The world’s first RSV vaccine has been approved by the FDA

Today, the U.S. Food and Drug Administration approved the world’s first vaccine to protect against RSV, or respiratory syncytial virus, designed to be administered as a single dose to adults over age 60. The vaccine, Arexvy, made by GSK, could be available this fall, CNN reports.

RSV typically causes cold symptoms and infects almost everyone by age 2. But since last fall there has been an unprecedented spike in RSV that has contributed to a threefold epidemic of RSV, COVID-19 and the flu, raising families with legitimate concern, especially those with newborns and older adults, both of whom the CDC says are at risk. greater risk of being hospitalized.

“For newborns, the danger is because of the immaturity of their immune systems, which have not been exposed to this virus, as well as the low caliber of their airways, which can become clogged with mucus much more quickly,” Amesh A. Adalja, MD, senior scientist at the Johns Hopkins Center For Health Security, POPSUGAR tells. “For the elderly, it’s the fact that they have a lot of comorbid conditions that exacerbate the infection, as well as the fact that they have immune aging.” [or deterioration]with your immune system not responding properly as it once could.”

With the approval of an RSV vaccine, we can begin to provide protection to some of those high-risk populations. “Today’s approval of the first RSV vaccine is a major public health achievement to prevent a disease that can be life-threatening and reflects the FDA’s continued commitment to the development of safe and effective vaccines for use in the United States. states,” Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

GSK’s FDA-approved vaccine, Arexvy, is now awaiting a recommendation for its use from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which meets in June.

The CDC’s Advisory Committee on Immunization Practices last met on Feb. 23 to discuss potential RSV vaccines, one for pregnant people and the other for the elderly, as well as the monoclonal antibody nirsevimab for infants. Going forward, “it is likely that multiple vaccines will be available, as well as nirsevimab, for next season, and together they should all have a significant impact on the burden of disease caused by RSV in high-risk populations,” Dr. Adalja says.

Keep reading for an overview of the other RSV vaccine candidates and what’s currently available to ward off infection.

GSK vaccine candidate

GSK developed a candidate called Arexvy, designed to treat AReSVi (Adult Respiratory Syncytial Virus). It is now the first vaccine approved for individuals age 60 and older.

Data published in February 2023 showed that the vaccine was more than 94% effective against severe RSV infection after nearly seven months. Now that it has been approved by the FDA, it will be submitted to the CDC panel for recommendation in June before being made available to the public.

RSV vaccine candidates from Pfizer

On Feb. 21, the FDA accepted Pfizer’s application for review of its vaccine, RSVpreF, which is being submitted for two separate approvals: for adults age 60 and older and pregnant people to protect against RSV in newborns from birth through term. first 6 months of pregnancy. to live. The FDA is expected to make a decision on Pfizer’s RSV vaccine for older adults by the end of May, and we should have an update on the maternal vaccine by the end of August, according to CNN.

Moderna’s vaccine candidate

On Jan. 17, Moderna announced that its RSV vaccine has proven to be 84 percent effective in preventing at least two or more symptoms in older adults (age 60 and older) and plans to submit a marketing authorization application in the coming months. for regulatory approval. .

Sanofi’s monoclonal antibody

Sanofi and AstraZeneca have produced a single-dose long-acting antibody called nirsevimab that helps prevent RSV infection in infants entering their first RSV season. According to a clinical study, nirsevimab reduced infections by 70% in healthy preterm babies born between 29 and 35 weeks. In January, the FDA agreed to review nirsevimab for approval. If approved, it would be the second monoclonal antibody on the market for infants.

Synagis monoclonal antibody

Palivizumab, which goes by the brand name Synagis, is an FDA-approved prescription injection recommended for high-risk babies born severely preterm at 29 weeks or earlier to protect them from severe RSV disease. Palivizumab is a monoclonal antibody – it’s not a vaccine, explains Dr Adalja. Where a vaccine would train the immune system to fight future infections, palivizumab is an immunizing agent that works by giving the body antibodies to protect it.