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(CNN) --
Moderna will seek emergency use authorization from the US Food and Drug Administration (FDA) for its COVID-19 vaccine for children ages 6 months to 5 years, the agency reported. company on Thursday.
"We believe that mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our ongoing fight against covid-19, and will be especially welcome by parents and caregivers," said 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.
The company said that two 25-microgram doses of its vaccine led to a similar immune system response in young children as two 100-microgram doses for adults ages 18 to 25.
Moderna said this should predict protection against COVID-19 and severe COVID-19 in people as young as 6 months.
In Thursday's statement, the company said the data showed "a robust neutralizing antibody response" and "a favorable safety profile."
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The efficacy of covid vaccines for young children
"We'd like to see something above 1,000 units, and what we actually saw here are levels between 1,400 and 1,800 units," Dr. Paul Burton, Moderna's chief medical officer, said in an interview with CNN.
"So that's extremely reassuring."
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Burton also said that the vaccines were very safe for this age group.
The most frequent reactions were pain at the injection site and fever.
There were no cases of heart inflammation or myocarditis in the study.
Heart inflammation has been 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 collected primarily during the wave of the omicron subvariant and included home testing 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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Data presented by Moderna on Thursday limited the analysis to only 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;
they were 37% effective in preventing symptoms in children aged 2 to 5 years.
The company said these efficacy estimates are similar to those in adults against the omicron variant after two doses.
Pfizer's vaccine for young children has also stumbled.
In clinical trials, the injections did not appear to elicit the same degree of immunity for children ages 2 to 4 as they do for young adults, prompting the company to consider giving children ages 6 months to 4 years a third dose .
The FDA has delayed its review of these injections until the company submits data on a third dose.
In recent days, Pfizer petitioned the FDA to greenlight a third booster dose for children ages 5 to 11.
Studies have shown that the efficacy of the vaccine has decreased significantly in this age group during the omicron subvariant.
On Wednesday, Burton said Moderna was also testing boosters, including variant-specific formulations.
"Our leading candidate now is something against the original strain and omicron," he said, predicting it would be the fall and winter booster formulation.
"And I think for these young children, what we're going to have to do is continue to follow the natural history and see what the variant is. What happens with young children as we go into the fall, and then the FDA and the CDC and regulators around the world can make recommendations on whether they need another booster later in the year."
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Vaccines against covid-19 for children
So far, no COVID-19 vaccines have been licensed for children under the age of 5, a population of about 18 million people in the United States alone.
Moderna's mRNA Covid-19 vaccine is already licensed for people 18 years of age and older.
The covid-19 vaccine manufactured by Pfizer and BioNTech is authorized for people over 5 years of age.
The FDA will review Moderna's submission and has said it will convene its Vaccines and Related Biologics Advisory Committee to weigh in on licensing vaccines for younger children.
The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, previously told CNN that the FDA is evaluating whether to consider emergency use authorization for the Moderna and Pfizer/BioNTech Covid-19 vaccines for young children by same time, instead of considering them separately.
Pfizer has said data on a third dose of the vaccine will be available this month.
Pfizer Chief Executive Officer Albert Bourla said the vaccine for younger children could be available as soon as June, if approved by the FDA.
Covid-19Vaccine against coronavirus
