“The benefits far outweigh the risk,” said Hank Bernstein, a pediatrician at Cohen Children’s Medical Center in New York and member of the advisory committee. This will provide protection for 12-15 year olds, will decrease transmission within families, will translate to community immunity, and will allow kids this summer to go to camp and back to school, he said.
While teens are less likely to develop serious Covid-19 than older adults, vaccinating this age group is also a critical part of ending the pandemic, Biden’s top medical adviser Anthony Fauci told POLITICO last week. FDA on Monday authorized the shot for that age group.
“We really do need to crush the outbreak, and you do that by essentially interrupting the chain of transmission; adolescent kids are part of the chain of transmission,” the longtime director of the National Institute of Allergy and Infectious Diseases said.
Playing catch-up: A CDC official said during the meeting that Covid-19 vaccines can now be given at the same time as other shots, a change that could help teens catch up on any vaccinations they have missed during the pandemic. Previously, the government had recommended that the public avoid getting other vaccines for two weeks before or after a Covid-19 shot.
This change is reflective of the substantial safety data gathered on the Pfizer-BioNTech, Moderna and Johnson & Johnson Covid-19 vaccines in adults, and prior experience giving multiple vaccines simultaneously. Clinicians and scientists presenting to the CDC panel said that people receiving multiple vaccines simultaneously will generate the same amounts of protective antibodies without increased risks of adverse side effects.
Big logistical questions loom: Rolling out the Pfizer-BioNTech vaccine to the 12-15 age group could complicate the logistics of distribution to adults. The shot would be the only one available for younger teens, which would mean that jurisdictions would need to prioritize its use for that age group to ensure availability. The shot also requires freezers for long-term storage, which could be a barrier for vaccine distributors in low-income or rural areas.
Background: A late-stage clinical trial in 2,300 children aged 12 to 15 found the vaccine to be 100 percent effective in preventing Covid-19 in that age group — and the younger teens actually developed higher antibody levels post-vaccination than did those aged 16 to 25. There were zero cases reported of Covid-19 reported in the participants who received the vaccine, and 34 cases reported in the placebo group.
Pfizer and other manufacturers are also studying their vaccines in much younger children — some infants — but do not expect those results until early fall. The timeline could complicate plans for complete school reopenings.
FDA said Monday that its vaccine advisory committee will meet on June 10 to discuss coronavirus vaccination in children, particularly those younger than 11. FDA does not have to take its committees’ discussions and votes into account when making authorization and approval decisions, but generally does.
Pfizer and BioNTech also filed for full FDA approval of their vaccine this month, the first coronavirus vaccine manufacturers to do so. Currently all the shots are authorized for emergency use, a bar lower than approval.