FDA-recommended COVID-19 vaccine for babies 6 months and older

USAany parent in the US been waiting to hear that the nation’s youngest children — those under the age of 5 — can be immunized against COVID-19. Finally, on June 15, an expert panel convened by the US Food and Drug Administration (FDA) said that two vaccines, manufactured by Pfizer-BioNTech and Moderna, were safe and effective. for children 6 months and older.

The FDA panel voted unanimously – 21-0 – that the benefits of the Moderna vaccine outweigh the risks for children 6 months to 5 years of age. They also voted unanimously that the benefits of the Pfizer-BioNTech vaccine outweigh the risks to children 6 months to 4 years of age.

The FDA generally follows the recommendations of its advisory committee and is therefore expected to allow the injections to be used in an emergency. Assuming that’s the case, the CDC’s vaccine advisory group will review the data and decide whether to make a formal recommendation for vaccination in this age group. or not.

If the CDC recommends the vaccine, children 6 months to 5 years old could get it as soon as next week, becoming the last age group eligible for the COVID-19 vaccine. While the rate of COVID-19 in this population is relatively low, hospitalization rates are increasing slowly, possibly due to dominance of the Omicron . variant. Follow Latest data from CDCMore than 2 million cases of COVID-19 have occurred in children 4 years of age and younger since the start of the pandemic, resulting in more than 440 deaths.

While members of the FDA committee widely feel that parents should be able to immunize their young children against COVID-19, some say it is important to keep the effects of the virus at bay. modest response of this disease to children. In response, Dr. Arthur Reingold, chair of epidemiology at the University of California, Berkeley School of Public Health, noted that children are routinely immunized against diseases that have a low risk of hospitalization and death — and COVID- 19 is no different.

Other members of the committee said the benefits of vaccination go beyond preventing disease. The photos can also reduce the rate of children developing complications like long-term COVID and provides some freedoms for families to remain isolated until their youngest members can be immunized.

Pfizer-BioNTech’s Pediatric Vaccine

Pfizer-BioNTech vaccine for children 6 months to 4 years is a three-shot regimen and each dose is 1/10 of the adult dose. Children will receive two doses three weeks apart and a third dose at least two months later.

In a company study of more than 4,500 children, the amount of antibodies produced by these children was compared with the amount of antibodies produced by those vaccinated between the ages of 16 and 25. This allowed the researchers to infer how much protection those antibodies would provide against COVID-19. In the children’s group, three doses effectiveness of vaccines against symptomatic disease was 80.4% during the time Omicron was widely circulated in the US – although that estimate is based on such a small number of cases that it is difficult to draw firm conclusions about the extent of protection. its defense in real situations.

That’s a long way off for the Pfizer-BioNTech vaccine. Companies began submitting their vaccines for FDA approval in this age group last December, after collecting data on a two-dose course. But those two doses produced relatively low levels of immunity, partly because they were tested while Omicron was dominating in the US. That caused the FDA and Pfizer-BioNTech to stop reviewing that data until the companies provide more information on whether adding a third dose increases levels of antibodies against the virus and thus immunity against COVID-19. The company reported those data in May.

Moderna’s Children’s Vaccines

Moderna’s vaccine for children 6 months to 5 years of age is given in two doses, and each dose is one-quarter of the dose used in adults. People vaccinated with Moderna will receive two doses four weeks apart.

Moderna has tested its two-dose vaccine on more than 6,300 children. Among those 2 to 5 year olds, the shots were about 37% effective at preventing symptomatic disease when Omicron was prevalent. For children 6 months to 2 years of age, the effectiveness against symptomatic disease is about 50%.

Similarities and differences

One of the biggest differences between the two vaccines is the number of shots: two for Moderna and three for Pfizer-BioNTech.

Pfizer-BioNTech switched to a three-dose schedule after trial results showed that its two doses for young children did not produce a strong enough immune response. During the FDA meeting, Pfizer officials said their goal is to avoid side effects like fever, which can discourage parents from getting their kids vaccinated.

While dosages also vary from company to company, both will give the youngest children a lower dose than those used for adults and older children, to best balance the benefits. protection from the potential risk of side effects. Those range from as mild as fever and swelling at the injection site to more serious, but rarer conditions, such as heart tissue inflammation and multisystem inflammatory syndrome (MIS-C), a status can cause inflammation in many parts of the body.

Both vaccines are relatively safe and produce no more side effects in children than in adults, although committee members did note the risk of myocarditis, an inflammation of the heart tissue. . that has been reported in young men aged between 16 and 25 years old. The CDC’s Vaccine Adverse Events Database does not show a higher incidence in young children.

What happens next?

If the CDC recommends vaccines for this youngest age group, concerned parents will likely have to make challenging decisions about which shots their child should get. Moderna’s two-dose regimen may be more convenient, and means fewer visits to the office or pharmacy, than Pfizer-BioNTech’s three-dose schedule. It will also take a much shorter time for children to be fully immunized. On the other hand, three doses of Pfizer-BioNTech seem to provide higher levels of antibodies against the virus.

Committee member, Dr. Paul Offit, director of Children’s Hospital of the Center for Immunization Education of Philadelphia, was concerned about Pfizer-BioNTech’s “surprisingly poor” vaccine efficacy after two doses. He and other panelists worry that parents won’t realize their kids aren’t well protected until the third shot — especially since kids the same age only need two doses of Moderna. .

Read more: FDA recommends urgent authorization of Moderna’s COVID-19 vaccine for children ages 6 to 17

However, additional doses may become necessary for all children, as the vaccine is designed to target the original SARS-CoV-2 virus. That virus has been replaced by waves of different variants; In particular, Omicron is better able to evade immunity produced by the vaccine than past variants. That’s why the FDA and CDC now recommend that all adults get a booster shot at least once after their initial two-dose vaccine with Pfizer-BioNTech or Moderna shots, to reverse the severity of their impairment. Antiviral antibodies return to levels that can protect against infection and serious illness.

While the committee was not tasked with assessing the need for additional doses at this meeting, the same experts will meet again on June 28 to discuss the booster and the COVID vaccination plan. -19 in the future. They will also review data regarding New vaccine developed to target Omicron especially.

Dr. Kristin Moffitt, infectious disease specialist at Boston Children’s Hospital (who does not serve on the FDA Commission program). “We’re in completely uncharted territory and in a very dynamic situation, as the virus and its evolution are really what’s driving the bus here.”

For example, it is possible that by the fall, health officials may have enough data from newer, Omicron-specific vaccines to decide that everyone – including children – should get less vaccine. at least one dose of that updated vaccine to maintain protection over the winter.

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Write letter for Jamie Ducharme at [email protected].

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