A GSK lab in London.
Oli Scarff | Getty Images
The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline to be used on adults ages 60 and older.
The approval, the primary ever globally by a regulatory body for an RSV vaccine, is a decisive victory for GSK in a race against drugmakers Pfizer and Moderna to bring to market a shot that targets the respiratory syncytial virus.
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Shares of GSK rose nearly 2% Wednesday following the approval.
GSK’s chief scientific officer Tony Wood said in a press release the choice “marks a turning point” in the corporate’s effort to scale back the “significant burden” of RSV.
The corporate will now give attention to ensuring eligible older adults within the U.S. can access the vaccine “as quickly as possible,” he said. GSK can even work toward regulatory review and approval of the shot in other countries.
London-based GSK during an earnings presentation last week said it has “thousands and thousands” of doses of the RSV vaccine able to ship.
The corporate plans to satisfy in June with the federal Centers for Disease Control and Prevention‘s vaccine advisory committee to hash out potential vaccination schedules for the U.S., in keeping with that presentation.
GSK’s shot can also be inching closer to approval within the European Union. Last week, the European Medicines Agency advisable that the corporate’s vaccine be approved by the EU for older adults.
The shot would help countries combat the following RSV season in the autumn.
The U.S. suffered an unusually severe RSV season last yr.
Cases of the virus in children and older adults overwhelmed hospitals across the country, largely because the general public stopped practicing Covid pandemic health measures that had helped keep the spread of RSV low.
RSV often causes mild, cold-like symptoms. But every year the virus kills 6,000 to 10,000 seniors and just a few hundred children younger than 5, in keeping with the CDC.
The FDA said the approval of GSK’s vaccine was based on data from a phase three trial on older adults.
In March, an independent panel of advisors to the FDA advisable the shot based on those trial results, which found the shot nearly 83% effective at stopping lower respiratory tract disease brought on by RSV. Disease was defined as two or more symptoms including shortness of breath, wheezing, cough, increased mucus production, crackles, low oxygen saturation, or need for oxygen supplementation.
The independent panel unanimously said the efficacy data on GSK’s vaccine was sufficient.
However the advisors also flagged potential issues of safety over a nervous system disorder, Guillain-Barre syndrome, which may be tied to the shot.
A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK’s vaccine, in keeping with an FDA briefing document. She was hospitalized for six months before being released.
The document said the girl was the one case of Guillain-Barre syndrome out of the greater than 12,000 individuals who received the shot.
GSK said in February that there may be insufficient evidence to verify the girl got Guillain-Barre because of this of GSK’s shot.
However the FDA said on the time that it considers the case to be related to GSK’s vaccine.
On Wednesday, the agency said it’s going to require GSK to conduct a study to further assess the danger of Guillain-Barre syndrome and one other side effect observed in a clinical trial that co-administered the RSV shot with a flu vaccine.
Guillain-Barre syndrome is a rare disorder during which the immune system attacks its own nerves, causing muscle weakness and sometimes paralysis. Most individuals recuperate completely from the disorder, but some cases might be fatal or have lasting effects.
The rate of Guillain-Barre syndrome is usually one to 2 cases per 100,000 people every year within the U.S., in keeping with the National Organization for Rare Disorders.
The FDA flagged the disorder as a possible safety issue with Pfizer’s RSV vaccine for older adults.
Two people developed Guillain-Barre syndrome after receiving Pfizer’s shot in a late-stage clinical trial with greater than 20,000 vaccine recipients.
Pfizer in February said it’s going to conduct a security study to further assess Guillain-Barre syndrome if the FDA approves its vaccine.
The pharmaceutical company is hoping to win that approval later this month.
No cases of Guillain-Barre syndrome were identified during a clinical trial of Moderna’s RSV vaccine.
Moderna plans to file an application for FDA approval in the course of the first half of this yr.