Moderna mResvia® Vaccine Approved for RSV

Moderna, a biotechnology company founded to develop mRNA medicines to treat and prevent diseases, has achieved a significant milestone. The company has received FDA approval for the new vaccine under a breakthrough therapy designation, marking Moderna’s second approved mRNA product. This is a testament to the strength and versatility of their mRNA platform. “The FDA approval of our second product, mRESVIA, is a collective achievement that we can all be proud of. It protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors,” said Stéphane Bancel, Chief Executive Officer of Moderna. 

Circuit Clinical’s Northern New Jersey research team, in collaboration with our Riverside Medical Site Partner, has been acclaimed several times by the Moderna clinical researchers for our outstanding enrollment and retention of participants. The team, led by Senior Site Director Jose Flores, achieved a 96% retention rate for participants and was ranked top 4 globally for retention, placing us in the top 1.5% of sites. While the Phase 3 research study is still underway, Moderna received early approval based on the data supplied to the FDA and the importance of this vaccine in preventing severe illness for adults over 60.

“The team has been doing an amazing job. We enrolled 50 patients. Our study team follows each participant for two years, starting with randomization. We achieved our success and recognition by Moderna because our research staff consistently followed up with patients with monthly safety calls, in-person visits, unscheduled illness visits, AEs, SAEs, and weekly eDiary review completion,” said Jose Flores.

Vaccines play a crucial role in preventing severe illnesses that are harmful to babies, children, and adults. Despite the progress in developing new treatments, people all over the world—including in the United States—still suffer from diseases that vaccines can help prevent. For this reason, Circuit Clinical has made an investment to expand our research capabilities to our Western New York region, leveraging the expertise of our Northern New Jersey team. 

“Our research goal with our site partners is to have the Circuit Team educate people in the community, using various community-specific tactics, on the importance of vaccinations in their overall personal health plan,” said Karen Pypniowski, Vice President of Site Operations.

Collaborating with biotech and pharmaceutical partners to help bring these important treatments to patients is Circuit’s mission. Moderna’s approval marks another remarkable result in which we are proud that our research contributions played a role in bringing new options to market. 

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