(CTN News) – The Food and Drug Administration has approved Moderna’s innovative COVID-19 vaccine, following the federal government’s tightening of vaccine regulations for the virus.

The FDA announced on Friday that mNEXSPIKE is now approved for administration to adults 65 and older, as well as people aged 12 to 64 who have at least one underlying condition that increases their susceptibility to serious infections.

The recipients must have had a previous COVID-19 vaccine.

On Saturday, the Cambridge, Massachusetts-based organization announced that the vaccine will be available during the 2025-2026 respiratory virus season. Moderna manufactures Spikevax for COVID-19 and mRESVIA for the respiratory syncytial virus (RSV).

According to Moderna CEO Stéphane Bancel, “The FDA’s approval of our third product, mNEXSPIKE, offers a substantial new resource to protect individuals at a high risk of severe COVID-19.” COVID-19 remains a significant public health threat, with over 47,000 deaths in the United States the previous year.

We appreciate the FDA’s prompt evaluation and commend the entire Moderna team on their consistent dedication to public health and diligent efforts.

STAT reported that the next-generation COVID-19 vaccine uses a more specific target to induce antibodies against the SARS-CoV-2 virus. The dose is one-fifth that of Spikevax, the current vaccine.

To evaluate mRNA-1283, Moderna conducted a Phase 3 clinical trial that was randomized, observer-blind, and included approximately 11,400 participants aged 12 and older. Moderna’s updated COVID-19 vaccine, Spikevax, was approved on September 6, 2024.

The primary goal was to compare the vaccine’s efficacy against COVID-19 14 days after administering mNEXSPIKE to Spikevax. In people aged 12 and up, the new vaccine had 9.3% higher relative efficacy than mRNA-1273. There was a 13.5% increase for people over the age of 65.

The Phase 3 trial reported four major adverse effects: headache, fatigue, myalgia, and injection site pain. According to the company, the likelihood of mNEXSPIKE causing a severe allergic reaction is low, with reactions typically occurring within minutes to one hour of administration.

According to Moderna, some people who received mRNA COVID-19 vaccines developed myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the heart’s outer lining). Males aged 12 to 24 are the demographic most vulnerable to difficulties.

The FDA has requested that Moderna conduct post-marketing studies to provide a more comprehensive evaluation of the product’s safety and efficacy. This study investigates the effects of vaccination on pregnant women and their infants when administered during gestation. The study must be submitted by the end of 2032.

Pfizer and Moderna approved COVID-19 vaccines in December 2020.

In January 2020, the United States reported its first COVID-19 case. In August 2021, the FDA granted full COVID-19 approval to Pfizer-BioNTech for people aged 12 and up, and Moderna in January 2022. They are still available to children aged 6 months and older with emergency use authorization.

Despite a directive from Health and Human Services Secretary Robert F. Kennedy Jr. earlier that week, the Centers for Disease Control and Prevention stated on Friday that children without preexisting health conditions “may receive” a COVID-19 vaccine.

The CDC revised and released the childhood immunization schedule late Thursday. Kennedy declared that the agency would no longer recommend vaccinations for healthy children and would revise the guidelines.

The revised schedule requires health insurance providers, including Medicare and Medicaid plans, to continue to cover pediatric vaccines. The classification of COVID-19 vaccinations during pregnancy is “No Guidance/Not Applicable,” with all pregnant women previously advised to get them.

After a six-week delay, the FDA approved Novavax’s COVID-19 vaccine with age restrictions this month. The agency approved the vaccine only for people 65 and older, as well as children 12 and older who have at least one underlying condition that increases the risk of severe illness.

HHS notified Moderna this week that $766 million in contracts had been cancelled. These contracts were for the development, testing, and licensing of vaccines for flu subtypes that could cause future pandemics, such as the deadly H5N1 avian influenza virus.

On January 20, 2020, the United States received its first COVID-19 case report.

According to the CDC, approximately 23% of adults in the United States were immunized as of April. The CDC estimated that 13% of children aged six months to 18 years were affected.

SOURCE: UPI