FDA Approves First Vaccine for RSV in Adults Aged 60 and Above

The Food and Drug Administration (FDA) has approved the world's first vaccine for respiratory syncytial virus (RSV) for adults aged 60 and above, developed by pharmaceutical company GlaxoSmithKline (GSK).[0] RSV is a common respiratory virus that can lead to serious illness, hospitalization, and death in infants and older adults, particularly those with weakened immune systems or underlying health conditions.[1] The vaccine, named Arexvy, was found to be 82% effective at preventing lower respiratory tract disease caused by RSV and 94% effective at preventing severe disease, according to data from an ongoing trial involving around 25,000 adults aged 60 and above.[2]

The approval of the vaccine comes after a severe RSV season in 2022, which led to an estimated 60,000 to 160,000 older adults being hospitalized with lung infections caused by RSV in the US alone, with 6,000 to 10,000 deaths from RSV infections each year.[1] “Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk of severe disease caused by RSV,” said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.[3] He added that the approval of the vaccine is “an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA's continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”[4]

While the vaccine's approval is a significant development in the fight against RSV, the FDA has required GSK to monitor for safety concerns from the vaccine, including the incidence of Guillain-Barré syndrome, a nerve disorder that can cause paralysis or weakness that rarely follows viral infections and vaccination. The FDA also identified one case of Guillain-Barré syndrome that was potentially related to the vaccine in a clinical trial, as well as a higher incidence of atrial fibrillation (irregular heart rhythm) among vaccine recipients relative to the control group.[5] The FDA is requiring GSK to conduct a study after the vaccine's rollout to “assess the signals of serious risks” for these rare side effects that might be linked to the vaccine.

A separate panel of the Centers for Disease Control and Prevention's vaccine advisers is expected to meet in June to discuss recommendations for the vaccine's use, a key step to guarantee insurance coverage ahead of the fall.[6] While only Pfizer is currently testing a vaccine to protect newborns, other companies are expected to offer vaccines for use in older adults.[7] In the meantime, GSK will focus on ensuring eligible older adults in the US can access the vaccine as quickly as possible and working towards regulatory review and approval of the vaccine in other countries.[8]

0. “FDA Approves First-Ever RSV Vaccine After Brutal 2022 Season” Forbes, 3 May. 2023, https://www.forbes.com/sites/mollybohannon/2023/05/03/fda-approves-first-ever-rsv-vaccine-after-brutal-2022-season

1. “‘A good day': FDA approves world's first RSV vaccine” Nature.com, 4 May. 2023, https://www.nature.com/articles/d41586-023-01529-5

2. “FDA Approves First Vaccine For RSV” HuffPost, 4 May. 2023, https://www.huffpost.com/entry/fda-rsv-vaccine-approved_n_6452f692e4b04616030fd3fa

3. “An RSV vaccine has been approved by the FDA. It’s a huge deal.” Vox.com, 4 May. 2023, https://www.vox.com/health/2023/5/4/23710959/rsv-vaccine-for-adults-arexvy-fda-approval

4. “FDA approves first vaccine for RSV, a moment six decades in the making” wlfi.com, 3 May. 2023, https://www.wlfi.com/news/fda-approves-first-vaccine-for-rsv-a-moment-six-decades-in-the-making/article_c9ca7e0a-18ac-5d02-aa85-79eb5de99b51.html

5. “FDA approves RSV vaccine for adults ages 60 and up” NBC News, 3 May. 2023, https://www.nbcnews.com/health/health-news/fda-approves-rsv-vaccine-rcna82461

6. “FDA approves first RSV vaccine to protect older adults” CBS News, 3 May. 2023, https://www.cbsnews.com/news/fda-approves-first-rsv-vaccine-to-protect-older-adults/

7. “Here's what we know about upcoming vaccines and antibodies against RSV” Science News Magazine, 27 Apr. 2023, https://www.sciencenews.org/article/vaccines-antibodies-rsv-virus

8. “FDA approves GSK's RSV vaccine for older adults, world's first shot against virus” CNBC, 3 May. 2023, https://www.cnbc.com/2023/05/03/rsv-vaccine-fda-approves-gsk-shot-for-older-adults.html

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