Moderna asks FDA to authorize Covid vaccine for children under 6 years 2022-04-28 06:07:58

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Moderna on Thursday asked the US Food and Drug Administration to approve a Covid vaccine for children aged 6 months to 5 years.

The vaccine was about 51% effective against infection from the omicron variant in children under the age of two and about 37% effective in children ages 2 to 5, according to a company press release. These levels are similar to a two-dose dose of protection for adults, said Dr. Paul Burton, Moderna’s chief medical officer.

The protection offered by Moderna vaccine against infection drops significantly below the high water level of 90% when the injection is first started. The omicron variant, which contains more than 30 mutations, is adept at avoiding antibodies that prevent the virus from invading human cells.

However, Burton said children younger than 6 who receive two doses should have high levels of protection against severe disease. The adults had about 1,000 units of antibodies after two injections with at least 70 percent protection from severe disease, he said, while the children in the study got 1,400 to 1,800 units of antibodies after two doses.

“What we do know is that these levels of antibodies would translate into very high protection against severe disease and hospitalization,” Burton said. He added that none of the children in the study were hospitalized with Covid.

Moderna plans to study a booster dose for children under six with a redesigned syringe targeting Omicron in addition to the original strain of the virus that emerged in Wuhan, China. One reason the vaccine’s effectiveness against infection has fallen so sharply is that current shots are still targeting the Wuhan strain, even though the virus has evolved significantly since it was first discovered in late 2019.

If permitted by the FDA, children under 6 years of age will receive two doses of 25 mcg, much smaller than the 100 mcg dose that is currently approved by the FDA as a primary vaccination series for adults. The safety profile for children is reassuring, Burton said, with 0.2% of children having a fever of 103 degrees Fahrenheit, or 40 degrees Celsius. About 17% of children under the age of 2 developed a fever of 100 degrees Fahrenheit while just over 14% of children between the ages of 2 and 6 developed that fever, according to a March press release about the study results.

Children younger than 6 years old are in the only age group in the United States not yet eligible for vaccination. The US Food and Drug Administration (FDA) has promised to move quickly to allow shots for infants, young children and preschoolers once vaccine makers have submitted their complete applications.

Dr. Peter Marks, who heads the Food and Drug Administration’s office responsible for vaccines, told the Senate Health Committee this week that a Drug Regulatory Committee of independent advisors will meet to review the data in full.

“We will proceed as quickly as we need to once the applications are completed,” Marks said. He told the committee that the FDA will publish a schedule next week for advisory committee meetings on several emergency use applications. The Food and Drug Administration is working on several potential dates for the committee to meet in June, according to a person familiar with the matter.

Parents have been waiting for months for a way to protect their children from the virus. During the Omicron winter wave, children under the age of 5 were hospitalized with Covid at five times the rate of the epidemic peak, when delta was prevalent, According to the Centers for Disease Control and Prevention. About 75% of children under the age of 11 contracted Covid as of February, according to data released by the CDC this week.

The Food and Drug Administration (FDA) originally sought the fast track to obtain authorization for Pfizer’s Covid vaccine for children under five in February by removing the first two doses of the three-shot vaccine. However, Pfizer decided to postpone its application and wait for the data in the third shot, because the results of the first two doses were not good enough.

Pfizer CEO, Albert Burla, In a podcast interviewThe first two shots were only 30% to 40% effective, he said, but he expects the third dose to significantly improve protection. The vaccine has a dose level of three micrograms, which is much smaller than the 30 micrograms used for adults.

Borla said he hopes Pfizer’s vaccine will receive FDA approval in June.



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