Moderna Requests FDA Approval for COVID-19 Vaccine for Children Under 6

In a positive development for parents of young children, Moderna has submitted a request to the FDA for authorization of its COVID-19 vaccine for kids aged 6 months to 6 years. This means that the nation’s youngest 18 million children are a step closer to vaccination, though the timeline for availability remains uncertain. A representative from Moderna indicated that it would take until approximately May 9 to finalize the necessary documentation for the FDA, after which the agency will need to make a decision.

Moderna’s CEO, Alex Johnson, expressed optimism, stating, “We believe that mRNA-1273 will offer safe protection to these young children against SARS-CoV-2, which is crucial in our ongoing battle against COVID-19 and will be especially reassuring for parents and caregivers.” The company’s clinical trial results indicated that the vaccine generates an antibody response in children similar to the response observed in adults aged 18 to 25. Although the trial size was insufficient to definitively measure effectiveness, preliminary data suggest the vaccine is 51 percent effective against symptomatic cases in children under 2, and 37 percent effective for those aged 2 to 5. While these numbers are lower than the initial adult vaccine effectiveness rates, they still provide significant protection. Moderna noted that the reduced effectiveness is largely due to the Omicron variant, which has led to an uptick in breakthrough cases. Additionally, the trial revealed no concerning safety issues, including no indications of heart inflammation, which has been a worry with both COVID-19 and its vaccines.

Timeline for Vaccination

So, when can parents expect to get their little ones vaccinated? The timeline hinges on several factors. Moderna is also seeking FDA approval for its COVID-19 vaccines for children aged 5-11 and teens aged 12-17 simultaneously. It’s uncertain whether the FDA will evaluate all three vaccines at once or prioritize the vaccine for the youngest age group, who have been unprotected throughout the pandemic. If the FDA opts to review all three together, it could extend the timeline.

Last week, Dr. Emily Carter, a key medical adviser, suggested that the FDA might wait for data from Pfizer’s clinical trials for comparison purposes, similar to the approach taken with adult vaccines. This would further prolong the process. Pfizer is developing a three-dose vaccine at one-tenth the strength of adult doses, while Moderna’s two-dose regimen is one-fourth the strength of its adult formulation. The FDA has stated that they might not assess the data until June, as they plan to consult an external advisory panel of experts. Sources indicate that the FDA is committed to a thorough and careful evaluation before greenlighting a vaccine for the youngest demographic. This means parents should prepare for additional waiting and patience. Moderna is also pursuing similar requests in other countries.

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In summary, Moderna has petitioned the FDA for the approval of its COVID-19 vaccine for children under 6, potentially paving the way for vaccination for the youngest members of society. While the timeline remains unclear, the process is underway, and parents may need to exercise patience as the FDA reviews the data.

Keyphrase: Moderna COVID-19 Vaccine for Children

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