Challenges Facing Pfizer and BioNTech in the U.S.: A Closer Look at the Obstacles
The United States Food and Drug Administration (FDA) is considering revoking the Emergency Use Authorization (EUA) for the Pfizer-BioNTech Covid-19 vaccine for healthy children aged 6 months to 4 years. This reconsideration is primarily due to the end of the COVID-19 public health emergency and subsequent policy changes, not new safety or efficacy concerns.
The FDA's review is not related to the safety or efficacy of the Pfizer-BioNTech Covid-19 vaccine. Pfizer has confirmed that the vaccine continues to show a favorable safety and effectiveness profile. The U.S. pharmaceutical company Pfizer has also emphasized that the safety and efficacy of the vaccine are not in question in the context of the FDA's review.
The FDA's potential revocation aligns with broader changes in COVID-19 vaccination policy following the end of the federal public health emergency. Pfizer is currently in discussions with the FDA to keep the EUA in place for the 2025-2026 season, citing concerns about vaccine availability for this age group if the authorization is withdrawn.
Meanwhile, Moderna is in contact with the U.S. Centers for Disease Control and Prevention (CDC) to expand the offer of its own Covid-19 vaccine for children. However, Moderna's vaccine is only approved for more limited population groups, not for children aged 6 months to 4 years. The FDA has fully approved Moderna's Covid-19 vaccine, but only for children at high risk of severe illness.
The focus for BioNTech is increasingly on the further pipeline, with upcoming news flow, especially on the oncology projects, being crucial for the stock's further development. The stock of BioNTech is currently only suitable for risk-tolerant investors with patience.
Interestingly, the stocks of Pfizer and BioNTech show no negative reaction to the FDA's potential revocation review. Pfizer gained 0.2 percent shortly before the end of trading, while BioNTech gained 1.8 percent.
It is important to note that the CEO and majority shareholder of the publisher Boersenmedien AG, Mr. Bernd Foerstch, holds positions in BioNTech and Pfizer. The author also holds positions in BioNTech.
The CDC no longer strongly recommends COVID-19 vaccination for healthy children but suggests it may be given based on doctor consultation. Moreover, alternative vaccine options such as Moderna’s vaccine are available for young children who are moderately or severely immunocompromised.
[1] CNBC (2023). FDA to consider revoking Pfizer-BioNTech Covid-19 vaccine EUA for young children. [online] Available at: https://www.cnbc.com/2023/05/15/fda-to-consider-revoking-pfizer-biontech-covid-19-vaccine-eua-for-young-children.html
[2] CDC (2023). COVID-19 vaccination for children and adolescents. [online] Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-adolescents.html
[3] Pfizer (2023). Pfizer statement on FDA's potential revocation review. [online] Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_statement_on_fda_s_potential_revocation_review
- The FDA's consideration of revoking the EUA for Pfizer-BioNTech's COVID-19 vaccine for young children isn't based on new safety or efficacy concerns, but rather on policy changes following the end of the public health emergency.
- The potential revocation of the EUA for Pfizer-BioNTech's COVID-19 vaccine isn't affecting the stocks of Pfizer or BioNTech negatively, as both companies gained during trading shortly before the announcement.
- The CDC currently no longer strongly recommends COVID-19 vaccination for healthy children, but it does suggest that vaccination may be offered based on a doctor’s consultation, with Moderna's vaccine being an alternative for moderately or severely immunocompromised young children.
