No Covid-19 vaccine has been approved for children under 5 in the United States – approximately 18 million people – and the timing of possible approval is not yet clear. Moderna officials said the FDA was expected to move quickly, and a Pfizer official suggested that the vaccine for younger children could be available in June if approved. Dr. Peter Marks, director of the FDA’s Center for Biological Assessment and Research, described vaccines for young children this week as “one of our top priorities,” but acknowledged that the agency needed full applications from vaccine manufacturers to complete its review. The FDA will ask its independent vaccine advisers to weigh the vaccines for younger children, and Marks said the agency will publish a timetable for next week’s advisory committee meetings.
Modern vaccine results
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 that two doses of 25 micrograms of the vaccine resulted in a similar immune response in young children as two doses of 100 micrograms for adults aged 18 to 25 years. And he said that this should provide protection from Covid-19 and severe Covid-19 until the age of 6 months. In a press release on Thursday, the company said the data showed “a strong neutralizing antibody response” and a “favorable safety profile”. “We like to see anything over 1,000 units and what we actually saw here is levels somewhere between 1,400 and 1,800 units,” Dr. Paul Burton, chief physician at Moderna, said Wednesday. “So this is extremely 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 cardiac inflammation or myocarditis in the study. Inflammation of the heart was an extremely rare side effect of mRNA vaccines. Myocarditis is more common after infection with Covid-19 than after vaccination. 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 vaccines seem less effective for children than for older age groups. The data presented by Moderna Thursday limited the analysis only to cases that were confirmed positive by sensitive PCR tests. In the revised analysis, the vaccines were 51% effective in preventing symptoms in children aged 6 months to 2 years. was 37% effective in preventing symptoms in children aged 2 to 5 years. The company said that these efficacy assessments are similar to those of adults versus Omicron after two doses. The Pfizer / BioNTech Covid-19 vaccine for young children has also stumbled. In clinical trials, two doses of 3 micrograms did not appear to produce the same degree of immunity in children aged 2 to 4 years as in young adults, prompting the company to consider administering a third dose to children aged 6 months to 4 years. The FDA also delayed reviewing these downloads until the company submitted data for a third installment.
Souvenirs 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 have shown that the effectiveness of the vaccine is significantly reduced in this age group during Omicron. Burton said Wednesday that Moderna is also testing amplifiers, including formulations for specific variants. “Our main candidate now is something against the original executive and Omicron,” he said, predicting that this would be the boost for the fall and winter. “And I think for these little kids, what we need to do is keep looking at natural history and see what the variation is? What happens to little kids as we get 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. “
What follows for vaccines for younger children
The FDA will evaluate Moderna’s submission and said it would convene an Advisory Committee on Vaccines and Related Biological Products to consider vaccine approval for younger children. If the FDA approves the vaccines, the vaccine consultants at the US Centers for Disease Control and Prevention will vote on whether to recommend them. The CDC director will then have to sign a vaccine recommendation before vaccines can be given. The director of the National Institute of Allergies and Infectious Diseases, Dr. Anthony Fauci said the FDA was considering whether to approve emergency use for both Moderna and Pfizer / BioNTech Covid-19 vaccines for young children at the same time, instead of 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 in June if approved by the FDA. CNN’s Jamie Gumbrecht contributed to this report.
