Moderna to resubmit combo vaccine application after FDA feedback

USA—Moderna has announced that it has withdrawn its application seeking approval for its combined influenza and COVID-19 mRNA vaccine candidate, known as mRNA-1083.

This decision came after discussions with the U.S. Food and Drug Administration (FDA).

The company plans to resubmit the application later this year, once it has additional vaccine efficacy data from a late-stage clinical trial of its experimental seasonal influenza vaccine, mRNA-1010, which is expected to report results this summer.

This move follows closely on the heels of an FDA announcement requiring new clinical trials for annual COVID-19 booster shots intended for healthy people under the age of 65.

Moderna’s combination vaccine, however, was specifically designed for adults aged 50 and older, aiming to protect against both COVID-19 and seasonal flu in a single shot.

In a press release, Moderna stated, “We continue to expect interim data from the mRNA-1010 trial to be available this summer.”

The company intends to use this data on flu vaccine efficacy to strengthen its resubmission to the FDA.

The ongoing phase 3 trial of mRNA-1010 is critical to demonstrating the vaccine’s effectiveness against influenza, which will complement the COVID-19 protection offered by mRNA-1083.

Moderna’s shares have faced significant pressure recently, partly due to declining revenue from COVID-19 vaccines as the pandemic eases and demand decreases.

Investor confidence has also been shaken by political developments, notably the appointment of Robert F. Kennedy Jr., a known vaccine skeptic, as Secretary of the Department of Health and Human Services.

This news contributed to a further 1.4% drop in Moderna’s stock during premarket trading on Wednesday.

Meanwhile, the FDA is expected to make a decision on Moderna’s next-generation COVID-19 vaccine—an essential component of the combined flu-COVID shot—by the end of May.

Moderna has indicated that it does not anticipate any delays in this decision, which is a positive sign for the company’s vaccine pipeline.

Earlier in May, Moderna pushed back the expected approval timeline for its combination vaccine to 2026.

This delay reflects the company’s cautious approach to ensuring the vaccine’s safety and efficacy before it hits the market.

Moderna has been relying heavily on revenue from its newer mRNA vaccines to offset the decline in sales of its original COVID-19 vaccine.

Additionally, the company’s respiratory syncytial virus (RSV) vaccine has not seen the uptake it hoped for, which contributed to a nearly 60% drop in Moderna’s stock price last year.

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