Moderna pulls application for COVID-flu combination shot
NEW YORK: Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot, which is due later this year.
The company said it pulled the application in consultation with the US Food and Drug Administration. It is the latest sign of increased regulatory scrutiny of the vaccine approval process since Robert F. Kennedy Jr. took the top US health job earlier this year.
Moderna's decision comes a day after the US FDA said it would require new clinical trials for approval of annual COVID-19 boosters for healthy people under 65.
The combination shot comprises a new COVID vaccine and an influenza vaccine, both under development by Moderna.
The company has previously said it does not expect a delay in the FDA's decision for the next-generation COVID vaccine, which is due by the end of the month.
Shares of the company have been battered by declining COVID revenue as well as investor concerns spurred by the appointment of Kennedy, who is a vaccine skeptic, as secretary of the US Department of Health and Human Services.
Moderna has been banking on revenue from newer mRNA shots to make up for falling sales of its COVID vaccine and less-than-expected uptake of its respiratory syncytial virus vaccine, which sent its shares down nearly 60 percent last year.
The company in early May pushed back the time frame for the likely approval of its combination vaccine — meant to protect adults aged 50 and above against both COVID-19 and influenza — to 2026.
The FDA last week approved rival Novavax's COVID-19 vaccine more than a month after missing the deadline for the shot's approval, and limited its use to people with conditions that put them at risk due to the illness.
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