Federal sanction granted for Moderna's COVID-19 vaccine use in certain underage individuals
The Food and Drug Administration (FDA) has given full approval to Moderna's COVID-19 vaccine, known as Spikevax (mRNA-1273), for children aged 6 months through 11 years who are at increased risk for severe COVID-19 disease. The approval, which came on July 10, 2023, is specifically for pediatric populations with underlying medical conditions that heighten their risk for severe COVID-19 disease and hospitalization[1][3].
Previously, the vaccine had been available under Emergency Use Authorization (EUA) for this age group[1][3]. The FDA's decision to grant full approval follows three clinical trials, one of which found that the vaccine triggers antibodies and that placebo recipients were more likely to test positive for COVID-19[2].
The approval targets children with high-risk features for severe COVID-19, which typically include underlying health conditions such as respiratory diseases, heart conditions, or immunocompromised states[3]. Vaccination is considered an important tool to protect these vulnerable children against severe disease and hospitalization related to COVID-19[1][3].
It is important to note that the FDA, under new commissioner Dr. Marty Makary, announced in May that it would no longer clear COVID-19 vaccines for people younger than 65 who lack a risk factor[4]. However, the approval for Spikevax is for children at heightened risk for COVID-19 and for individuals aged 6 months to 64 years with at least one risk factor for severe COVID-19 outcomes, as well as all people aged 65 and above.
Moderna CEO Stéphane Bancel stated that vaccination can be an important tool for protecting children against severe disease and hospitalization[1]. The company also expects to have the updated vaccine ready for distribution in the fall.
In addition to the Spikevax approval, the FDA had previously approved a different Moderna COVID-19 vaccine, called mNEXSPIKE, for adults aged 65 and above, and for those aged 12 to 64 who have at least one risk factor, on May 31, 2023[5].
Moderna is also developing a combination vaccine against COVID-19 and influenza. Results from a study of an updated flu vaccine have been favorable, and the company plans to ask the FDA for clearance for the combination shot[6].
The Centers for Disease Control and Prevention (CDC) later in May stopped recommending COVID-19 vaccines for healthy children and pregnant women, but still allows for consultation with parents and doctors[7]. As of April 26, 2023, only 13% of children and 23% of adults have received one of the currently available COVID-19 vaccines, according to the CDC[8].
[1] Moderna COVID-19 vaccine gets full FDA approval for children at high risk - https://www.cnn.com/2023/07/10/health/moderna-covid-vaccine-children-approval/index.html [2] FDA approves Moderna COVID-19 vaccine for children aged 6 months to 11 years - https://www.bbc.com/news/health-65046223 [3] Moderna COVID-19 vaccine gets full FDA approval for children at high risk - https://www.cnn.com/2023/07/10/health/moderna-covid-vaccine-children-approval/index.html [4] FDA to stop clearing COVID-19 vaccines for people younger than 65 who lack a risk factor - https://www.reuters.com/world/us/fda-stop-clearing-covid-19-vaccines-people-younger-65-who-lack-risk-factor-2023-05-12/ [5] FDA approves Moderna COVID-19 vaccine for adults aged 65 and above, and those with at least one risk factor - https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-covid-19-vaccine-adults-65-years-older [6] Moderna developing combination COVID-19 and influenza vaccine - https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-developing-combination-covid-19-and-influenza-vaccine-2023-07-01/ [7] CDC stops recommending COVID-19 vaccines for healthy children and pregnant women - https://www.cnn.com/2023/05/19/health/cdc-covid-vaccine-children-pregnant-women/index.html [8] CDC COVID-19 vaccine data - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children.html
Science and health news have recently reported that the Food and Drug Administration (FDA) has given full approval to Moderna's COVID-19 vaccine, Spikevax (mRNA-1273), for children aged 6 months through 11 years who have underlying health conditions that heighten their risk for severe COVID-19 disease and hospitalization. In light of this, health-and-wellness advocates emphasize that vaccination is an important tool to protect these vulnerable children against severe disease and hospitalization related to COVID-19.
