HQ Team
August 23, 2024: The US Food and Drug Administration has granted emergency use authorisation to the Covid-19 vaccine made by Pfizer Inc., and ModernaTX Inc., which incorporates a new component to fight a variant of the virus.
The latest approval includes a single (monovalent) component to combat the KP.2 strain of the Omicron variant.
“The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalisation and death,” according to a statement from the USFDA.
In June, the FDA advised manufacturers of licensed and authorised Covid-19 vaccines to produce monovalent shots for the JN.1 variant.
‘Better protection’
As the SARS-CoV-2 virus evolved and cases rose, the regulator subsequently determined and advised manufacturers that the preferred JN.1 lineage for the Covid-19 vaccines (2024-2025 formula) was the KP.2 strain and told the producers to incorporate KP.2 “if feasible.”
“Vaccination continues to be the cornerstone of Covid-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
“These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given the waning immunity of the population from previous exposure to the virus and prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” he said.
The updated mRNA vaccines are manufactured using a similar process as previous formulas of these vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks, according to the statement.
Annual assessment
The USFDA approved the use of Moderna’s shot, branded as Spikevax, and Comirnaty — jointly developed by Pfizer and BioNTech, in both children aged six months and older, and adults.
Unvaccinated individuals six months through four years of age are eligible to receive three doses of the updated, authorized Pfizer-BioNTech Covid-19 vaccine or two doses of the updated, authorized Moderna Covid-19 Vaccine.
US individuals 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax. If previously vaccinated, the dose is administered at least two months after the last dose of any Covid-19 vaccine.
The updated vaccines are expected to provide protection against Covid-19 caused by the currently circulating variants. “Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of Covid-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines,” according to the statement.
