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Approval of Two RSV Vaccines Gives Hope to Most Vulnerable Populations

Dr. Sean Cloonan

June 28, 2023

Approval of Two RSV Vaccines Gives Hope to Most Vulnerable Populations

Reports that two drugmakers are expected to have RSV vaccines available this fall for those aged 60 and over certainly represent good news.

Respiratory syncytial virus (RSV) is a common and contagious virus that infects the respiratory tract. It is so common, in fact, that many if not most of us have likely had it, and more than once, throughout our lives. It is one of the causes of the common cold, with symptoms including a runny nose, coughing, sneezing, wheezing and fever.

However, RSV can evolve into more serious conditions like pneumonia, especially in the elderly and the immunocompromised. Likewise, it can cause bronchiolitis and other respiratory distress in infants; in fact, acute bronchiolitis due to RSV is the leading cause of infant hospitalizations in the U.S. and in the E.U. According to the Centers for Disease Control and Prevention, RSV causes an estimated 58,000 hospitalizations and up to 500 deaths per year for children younger than 5, and 177,000 hospitalizations and 14,000 deaths per year for those aged 65 and older.

In early May, the U.S. Food and Drug Administration approved GSK’s vaccine Arexvy for adults 60 and older, and at the end of the same month it okayed Pfizer’s Abrysvo vaccine for the same age group. Abrysvo has been found to be about 67% effective against cases of the virus with two symptoms, and 86% effective against cases with three or more symptoms, while Arexvy was found to be approximately 83% effective against the virus.

Both vaccines are expected to be available this fall, though precise dates and costs have not been revealed.

The impact of these vaccines has the potential to be extremely significant. A 60-80% reduction in disease burden will translate into fewer hospital admissions, fewer ICU admissions and fewer deaths in vaccinated individuals. By reducing the incidence of RSV in older adults, the vaccines may have a knock-on effect for newborns; while there is no vaccine for the 5-and-under set, the fact that grandparents will have a lower incidence of RSV means they are less likely to pass it on to their grandchildren.

There are some things to keep in mind. As with all vaccines, side effects may include shoulder soreness, redness, headache, and/or fatigue. It is also worth noting that two recipients of the Pfizer shot and one recipient of the GSK injection developed cases of the autoimmune disorder Guillain-Barré Syndrome, which attacks the nervous system. The Guillain-Barré Syndrome is a rare side effect of some other vaccines, including the flu vaccine. It is also a result of many common infections.

Further data on side effects and complications will be collected after the vaccines go into circulation. Follow up studies will determine if and when booster doses may be of benefit.

Even with these caveats, the FDA’s approval of both vaccines should be considered net positives at this point. I consider the results that the agency based its decisions upon to be both encouraging and impressive.

Dr. Sean Cloonan is a board-certified specialist in infectious diseases and internal medicine and infectious diseases at Scarsdale Medical Group in Harrison. For an appointment, call 914-723-8100.

Dr. Sean Cloonan

Dr. Sean Cloonan is an Infectious Disease physician practicing in the Harrison location. For information or to make an appointment, call (914) 723-8100.