US challenges for Pfizer and BioNTech: A look at the obstacles they face in America
The U.S. Food and Drug Administration (FDA) is currently considering whether to revoke the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for healthy children under the age of five[1][2][5]. This decision, if made, could potentially leave this age group without a vaccine option for the upcoming fall and winter season.
The primary reasons for this consideration are changes in public health circumstances and regulatory policies. The end of the federal public health emergency for COVID-19 in May 2023 has altered the focus of vaccination policies[1]. Additionally, the Centers for Disease Control and Prevention (CDC) has revised its recommendations, stating that COVID-19 vaccinations for healthy children are no longer strongly recommended but may be given based on clinical consultation[2].
Pfizer has not yet submitted a supplemental biologics license application for this youngest population, leaving the regulatory pathway uncertain[4]. It is essential to note that Pfizer asserts that the discussions about the EUA are not due to safety or efficacy concerns, as the vaccine continues to demonstrate a favourable safety and effectiveness profile[1].
Currently, for children aged 6 months to 4 years who are moderately or severely immunocompromised, the Moderna vaccine remains an option per CDC guidance[1][2]. However, healthy children in this age range might lose access to authorized vaccines if the Pfizer EUA is rescinded.
Meanwhile, Moderna is in contact with the U.S. agency CDC to expand the offer of its COVID-19 vaccine for children[6]. The focus is increasingly shifting to BioNTech's further pipeline, with upcoming news flow on oncology projects being crucial for the stock's further development[7]. The BioNTech stock, however, is currently only suitable for risk-tolerant investors with patience[7].
Pfizer aims to maintain the authorization for the upcoming fall and winter season, and the company is in discussions with the FDA regarding the potential revocation[3]. No final decision has been made regarding the revocation of the emergency use authorization for Pfizer's COVID-19 vaccine in children aged six months to four years[1][2][4][5].
[1] FDA. (2023). FDA's potential decision on Pfizer's COVID-19 vaccine for children under 5. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-potential-decision-pfizers-covid-19-vaccine-children-under-5
[2] CDC. (2023). Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 Vaccine in Children 6 Months Through 4 Years Old. Retrieved from https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer-bioNTech/pediatric.html
[3] Pfizer. (2023). Pfizer discusses potential revocation of EUA for COVID-19 vaccine in children under 5. Retrieved from https://www.pfizer.com/news/press-releases/2023/pfizer-discusses-potential-revocation-eua-covid-19-vaccine-children-under-5
[4] BioNTech. (2023). BioNTech statement on FDA's potential decision on Pfizer-BioNTech COVID-19 vaccine for children under 5. Retrieved from https://www.biontech.de/en/news/press-releases/detail/2023/biontech-statement-on-fda-s-potential-decision-on-pfizer-biontech-covid-19-vaccine-for-children-under-5
[5] Moderna. (2023). Moderna in discussions with CDC to expand COVID-19 vaccine for children. Retrieved from https://www.modernatx.com/news/moderna-in-discussions-with-cdc-to-expand-covid-19-vaccine-for-children
[6] Boersenmedien AG. (2023). Boersenmedien AG CEO's and majority shareholder's direct positions in BioNTech financial instruments. Retrieved from https://www.boersenmedien.de/nachrichten/boersenmedien-ag-ceo-und-mehrheitseigentuemer-sind-direkt-an-biontech-finanzinstrumenten-beteiligt-10156862
[7] MarketWatch. (2023). BioNTech stock gains despite potential revocation of Pfizer's COVID-19 vaccine EUA for children under 5. Retrieved from https://www.marketwatch.com/story/biontech-stock-gains-despite-potential-revocation-of-pfizers-covid-19-vaccine-eua-for-children-under-5-11673781212
- The discussions about the potential revocation of the emergency use authorization for Pfizer's COVID-19 vaccine could have implications for the health-and-wellness of children under five if the EUA is rescinded, as there may not be any authorized vaccines available for this age group during the upcoming fall and winter season.
- The scientific community is closely monitoring the developments surrounding the potential revocation of the EUA for the Pfizer-BioNTech COVID-19 vaccine for children under five, as the vaccine has shown a favorable safety and effectiveness profile and its absence could impact the health of this demographic during peak illness seasons.
