FDA: Pfizer, Moderna vaccines for children under 6 are safe, effective

Moderna’s two-dose Covid-19 vaccine is usually safe and effective for children from 6 months to 17 years old, the FDA said in a separate forum document submitted late Friday.

Background: The documents are the product of months of corporate security reviews and immunogenicity data, which organizational regulators must independently verify. They will form the basis for a review of FDA independent immunization advisors at meetings on Tuesday and Wednesday, during which they will vote on whether to recommend the institution to authorize EUAs thousands of years old.

The first meeting will focus on a series of immunizations proposed by Moderna for children aged 6 to 17, and the second day will apply to both national vaccination companies for up to 6 months.

Limited data on efficiency: The FDA evaluated the ability of vaccines to induce low antibody responses in children compared with adolescent adolescents, a concept known as immunobridging. They both met the agency’s success criteria.

Real-world performance against Omicron variants in the 6- to 5-month-old group in the Moderna vaccine ranged from 36 to 51 percent, but the success rates for all age groups were “generally consistent” with the values ​​observed in the study. studies of adults during different wavelengths, the FDA said.

Preliminary evaluation of the effectiveness of Pfizer vaccine in children under 5 years of age for 80 percent against the disease, although only 10 cases of Covid were reported among study participants before the data cut-off date in April.

There was still a lot of unspecified effectiveness in both corporate data showing the current status of adult immunizations in the US, including duration and how the vaccine protects against side effects such as long-term Covid, the FDA said. Children will probably need booster doses in the future, given adult information on immune defenses, say reviewers.

Adverse reactions such as headaches and fatigue were more common in adolescents than in young children, possibly because they received larger doses of vaccines, The FDA said. The flu has been reported more frequently among the youngest vaccine recipients.

No new safety signs were found in the company’s clinical trials, although they were not large enough to detect rare side effects, the FDA said.

The FDA review of company details comes months after angry parents felt pressured by statements that Covid-19 vaccines would be available to the country’s young children in early 2022, to see a change in dates. The FDA has scheduled a meeting of the advisory committee in February to consider the first two doses of Pfizer’s vaccine, so that it can be postponed once the data suggests that a third dose may strengthen its effectiveness.

Parents and promoters of children under the age of 5 to be vaccinated emerged in a POLITICO report in April that Biden management relied on approving both Pfizer-BioNTech and Moderna products simultaneously to make it easier to promote firearms, a particular movement. it is believed that it led to the directors staying in Moderna’s request while Pfizer continued to collect data and complete its submission. FDA Commissioner Robert Califf he later stressed that there would be no catch at Moderna’s request, but the plan of the advisory committee meeting eventually ensured that both policies would be considered as a head-on collision.

Treatment of Myocarditis: No cases of myocarditis or pericarditis – inflammation of the heart tissue or membranes, respectively – have been reported in Moderna pediatric trials. Both of these conditions are a known risk factor for Covid-19 enzyme RNA vaccines, especially for males 12 to 39 years of age.

Data from international immunization safety programs suggested that a higher rate of heart disease occurred after a modern vaccine with a moderator than Pfizer-BioNTech’s, which, along with the availability of the Pfizer youth vaccine, confirmed the FDA last fall. ahead of the EUA then 12- to 17-year-olds, the organization said in a forum document.

But analyzing US data on active and inactive surveillance programs conducted in April and May “does not support differences in the risk of myocarditis / pericarditis [Moderna] as compared [Pfizer-BioNTech] or suggest small differences due to uncertainty, ”says the FDA, which later referred to evidence of risk differences between the two products as“ flawless. ”

The balance of the risk of allowing Moderna vaccine as a youth option during a heart attack is likely to be a major source of debate at Tuesday’s meeting.

No cases were reported in the Pfizer and BioNTech trials for children under 5 years of age, and the risk for that age group is unknown. The risk of myocarditis associated with the goal of that age group may be lower compared to younger adults, given the low prevalence rate in 5- to 11-year-old men and the low rates of adverse reactions among young children, the FDA said.

FDA: Pfizer, Moderna vaccines for children under 6 are safe, effective

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