FDA Greenlights Merck’s RSV Shot for Newborns — Clinical Trials Showed 11.71% Rate of Serious Adverse Events, Including Death

FDA Greenlights Merck’s RSV Shot for Newborns — Clinical Trials Showed 11.71% Rate of Serious Adverse Events, Including Death

The antibody shot will be marketed as Enflonsia and launched this coming RSV season to…

Children's Health Defense

by Brenda Baletti, Ph.D.

The U.S. Food and Drug Administration (FDA) on Monday approved Merck’s new monoclonal antibody shot, which the company said is designed to protect newborns and infants against respiratory syncytial virus (RSV).

The antibody shot, clesrovimab, will be marketed as Enflonsia and launched this coming RSV season to challenge Sanofi and AstraZeneca’s blockbuster Beyfortus shot.

Beyfortus, first approved in 2023, generated $1.8 billion in sales last year, FiercePharma reported.

PR Newswire projected that the global RSV vaccine and antibody market would reach $13.59 billion by 2030.

Merck said its monoclonal antibody has about the same efficacy rate as Beyfortus. In clinical trials, the shot reduced RSV-related hospitalization by 84.3% compared to placebo, and the incidence of RSV that needed to be medically attended by 60.5% versus placebo, through age 5 months in the clinical trials…

READ FULL ARTICLE HERE… (childrenshealthdefense.org)

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