US FDA delays approval for Moderna vax for teens
Moderna also said it will delay filing a request for emergency use authorisation for a smaller dose of the vaccine for younger kids aged six to 11 while the FDA completes its review.
US drug maker Moderna has announced the development of a single-dose vaccine candidate that is a combination of a Covid-19 booster as well as a seasonal flu jab.
“We believe our mRNA platform can solve the world’s greatest health challenges, from diseases impacting millions, to ultra-rare diseases impacting dozens, to medicines personalised down to the individual level,” CEO Stephane Bancel said.
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“Today we are announcing the first step in our novel respiratory vaccine programme with the development of a single dose vaccine that combines a booster against Covid-19 and a booster against flu,” she added.
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The combination vaccine mRNA-1073 encodes for the Covid-19 spike protein and the flu hemagglutinin glycoproteins.
Moderna is developing vaccines against viral diseases including vaccines against acute respiratory infections, vaccines against persistent infections, as well as vaccines against threats to global public health.
“We are making progress on enrolling patients in our rare disease programmes, and we are fully enrolled in our personalised cancer vaccine trial. We believe this is just the beginning of a new age of information-based medicines,” Bancel said.
The US drug maker has, last week, applied to the US Food and Drug Administration (FDA) for the evaluation of a booster dose of its mRNA-based Covid-19 vaccine.
Early trials have shown that the mRNA-1273 booster shot at 50 microgram dose level induced robust antibody responses of more than 40 times against the highly infectious Delta variant (B.1.617.2), the company has said.
The US regulatory body had authorised the emergency use of the Moderna’s Covid-19 vaccine in individuals 18 years of age or older in December, 2020. It has received emergency authorisation for use of its Covid-19 vaccine in adults from health agencies in more than 50 countries.
The Moderna Covid-19 vaccine is an mRNA vaccine against Covid-19 encoding for a prefusion stabilised form of the Spike (S) protein.
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