In a significant advancement in the fight against COVID-19, US researchers have made notable progress in developing new mRNA vaccines. Two key developments include:
### Updated mRNA COVID-19 Vaccines
The US Food and Drug Administration (FDA) has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc. These vaccines have been updated to include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2, providing better protection against currently circulating variants and serious consequences of COVID-19, including hospitalization and death.
### Next-Generation COVID-19 Vaccine
The FDA has also approved Moderna’s next-generation COVID-19 vaccine, mRNA-1283, marketed under the name mNEXSPIKE. This vaccine targets specific portions of the SARS-CoV-2 spike protein and is engineered to be given in a smaller dose. mNEXSPIKE has been approved for adults 65 and older and individuals between 12 and 64 years old with at least one condition that puts them at risk for severe COVID-19 outcomes.
*Key Features of mNEXSPIKE:*
– *Smaller Dose*:
One-fifth the dose of the current vaccine, Spikevax
– *Targeted Approach*:
Encodes two segments of the SARS-CoV-2 spike protein, eliciting effective antibodies against COVID-19
– *Noninferior Efficacy*:
Met primary goal of showing noninferior efficacy compared to Spikevax in a Phase 3 clinical trial
– *Efficacy in Adults*:
More effective than Spikevax in adults, according to Moderna
*Future Directions:*
– *Annual Assessment*:
The FDA anticipates that COVID-19 vaccine composition will need to be assessed annually, similar to seasonal influenza vaccines
– *Combination Vaccines*:
Moderna is working on a combination shot that includes mRNA-1283 and a seasonal flu vaccine, which may require additional testing and regulatory frameworks
– *Ongoing Research*:
The FDA will continue to review and take regulatory action on COVID-19 vaccine applications.
