Moderna says its coronavirus vaccine for young children is safe, but efficacy is...more complicated
Source: Washington Post
Vaccine maker Moderna announced Wednesday its two-dose pediatric coronavirus vaccine was safe in young children, toddlers and babies in a study. But the effectiveness of the shot in children 6 months to 5 years old was more of a mixed picture because of the challenge presented by the highly transmissible omicron variant. In a trial of the vaccine, the shot met the main criteria the company and regulators had defined for success, generating immune defenses equivalent to those that protected young adults before the omicron variant emerged, according to a Moderna news release.
But in the face of omicron, the immune defenses mustered by two doses in adults were less robust, particularly in preventing infections — and the same pattern was seen in children, with vaccine efficacy of about 40 percent. Two years into the coronavirus pandemic, progress toward a pediatric vaccine has been impatiently awaited by parents and pediatricians as children younger than 5 remain the last group not eligible for a vaccine. There are about 19 million children in this age group in the United States. Moderna said it plans to submit the data on children 6 months to 5 years old to the Food and Drug Administration in the coming weeks.
In a briefing Tuesday, company representatives told government officials they planned to file for emergency authorization in mid-April, according to a senior Biden administration official who spoke on the condition of anonymity because they were not authorized to speak.Children received two shots of a 25-microgram dose, a quarter of the adult dose. The data has not been published or peer-reviewed. The findings reflect the complicated and changing landscape of the pandemic. The original vaccine trials enrolled tens of thousands of participants and waited to see whether participants who received a vaccine were less likely to get sick than those who received a placebo. Those trials showed that, against an earlier version of the virus, the Moderna vaccine was more than 90 percent effective in preventing illness in adults.
To swiftly extend eligibility of the vaccine beyond adults, the children’s trials were designed primarily to measure safety and whether the vaccines conjured the same levels of virus-fighting antibodies. When the trial of the Moderna vaccine started, success was defined as immune responses equivalent to what was reported among young adults in the pre-omicron period. The Moderna trial hit that benchmark in young children. But two doses have turned out to be far less effective against the highly transmissible omicron variant in adults, and that also held true for children. While protection against infection in young children was about 40 percent overall, it was slightly lower in children younger than 2 years old.
Read more: https://www.washingtonpost.com/health/2022/03/23/moderna-says-its-coronavirus-vaccine-young-children-is-safe-efficacy-is-more-complicated-picture/
Full headline: Moderna says its coronavirus vaccine for young children is safe, but efficacy is a more complicated picture
Link to their press release - https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-its-COVID-19-Vaccine-Phase-23-Study-in-Children-6-Months-to-Under-6-Years-Has-Successfully-Met-Its-Primary-Endpoint/default.aspx
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