Pfizer Asks FDA to Approve RSV Vaccine for Adults as Young as 18 Years Old

Stock.adobe.com

It could be time for many Americans to add another vaccine to their list.

Pfizer recently announced the results of a study for its RSV vaccine. While the vaccine is already approved for older Americans, the results of the study reportedly show that it is also effective for adults as young as 18. As such, Pfizer is asking FDA to approve the vaccine for adults aged 18 to 59.

In a press release, Pfizer stated that Abrysvo met all of its primary endpoints for adults in specified age range who had an increased risk of RSV.¹ The study was named MONeT, which is short for RSV Immunization Study in Adults at Higher Risk of Severe Illness. It was conducted to see the efficacy of the vaccine in adults who suffer from certain conditions, such as asthma, diabetes, and chronic obstructive pulmonary disease. These conditions put the patients at a higher risk of illness from RSV.

In a press release, Pfizer’s senior vice president and head of vaccine research and development Annaliesa Anderson, PhD., said, “These encouraging results provide evidence that Abrysvo can help protect adults with increased risk against RSV-associated illness. We are excited to address a significant unmet need, pending regulatory authority approval, as Abrysvo has the potential to become the first and only RSV vaccine for adults 18 years and older.”

According to Pfizer, RSV is responsible for 60,000-160,000 hospitalizations and between 6,000-13,000 deaths each year in America. It is capable of causing serious infections in infants, older adults, and adults with chronic medical conditions, such as those previously stated in this article.

This is the most recent vaccine that Pfizer has sought approval for.

The company issued a press release on March 13, 2024, announcing that the European Commission had approved Pfizer’s pneumococcal conjugate vaccine for infants and children.² The vaccine, Prevenar 20 provides broad protection against 20 stereotypes responsible for the majority of pneumococcal infections across the globe.

In the press release, Pfizer’s chief international commercial officer and executive vice president Alexandre de Germay, said, “The EC’s authorization of Prevenar 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU. Prevenar 20 builds on Pfizer’s decades-long commitment to develop vaccines to help prevent potentially life-threatening infections, and we are proud to now provide the broadest serotype coverage of any pneumococcal conjugate vaccine for children in Europe.”

In the US, Prevanar 20 is approved for the following indications: prevention of infection from 20 Streptococcus pneumoniae strains in children 6 weeks and older, the prevention of middle ear infection caused by 7 of the strains in children 6 weeks or older, and protection against the same Streptococcus penumonia strains in adults 18 years and older.

Sources

1. Pfizer Announces Positive Top-Line Results from Phase 3 Study of Abrysvo in Adults Aged 18 to 59 at Increased Risk for RSV Disease. Pfizer. April 9, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-study-1
2. European Commission Approves Pfizer’s Prevenar 20 to Help Protect Infants and Children Against Pneumococcal Disease. Pfizer. March 13, 2024. Accessed April 9, 2024. https://www.pfizer.com/news/press-release/press-release-detail/european-commission-approves-pfizers-prevenar-20r-help