May 31 (UPI) — The Food and Drug Administration has approved Moderna’s new COVID-19 vaccine, days after the federal government tightened vaccine standards for the virus.
The FDA announced Friday that mNEXSPIKE can be given to adults 65 and older and those 12 to 64 with at least one underlying condition that could put them at risk of severe infection. Recipients also must have been previously vaccinated for COVID-19.
The company, headquartered in Cambridge, Mass., said Saturday it expects to have the vaccine available for the 2025-2026 respiratory virus season. Moderna also produces Spikevax for COVID-19, and mRESVIA for the respiratory syncytial virus, or RSV.
“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Stéphane Bancel, chief executive officer of Moderna, said. “COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA’s timely review and thank the entire Moderna team for their hard work and continued commitment to public health.”
STAT reported the next-generation COVID-19 vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus. The dose is one-fifth the doage used in Spikevax, the current vaccine.
Moderna conducted a randomized, observer-blind Phase 3 clinical trial of approximately 11,400 participants aged 12 years and older to test the mRNA-1283. The primary efficacy was to demonstrate the vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with Spikevax, Moderna’s updated COVID-19 vaccine approved on Sept. 6, 2024.
The new vaccine showed a 9.3% higher relative vaccine efficacy than the mRNA-1273 in individuals aged 12 years and older. It was 13.5% better in adults aged 65 and older.
In the Phase 3 trial, the most common side effects were injection site pain, fatigue, headache and myalgia.
The company said there is a very small chance that mNEXSPIKE could cause a severe allergic reaction, usually within a few minutes to 1 hour after getting a dose of mNEXSPIKE.
Myocarditis, which is inflammation of the heart muscle, and pericarditis, which is inflammation of the lining outside the heart, have occurred in some people who have received mRNA COVID-19 vaccines, Moderna said. Of those with problems, they are among males12 through 24.
The FDA has asked Moderna to conduct post-marketing studies to continue to evaluate the safety and effectiveness of the product. This includes a study on the outcomes of pregnant people and their babies when the vaccine was administered during pregnancy. The study is to be submitted by the end of 2032.
Pfizer was the first COVID-19 vaccine to receive emergency approval in December 2020 and Moderna was followed one week later. The first COVID-19 cases were reported in the United States in January 2020.
The FDA first granted Pfizer-BioNTech full COVID-19 approval for those 12 and older in August 2021 and Moderna in January 2022. They remain available under emergency use authorization for children as young as 6 months.
On Friday, the Centers for Disease Control and Prevention said children without underlying health conditions “may receive” a COVID-19 vaccine, contradicting a directive by Health and Human Services Secretary Robert F. Kennedy Jr. earlier in the week.
The CDC updated the childhood immunization schedule published late Thursday. Kennedy, who said the agency would stop recommending the shots for healthy children, noted the guidelines would be changed.
The new schedule also requires health insurance companies, Medicare and Medicaid plans to continue to cover the vaccines for children.
COVID-19 shots during pregnancy are listed as “No Guidance/Not Applicable,” where they were previously recommended for all pregnant adults.
Earlier this month, the FDA approved Novavax’s COVID-19 vaccine with age restrictions after a six-week delay. The agency approved the vaccine only for people 65 and older and those 12 and older with at least one underlying condition at a higher risk of severe illness.
This week, HHS notified Moderna that it was canceling contracts worth $766 million to develop, test and license vaccines for flu subtypes that could trigger future pandemics, including the dangerous H5N1 bird flu virus.
The first COVID-19 case was reported in the United States on Jan. 20, 2020.
About 23% of U.S. adults are estimated to be up to date with the vaccine, according to the CDC through April. For children 6 months and up to 18, it is an estimated 13.%, the CDC reported.
