By Aria Bendix -
NBC News
The Food and Drug Administration (FDA) approved this Wednesday the first vaccine in the world against respiratory syncytial virus (RSV) for people 60 years of age or older, developed by the pharmaceutical company GSK and applied in one dose.
The vaccine is the fruit of six decades of research against this respiratory disease, which is usually mild for healthy adults but can lead to pneumonia or bronchiolitis (which inflames the airways and clogs them with mucus).
Older adults and infants are most at risk:
RSV kills up to 10,000 people age 65 and older and up to 300 children under age 5 each year in the United States.
In a large clinical study, one dose of the new vaccine reduced the risk of symptomatic illness by 83% and the risk of severe illness by 94%.
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Stock image of a vaccine from RSV.NBC
The Centers for Disease Control and Prevention (CDC) has yet to issue a recommendation before the vaccine can go to market.
Its advisory committee will meet in June to assess whether to recommend its use.
Dr. Phil Dormitzer, GSK's vice president and head of vaccine development, said they are already making the shots.
"The goal is to have them available in the fall so people can get them before the season starts in the late fall and winter," Dormitzer said.
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RSV cases generally peak between late December and mid-February, but in 2022 they began to rise in the summer, when sanitary measures were relaxed due to the coronavirus pandemic.
As of late April, the seasonal hospitalization rate was about 51 per 100,000 people, according to the CDC.
Which exceeded the 19 hospitalizations per 100,000 inhabitants registered the previous year.
GSK's clinical trial showed that its vaccine's protection lasted at least six months.
“It's not like you have to wait until the last minute because its duration will be short,” Dormitzer said.
"We know from the studies we've done that getting a shot, for example, in the fall, should protect you for the entire RSV season," added Dormitzer, who said the company's data also suggests it's safe to give the RSV vaccine. RSV at the same time as a standard flu vaccine.
GSK is still studying whether the vaccine can be given alongside high-dose or adjuvanted flu vaccines (with an added ingredient to promote a better immune response), which are the types the CDC recommends for older adults.
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The drugmaker continues to collect data on the drug's safety and will continue to collect data on the performance of its new vaccine in upcoming RSV seasons.
So far, commonly reported side effects in the trial include pain at the injection site, fatigue, and muscle pain.
The FDA noted a higher incidence of irregular heart rhythm among those who received the vaccine compared with the control group and identified a case of Guillain-Barré syndrome, a rare disorder that damages nerve cells and causes muscle weakness or paralysis, which was potentially linked to the vaccine.
Dormitzer said it's hard to know what to make of the Guillain-Barré case, but added: "I wouldn't say it's a big concern right now."
In March, an FDA advisory panel voted 10-2 to approve the vaccine based on its safety and unanimously recommended it based on its effectiveness.
The future of RSV vaccines
A second RSV vaccine for older adults from the Pfizer company will be evaluated for FDA approval this month.
A panel that advises that agency voted 7-4 in favor of recommending the dose for its safety and efficacy.