Moderna Initiates Rolling Submission for COVID-19 Vaccine

June 02, 2021 - Moderna recently announced that it initiated the rolling submission process for a Biologics License Application (BLA) for its mRNA COVID-19 vaccine.

The company will continue to submit data to support the BLA to FDA on a rolling basis over the next few weeks, with request for a priority review. COVID-19 Vaccine Moderna is currently available under FDA emergency use authorization to prevent the virus in individuals 18 years of age and older.

The authorization assures the public and medical community that FDA has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information, proving that the known and potential benefits outweigh the known and potential risks of the vaccine. 

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

“We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission,” Bancel continued. 

READ MORE: Moderna, Aldevron Expand Partnership for mRNA COVID-19 Vaccine

So far, over 124 million doses of COVID-19 Vaccine Moderna has been administered in the US. 

EU Authorizes Pfizer, BioNTech COVID-19 Vaccine in Adolescents 

Pfizer and BioNTech recently announced that the Conditional Marketing Authorization (CMA) for its COVID-19 vaccine, called Comirnaty in the EU, was granted to include individuals 12 to 15 years of age.

In mid-January, the EU granted CMA for Comirnaty based on recommendations from the European Medicines Agency (EMA) to use the candidate for active immunization to prevent the coronavirus in individuals 18 years of age and older.

Health officials can now roll out the vaccine across the EU throughout 2021, including to its 27 member states. 

Comirnaty was the first COVID-19 vaccine to be authorized in the EU and is the first to have its CMA extended to adolescents, a Pfizer spokesperson said. 

READ MORE: Emergency Use Authorization Granted for GSK-Vir COVID-19 Antibody

“This is a meaningful moment for adolescents, parents and entire families who are seeking protection from this virus and a return to normalcy,” Albert Bourla, chairman and chief executive officer at Pfizer, said in the announcement. 

“We appreciate the agency’s thorough and efficient review of the data from our clinical trial and look forward to seeing more people across Europe immunized as a result of today’s decision,” Bourla continued. 

The EU decision is based on data from a Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years of age. Participants received two 30μg doses of Comirnaty.

Trial results showed that the vaccine was 100 percent effective in participants with or without prior COVID-19 infection, as well as robust antibody responses. 

Additionally, a pediatric study evaluating the safety and efficacy of the COVID-19 vaccine in children six months to 11 years of age is ongoing. Results from the study are expected in September 2021.

READ MORE: Japan Grants AstraZeneca’s COVID-19 Vaccine Emergency Use

“Today’s extension of our COVID-19 vaccine authorization in the European Union is another critical milestone in our collective effort to broaden vaccination programs to as many people as possible,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.

“Making vaccines available to adolescents will help re-open schools, and support the return to a normal day-to-day life,” Sahin continued. 

Sanofi, GSK Begin Enrollment for Phase 3 Trial of COVID-19 Vaccine Candidate

GSK and Sanofi recently began enrollment of their Phase 3 clinical trial to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate.

The global, randomized, placebo-controlled trial is a two-stage approach that will include over 35,000 volunteers 18 years of age and older from multiple countries, including the US, Asia, Africa, and Latin America.

The primary endpoint is the prevention of symptomatic COVID-19 in COVID-naïve adults, while the secondary endpoint is the prevention of severe COVID-19 disease and prevention of asymptomatic infection. 

The study will initially uncover the efficacy of a vaccine formulation targeting the original D.614 virus, or the Wuhan virus, while a second stage will evaluate a second formulation targeting the B.1.351, or the South African variant. 

Following positive results from the recent Phase 2 study, the companies will begin clinical studies to assess the ability of the vaccine candidate to elicit a strong booster response, regardless of the initial vaccine platform received.

 “We believe further solutions for COVID-19 are very much needed to help reach people around the world, especially as the pandemic evolves and variants continue to emerge. Adjusting our technology and study designs reflects this need and will further build the potential of this adjuvanted protein-based vaccine,” Roger Connor, president of GSK, said in the announcement. 

“We are grateful to the volunteers who will take part in the trials and hope the results will add to the encouraging data we’ve seen so far so we can make the vaccine available as quickly as possible,” Connor continued.