March 21, 2022
We have received questions from the community regarding any potential updates to our policy on COVID-19 vaccines and gene therapy clinical trials. In response, we are providing this brief update to our December 2020 community bulletin, which you may find here.
Note that the information below is current as of March 21, 2022 and is subject to change. For more on COVID-19 vaccines, please view the CDC’s COVID-19 website. Disclaimer: whether or not to vaccinate is a medical decision, and should be discussed with a healthcare provider.
Covid-19 Vaccines And Eligibility For Clinical Trials (Updated March 8, 2022)
- Will COVID vaccination be required for entry to a Sarepta clinical trial?
We strongly recommend that clinical trial participants be vaccinated against COVID-19. Note that this recommendation does not apply to individuals for whom an approved COVID-19 vaccine is not available, such as children under the age of 5 years.
- Will COVID vaccination be an exclusion criterion for a Sarepta gene therapy trial?
By current protocol, gene therapy clinical trial participants cannot receive a live vaccine within ~4 weeks or an inactive vaccine within ~2 weeks of the Day 1 gene therapy visit. The approved mRNA and the Johnson & Johnson vaccines are inactive vaccines. Additionally, participants cannot receive vaccines during the first 3 months after the Day 1 visit. These policies are in place for safety reasons and because the increased steroids given with gene therapy could lessen the intended effect of a vaccine. Note that this restriction would apply to each dose of a vaccine, including a booster dose.