Moderna withdraws application for US approval of combined flu-Covid shot
Share this @internewscast.com

Moderna said on Wednesday it had withdrawn an application seeking approval for its flu and Covid combination vaccine candidate after discussions with the US Food and Drug Administration.

The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine, which it expects to report this summer.

The 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 years old.

Shares of the company have been battered by declining Covid revenue as well as investor concerns spurred by the appointment of the vaccine skeptic Robert F Kennedy Jr as secretary of the Department of Health and Human Services.

The shares fell another 1.4% in premarket trading on Wednesday.

The FDA is due to make a decision on Moderna’s next-generation Covid-19 vaccine, which is a component of the combination flu-Covid shot, by the end of the month. Moderna has previously said it does not expect a delay in that decision.

Moderna in early May pushed back the time frame for likely approval of its combination vaccine – meant to protect adults aged 50 and above against both Covid-19 and influenza – to 2026.

The company 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% last year.

Share this @internewscast.com
You May Also Like

Widower Remembers ‘Horrendous’ Symptoms After Wife Dies from Dog Scratch

A man whose wife died after contracting rabies when a dog scratched…

Groundbreaking Study Unveils Shocking Connection Between Autism and Alzheimer’s: Experts Warn About Shared ‘Cause’ and Identify High-Risk Cities

Exposure to a toxic metal as far back as childhood could raise…

Chantelle Houghton flaunts stunning five stone weight loss in a low-cut swimsuit during a yoga session in Tenerife

Chantelle Houghton showed off her incredible weight loss in a plunging patterned swimsuit…

Important Alert for Individuals with Mouth Ulcers

Mouth ulcers are common, but experts have warned you should report them…

Woman Sheds 7st in 10 Months Without Mounjaro: Her Weight Loss Journey Revealed

A woman has revealed how she lost seven stone in ten months…

Could YOUR tap water be tainted with ‘forever chemicals’ connected to thyroid issues, high cholesterol, and cancer? Here’s why it’s a concern for everyone

Sarah Simon, the 49-year-old manager of tourist company Panoramic Jersey, has lived…

Study Indicates Immune System Activated by Seeing Someone Who Might Be Contagious

Whether it’s the person brandishing a tissue on the train or the…

Health Authorities Alert Public to Fatal Lung Disease Surge in Prominent US City

Health officials in New York have issued a warning following the outbreak…

Veterinary Clinic Employee Reveals the Best Dog Breeds for New Pet Owners

A woman who works at a vet clinic has shared the top…

NHS England Releases Crucial Guidance as Resident Doctors Strike

NHS England has delivered an essential message to anyone experiencing a medical…