“We believe that mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our long-term fight against COVID-19 and will be especially welcomed by parents and caregivers.” Stefan Bansel, CEO of Moderna, said in a press release.
Covid-19 vaccines for children under the age of 5 are not allowed in the United States – about 18 million people – and a timetable for possible authorization is not yet clear. Moderna officials said the FDA was expected to move quickly, and a Pfizer official suggested that its vaccine for younger children could be available in June if allowed.
Dr Peter Marx, director of the FDA’s Center for Biological Substance Evaluation and Research, called vaccines for young children “one of our top priorities” this week, but acknowledged that the agency needed full applications from manufacturers. of vaccines to complete your examination.
The FDA will ask its independent vaccine advisers to evaluate vaccines for younger children, and Marx said the agency will release a schedule for next week’s advisory committee meetings.
The results of the Moderna vaccine
At the end of 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 25 micrograms of its vaccine led to a similar immune response in young children as two doses of 100 micrograms for adults aged 18 to 25. And it is said that this should predict protection against Covid-19 and severe Covid-19 up to 6 months of age.
In a news release Thursday, the company said the data showed a “strong response to neutralizing antibodies” and a “favorable safety profile”.
“We like to see just over 1,000 units, and what we’ve actually seen here are levels somewhere between 1,400 and 1,800 units,” Dr. Paul Burton, Moderna’s chief medical officer, said Wednesday. “So that’s extremely reassuring.”
Burton also said vaccines are very safe for this age group. The most common reactions are injection site pain and fever. There were no cases of heart inflammation or myocarditis in the study. Inflammation of the heart is 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 mainly during the Omicron wave and included home tests for Covid-19. As a result, the company said vaccines appear to be less effective for children than for older groups.
The data presented by Moderna Thursday limited the analysis to cases confirmed as positive by sensitive PCR tests. In the revised analysis, vaccines were 51% effective in preventing symptoms in children aged 6 months to less than 2 years; they are 37% effective in preventing symptoms in children aged 2 to 5 years. The company said that these efficacy evaluations were similar to those in adults versus Omicron after two doses.
Pfizer / BioNTech’s Covid-19 vaccine for young children has also stumbled. In clinical trials, two doses of 3 micrograms did not appear to generate the same level of immunity in children aged 2 to 4 as in young adults, prompting the company to consider giving a third dose to children aged 6 months to 4 years. . . The FDA also delayed the review of these vaccines until the company provided a third dose.
Boosters for younger children?
On Tuesday, Pfizer asked the FDA to give the green light for a third or booster dose for children ages 5 to 11. Studies show that the effectiveness of the vaccine decreased significantly in this age group during Omicron.
Burton said on Wednesday that Moderna was also testing boosters, including variant-specific formulations.
“Our leading candidate is now against the original strain and Omicron,” he said, predicting that this would be the wording for reinforcement for the fall and winter.
“And I think for these little kids, what we’re going to have to do is keep following natural history and see what the option is.” What happens to young children as we enter the fall? And then the FDA and the CDC and regulators around the world can make recommendations about whether they need another booster later in the year. “
What about vaccines for younger children
The FDA will evaluate Moderna’s performance and say it will convene its Advisory Committee on Vaccines and Related Organic Products to assess the authorization of vaccines for young children. If the FDA approves the vaccines, vaccine advisers at the Centers for Disease Control and Prevention in the United States will vote on whether it should be recommended. The CDC director will then need to sign a vaccine recommendation before injections can be given.
The director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, said the FDA was considering whether to consider an emergency authorization for Moderna and Pfizer / BioNTech Covid-19 for young children at the same time, rather than looking at them separately.
Pfizer said data on the third dose of the vaccine will be available this month. Pfizer CEO Albert Burla said the vaccine for younger children could be available in June if approved by the FDA.
CNN’s Jamie Gumbrecht contributed to this report.
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