U.S. Challenges for Pfizer and BioNTech - Comprehensive Insights Revealed
The United States Food and Drug Administration (FDA) is reviewing the potential revocation of the emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 vaccine for healthy children under the age of five. This move is part of a regulatory reassessment following the end of the COVID-19 public health emergency.
The vaccine for children under five is currently the only available coronavirus vaccine option for that age group in the U.S. If the EUA is not renewed, it would eliminate this option. However, it's important to note that the safety and efficacy of the vaccine are not in question, according to Pfizer.
The FDA's review is primarily due to regulatory decisions following the end of the COVID-19 public health emergency in May 2023. The vaccine continues to show a favorable profile in terms of safety and efficacy. Pfizer is in discussions with the FDA regarding the potential revocation of the EUA and has requested that it remain in place for the 2025-2026 season.
Meanwhile, Moderna is in contact with the U.S. CDC to expand the offer of its own Covid-19 vaccine for children. The FDA has fully approved Moderna's vaccine, but only for children with an increased risk of severe illness. Children aged 6 months to 4 years who are immunocompromised may still receive the Moderna vaccine, per CDC guidelines.
On the stock market, Pfizer's stock is up 0.2% shortly before the close of trading, while BioNTech's stock is up 1.8%. The protein-based vaccine from Novavax is currently not available for children under the age of 12. BioNTech's focus is increasingly shifting to its pipeline, with upcoming news flow, especially regarding oncology projects, being crucial for the further development of the stock.
It's worth noting that the CEO and majority shareholder of the publisher Boersenmedien AG, Mr. Bernd Foertsch, and the author hold direct positions in BioNTech, which could benefit from the potential price development resulting from the publication.
The FDA's review of the EUA for the Pfizer-BioNTech Covid-19 vaccine does not involve safety or efficacy concerns. Only a small target group would be affected by such a decision. Pfizer continues to have a positive profile in terms of the safety and efficacy of its Covid-19 vaccine.
[1] Centers for Disease Control and Prevention. (2023). COVID-19 Vaccines for Children and Teens. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html [2] U.S. Food and Drug Administration. (2023). Emergency Use Authorization. Retrieved from https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [3] Pfizer Inc. (2023). Pfizer Seeks to Maintain Authorization for Covid-19 Vaccine for Fall and Winter Season. Retrieved from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-seeks-to-maintain-authorization-for-covid-19-vaccine-for-fall-and-winter-season
- The FDA's review of the emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 vaccine is not focused on its safety or efficacy, but rather a regulatory reassessment following the end of the COVID-19 public health emergency.
- Pfizer's Covid-19 vaccine, approved for emergency use in children under five in the US, continues to have a positive profile in terms of safety and efficacy, despite discussions about the potential revocation of the EUA for the 2025-2026 season.
