Food and medication administration approved Monday Merck 's shot designed to protect babies from the respiratory syncitial virus during their first season of the virus, which takes a rival to a similar treatment to a similar treatment of Healthy and Astrazeneca.
The decision will allow the company to launch the drug, which will be marketed as Enflonsia, before the RSV season that generally begins around autumn and winter and lasts during spring. Merck said in a statement that he expects orders to begin so that the shot begins in July, with shipments delivered before the virus begins to spread widely.
The approval gives doctors a new option to address the virus, which causes thousands of deaths among older Americans and hundreds of deaths among babies every year. RSV complications are the main cause of hospitalization among newborns.
“We are committed to guaranteeing the availability of [Enflonsia] In the United States before the start of the next RSV season to help reduce the important burden of this generalized seasonal infection in families and medical care systems, “said Dr. Dean Li, president of Merck Research Laboratories.
Merck will compete against a great success of Sanofi and Astrazeneca called Beyfortus, which was scarce throughout the country during the 2023 RSV season due to the unprecedented demand.
Both are preventive monoclonal antibodies, which administer antibodies directly to the bloodstream to provide immediate protection. But each one points to a different part of the virus, which makes comparison difficult directly.
Merck taking can be administered to babies regardless of their weight, which the company said it can offer convenience in terms of dosage. Meanwhile, Beyfortus's recommended dose is based on a baby's body weight.
Sanofi revealed on Monday an aggressive effort to increase Beyfortus's supply, including a plan to start sending the shot at the beginning of the third quarter. Last year, Beyfortus reserved sales of € 1.7 billion ($ 1.8 billion).
RSV vaccines are also available in the United States of companies such as Pfizer, GSK and Modern. But those shots are only for use in adults or pregnant women. Recently, the FDA paused in RSV shots tests in young children while evaluating security concerns.
All companies in the market are waiting for a meeting of vaccines for external vaccines to the centers for disease control and prevention from June 25 to 27, when they will form recommendations for RSV shots and other immunizations.
In the medium -to -late stage testing in envelope, the shot reduced hospitalizations related to the RSV by more than 84% and decreased hospitalizations due to lower respiratory infections by 90% compared to a placebo among babies up to five months. The shot also reduced the lower respiratory infections that required medical care in more than 60% compared to a placebo for five months.
RSV is a common cause of infections of the lower respiratory tract, such as pneumonia.
