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news.The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing authorisation for Pfizer and BioNTech’s LP.8.1-adapted monovalent Covid-19 vaccine.
Till date, more than a billion adults and children globally have received the vaccine. Credit: CDC on Unsplash.
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This updated vaccine is aimed at individuals aged six months and older.
The CHMP’s endorsement is based on a comprehensive body of evidence, including clinical, non-clinical, and real-world data, affirming the efficacy and safety of Pfizer and BioNTech’s Covid-19 vaccines.
Pfizer noted that the LP.8.1 adaptation is in line with the EMA’s Emergency Task Force’s advice to target the LP.8.1 variant, with the aim of sustaining vaccine effectiveness as the SARS-CoV-2 virus evolves.
The European Commission is expected to review the CHMP’s recommendation and make a final decision shortly.
In anticipation, Pfizer and BioNTech have commenced production of the vaccine to ensure immediate availability for EU member states post-approval, aligning with the anticipated increase in vaccine demand during the fall and winter seasons.
The LP.8.1-adapted vaccine has demonstrated enhanced immune responses against various SARS-CoV-2 lineages, surpassing the response from prior adaptations such as the JN.1 and KP.2-adapted vaccines.
The companies have also presented this data to regulatory bodies worldwide, reinforcing their commitment to addressing the evolving challenges of the pandemic.
They are continuing to monitor the evolving Covid-19 epidemiology in preparation to meet public health needs across the globe.
More than a billion adults as well as children globally have received the Pfizer-BioNTech vaccine till date.
Pfizer and BioNTech’s Covid-19 vaccines are based on the latter’s mRNA technology and were developed by both companies.
