COVID-19 vaccine, mNexspike, by the FDA marks a significant advancement in the ongoing fight against the pandemic. This new formulation is specifically targeted at adults aged 65 and older, as well as individuals aged 12 to 64 with underlying health conditions that heighten their risk for severe illness . Notably, mNexspike utilizes only one-fifth of the dose present in Moderna’s original vaccine, Spikevax, thereby potentially enhancing accessibility and reducing resource consumption while maintaining efficacy.
COVID-19 vaccine, Spikevax — by refining its immune target.
The approval “adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Stephane Bancel, Moderna’s CEO, said in a statement Saturday.
The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.
FDA’s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax®), Moderna’s original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.
On Thursday, the CDC’s website page that hosts a schematic of the adult vaccine schedule was changed to remove the recommendation for pregnant people to get Covid vaccines. In its place is a gray bar that indicates there is no guidance for use of Covid vaccine in pregnant people. However, other pages on the agency’s website continue to urge pregnant people to get Covid boosters while pregnant to protect themselves and their fetus. The FDA’s approval letter also asks Moderna to conduct a new randomized controlled trial in adults 50 to 64 to determine if they still  benefit from Covid vaccination. In a commentary posted in the New England Journal of Medicine earlier this month, FDA Commissioner Marty Makary and Vinay Prasad, the newly appointed head of the FDA’s vaccines division, argued that it was not clear Covid shots still confer benefits to people who are not at high risk of severe infection, and they announced that going forward, use of the vaccines would be targeted to high-risk groups and adults 65 and older
In a Phase 3 clinical trial involving over 11,400 participants aged 12 and older, mNexspike demonstrated safety comparable to its predecessor and showed improved efficacy metrics. The results indicated a relative vaccine efficacy increase of 9.3% for those aged twelve and older and an impressive increase of 13.5% for seniors. This data suggests that mNexspike may offer better protection while minimizing dosage requirements. As public health strategies evolve to combat COVID-19 effectively, this approval underscores the importance of adaptive responses in vaccine development.
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