The Food and Drug Administration on Thursday expanded the emergency use authorization for Pfizer and BioNTech’s Covid-19 booster shot to cover 16- and 17-year-olds, making it the only booster shot currently available in the United States for teenagers in this age group.
The move to make the shots available to them comes at a time when the Biden administration is trying to increase uptake of booster shots to build up immunity to battle a surge in Delta variant cases and a feared winter wave of infections potentially caused by the new and highly transmissible Omicron variant.
“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19,” Acting FDA Commissioner Janet Woodcock said in a statement.
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The FDA made the decision without consulting its independent vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. And Rochelle Walensky, director of the Centers for Disease Control and Prevention, is expected to sign off on the extension without asking the advice of the CDC’s independent vaccine experts, the Advisory Committee on Immunization Practices, or ACIP. It remains to be seen if she will say 16- and 17 -year-olds “should” or “may” get a booster shot.
Both advisory committees would likely have asked pointed questions about the risks associated with giving booster shoots to 16- and 17-year-olds, given the fact that the messenger RNA vaccines — like the Pfizer product and Moderna’s vaccine — have been linked to elevated rates of myocarditis and pericarditis, an inflammation of heart muscle or tissue around the heart, respectively.
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“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech Covid-19 vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against Covid-19 and the associated serious consequences that can occur including hospitalization and death,” the FDA statement said.
Reports of myocarditis and pericarditis after the administration of mRNA vaccines have mainly been seen in males, with rates highest among those in their teens and early 20s. In a presentation at a Nov. 2 meeting of the ACIP, it was reported that the highest rate of reported cases of myocarditis and pericarditis after mRNA vaccinations was among males 16- and 17-years-olds, with the conditions reported at a rate of 69 cases per 1 million doses of mRNA vaccines given.
These conditions can be caused by a number of triggers, including some infections. Classic cases of myocarditis and pericarditis peak in the mid to late teens, when they appear at a rate of about 18 cases per 1 million, according to the CDC. Most of the myocarditis and pericarditis cases linked to the vaccination are less severe and quicker to resolve themselves than standard cases of pericarditis and myocarditis.
The incidence of myocarditis and pericarditis after Covid vaccination is higher after the second dose. It is currently not known how frequently it might occur after a third dose.
As with older individuals, the booster shot for 16- and 17-year-olds should be given at least six months after the second shot of the primary vaccination series. Many states opened up Covid vaccine access to 16- and 17-year-olds in late April, meaning some teens in this age group are already eligible to get a booster shot.
“While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of Covid-19 and any future variants is getting all eligible people fully vaccinated with the first two-dose series and a booster dose as recommended,” Pfizer CEO Albert Bourla said in a statement.
In the statement, Pfizer and BioNTech said they plan to submit a supplemental biologics license application for approval of a booster dose of their Covid-19 vaccine in individuals 16 years of age and older. The partnership was the first to earn full approval of the primary series of their vaccine; to date the vaccine, sold under the brand name Comirnaty, is the only Covid vaccine in use in the United States to be fully licensed.