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Expert Rev Vaccines
. 2025 Apr 4;24(1):261-266.
doi: 10.1080/14760584.2025.2480282. Epub 2025 Apr 4. A plain language summary of the available safety data for the BNT162b2 COVID-19 vaccine: development, approval, and surveillance of use
Frank van den Ouweland 1 , Nicola Charpentier 2 , Özlem Türeci 3 , Ruben Rizzi 4 , Claudia Lindemann 5 , Federico Mensa 6
Affiliations
No abstract available
Plain language summary
What is this summary about?There is a vast amount of research available on the safety of coronavirus disease 2019 (COVID-19) vaccines. This article aims to summarize the evidence available on the safety of the COVID-19 vaccine, BNT162b2 (Comirnaty®). It covers the development and approval processes of the BNT162b2 vaccine, adaptation of the vaccine for the seasonal COVID-19 variant, potential adverse reactions (unwanted or harmful reactions) of the vaccine, and the continued monitoring of vaccine safety.What are some of the key takeaways?Development and approval processes for COVID-19 vaccines were sped up to provide rapid access in a public health emergency, while maintaining strong safety standards. Since coming into use, COVID-19 messenger RNA (mRNA) vaccines have undergone an unprecedented level of surveillance, generating a huge amount of evidence on vaccine safety. The original BNT162b2 vaccine has been updated multiple times during the pandemic to adapt to changes occurring in the virus that causes COVID-19, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and provide improved protection. Also, vaccine developers continue to monitor the safety of COVID-19 vaccines in close collaboration with regulatory bodies. The evidence presented demonstrates that serious adverse reactions following COVID-19 mRNA vaccination are very rare and that mild reactions, such as swelling and redness at the site of injection, generally resolve after a few days.[Box: see text].
. 2025 Apr 4;24(1):261-266.
doi: 10.1080/14760584.2025.2480282. Epub 2025 Apr 4. A plain language summary of the available safety data for the BNT162b2 COVID-19 vaccine: development, approval, and surveillance of use
Frank van den Ouweland 1 , Nicola Charpentier 2 , Özlem Türeci 3 , Ruben Rizzi 4 , Claudia Lindemann 5 , Federico Mensa 6
Affiliations
- PMID: 40183376
- DOI: 10.1080/14760584.2025.2480282
No abstract available
Plain language summary
What is this summary about?There is a vast amount of research available on the safety of coronavirus disease 2019 (COVID-19) vaccines. This article aims to summarize the evidence available on the safety of the COVID-19 vaccine, BNT162b2 (Comirnaty®). It covers the development and approval processes of the BNT162b2 vaccine, adaptation of the vaccine for the seasonal COVID-19 variant, potential adverse reactions (unwanted or harmful reactions) of the vaccine, and the continued monitoring of vaccine safety.What are some of the key takeaways?Development and approval processes for COVID-19 vaccines were sped up to provide rapid access in a public health emergency, while maintaining strong safety standards. Since coming into use, COVID-19 messenger RNA (mRNA) vaccines have undergone an unprecedented level of surveillance, generating a huge amount of evidence on vaccine safety. The original BNT162b2 vaccine has been updated multiple times during the pandemic to adapt to changes occurring in the virus that causes COVID-19, called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and provide improved protection. Also, vaccine developers continue to monitor the safety of COVID-19 vaccines in close collaboration with regulatory bodies. The evidence presented demonstrates that serious adverse reactions following COVID-19 mRNA vaccination are very rare and that mild reactions, such as swelling and redness at the site of injection, generally resolve after a few days.[Box: see text].