The speed with which the COVID-19 vaccines were developed raised concerns among healthcare professionals and the general public alike regarding both the long-term efficacy and safety of the vaccines. Though certain vaccines were granted emergency use authorization given the gravity of the public health crisis, efficacy and safety data have been diligently collected throughout the time that vaccines have been deployed.
Though the rise of the delta variant has been accompanied by an apparent reduction in vaccine efficacy, positive safety data continue to accumulate. A new publication in the medical journal JAMA has provided new information on safety surveillance of the vaccines. As highlighted in the publication, the continuing surveillance of safety after the marketing of the vaccines is critical to ensure that safety signals are picked up in the case that even rare events may be associated with one or multiple of the vaccines.
Data collected thus far suggest that the Vaccine Adverse Events Reporting System (VAERS), which is co-sponsored by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) is sensitive enough to capture anaphylaxis 13% to 76% of the time and Guillain-Barre syndrome between 12% and 64% of the time across different vaccines. In addition, the data on the nearly 12 million mRNA vaccine doses that have thus far been administered to more than 6 million people fail to identify enhanced risks associated with the vaccine.
Importantly, though mRNA vaccination has not been found to raise the risk of the heart conditions myocarditis and pericarditis across all vaccine recipients, it has proven to elevate risk of these conditions in those between the ages of 12 and 39. The FDA label for these vaccines has been revised accordingly.
It will be important now that the Pfizer vaccine has received full FDA approval and emergency use authorization appears to be getting closer for those under the age of 12 that we continue to monitor the effects of the vaccines in both the short and long term. While the vaccines appear to be doing a great deal to mitigate negative health effects associated with the COVID-19 virus, we are still far from understanding the long-term effects of the vaccines on different groups and being able to adequately weigh the risks and benefits of the vaccines for distinct populations.
Blumenthal KG, Phadke NA, Bates DW. Safety Surveillance of COVID-19 mRNA Vaccines Through the Vaccine Safety Datalink. JAMA. Published online September 3, 2021. doi:10.1001/JAMA.2021.14808