Moderna is seeking an emergency use authorization for the Covid-19 vaccine for children aged 6 months to 5 years 2022-04-28 06:00:12

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“We believe mRNA-1273 will be able to safely protect these children from SARS-CoV-2, which is very important in our ongoing fight against COVID-19, and will be especially welcome by parents and caregivers,” said Stephan Bancel, Chief Executive Officer Moderna. , he said in a press release.

In late March, Moderna announced the results of a clinical trial involving 2,500 children aged 6 months to 24 months and 4,200 children aged 2 to 5 years. The company said two doses of the 25-microgram vaccine resulted in a similar immune response in young children. Two doses of 100 mcg for adults aged 18 to 25 years. She said this should predict protection against Covid-19 and severe Covid-19 up to 6 months of age.

In a press release Thursday, the company said the data showed a “strong antibody response” and an “appropriate safety profile.”

“We’d like to see anything over 1,000 units, and what we’ve actually seen here are levels between 1,400 and 1,800,” said Dr. Paul Burton, Moderna’s chief medical officer, on Wednesday. “So that’s very reassuring.”

Burton also said that vaccines have been very safe for this age group. The most common reactions were pain at the injection site and fever. There were no cases of inflammation of the heart or myocarditis in the study. Carditis was an extremely rare side effect of mRNA vaccines. Myocarditis is more common after infection with Covid-19 than after vaccination.

Moderna says its Covid-19 vaccine works as well in children as it does in adults

The results announced in March were mostly collected during the Omicron wave, and included a home test for Covid-19. As a result, the company said, the vaccines appear to be less effective for children than they do in older age groups.

Data provided by Moderna Thursday restricted analysis only to cases confirmed positive by sensitive reverse transcriptase-polymerase chain reaction (RT-PCR) tests. In the revised analysis, vaccines were 51% effective in preventing symptoms in children aged 6 months to less than 2 years; It was 37% effective in preventing symptoms in children between the ages of 2 and 5 years. These efficacy estimates are similar to those for adults against Omicron after two doses, the company said.

Pfizer/BioNTech’s Covid-19 vaccine for young children is also faltering. In clinical trials, two doses of 3 micrograms were taken Doesn’t seem to be born The same degree of immunity for children aged 2 to 4 years as it was for adults, prompting the company to consider giving children aged 6 months to 4 years a third dose. FDA also I delayed reviewing it From these shots until the company provides data on a third dose.

Boosters for young children?

Tuesday, Pfizer asked the FDA To give the green light a third dose or booster dose for children ages 5 through 11. Studies have shown that vaccine efficacy was significantly diminished in this age group during use of Omicron.
Pfizer seeks FDA permission to use Covid-19 Booster for children ages 5 to 11

Burton said Wednesday that Moderna has also been testing boosters, including formulations for variants.

“Our main candidate now is something against the original strain and Omicron,” he said, predicting the fall-winter booster formula.

“And I think for these young children, what we have to do is continue to follow the natural history and see, what’s the alternative? What’s going on with young children as we enter fall? Then the Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) and the regulators can around the world making recommendations on whether they need another booster later in the year.”

What’s next for vaccinations for younger children

No Covid-19 vaccines have been authorized for children under the age of 5 in the United States – about 18 million people.

Moderna’s mRNA Covid-19 vaccine is approved for people 18 and older and the Pfizer/BioNTech vaccine for ages 5 and older.

The FDA will evaluate Moderna’s report and say it will convene an advisory committee meeting on Vaccines and Related Biological Products to influence vaccine authorization for younger children.

The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, said the Food and Drug Administration is considering whether to consider emergency-use authorization for both Moderna and Pfizer/BioNTech’s Covid-19 vaccines for young children at the same time, rather than looking at them separately.

Pfizer said data for the third dose of the vaccine will be available this month. Pfizer CEO Albert Burla said a vaccine for younger children could be available in June, if the Food and Drug Administration allows it.

CNN’s Jimmy Gombrecht contributed to this report.

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