A US Food and Drug Administration panel on Wednesday recommended two doses of the RSV vaccine for older adults, after approving an initial dose earlier this week.
The panel voted to approve a second shot against the common winter respiratory virus — sometimes severe in the elderly and young — from Pfizer and GlaxoSmithKline. It voted Tuesday to recommend the first shot, 7-4.
Both jabs will be available for adults 60 and older—and could be ready as soon as this summer, Dr. Ali Alhassani, chief clinical officer at Summer Health, said fortune
The panel’s recommendations are usually adopted by the FDA. Final approval will come from the US Centers for Disease Control and Prevention.
Pfizer is also seeking approval for an RSV vaccine for pregnant women, to provide protection to babies from birth to the first six months of life. It showed 82% effectiveness over 90 days, and 69% effectiveness up to six months, Pfizer announced in November, citing Phase 3 clinical trial data. The FDA is set to review the vaccine in August, according to the company.
RSV, or respiratory syncytial virus infection, is a common illness that usually presents as a mild cold. Almost everyone has been infected by age 2, according to the CDC.
But RSV is not light for everyone. The virus hospitalizes tens of thousands of babies, young children, and the elderly every year in the U.S. And kills between 6,000 and 10,000 elderly people in the U.S. every year, according to the national public health agency.
Symptoms can range from cold-like illnesses such as sneezing, sore throat, fever, and nasal congestion, to bronchiolitis and pneumonia, which can be fatal. What’s more, patients can quickly get worse.
RSV can also worsen symptoms in people with chronic health problems like asthma, chronic obstructive pulmonary disease (COPD), or congestive heart failure, according to the CDC.
Those at highest risk of severe outcomes from RSV, according to the CDC, include:
- Older adults 65+
- Infants 6 months and younger
- Babies born prematurely
- Adults and children younger than 2 with chronic heart or lung disease
- Elderly people and children with weakened immune systems
- Children with neuromuscular disorders, such as difficulty swallowing or clearing mucus
RSV cases are increasing after a spike in November. The virus, along with COVID and the flu, was part of what some public health officials called a “tripledemic” late last year that put hospital capacity at risk as the virus’s circulation increased, possibly as a result of pandemic restrictions. While the impact on the U.S. health system is significant, other factors such as general hospital bed availability and healthcare workforce shortages contribute, and RSV rates are not particularly high, experts say.
While RSV is a common winter virus, it can occur at any time of the year. COVID disrupts the seasonal patterns of many viruses, resulting in unusual levels of RSV in the spring to fall of 2021.
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