FDA grants full approval to Moderna Covid vaccine for kids but limits eligibility
Moderna’s Covid-19 vaccine for children has received full approval from the Food and Drug Administration, marking a significant milestone as the first Covid vaccine for kids in the United States to move beyond emergency use authorization. This approval, however, comes with a specific requirement – the vaccine is intended for children with underlying medical conditions that put them at higher risk of severe illness from Covid.
The company announced that the FDA has granted a supplemental Biologics License Application for its vaccine, Spikevax, to include children aged 6 months to 11 years. Previously, Spikevax had been approved for use in individuals 12 years and older earlier this year.
Moderna’s CEO, Stéphane Bancel, emphasized the importance of vaccinating children against Covid, especially those with pre-existing medical conditions. He stated, “Covid-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization.”
The company plans to have an updated version of the vaccine available for the upcoming 2025-26 respiratory virus season. Children aged 6 months to 23 months who have not previously been vaccinated against Covid will require two doses, spaced one month apart. For children who have already received a vaccine or are older than 2 years, a single dose will be sufficient.
The decision to limit eligibility for the vaccine follows a controversial announcement by health secretary Robert F. Kennedy Jr. in late May, where he revised the recommendations for Covid vaccination. According to Kennedy, healthy children and pregnant individuals should no longer receive the Covid vaccine, a move that has been met with criticism from health experts.
Fiona Havers, a former medical epidemiologist at the CDC, expressed concern over the new vaccination policies, particularly regarding young children’s vulnerability to severe Covid. Data presented to the CDC’s Advisory Committee on Immunization Practices showed that infants under 6 months and children aged 6 to 23 months have a high risk of hospitalization due to Covid.
The abrupt change in vaccination recommendations has caused uncertainty among parents seeking to protect their children from Covid. The FDA’s approval stipulation may also deter healthcare providers from recommending the vaccine for infants, potentially leaving them at risk of severe illness.
In conclusion, the FDA’s full approval of Moderna’s Covid-19 vaccine for children is a significant development in the fight against the pandemic. However, the limitations on eligibility and changing vaccination guidelines pose challenges for parents and healthcare providers seeking to safeguard young children from the virus. It remains crucial for authorities to consider the best interests of children’s health and well-being in the ongoing vaccination efforts.
