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The FDA Committee recommends Moderna two-dose Covid vaccine for children aged 6 to 17 years

A young man gets his Covid-19 vaccination at a vaccination clinic. People get the Moderna vaccine in Milford, Pennsylvania.

Preston Ehrler | LightRocket | Getty pictures

Modern’s two-dose Covid-19 vaccine for children aged 6 to 1[ads1]7 years received approval from the Food and Drug Administration’s committee of independent vaccination experts on Tuesday, an important step on the way to distributing it to children.

The committee voted unanimously to recommend the shots for use in kindergartens through high school students after a full-day public meeting that weighed how safe and effective the shots are.

The most common side effects of the vaccines were injection site pain, fatigue, headache, chills, muscle aches and nausea. No cases of myocarditis, a type of heart inflammation, were found during Modern’s clinical trials in children in these age groups, according to the FDA.

The clinical trials were conducted before the omicron variant became dominant. As a consequence, it is unclear how much protection two shots would provide in these age groups right now. A third shot in other age groups has been shown to significantly increase protection against omicron. Dr. Doran Fink, a senior official at the FDA’s vaccine office, said that Moderna intends to provide data soon on a third dose for these age groups.

Estimates of vaccine efficacy are against other Covid variants that are no longer dominant. The shots for teens ages 12 to 17 had an estimated 90% efficacy against disease from the alpha variant and the original Covid strain that was first discovered in Wuhan, China, according to an FDA presentation. The shots for children aged 6 to 11 had estimated an estimated efficiency of 76% effective in preventing disease from the delta variant.

Children ages 6 to 11 will receive less than 50 micrograms of shot, while teens ages 12 to 17 will receive the same dose as adults at 100 micrograms.

Dr. Paul Offit, a committee member, said two doses are unlikely to provide protection against mild disease from omicron subvariants, but they are likely to protect against serious illness with a third dose.

“I think the benefits clearly outweigh the risks, but I say that with the comfort provided, it will be a third dose,” said Offit, a pediatrician and infectious disease specialist at the Children’s Hospital of Philadelphia. “If it were not true, I would not feel the same way. We are not in the same part of this pandemic anymore. It is a different time.”

However, Dr. Eric Rubin said that the FDA will always evaluate the vaccine’s effectiveness based on previous Covid variants given how fast the virus develops and the time it takes to collect data.

“We have to make decisions based on the best data we have, which will always be old data in an eruption that is constantly moving,” said Rubin, an FDA committee member and an expert on infectious diseases at Harvard.

The FDA is expected to approve the vaccines this week. The disease control and prevention centers must then acknowledge the shots before pharmacies and doctors can begin administering them. Modern vaccinations in this age group can start as early as next week.

Children aged 5 and over are already eligible for vaccination with Pfizer and BioNTech’s vaccine, although many parents have not had their children vaccinated. About 30% of children aged 5 to 11 and 60% of teenagers 12 to 17 are fully vaccinated from the beginning of June.

Approval of Moderna’s vaccine for children aged 6 to 17 will bring qualification in line with Pfizer’s shot. This will also allow the FDA to approve both Moderna and Pfizer’s vaccines for children under 5 years of age at the same time. The FDA committee meets on Wednesday to discuss the vaccine for infants through preschoolers, the only age group that is not eligible for vaccination.

Risk of myocarditis

Moderna asked the FDA to approve the vaccine for teens 12 to 17 more than a year ago in June 2021. However, the FDA refrained from approving the shot when international data indicated that Moderna’s vaccine had a higher risk of heart inflammation, known as myocarditis. , than Pfizer’s shot. Moderna asked for authorization for the age group 6 to 11 years in March this year.

However, US vaccine monitoring through May did not find a significantly higher risk of myocarditis with Moderna’s vaccine compared to Pfizer’s shots in men aged 18 to 25, FDA official Hui-Lee Wong said during a presentation to the committee on Tuesday.

Pfizer and Modern’s shots use the same messenger RNA technology. They both have a risk of myocarditis, usually after the second dose and usually in young men and teenage boys. However, the CDC has found that the risk of myocarditis is higher from Covid infection than vaccination. Myocarditis is usually caused by viral infections.

The CDC has found 635 cases of myocarditis in children and adolescents aged 5 to 17 of more than 54 million administered Pfizer doses. The risk is highest among teenage boys ages 12 to 17 after the second dose, according to the CDC. There does not appear to be an increased risk for children ages 5 to 11, according to the CDC.

There were approximately 46 reports of myocarditis per million second Pfizer doses among teenage boys aged 12 to 15 seven days after receiving the shot, and 75 reports per million second doses among boys aged 16 to 17, according to CDC data.

“I’m a little sober about the myocarditis data and the frequency with which it happens,” said Dr. Mark Sawyer, a professor of pediatrics at the University of California San Diego and a temporary voting member. “So it clearly needs to be closely monitored going forward as we expand the use of the vaccine.”

People who develop myocarditis after vaccination are usually hospitalized for several days as a precaution. However, most patients appear to recover completely around three months after their diagnosis, according to a CDC survey among cardiologists and other healthcare professionals.

Covid effect on children

Although Covid is generally less severe in children than adults, more children were hospitalized with the virus during the omicron wave than at any other time in the pandemic, according to the CDC. Approximately two-thirds of children aged 5 to 17 years hospitalized with Covid had at least one underlying health condition, such as diabetes or obesity.

Dr. Katherine Fleming-Dutra, a CDC official, told the FDA committee that a majority of the children were hospitalized because they had Covid. In other words, most of them did not test positive for the virus after admission for another health reason.

Covid has killed 202 children aged six months to 4 years, 189 children aged 5 to 11 years, and 443 children and teenagers aged 12 to 17 years since January 2020. Covid is among the five leading causes of death for children under 19 years – years old, according to the CDC.

In total, more than 13 million children under the age of 18 have been infected with Covid during the pandemic, according to the CDC. It is unclear how many children in the United States have long Covid. However, a national study in the UK found that up to 8% of children have Covid symptoms for more than 12 weeks. Long Covid can occur even after mild infections.

Ruth Link-Gelles, a CDC official, said it was “extremely likely” that a new wave of infections would occur when new omicron variants, BA.4 and BA.5, began to circulate more.

“It is important to keep in mind that we are vaccinating children, or potentially vaccinating children, now with an expectation that vaccination will protect them in the coming months, when we expect further increases,” said Link-Gelles.

CNBC Health & Science

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