Moderna on Thursday asked the Food and Drug Administration to approve the Covid vaccine for children aged 6 months to 5 years.
The vaccine was about 51% effective against omicron infection in children under 2 years of age and about 37% effective in 2- to 5-year-old children, according to a company press release. Dr Paul Burton, Moderna’s chief medical officer, said these levels were similar to protection at two adult doses.
The protection that Moderna’s vaccine provides against infection has been significantly reduced by a high level of effectiveness of 90% on the first administration of the vaccines. The omicron variant, which has more than 30 mutations, has been able to avoid antibodies that block the virus from invading human cells.
However, Burton said that children under the age of 6 who receive two doses should have high levels of protection against serious illness. Adults had about 1,000 units of antibody after two injections with at least 70% protection against severe disease, while children in the study had 1,400 to 1,800 units of antibody after two doses, he said.
“What we do know is that these antibody levels will become very high protection against serious illness and hospitalization,” Burton said. None of the children in the study were hospitalized with Covid, he added.
Moderna plans to study a booster dose for children under the age of 6 with a modified injection that targets omicron, as well as the original strain of the virus that appeared in Wuhan, China. One of the reasons the effectiveness of the vaccine against infection has declined so dramatically is that current vaccines are still targeting the Wuhan strain, although the virus has evolved dramatically since it was first discovered in late 2019.
If approved by the FDA, children under the age of 6 will receive two injections of 25 micrograms, a much smaller dose than the 100 micrograms vaccines currently approved by the FDA as the main adult vaccination series. Burton said the child safety profile was reassuring, with 0.2 percent of children developing a fever of 103 degrees Fahrenheit or 40 degrees Celsius. About 17% of children under the age of 2 have developed a fever of 100 degrees Fahrenheit, while slightly more than 14% of children aged 2 to 6 have developed such a fever, according to a Moderna press release published in March on the results of the study.
Children under the age of 6 are in the only age group in the United States that does not yet qualify for vaccination. The FDA has promised to take swift action to allow injections for babies, young children and preschoolers once vaccine manufacturers submit full applications.
Dr Peter Marx, who heads the FDA’s office responsible for vaccines, told the Senate Health Committee this week that a committee of independent advisers to the drug regulator would meet to review the data in its entirety.
“We will proceed with the necessary speed once we have full applications,” Marx said. He told the committee that the FDA will publish a schedule next week for advisory committee meetings on several emergency applications. The FDA is in the process of clearing out several potential dates for a committee meeting in June, according to someone familiar with the matter.
Parents have been waiting for months for a way to protect their children from the virus. During the winter micron wave, children under the age of 5 were hospitalized with Covid at five times the rate of the pandemic peak, when the delta was dominant, according to the Centers for Disease Control and Prevention. About 75% of children under the age of 11 were infected with Covid by February, according to data released by the CDC this week.
The FDA initially tried to speed up the approval of Pfizer’s Covid vaccine for children under 5 in February by clearing the first two doses of the vaccine with three injections. However, Pfizer decided to postpone its application and wait for data on the third shot, as the results of the first two doses were not good enough.
Pfizer CEO Albert Burla said in a podcast interview that the first two injections were only 30% to 40% effective, but he expected the third dose to significantly improve protection. The vaccine has a dosage level of three micrograms, much less than the 30 micrograms used for adults.
Burla said he hopes the Pfizer vaccine will be approved by the FDA in June.
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