Moderna's updated Covid-19 vaccine is now authorized for individuals aged 65 and over in the United States
Vaccine Approved for High-Risk Individuals: Moderna's mNEXSPIKE
Here's the lowdown on Moderna's newest COVID-19 vaccine, mNEXSPIKE: it's been given the green light by the Food and Drug Administration (FDA) for folks aged 65 and above, and for those between 12 and 64 with pre-existing health issues that put them at risk for severe COVID-19, as defined by the Centers for Disease Control and Prevention (CDC).
Moderna expects to have this game-changer available for the 2025-2026 respiratory virus season. The company's CEO, Stephane Bancel, described this development as "an important new tool to help protect people at high risk of severe disease from COVID-19."
An interesting twist in the regulatory landscape is happening under the Department of Health and Human Services, steered by long-time vaccine skeptic, Robert F Kennedy Jr. This department is beefing up oversight of vaccines, adding to concerns about potential disruptions to the review process of treatments and vaccines.
The FDA aims to review drugmakers' COVID-19 booster shots against an inert placebo in healthy adults under 65 for approval, which effectively limits the shots to older adults and those at high risk of severe illness.
The mNEXSPIKE vaccine has an advantage over competitors because it can be stored in refrigerators, rather than freezers, making distribution a breeze, especially in developing countries where supply-chain issues could complicate vaccine rollouts.
The CDC, also under Kennedy's supervision, recently clarified that COVID vaccines remain an option for healthy kids when parents and doctors agree it's necessary. This decision has provided some relief to investors, as it keeps the existing framework for older adults and at-risk individuals who generally seek out the shots.
The approval for mNEXSPIKE was based on late-stage trial data, indicating that it's not inferior to the original Moderna vaccine, Spikevax, in individuals aged 12 and up, and boasts superior efficacy in adults aged 18 and above in the study.
Cuts Delay Regulatory Reviews
Kennedy's shakeup at the health departments has resulted in mass layoffs to align with President Donald Trump's aim to slim down the federal government. This move has only amplified concerns about possible delays to the regulatory review process for treatments and vaccines.
The CDC's panel of vaccine experts discussed recommending booster shots only for populations at risk of severe COVID-19 for the upcoming immunization campaign in April.
The FDA recently approved Novavax's COVID vaccine, Nuvaxovid, but limited its use to older adults and those over 12 with conditions that increase the risk of severe illness due to COVID-19.
Health issues putting individuals at additional risk range from diabetes and heart disease to behaviors like physical inactivity and substance abuse, according to the CDC.
While Moderna's shots, along with Comirnaty from Pfizer-BioNTech, are mRNA-based, Novavax's vaccine is protein-based and requires more time to manufacture.
Moderna recently withdrew its application seeking approval for its flu-and-COVID combination vaccine candidate, opting to wait for more efficacy data from a late-stage trial of its influenza shot.
- Related: COVID drug output surges as cases soar in Thailand
Enrichment Data:
- High-Risk Individuals: mNEXSPIKE is approved for all adults 65 years and older and for individuals aged 12 to 64 years with at least one CDC-defined underlying risk factor for severe COVID-19[1][3][4].
- Previously Vaccinated: The vaccine is intended for individuals who have previously received a COVID-19 vaccine[4].
- Safety Considerations: Individuals should not receive mNEXSPIKE if they have had a severe allergic reaction to any Moderna COVID-19 vaccine or component[4].
- Age-Specific Efficacy: The shot shows superior efficacy compared to Spikevax in adults 18 years of age and older in the study, while it's not inferior to Spikevax in individuals aged 12 years and older[4].
- In the regulatory landscape, the Department of Health and Human Services, under the supervision of long-time vaccine skeptic Robert F Kennedy Jr, is beefing up oversight of vaccines, which has raised concerns about potential disruptions to the review process of treatments and vaccines like Moderna's mNEXSPIKE for health-and-wellness.
- Moderna's mNEXSPIKE, a COVID-19 vaccine, is approved for all adults aged 65 years and older and for individuals aged 12 to 64 years with at least one CDC-defined underlying health-and-wellness risk factor for severe COVID-19, making it a crucial tool for protecting high-risk individuals.
