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Moderna is seeking permission for the emergency use of vaccines for children


(CNN) – Moderna will seek emergency use authorization from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine for children ages 6 months to 5 years, the company said Thursday.

“We believe that mRNA-1273 will be able to protect these children safely from SARS-CoV-2, which is so important in our ongoing fight against covid-19, and will be especially welcomed by parents and caregivers,” by Stéphane Bancel. , CEO of Moderna, in a statement.

In late March, Moderna announced the results of a clinical trial that included 2,500 children ages 6 to 24 months and 4,200 children ages 2 to 5 years. The company said that two doses of 25 micrograms in its vaccine led to a similar immune system response in young children as two doses of 100 micrograms for adults aged 18 to 25. Moderna said that this should predict protection against COVID-19 and COVID-19 are severe in people as young as 6 months.

In a statement Thursday, the company said the data showed “a robust neutralized antibody response” and “a favorable security profile.”

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The effectiveness of covid vaccine for young children

“We would like to see something above 1,000 units, and what we actually saw here is the level between 1,400 and 1,800 units,” Dr. Paul Burton, Moderna’s chief medical officer, said in an interview with CNN. “So that’s pretty reassuring.”

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

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The results announced in March were collected mainly during the omicron subvariant wave and included home tests for covid-19. As a result, the company said the vaccines appeared less effective for children than for older age groups.

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The data presented by Moderna on Thursday limited the analysis only to cases confirmed positive by PCR tests. In the revised analysis, the vaccines were 51% effective in preventing symptoms in children aged 6 to 24 months; were 37% effective in preventing symptoms in children aged 2 to 5 years. The company said that these efficacy estimates are similar to those of adults versus omicron variants after two doses.

Pfizer vaccine for toddlers also stumbles. In the clinical trials, the injections did not appear to trigger the same degree of immunity for children 2 to 4 years of age as they did for young adults, prompting the company to consider children 6 months and 4 years of age. a third dose. The FDA delayed its review of these injections until the company submitted data on a third dose.

In recent days, Pfizer has filed a petition with the FDA to issue a third booster dose for children ages 5 and 11. Studies show that the effectiveness of the vaccine is greatly reduced in this age group during the omicron subvariant.

On Wednesday, Burton said Moderna was also testing recalls, including specific variant formulations.

“Our current leading candidate is something against the original strain and omicron,” he said, predicting that it would be the fall and winter recall formulation. “And I think for these teens, what we’re going to have to do is continue to follow the natural history and see what the variant is. CDCs and regulators around the world can make recommendations on whether they need another recall later in the year. . “

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Covid-19 vaccine for children

To date, there are no COVID-19 vaccines licensed to children under the age of 5, a population of about 18 million people in the United States alone.

The Covid-19 Moderna mRNA vaccine is already licensed for people 18 years of age or older. Pfizer and BioNTech have manufactured the authorized covid-19 vaccine for people over 5 years of age.

The FDA will review Moderna’s submission and said it will convene a Vaccine and Biological Advisory Committee on Vaccines to weigh licensed immunizations for younger children.

The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, has previously told CNN that the FDA is evaluating whether it should consider authorizing emergency use of Moderna and Pfizer / BioNTech Covid-19 vaccines for young children at the same time, instead of sa. in considering them separately.

Pfizer said data on a third dose of the vaccine will be available this month. Pfizer CEO Albert Bourla said the vaccine for younger children could be available as early as June, if authorized by the FDA.

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