COVID-19 vaccine for children: Moderna seeks permission for emergency use of Covid-19 vaccine for children aged 6 months to 5 years

NEW YORK CITY – Moderna is requesting permission for emergency use from the U.S. Food and Drug Administration for its Covid-19 vaccine for children aged 6 months to 5 years, the company said Thursday.

“We believe that mRNA-1273 will be able to safely protect these children from SARS-CoV-2, which is so important in our ongoing fight against COVID-19, and will be especially welcomed by parents and caregivers,” said Stephen Bansel, CEO of Officer Moderna , said in a press release.

In late March, Moderna announced the results of a clinical study that included 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 led to a similar immune response in young children. as two doses of 100 micrograms for adults aged 18 to 25 years. And it says it should predict protection against Covid-19 and severe Covid-19 by 6 months of age.

In a press release Thursday, the company said the data showed a “reliable neutralizing antibody response” and a “favorable safety profile.”

“We like to see anything that exceeds 1,000 units, and what we’ve actually seen here are levels somewhere between 1,400 and 1,800 units,” said Dr. Paul Burton, Moderna’s chief physician, on Wednesday. “So it’s extremely encouraging.”

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

The results, announced in March, were mostly collected during the Omicron wave and included home testing on Covid-19. As a result, the company said vaccines look less effective for children than for older age groups.

The data presented by Moderna Thursday limited the analysis to only cases confirmed positive as a result of sensitive polymerase chain reaction tests with reverse transcription. In the revised analysis, vaccines were 51% effective in preventing symptoms in children aged 6 months to 2 years; they were 37% effective in preventing symptoms in children aged 2 to 5 years. The company said these efficacy evaluations were similar to those among adults versus Omicron after two doses.

The Covid-19 vaccine for young children Pfizer / BioNTech also stumbled. In clinical trials, two 3-microgram doses did not create the same level of immunity for children aged 2 to 4 years as for young adults, prompting the company to consider giving children aged 6 months to 4 years a third dose. . The FDA has also postponed consideration of these images until the company provides data on the third dose.

Boosters for young children?

On Tuesday, Pfizer asked the FDA to give the green light a third or booster dose for children ages 5 to 11. Studies have shown that the effectiveness of the vaccine decreased significantly in this age group during Omicron.

On Wednesday, Burton said Moderna was also testing accelerators, including formulations for specific options.

“Our leading candidate is now something against the original strain and Omicron,” he said, predicting it would be a stimulus for fall and winter.

“And I think for these young children we will need to keep an eye on natural history and see what that option is? What happens to young children when we start fall? And then the FDA and CDC and regulators around the world can make recommendations about whether they need another booster later this year. “

What will happen next with vaccines for young children

Covid-19 vaccine is not allowed in the United States for children under 5 years of age – about 18 million people.

The Covid-19 mRNA vaccine from Moderna is approved for people aged 18 and over, and Pfizer / BioNTech is approved for people 5 and older.

The FDA will evaluate Moderna’s application and said it is convening its Advisory Committee on Vaccines and Related Biological Products to weigh the vaccine permit for young children.

Director of the National Institute of Allergy and Infectious Diseases Dr Anthony Foci said the FDA is considering whether to consider allowing the emergency use of Moderna and Pfizer / BioNTech Covid-19 vaccines for young children at the same time, rather than considering them separately. .

Pfizer said data on the third dose of the vaccine would be available this month. Pfizer CEO Albert Burla said the vaccine for young children could go on sale in June if the FDA allows it.

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COVID-19 vaccine for children: Moderna seeks permission for emergency use of Covid-19 vaccine for children aged 6 months to 5 years

Source link COVID-19 vaccine for children: Moderna seeks permission for emergency use of Covid-19 vaccine for children aged 6 months to 5 years