Ask the Experts: Respiratory syncytial virus (RSV): Vaccine Products

Results (5)

In May 2023, FDA licensed two RSV vaccines: RSVPreF3 (Arexvy, GSK) and RSVpreF (Abrysvo, Pfizer). They are both licensed for the prevention of RSV-associated lower respiratory tract disease (LRTD) in adults 60 age years and older in the United States. Only Abrysvo is licensed for use during pregnancy (during 32 through 36 weeks and 6 days’ gestation) for the prevention of RSV disease in infants. Both vaccines are recombinant protein vaccines that contain the prefusion form of a spike protein on the surface of the RSV virus. Because these vaccines contain only a piece of the virus, they cannot cause RSV illness.

The GSK RSVPreF3 vaccine, Arexvy, includes an AS01adjuvant, a chemical designed to enhance the immune response to vaccination. AS01 is the same adjuvant used in GSK’s recombinant zoster vaccine (Shingrix), but Arexvy contains half the amount of adjuvant as a dose of Shingrix. Pfizer’s vaccine does not contain an adjuvant.

For further information about both vaccines, the package inserts are available from FDA: Package Insert – AREXVY (fda.gov) and Package Insert – ABRYSVO (fda.gov).

Last reviewed: January 22, 2024

Both RSVPreF3 (Arexvy, GSK) and RSVpreF (Abrysvo, Pfizer) vaccines were effective in preventing RSV-associated lower respiratory tract disease (LRTD) in clinical trial participants, over the course of two RSV seasons.

The global clinical trials for RSVPreF3 (Arexvy, GSK) vaccine involved nearly 25,000 participants and some participants were followed for 2 RSV seasons. One dose had an efficacy of 82.6% during the first RSV season and 56.1% during the second season in preventing symptomatic, laboratory-confirmed RSV-associated LRTD.

The RSVpreF (Abrysvo, Pfizer) vaccine global clinical trials involved nearly 37,000 participants, and some participants were followed for 2 RSV seasons. Efficacy of 1 dose in preventing symptomatic, laboratory-confirmed RSV-associated LRTD was 88.9% during the first RSV season and 78.6% during a partial second season.

Few people enrolled in the clinical trials were either frail or of advanced age (80 or older), and none lived in long-term care facilities. People with immunocompromising conditions were excluded from clinical trials. For this reason, the clinical trials did not measure how well the vaccines would work in the people at highest risk of serious RSV disease.

Last reviewed: January 22, 2024

Currently, protection from serious lower respiratory tract disease (LRTD) after RSV vaccination is expected to last for about two RSV seasons. In clinical trials, the efficacy of the vaccine was tested in some people over 2 RSV seasons, and both vaccines provided significant protection in the second season. RSV vaccination is currently recommended as a single dose. ACIP will update its recommendations as more data become available over time concerning the durability of protection from a single dose and the effectiveness of revaccination.

Last reviewed: January 22, 2024

Both RSV vaccines are currently licensed and recommended as a one-time dose for any person; data are not available at this time to make recommendations for revaccination. At this time, a pregnant person who receives Abrysvo during one pregnancy is not recommended to receive Abrysvo during a subsequent pregnancy. ACIP will make decisions concerning revaccination as more data become available.

Last reviewed: January 22, 2024

No. Only the RSVpreF vaccine, Abrysvo by Pfizer, is licensed and recommended for use between 32 weeks and 36 weeks 6 days of gestation to prevent RSV-associated lower respiratory tract disease in infants younger than 6 months old. Do not use Arexvy (GSK) during pregnancy.

Last reviewed: January 22, 2024

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