FDA approves Merck RSV shot for infants in order to be able to compete with Sanofi AstraZeneca
The Food and Drug Administration approved on Monday Merck 'S shot to protect infants from respiratory syncytial virus during the first season of the virus and brings a rival to a similar treatment of for marketing Sanofi And Astrazeneca.
The decision will enable the company to start the medication before the RSV season, which is marketed as an Enflonsia, which normally begins for autumn and winter and lasts spring. Merck said in a press release that the orders for the shot were expected in July. The programs are presented before the virus spreads strongly.
Admission gives the doctors a new option to combat the virus, which causes thousands of deaths in older Americans and hundreds of deaths in infants. Complications from RSV are the most common cause of hospital stays in newborns.
“We strive to ensure availability of availability [Enflonsia] In the United States before the start of the upcoming RSV season to reduce the significant burden of this widespread seasonal infection to families and health systems, said Dr. Dean Li, President of Merck Research Laboratories, in a press release.
Merck's shot will compete against a similar blockbuster treatment by Sanofi and Astrazeneca called Beyfortus, which was nationwide during the 2023 RSV season due to an unprecedented demand.
Both are preventive monoclonal antibodies that deliver antibodies directly into the bloodstream in order to offer immediate protection. But each aims at another part of the virus, which makes it difficult to compare it directly.
Merck's shot can be administered for infants regardless of their weight, which the company could offer according to the company with regard to the dosage. In the meantime, the recommended dosage of Beyfortus is based on a child's body weight.
Sanofi found an aggressive effort on Monday to increase Beyfortus, including a plan to send the shot at the beginning of the third quarter. Last year Beyfortus booked sales of € 1.7 billion (1.8 billion US dollars).
Vaccines for RSV are also available in the USA of companies such as PfizerPresent GSK And Modern. However, these recordings are only used for adults or pregnant women. The FDA recently examined the examination of RSV recordings in small children while evaluating security concerns.
All companies on the market are waiting from June 25th to 27th at a meeting of external vaccine advisors to the centers for the control and prevention of diseases if they will form recommendations for RSV shots and other vaccinations.
In the middle to late level against enflons, the shot reduced hospital stays in connection with RSV by more than 84% and reduced hospital stays due to infections with a lower respiratory tract by 90% compared to a placebo in infants in five months. The shot also reduced the lower respiratory infections, which required medical help by more than 60% compared to a placebo by five months.
RSV is a common cause of infections of the lower airways such as pneumonia.
