The US Food and Drug Administration (FDA) has approved and granted emergency use authorisation (EUA) for Moderna and Pfizer-BioNTech’s updated mRNA Covid-19 vaccines, Comirnaty and Spikevax.
The vaccines have been specifically formulated to combat the currently circulating Omicron variant KP.2 strain of SARS-CoV-2.
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The approval relates to the 2024/2025 formula of the vaccines, expected to provide enhanced protection against severe outcomes of the virus.
Comirnaty and Spikevax are approved for use in individuals aged 12 and above.
The Moderna and Pfizer-BioNTech Covid-19 vaccines have received EUA for emergency use in children aged from six months to 11 years.
These vaccines aim to offer better protection against hospitalisation and death.
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By GlobalDataIn early June 2024, the FDA advised vaccine manufacturers to focus on the monovalent JN.1 vaccines for the 2024/2025 formula.
However, with the ongoing evolution of the virus and a rise in Covid-19 cases, the agency noted that they shifted their recommendation to the KP.2 strain to ensure the vaccines are as effective as possible against the variants in circulation.
Individuals receiving the updated mRNA vaccines may encounter side effects similar to those experienced with previous vaccines.
The FDA has based its latest approvals and authorisations on manufacturing and nonclinical data that support the inclusion of the new formula in the vaccines.
The manufacturing process of the updated vaccines remains similar to that of the previous versions.
FDA Center for Biologics Evaluation and Research director Peter Marks stated: “These updated vaccines meet the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality.
“Given waning immunity of the population from previous exposure to the virus and from 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.”
mRNA vaccine coverage on Pharmaceutical Technology (or Clinical Trials Arena) is supported by Trilink. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
