FDA approves Moderna's RSV vaccine for seniors, the corporate's second ever product

The Food and Drug Administration approved on Friday Modern Respiratory syncytial virus vaccine for adults ages 60 and older, the corporate's second product ever to hit the U.S. market.

The decision is a victory for Moderna, which urgently needs one other income amid falling demand for its Covid vaccine, its only commercially available product.

The approval of the Moderna vaccine relies on a late phase clinical trial in older adults, who’re more at risk of severe cases of RSV. The virus kills between 6,000 and 10,000 seniors annually and leads to 60,000 to 160,000 hospitalizations, based on Data from the Centers for Disease Control and Prevention.

Moderna's vaccine is marketed under the brand name mRESVIA. It is the primary messenger RNA vaccine approved for a disease apart from Covid. The company's vaccine can be the one RSV vaccine available in a prefilled syringe, making it easier to manage to patients.

A Advisory Board The CDC will vote in June on recommendations for the use and intended audience of the Moderna vaccine. The company expects a advice reminiscent of that for existing RSV vaccines from GSK And PfizerModerna executives said during a conference call on May 1.

A positive advice from the CDC would allow Moderna's vaccine to compete against GSK and Pfizer, which launched their respective vaccines within the U.S. last fall. Pfizer's vaccine has lagged GSK's up to now, but each vaccines have generated a whole lot of tens of millions in sales up to now.

Moderna's full-year 2024 revenue forecast of around $4 billion includes revenue from its RSV vaccine.

The approval shows how versatile Moderna's messenger RNA platform is beyond treating Covid. The biotech company is using this technology to fight a variety of different diseases, including RSV, cancer and a highly contagious gastrointestinal virus called norovirus.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said in a press release. “With mRESVIA, we continue to make a difference for patients by addressing global public health threats related to infectious diseases.”

The biotech company currently has greater than 40 products in development, several of that are in advanced testing phases. This includes its combination vaccine against Covid and flu, which could possibly be approved as early as 2025.

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Moderna can be developing, amongst other things, a standalone flu vaccine, a customized cancer vaccine along with Merck, and vaccines against latent viruses.

Moderna says it expects sales growth again in 2025 and expects to interrupt even in 2026 due to the introduction of latest products.

Investors have high hopes for the long-term potential of Moderna's mRNA product pipeline: The company's shares have risen greater than 40% this 12 months after falling nearly 45% in 2023.

Data from vaccine studies

The FDA was originally scheduled to make a call on Moderna's vaccine on May 12, however the agency delayed approval, citing internal “administrative constraints.”

A Phase 3 study A study of around 37,000 people showed that Moderna's vaccine was 83.7% effective after about three months and prevented at the very least two symptoms of RSV infection. Data That February study found that vaccine effectiveness had dropped to 63% after 8.6 months.

At the time, these results raised concerns amongst investors that the vaccine’s effectiveness would decline faster than that of the vaccines from GSK and Pfizer. Moderna in a opinion These comparisons are usually not possible without direct comparison tests.

The company added that its study had different study populations, geographic locations and case definitions for RSV, amongst other things.

No significant safety concerns were identified amongst patients who received the shot as a part of the study. Most uncomfortable side effects were mild to moderate and included pain on the injection site, fatigue, headache, muscle aches and joint pain.

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