We all have spent the last several months doing our best to keep ourselves and our families safe, while adjusting to this new virtual world. PPMD recognizes this has been nothing short of challenging, and we remain committed to providing support, community engagement, and the most accurate and up-to-date information possible during a time of unknowns. This extends to new learnings of COVID-19 vaccines, which PPMD believes to be the best form of protection against the virus, and we hope is a potential solution to alleviate this pandemic.
Over the past several months, we have learned more about the emerging COVID-19 vaccine frontrunners and their promising efficacy results from their respective phase 3 studies. Two companies, Pfizer-BioNTech and Moderna Therapeutics, submitted requests for Emergency Use Authorization (EUA) to the FDA in hopes of receiving an approval by the end of 2020. On December 10, the U.S. FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 4 in support of the FDA granting Emergency Use Authorization (EUA) for the Pfizer-BioNTech BNT162b2 product. Moderna Therapeutics has a meeting with the VRBPAC scheduled on Thursday, December 17.
While this is great news, we recognize imminent approvals brings with it a multitude of questions regarding distribution, long-term safety, and general eligibility. For this reason, PPMD invited Dr. Tim Cripe, who brings expertise on vaccine development and clinical trials, and Dr. Tim Franson, who offers insight into the FDA and regulatory pathways, to guide us through currently available data on vaccine mechanisms of action, development, and regulatory pathways for approval and distribution by joining us for a webinar on December 11, 2020 to discuss what we know.
Watch: COVID-19 Vaccination & Duchenne: What You Need To Know
COMPLETE PPMD’S NEW SURVEY – IMPACT OF THE COVID-19 PANDEMIC ON DUCHENNE
PPMD has launched our second COVID-19 Pandemic Impact Survey related to your experiences during the pandemic for accessing care, trials, and approved therapies. Our latest survey delves into new questions around telemedicine experiences, as well as updated questions on trials and approved therapies. Please help us by completing this new survey, whether or not you participated in our earlier spring survey. The data you provide through these surveys is vital to informing and shaping the work of relevant stakeholder groups in the Duchenne and Becker community, including physicians, drug developers, and patient advocacy groups.Complete Survey >