December 9, 2021 – FDA approves additional doses of Pfizer’s COVID-19 vaccine, paving the way for millions of teenagers to get a third dose vaccine starting 6 months after their second dose. The CDC quickly followed suit, allowing amplifiers to start immediately.
The FDA said its approval for the emergency use of amps for 16- and 17-year-olds is based on data from 200 people aged 18 to 55 when they received the supplement. Pfizer is required to collect safety data in post-approval studies.
“The FDA has determined that the benefits of a single dose of Pfizer-BioNTech vaccine against COVID-19 or Comirnaty outweigh the risks myocarditis and pericarditis in persons aged 16 and 17 to ensure continued protection against COVID-19 and related serious consequences that may occur, including hospitalization and death, ”the agency said in a press release.
Israel gave extra doses of Pfizer vaccine to all over the age of 12 from the end of August. Data from that country show that cases of myocarditis are still very rare, even in younger age groups, and are mild and transient.
Approval comes when the effectiveness of current vaccines against a new variant of Omicron has become a point of intensive scientific research.
Early studies suggest that dose doses may be needed to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that vaccine protection holds up well against serious illness and death, at least with Delta and early versions of the virus.
How well it will work against Omicron and how serious Omicron infections can be for different age groups remains open questions.
The World Health Organization on Wednesday called on countries not to wait for all science to emerge, but to act now to curb any potential threat.
Early evidence of Omicron suggests that it is highly contagious, perhaps even more so than Delta, although early reports suggest symptoms caused by this version new coronavirus may be less severe than in previous waves. Experts have warned that it is not yet known how serious Omicron infections can be, as the first cases were found in younger people, who have milder symptoms of COVID-19 than adults and the elderly.
“Vaccination and supplementation when you meet the conditions, along with other preventative measures such as masking and avoiding large crowds and poorly ventilated areas, remain our most effective methods of combating COVID-19,” said Acting FDA Commissioner Janet Woodcock, MD. . . “As people gather indoors with family and friends for the holidays, we cannot give up all the preventive public health measures we have taken during pandemic. As both the delta and omicron variants continue to spread, vaccination remains the best protection against COVID-19. “
In mid-November, the FDA approved Pfizer boosters for all people over the age of 18, but the agency gave up expanding the use of boosters to younger age groups, in part because they have the highest risk of very rare side effects. myocarditis – swelling of the heart muscle or sac around the heart.
Cases of myocarditis appear to be temporary, with patients fully recovering, although they need to be monitored in hospital. The risk of myocarditis with COVID-19 infection is many times higher than with vaccines.
There was also little data to support the need for adjunctive drugs in this age group, as children and adolescents tend to have milder COVID-19 disease, although they are still at risk for post-COVID complications such as long COVID and a delayed response to a virus called post-acute consequences of SARS-CoV-2 infection among children or PAS-C.
All that changed with the arrival of Omicron.