Moderna’s RSV vaccine candidate has been granted a Breakthrough Therapy Designation by the FDA, a major step forward in the fight against the debilitating respiratory virus. This designation, which recognizes the potential of the vaccine to address an unmet medical need, is a promising sign that the long-awaited vaccine could soon be available to the public.
The groundbreaking Phase III ConquerRSV trial has earned mRNA-1345, a mRNA-based vaccine, a prestigious regulatory honor. In the trial, the vaccine achieved an impressive 83.7% efficacy against RSV lower respiratory tract disease in older adults, marking a major breakthrough in the fight against the virus.
Moderna CEO Stephane Bancel expressed optimism of bringing the company’s RSV vaccine candidate for older adults to the market in a safe and timely manner, noting that he looks forward to productive conversations with the FDA.
The company is aiming to seek regulatory approval in the first half of 2023, with plans to submit the necessary paperwork in the coming months. This marks an exciting step forward in their growth and development.
Spikevax, Moderna’s COVID-19 vaccine, uses the same lipid nanoparticle envelope as mRNA-1345, making them two of the most advanced vaccines in the world. These cutting-edge technologies offer a promising chance at protecting against the virus.
Bancel heralded the extraordinary potential of the mRNA infectious disease vaccine platform and its most recent success, Spikevax, following the unveiling of its Phase III trial data – the second of its kind to show positive results.
The ConquerRSV trial was a groundbreaking clinical trial, enrolling 37,000 elderly patients in order to study the effects of RSV-associated lower respiratory tract disease (RSV-LRTD). After 64 cases of RSV-LRTD were identified, an interim analysis was conducted in order to gain further insights into the disease. This was a landmark study in its field, and the results are eagerly anticipated.
Out of the 64 people studied, an impressive 55 cases were found among those who received a placebo, while a mere nine cases were discovered among those who received mRNA-1345. This marks an impressive success for the novel vaccine.
Moderna’s COVID-19 vaccine sales hit a mammoth figure of $18.4 billion this year, according to company officials at the J.P. Morgan Healthcare Conference. However, the company is expecting this figure to dwindle down to $5 billion in 2023, based on existing purchase agreements.
Moderna’s RSV vaccine candidate is trailing behind the competition, yet still remains a promising contender in the race to find an effective vaccine.
In November, the U.S. Food and Drug Administration (FDA) gave GlaxoSmithKline’s RSV vaccine candidate for older adults the green light for priority review, a move that could help protect this vulnerable population from the virus.
The FDA is set to make a decision in May regarding potential RSV vaccines from Pfizer and BioNTech. With the potential to make a major impact on healthcare, the review of these vaccines is highly anticipated.