A 5-year-old received his first dose of coronavirus vaccine at Texas Children’s Hospital in Houston last year. Credit … Meredith Kohut for The New York Times
The Food and Drug Administration on Friday approved the Moderna and Pfizer-BioNTech coronavirus vaccines for the nation’s youngest children, a relief for many parents concerned about protecting their children 18 months after the vaccines were first given to adults.
Regulators followed the recommendation of independent experts from an advisory committee that voted unanimously Wednesday in favor of the two vaccines. All Americans, with the exception of approximately 20 million children under the age of 5, have had the opportunity to protect themselves from Covid-19 for months and are eligible for booster vaccines.
A separate consultative panel at the Centers for Disease Control and Prevention meets on Friday and Saturday. CDC Director Rochelle P. Valenski will then issue his own recommendation, the final step before the doses are released.
Absorption may be low, which would be particularly worrying for children with comorbidities that could make them more vulnerable to hospitalization with the virus.
Studies by both Pfizer and Moderna have shown that the Omicron variant significantly dulls the power of vaccines to prevent symptomatic infection in young children, just as it does in adults.
Pfizer said two doses of its vaccine were only about 28 percent effective in preventing disease, while three doses were 80 percent effective. But this estimate of 80 percent is based on only 10 cases in a subgroup of 1,678 participants in the process. The Moderna vaccine was about 51% effective in children 6 months to 2 years of age and 37% effective in children 2 to 5 years of age.
However, Dr. Robert M. Caliph, FDA Commissioner, said in a statement: “As we have seen in older groups, we expect younger children’s vaccines to provide protection against the worst effects of Covid-19, such as hospitalization. and death. “
After the federal government provided 10 million doses to states, pharmacies and healthcare providers in recent weeks, the response has been silenced, according to data collected by federal officials. Only 2.5 million doses of Pfizer-BioNTech vaccine have been claimed, about half of those available. And about 1.3 million doses of Moderna, about a quarter of what was offered, were ordered.
Federal officials said states are usually gradually increasing orders as vaccination campaigns develop. But less than 40 percent of children ages 5 to 11 have received at least one dose of coronavirus vaccine, a sign that families, including those whose adult members have been eagerly vaccinated, may be reluctant to vaccinate their children. , at least immediately.
The Pfizer vaccination regimen is three doses at one-tenth the strength of the adult dose. The first two doses are three weeks apart; the third dose is at least two months after the second. This means that it will take three months to be fully vaccinated.
The Moderna vaccine is given in two doses, four weeks apart, at a quarter of the strength of the adult dose. Its dose is significantly stronger than that of Pfizer, and the time frame is shorter, which may be to the liking of parents who want their children to complete the series.
The FDA said both vaccines may need boosters. This would mean that the Pfizer-BioNTech vaccine would be four doses and Moderna three.
Some pediatric and vaccine experts say it is a mistake to try to compare the two vaccines, especially on which is more effective.
“I don’t think there is enough convincing evidence to say that one is better than the other,” said Dr. Christine Moffitt, a doctor at Boston Children’s Hospital, which treated young patients with Covid-19. “We all have to admit that comparing the two face to face is very complicated, given that they have been studied differently.”
Dr James Conway, a pediatric infectious disease expert at the University of Wisconsin-Madison, said the two vaccines were tested at different times when different variants were circulating.
He also said it was difficult to determine how much protection any vaccine could provide, given newer, more contagious versions of the virus that continue to mutate. “You’re kind of playing Whac-a-Mole,” he said.
Evaluating the effectiveness of Pfizer, said Dr. Moffitt, is particularly unreliable because there are so few cases of the virus among participants in the trial after the third dose. “We will have to wait and be patient to understand the true effectiveness of each of these vaccines.”
The Pfizer vaccine is approved for children over 5 years of age for many months, while Moderna is restricted to adults.
Dr Moffitt and other pediatric experts said that since it has been given to millions of older children, some parents may feel more comfortable with the Pfizer-BioNTech vaccine, although it will take longer for children to be fully vaccinated. . Others, who hope for faster results and may have vulnerable family members, may prefer the Moderna vaccine.
Some families can go with the brand that the siblings and parents received, or take what is available nearby.
Some pediatricians, nurses, and pharmacists may be more familiar with Pfizer and may not want to introduce another product.
Dr Conway said his advice to parents was that “something is better than nothing”.
“Noah Wayland and Sharon LaFranier.”
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