A GSK laboratory in London.
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The Food and Drug Administration on Wednesday approved an RSV vaccine manufactured by GlaxoSmithKline for use in adults over 60 years of age.
The world’s first regulatory approval of an RSV vaccine is a crucial victory for GSK in a race against drug manufacturers Pfizer And Modern to market a shot that targets respiratory syncytial virus.
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Shares of GSK rose nearly 2% on Wednesday after the approval.
Tony Wood, GSK’s chief scientific officer, said in a statement the decision “marks a turning point” in the company’s efforts to reduce the “significant burden” of RSV.
The company will now focus on making sure eligible older adults in the US can access the vaccine “as soon as possible,” he said. GSK will also work towards regulatory review and approval of the shot in other countries.
London-based company GSK said during a results presentation last week it had “millions” of doses of the RSV vaccine ready to be shipped.
According to the presentation, the company plans to meet with the Vaccine Advisory Committee of the Federal Centers for Disease Control and Prevention in June to discuss possible vaccination plans for the United States.
GSK inclusion is also nearing approval in the European Union. Last week, the European Medicines Agency recommended that the company’s vaccine be approved by the EU for older adults.
The shot would help countries tackle the next fall RSV season.
The USA endured an unusually difficult RSV season last year.
Cases of the virus in children and older adults overwhelmed hospitals across the country, largely because the public stopped practicing the Covid pandemic health measures that had helped contain the spread of RSV.
RSV usually causes mild, cold-like symptoms. But every year the virus kills 6,000 to 10,000 seniors and a few hundred children under the age of 5, according to the CDC.
The FDA said approval of GSK’s vaccine was based on data from a Phase 3 trial in older adults.
In March, an independent panel of FDA advisors recommended the syringe based on these study results, which found the syringe to be nearly 83% effective in preventing lower respiratory disease caused by RSV. Illness was defined as two or more symptoms, including shortness of breath, wheezing, coughing, increased mucus production, crackling, low oxygen saturation, or the need for oxygen supplementation.
The independent panel unanimously stated that the data on the efficacy of GSK’s vaccine was sufficient.
However, the advisers also pointed to potential safety issues related to a nervous system disorder, Guillain-Barré syndrome, which may be linked to the shooting.
A 78-year-old woman in Japan was diagnosed with Guillain-Barré syndrome nine days after receiving the GSK vaccine, according to an FDA briefing document. She was hospitalized for six months before being discharged.
According to the document, the woman was the only case of Guillain-Barre syndrome among the more than 12,000 people who received the shot.
GSK said in February there was insufficient evidence to confirm the woman contracted Guillain-Barre as a result of GSK’s shot.
But the FDA said at the time it considered the case related to GSK’s vaccine.
On Wednesday, the agency said GSK must conduct a study to further assess the risk of Guillain-Barre Syndrome and another side effect observed in a clinical trial in which the RSV vaccine was given with a flu vaccine.
Guillain-Barré Syndrome is a rare condition in which the immune system attacks its own nerves, causing muscle weakness and sometimes paralysis. Most people fully recover from the disorder, but some cases can be fatal or have lasting effects.
The rate of Guillain-Barre syndrome is typically one to two cases per 100,000 people per year in the United States, according to the National Organization for Rare Disorders.
The FDA has flagged the disorder as a potential safety issue with Pfizer’s RSV vaccine for older adults.
Two people developed Guillain-Barré syndrome after receiving Pfizer’s syringe in a late-stage clinical trial of more than 20,000 vaccine recipients.
Pfizer said in February it will conduct a safety study to further evaluate Guillain-Barre syndrome if the FDA approves its vaccine.
The pharmaceutical company hopes to receive this approval later this month.
No cases of Guillain-Barré Syndrome were identified during a clinical trial of Moderna’s RSV vaccine.
Moderna plans to submit an application for FDA approval in the first half of this year.
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