible. We have to let the science and data guide us. The FDA is working around the clock to support the process for making COVID-19 vaccines available for children.”