On January 21, 2021, Health and Human Services (HHS) published a final rule in the Federal Register that changes a key part of the Vaccine Injury Compensation Program (VICP) addressing how shoulder injuries following vaccination, as well as vasovagal syncope, are dealt with in the Program.

While vaccine injuries are considered to be rare, shoulder injuries following vaccination are among the most common vaccine adverse events and so in 2017, the Vaccine Injury Table was amended to add Shoulder-Injury-Related-to-Vaccine-Administration (SIRVA) to the Table.

As the clamor grows for an effective Covid-19 vaccine, questions regarding vaccine safety have been foremost in the minds of the public. A recently published article in the pre-eminent journal, Science, by lead author, David M. Knipe, provides an overview into the vaccine safety regulatory framework in place in the United States and discusses how that framework came-to-be over the last several decades.

Among the common vaccine safety measures discussed by the authors are quality control checks to ensure that each batch of vaccine meets strict formulation standards and monitoring adverse events both before and after licensing to determine whether additional study, or alternate action, is needed. The article also discusses the Food and Drug Administration’s (“FDA”) specific guidance to pharmaceutical companies developing potential Covid-19 vaccines, including recommendations for post-licensure reporting and post-licensure studies in light of the likelihood for emergency-use approval of Covid-19 vaccines.

Given the news over the last few weeks of three different Covid-19 vaccines with encouraging Phase-3 clinical trial results, this informative article is extremely well-timed.