Moderna Asks FDA to Allow Covid Vaccine for Children Under 6

On Thursday, Moderna asked the Food and Drug Administration to approve its Covid vaccine for children aged 6 months to 5 years.

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

The protection against infection provided by the Moderna vaccine has been significantly reduced from its peak of 90% when the vaccines were first introduced. The omicron variant, which has more than 30 mutations, is able to evade antibodies that block the entry of the virus into human cells.

However, Burton said that children under the age of 6 receiving two doses should have a high level of protection against severe disease. Adults had about 1,000 antibody units after two injections with at least 70% protection against severe disease, while children in the study had between 1,400 and 1,800 antibody units after two doses, he said.

“We know that these levels of antibodies provide very high protection against severe illness and hospitalizations,” Burton said. He added that none of the children in the study had been hospitalized with Covid.

Moderna plans to study a booster dose for children under 6 with a redesigned shot that targets omicron as well as the original strain of the virus that originated in Wuhan, China. One of the reasons the effectiveness of the vaccine against the infection has declined so dramatically is that current vaccines still target the Wuhan strain, even though the virus has changed significantly since it was first discovered in late 2019.

If the FDA approves, children under 6 years of age will receive two 25 mcg shots, much less than the 100 mcg dose currently approved by the FDA as an adult primary vaccination series. Burton said the safety profile for children is reassuring, with 0.2% of children developing a fever of 103 degrees Fahrenheit or 40 degrees Celsius. About 17% of children under the age of 2 had a fever of over 100 degrees Fahrenheit, while just over 14% of children between the ages of 2 and 6 developed such a fever, according to Moderna’s March press release on the results of the study. .

Children under 6 are the only age group in the US not yet eligible for vaccination. The Food and Drug Administration (FDA) has promised to quickly allow vaccines for infants, toddlers and preschoolers once full applications are submitted by vaccine manufacturers.

Dr. Peter Marks, who heads the FDA’s vaccine office, told the Senate Health Committee this week that a committee of independent drug regulator advisers will meet to fully review the data.

“We will continue to work at all the necessary speed, as soon as we have applications ready,” Marks said. He told the committee that the FDA would release a schedule of advisory committee meetings for several emergency use applications next week. The FDA is in the process of agreeing on several possible dates for the committee meeting 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 winter omicron wave, children under 5 were hospitalized with Covid five times more than at the peak of the pandemic, when delta dominated. according to the Centers for Disease Control and Prevention. About 75% of children under the age of 11 were infected with Covid as of February, according to data released by the CDC this week.

Initially, the FDA sought to expedite registration of the Pfizer Covid vaccine for children under 5 in February by authorizing the first two doses of the triple vaccine. However, Pfizer decided to delay the application and wait for data on the third dose, as the results of the first two doses were not good enough.

Pfizer CEO Albert Burla, in an interview podcast, said the first two shots were only 30% to 40% effective, but he expects the third dose to greatly improve protection. The vaccine has a dosage of three micrograms, much less than the 30 micrograms used for adults.

Burla expressed hope that Pfizer’s vaccine would receive FDA clearance in June.

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