FDA Approves Pfizer’s RSV Vaccine For Older Adults

Topline

The Food and Drug Administration on Wednesday approved Pfizer’s vaccine to protect older adults from RSV, weeks after the agency greenlit the very first shot against the common and potentially lethal infection following decades of unsuccessful attempts and numerous setbacks.

Pfizer’s RSV shot is only the second to secure FDA approval.

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Key Facts

The FDA authorized Pfizer’s shot to protect adults ages 60 years and older from respiratory syncytial virus, or RSV, a common respiratory infection that typically only causes mild, cold-like illness in healthy adults but can trigger severe, possibly fatal, disease in older adults, as well as infants and people with underlying medical issues.

The shot, marketed as Abrysvo, was around 67% effective at protecting against milder illness from RSV and nearly 86% effective against severe illness, according to Pfizer’s late-stage clinical trial.

A clinical trial run by Pfizer that involved around 37,000 people from around the world informed the agency’s decision.

An advisory committee from the Centers for Disease Control and Prevention will meet in late June to discuss the shot, particularly who should receive it and how often.

Pfizer said the shots could be available for seniors by fall, ahead of the coming RSV season, pending the outcome of the CDC’s meeting.

Crucial Quote

“A vaccine to help prevent RSV had been an elusive public health goal for more than half a century,” said Annaliesa Anderson, senior vice president and chief scientific officer for vaccine research and development at Pfizer. Anderson said the shot “will address a need to help protect older adults against the potentially serious consequences of RSV disease.”

News Peg

Pfizer’s shot is only the second vaccine authorized against RSV in the U.S. after the FDA approved a product from pharma firm GSK in early May. The agency’s approval comes after decades of hard work from scientists, who have faced numerous setbacks and failure in the quest to protect people against the common and sometimes lethal infection. GSK’s shot, Arexvy, beat out a crowded field of competitors that included the likes of Pfizer, Moderna and Johnson & Johnson.

What To Watch For

The FDA is also considering Pfizer’s shot to protect children against RSV. The infection can be very dangerous for very young children and kills between 100 and 300 children under five years old in the U.S. each year. It is a particular threat early on in life when inflammation and mucus can easily block already small airways. Pfizer’s shot, if approved, would be the first to protect younger people from the virus. It would do so from birth and is administered to pregnant people. The agency’s advisory panel has recommended it authorize the shot.

Big Number

14,000. That’s how many deaths RSV infections are estimated to cause in adults 65 and over in the U.S. every year, according to government data. Around 160,000 are also estimated to be hospitalized with the virus.

What We Don’t Know

Pfizer has not said how much the vaccine will sell for but the company has reportedly said it will be widely available with no out-of-pocket costs for most older Americans who are covered by Medicare if the CDC recommends it for routine use. The company has previously said it plans to distribute the shot more equitably to less affluent countries that may be less able to afford it and where RSV is more likely to kill. Analysts expect the overall RSV vaccine market is likely to be worth billions of dollars.

FDA Approves Pfizer’s RSV Vaccine For Older Adults—It Could Be Available This Fall