Moderna's two-dose Covid-19 vaccine for kids ages 6 through 17 got the endorsement from the Food and Drug Administration's committee of independent immunization experts on Tuesday.
After an all-day public meeting, the committee unanimously voted to recommend the shots for use in kindergarteners through high school.
Pain at the injection site was the most common side effect of the vaccine. Moderna did not find any cases of myocarditis in children in these age groups.
The trials were done before the variant became dominant. It's not clear how much protection two shots would give in these age groups. It has been shown that a third shot increases protection against omicron. Moderna plans to give data soon on a third dose for these age groups.
The effectiveness of the vaccines is estimated against other Covid variants. According to a FDA presentation, the shots for teenagers ages 12 to 17 had an estimated effectiveness of 90 percent against illness from the alpha variant and original Covid strain. The shots for kids ages 6 to 11 had an estimated effectiveness of 75%.
The 50 microgram shots would be given to children ages 6 to 11 and the 100 microgram shots to teens ages 12 to 17
Two doses are unlikely to provide protection against mildness illness from omicron's subvariants, but they are likely to protect against severe illness with a third dose.
Offit said that the benefits were outweighing the risks and that there would be a third dose. I wouldn't feel the same if that wasn't true. We are not in the same place as before. It isn't the same time.
The FDA will always be evaluating vaccine effectiveness based on the previous Covid variant given how quickly the virus can evolve and how long it takes to gather data, according to Dr. Rubin.
Rubin is an infectious disease expert at Harvard and a member of the FDA.
The vaccine is expected to be approved by the FDA this week. The shots have to be approved by the Centers for Disease Control and Prevention before they can be given to patients. The moderna vaccinations could start next week.
Many parents don't get their kids immunized, but children ages 5 and up are eligible for the vaccine. Around 30% of kids ages 5 to 11 and 40% of teens 12 to 17 are fully vaccine free.
Eligibility in line with Pfizer's shots would be brought about by authorizing Moderna's vaccine. The FDA would be able to approve both Moderna and Pfizer's vaccines at the same time. The FDA will hold a meeting on Wednesday to discuss the vaccine for infants through preschoolers.
The FDA was asked to approve the vaccine for teenagers more than a year ago. International data showed that Moderna's vaccine had a higher risk of heart inflammation than Pfizer's vaccine. The 6 to 11 age group was requested by Moderna.
During a presentation to the committee Tuesday, the FDA said that Moderna's vaccine did not increase the risk of myocarditis compared to Pfizer's vaccine.
The shots use the same technology. Both of them carry a risk of myocarditis in young men and teenage boys. The risk of myocarditis is higher from Covid infections. The most common causes of myocarditis are viral infections.
Out of 54 million Pfizer doses, the CDC has found 635 cases of myocarditis in children and teenagers. The risk is highest for teenage boys after the second dose. According to the CDC, there doesn't seem to be an elevated risk for children ages 5 to 11.
There were about 46 reports of myocarditis per million second Pfizer doses among teenage boys ages 12 to 15 seven days after receiving the shot, according to CDC data.
Mark Sawyer is a professor of pediatrics at the University of California San Diego. We need to watch that closely as we expand the use of the vaccine.
People who get myocarditis after getting a vaccine are usually hospitalized for a few days. According to a survey of cardiologists and other health-care providers, most patients recover within three months.
According to the CDC, more kids were hospitalized with Covid during the omicron wave than at any other point of the Pandemic. Most of the kids hospitalized with Covid had at least one underlying health condition.
Most of the kids were hospitalized because they had Covid, according to a CDC official. Most of them did not test positive for the virus after they were admitted to the hospital.
Since January 2020, Covid has killed 202 children ranging in age from 6 months to 4 years old. According to the CDC, covid is one of the top causes of death for children under the age of 19 years old.
According to the CDC, more than 13 million children under the age of 18 have been exposed to Covid. It is not known how many children in the US have Covid. Up to 8% of children in the United Kingdom have Covid symptoms for more than a year. Mild infections can lead to long covid.
As new omicron subvariants, BA.4 and BA.5 start circulating more, it is likely that there will be another surge of infections.
Link-Gelles said that it was important to keep in mind that the vaccine would protect them in the coming months.
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