Moderna shares down after pulling Covid-flu combo vaccine software

Moderna is banking on new mRNA merchandise to choose up gross sales amid falling Covid-19 vaccine demand. Credit score: Lutsenko_Oleksandr through Shutterstock.

Moderna has “voluntarily” withdrawn its software to the US Meals and Drug Administration (FDA) for approval of its Covid-19 and flu mixture vaccine amid a current tightening of regulatory necessities by US Well being Secretary Robert F Kennedy (RFK) Jr.

The US drugmaker was temporary on particulars in its 21 Could press launch, saying solely that it had pulled the biologics licence software (BLA) for its combo shot mRNA-1083 “in session with the FDA”.

Shares within the Nasdaq-listed firm opened 0.4% down at market open on Wednesday (21 Could) following the announcement, although they continued to fall by 4% all through the morning. Moderna has a market cap of $10.4bn.

This month, the corporate stated the FDA wished to see efficacy knowledge from its flu vaccine earlier than approving the combo shot, which raised questions on a possible delay.

Moderna plans to resubmit later this yr after gathering further efficacy knowledge in an ongoing Part III trial for its influenza vaccine mRNA-1010 (NCT06602024). Interim knowledge is anticipated later this yr.

The choice additionally comes a day after the FDA stated it will require new scientific trials for approval of annual Covid-19 boosters for wholesome individuals below 65 years.

Though Moderna’s mRNA-1083 is being developed for adults aged 50 years and older, it’s a signal of a widening clampdown on the quantity and high quality of proof vaccine makers have to generate through the approval course of.

Moderna already has a powerful basis of knowledge for the vaccine. A Part III trial (NCT06097273) investigating the vaccine in two age group cohorts of round 4,000 every met its major endpoint of non-inferiority to different licensed vaccines in June 2024.

The mixture vaccine includes mRNA-1010 and mRNA-1283, the latter being Moderna’s next-generation Covid-19 vaccine candidate. Every investigational vaccine has independently demonstrated constructive Part III scientific trial outcomes.

The applying shelving is a setback for Moderna, which was banking on gross sales of a brand new wave of mRNA vaccines amid falling gross sales for its Covid-19 vaccine and weak demand for the respiratory syncytial virus (RSV) vaccine mRESVIA.

mRESVIA was accepted by the FDA final yr, however uptake for the vaccine has been low after a restricted suggestion from the US Facilities for Illness Management and Prevention (CDC). Grappling market share off GSK and Pfizer, who each already had RSV vaccines in the marketplace, has additionally confirmed tough.

This month, Moderna stated it will scale back annual spending by round $1.5bn by 2027 to offset the affect of slowing Covid-related product gross sales.

Shares in Moderna have constantly fallen for the reason that Covid-19 pandemic and took an extra battering when RFK Jr, a vaccine sceptic, was confirmed because the US Well being Secretary. Moderna additionally belongs to a pharmaceutical trade that dealing with the prospect of sector-specific tariffs by President Donald Trump.

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