A GSK lab in London.
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Approval, a first globally by a regulatory body for an RSV vaccineA decisive victory for GSK Caste against drug makers pfizer And Modern to bring a shot to market that targets respiratory polynuclear virus,
GSK shares rose about 2% on Wednesday following the approval.
Tony Wood, GSK’s chief scientific officer, said in a statement that the decision is “a turning point” in the company’s effort to reduce the “significant burden” of RSV.
The company will now focus on making sure eligible older adults in the US can get the vaccine “as soon as possible”. GSK will also work towards regulatory review and approval of the shot in other countries.
London-based GSK during a income presentation Last week, it said it had “millions” of doses of the RSV vaccine ready to ship.
The company plans to meet with the federal government in June. Centers for Disease Control and PreventionAccording to that presentation, the Vaccine Advisory Committee to hash out a possible vaccination schedule for the US.
GSK’s shot is also inching closer to approval in the European Union. last week, the European Medicines Agency recommended that the company’s vaccine be approved by the European Union for older adults.
The shot will help countries compete for the next RSV season in the fall.
america suffered unusually severe RSV season last year.
Cases of the virus among children and older adults overwhelmed hospitals across the country, largely because the public stopped exercising covid Epidemic health measures helped keep the spread of RSV down.
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 age 5, according to the CDC.
FDA says approval for GSK’s vaccine is based on Phase III data testing on older adults.
In March, an independent panel of advisors to the FDA recommended the shot based on trial results that found the shot to be about 83% effective at preventing lower respiratory tract illness caused by RSV. Disease was defined as two or more symptoms including shortness of breath, wheezing, cough, increased sputum production, crackles, low oxygen saturation, or the need for oxygen supplementation.
The independent panel unanimously said that the efficacy data on GSK’s vaccine was sufficient.
But the advisories also flagged potential safety issues over a nervous system disorder, Guillain-Barré syndrome, that may be tied to the shot.
According to the FDA, a 78-year-old woman in Japan was diagnosed with Guillain-Barré syndrome nine days after receiving the GSK vaccine. briefing document, She was hospitalized for six months before being released.
The woman was the only case of Guillain-Barre syndrome out of more than 12,000 people who were shot, the document said.
GSK said in February that there was insufficient evidence to confirm the woman was Guillain-Barre as a result of GSK’s shot.
But FDA It said at the time that it believed the matter to be related to the GSK vaccine.
On Wednesday, the agency said GSK would need to conduct a study to assess the risk of Guillain-Barre syndrome and another side effect seen in a clinical trial that co-administered the RSV shot with the flu vaccine. administers.
Guillain-Barre syndrome is a rare disorder In which the immune system attacks its own nerves, causing muscle weakness and sometimes paralysis. Most people make a full recovery from the disorder, but some cases can be fatal or have lasting effects.
Rate According to the National Organization for Rare Disorders, Guillain-Barré syndrome occurs in one to two cases per 100,000 people each year in the United States.
The FDA flagged the disorder as a potential safety issue with Pfizer’s RSV vaccine for older adults.
Two People advanced Guillain-Barré syndrome after receiving Pfizer’s shot in the final phase of clinical trials with more than 20,000 vaccine recipients.
Pfizer in February Said If the FDA approves its vaccine, it will conduct a safety study to further assess Guillain-Barré syndrome.
The pharmaceutical company is hoping to win that approval later this month.
No cases of Guillain-Barre syndrome were identified during clinical trial of Moderna’s RSV vaccine.
Moderna plans to file an application for FDA approval in the first half of this year.