Regulatory Ahead of the seasonal spike, Pfizer and BioNTech’s Covid...

Ahead of the seasonal spike, Pfizer and BioNTech’s Covid vaccine receives FDA greenlight


The U.S. FDA has taken a significant step by approving modified mRNA vaccines for COVID-19 from Pfizer-BioNTech and Moderna while discontinuing the use of their older bivalent shots in the United States. 

The FDA’s approval revolves around these vaccines being tailored to combat the latest variants of the virus effectively. Both Pfizer-BioNTech and Moderna have received separate vaccine formulations optimized for this purpose. Importantly, these vaccines are now authorized for individuals aged 12 and above, with emergency authorization also granted for children as young as 6 months up to 11 years old.

The key enhancement in these vaccines involves the addition of a monovalent component designed to target the omicron variant XBB.1.5, which has been a source of concern recently.

Moderna has placed significant focus on the resurgence of COVID-19 and has expressed apprehensions regarding the possibility of a “tripledemic” involving COVID-19, influenza, and respiratory syncytial virus during the approaching autumn and winter periods. The Advisory Committee on Immunization Practices of the U.S. Centers for Disease Control and Prevention is scheduled to convene shortly to furnish guidance on the application of these revised vaccines, aiming to guarantee a knowledgeable and synchronized reaction to the changing circumstances.

The FDA’s approvals were based on thorough evaluations of manufacturing data related to the shift in the 2023-24 season. A comprehensive body of evidence, including clinical trials, non-clinical studies, and real-world data, all confirming the safety and effectiveness of Pfizer and BioNTech’s COVID-19 vaccines was considered before approval. Furthermore, preclinical data indicates that this season’s vaccine significantly enhances immune responses against multiple Omicron XBB-related sublineages compared to previous bivalent vaccine formulations.

Moderna has already initiated the distribution of vaccine doses to various vaccination sites across the United States, with expectations that these vaccines will be accessible shortly.

Pfizer and BioNTech have proactively manufactured vaccine doses in advance to ensure a consistent supply, aligning with the expected surge in demand during the fall and winter seasons, when respiratory illnesses tend to increase.

This season’s vaccine has been specifically customized to target the SARS-CoV-2 XBB.1.5 sublineage and is intended to be administered as a single dose for most individuals aged 5 and older. Preclinical data suggests that this updated COVID-19 vaccine generates more robust neutralizing antibody responses against various Omicron-related sublineages, including XBB.1.5, BA.2.86 (Pirola), and EG.5.1 (Eris), which are currently predominant in the U.S.

To ensure widespread accessibility, Pfizer and BioNTech are collaborating closely with pharmacies, hospitals, and clinics nationwide to make this season’s vaccine readily available to the public.

Albert Bourla, Chairman and Chief Executive Officer at Pfizer, emphasizes the critical timing of this decision, given the rising COVID-19 cases. He encourages individuals to get vaccinated, potentially combining their COVID-19 vaccine with their annual flu shot for convenience and enhanced protection during the peak season for respiratory viruses.

Prof. Ugur Sahin, M.D., CEO, and Co-founder of BioNTech, highlights the importance of adapting vaccines to match the circulating virus variants or sublineages, particularly due to the seasonal pattern that COVID-19 exhibits, similar to other respiratory viruses.

This season’s COVID-19 vaccine will be readily available in various healthcare settings across the United States, with options for pre-filled syringes or single-dose vials, ensuring accessibility for a wide range of individuals.

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