MAY 17, 2022
U.S. health regulators cleared for use a booster shot of the Covid-19 vaccine from Pfizer Inc. and BioNTech SE for children 5 to 11 years, expanding booster access to about 28 million youngsters.
The decision Tuesday by the U.S. Food and Drug Administration permits a third dose of the shot at least five months after the second dose.
It comes weeks after the drugmakers said a third shot safely generated a strong immune response in the children, including significantly increasing antibody levels against the Omicron variant.
“A booster dose can help provide continued protection against Covid-19 in this and older age groups,” said Peter Marks, who heads the FDA’s vaccine division.
Many children now eligible for the shots might not get them, however. Vaccinations among the youths have been relatively low compared with rates in older people. Opinion surveys have found limited support among parents for vaccinating their children, suggesting many of them don’t plan to have their children get a booster.
Under the FDA’s authorization, the booster would be the same 10-microgram dose as the initial two shots the children received. The dosage is one-third the amount that people 12 years old and up receive.
Before the 5- to 11-year-olds can get the boosters, a panel of vaccine experts advising the Centers for Disease Control and Prevention are expected to meet and vote on whether to endorse the shots.
The meeting of the CDC panel, the Advisory Committee on Immunization Practices, is scheduled to take place Thursday, and the CDC usually endorses its recommendation soon afterward.
Once the CDC signs off, the additional doses are expected to be available at pediatrician offices, retail pharmacies and other places where children have already been going for shots.
Supplies should be sufficient to meet demand, according to the U.S. government and the drugmakers.
Booster doses of the Pfizer-BioNTech vaccine are already authorized for people as young as 12 in the U.S. The FDA recently greenlighted second boosters for people who are 50 years old and up or who have weakened immune systems.
Overall, children are less likely than adults to become infected with Covid-19 or develop severe disease, and many who develop cases experience mild or no symptoms, according to health experts and studies.
The hospitalization rate in children, however, increased during the Omicron wave, especially among those who weren’t vaccinated.
Health authorities have encouraged vaccines and boosters to prevent severe disease and help protect people more vulnerable to serious cases. The boosters restore vaccines’ efficacy, which has been found to wane after several months, according to many studies.
Research has also found that adults need at least three doses to have the same level of protection against the Omicron variant that vaccines had conferred for the earliest version of the virus.
Five- to 11-year-olds have been eligible for the two-dose primary series of the Pfizer-BioNTech vaccine since October, after researchers found it to be 90.7% effective at preventing symptomatic Covid-19.
The pace of vaccinations has been slow, with only about one in three children getting at least one dose, according to the American Academy of Pediatrics. Nearly 75% of people 12 years old and above are fully vaccinated, the CDC said.
About a third of parents of 5- to 11-year-olds surveyed in April by the Kaiser Family Foundation said they definitely wouldn’t get their children vaccinated, and another 12% said they wouldn’t unless their schools required it.
In Pfizer and BioNTech’s study evaluating the extra shot, 140 children between 5 and 11 years old got the third dose, and researchers analyzed blood samples from 30 of the young subjects.
The researchers found a 36-fold increase in neutralizing antibodies against Omicron one month after the third dose, compared with levels measured one month after the second dose, the companies said.
Data from study subjects not previously infected with Covid-19 showed a sixfold increase in neutralizing antibodies against the original strain one month after the extra shot compared with one month after the second dose, Pfizer said.
Researchers haven’t determined to date how well the extra shot protects against Covid-19 because too few children have become sick. Researchers could still learn more as the trial continues, a Pfizer spokesman.
The study’s findings haven’t been published yet in a peer-reviewed medical journal.