Moderna Submits Initial Data to FDA for COVID-19 Vaccine Booster

September 07, 2021 - Moderna recently submitted initial data to the FDA to evaluate a booster dose of its COVID-19 vaccine, mRNA-1263, at the 50 microgram dose level. 

The company will submit data to the European Medicines Agency (EMA) and other regulatory authorities worldwide in the near future. 

“We are pleased to initiate the submission process for our booster candidate at the 50 µg dose with the FDA,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement.

“We will continue to generate data and transparently share to support governments and regulators as they make evidence-based decisions regarding future vaccination strategies,” Bancel continued. 

Moderna’s data from the Phase 2 study of mRNA-1263 showed that a booster dose of the vaccine at the 50 microgram dose level boosted neutralizing antibody titers across all age groups, notably in older adults aged 65 and older.

The safety profile following dose three was similar to that observed previously for dose two of the vaccine. 

And an additional analysis also found that a booster dose of mRNA-1273 at the same dosage level elicited robust antibody response and substantially increased geometric mean titers (GMT) for all variants of concern. 

The variants included the Beta, Gamma, and Delta variants. 

Merck, Ridgeback Bio Initiate Phase 3 COVID-19 Trial

Merck and Ridgeback Biotherapeutics recently launched a Phase 3 clinical trial to evaluate their COVID-19 treatment, molnupiravir, in individuals with coronavirus exposure. 

The MOVe-AHEAD trial is a randomized, placebo-controlled study evaluating the safety and efficacy of molnupiravir compared to placebo to prevent COVID-19 within households. 

The trial will enroll nearly 1,332 individuals 18 years of age and older who live in the same household as an infected individual with at least one symptom. The trial’s primary endpoint is participants with COVID-19 through Day 14, the percentage of patients with an adverse event, and the percentage of participants who discontinued the study due to an adverse event.

Individuals who have received a COVID-19 vaccine are not eligible to participate in the trial. 

“As the pandemic continues to evolve and surges are being reported in many places around the world, it is important that we investigate new ways to protect individuals exposed to the virus from becoming infected with symptomatic disease,” Nick Kartsonis, MD, senior vice president of vaccines, infectious diseases, and clinical research at Merck, said in the announcement. 

“If successful, molnupiravir could provide an important additional option towards reducing the burden of COVID-19 on our communities,” Kartsonis continued.

Researchers are also studying molnupiravir in Part 2 of the global Phase 3, randomized, placebo-controlled MOVe-OUT trial studying non-hospitalized patients with mild to moderate coronavirus and at least one risk factor associated with poor disease outcomes. 

Merck will present trial data in the second half of 2021.

GSK, SK bioscience Initiate Phase 3 Study of COVID-19 Vaccine Candidate 

GSK and SK biosciences recently initiated a Phase 3 clinical study of SK’s COVID-19 vaccine candidate, GBP510, combined with GSK’s pandemic adjuvant. 

The global, randomized trial will enroll nearly 4,000 participants from various countries to evaluate the safety and immunogenicity of GBP510 compared to AstraZeneca’s COVID-19 vaccine.  

The global Phase 3 trial will be the first to compare two different COVID-19 vaccine candidates. 

“There remains a need for accessible and affordable COVID-19 vaccines to ensure equitable access and to protect people across the world. We are pleased to contribute with GSK’s pandemic adjuvant and to be working with SK to deliver the vaccine at scale via COVAX if it is approved,” Thomas Breuer, chief global health officer at GSK, said in the announcement.

The advance to Phase 3 trial follows positive interim Phase 1/2 data results, which showed that all participants who received GBP510 demonstrated a 100 percent seroconversion rate. 

And neutralizing antibody titers were between five and eight times higher than sera from individuals recovered from COVID-19. 

“Taking this important step towards overcoming the global pandemic situation, SK and GSK will bring our technical expertise together for the development of an adjuvanted protein-based vaccine candidate, GBP510,” Jaeyong Ahn, CEO of SK bioscience, said in the announcement. 

GSK will present Phase 3 study results in the first half of 2022. And the COVAX facility will supply GBP510 at scale worldwide.