GSK laboratory in London.
Ole Scarf | Getty Images
On Wednesday, the Food and Drug Administration approved the RSV vaccine GlaxoSmithKline For use in adults 60 years of age or older.
The approval, the first of its kind globally by a regulatory body for an RSV vaccine, is a decisive victory for GSK in a race against drugmakers. Pfizer And accident To market a shot targeting respiratory syncytial virus.
Shares of GSK rose about 2% on Wednesday after the approval.
GSK’s chief scientific officer, Tony Wood, said in a statement that the decision “marks a turning point” in the company’s efforts to reduce the “significant burden” of RSV.
He said the company will now focus on ensuring that eligible seniors in the United States get the vaccine “as quickly as possible.” GSK will also work towards regulatory review and approval of the shot in other countries.
London-based GSK said during an earnings presentation last week that it had “millions” of doses of the RSV vaccine ready to ship.
The company plans to meet in June with the federal Centers for Disease Control and Prevention’s Vaccine Advisory Committee to outline potential vaccination schedules for the United States, according to this presentation.
GSK’s shot is also getting closer to approval in the European Union. Last week, the European Medicines Agency recommended EU approval of the company’s vaccine for seniors.
The shot will help countries battle the upcoming RSV season in the fall.
The United States suffered an unusually severe RSV season last year.
Hospitals across the country have been overwhelmed by cases of the virus in children and the elderly, in large part because the public has stopped practicing Covid pandemic health measures that have helped keep the spread of RSV down.
RSV usually causes mild, cold-like symptoms. But each year the virus kills 6,000 to 10,000 seniors and a few hundred children under 5, according to the Centers for Disease Control and Prevention.
The US Food and Drug Administration said approval of the GSK vaccine was based on data from a Phase 3 trial in older adults.
In March, an independent panel of advisors to the Food and Drug Administration (FDA) recommended the shot based on results from a trial, which found the shot to be approximately 83% effective in preventing lower respiratory illnesses caused by respiratory syncytial virus. Illness was defined as two or more symptoms including shortness of breath, wheezing, coughing, increased mucus production, crackling, decreased oxygen saturation, or need for oxygen supplementation.
The independent panel unanimously said that the efficacy data on the GSK vaccine was sufficient.
But the advisors also pointed to potential safety issues related to a nervous system disorder, Guillain-Barre syndrome, that may be linked to the injection.
A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving the GSK vaccine, according to an FDA briefing document. She was hospitalized for six months before being released.
The document said the woman was the only case of Guillain-Barre syndrome among more than 12,000 people who received the shot.
GSK said in February that there was insufficient evidence to confirm that the woman had Guillain-Barre as a result of the GSK bullet.
But the US Food and Drug Administration said at the time that it considered the case to be related to the GSK vaccine.
On Wednesday, the agency said it would ask GSK to conduct a study to assess the risk of Guillain-Barre syndrome and another side effect observed in a clinical trial that co-administered the RSV flu vaccine.
Guillain-Barre syndrome is a rare disorder in which the immune system attacks its own nerves, causing muscle weakness and sometimes paralysis. Most people recover completely from this disorder, but some cases can be fatal or have permanent effects.
The rate of Guillain-Barre syndrome is usually one to two cases per 100,000 people each year in the United States, according to the National Organization for Rare Disorders.
The Food and Drug Administration (FDA) has identified the disorder as a potential safety issue with Pfizer’s RSV vaccine for seniors.
Two people developed Guillain-Barre syndrome after receiving a Pfizer vaccine in a late-stage clinical trial with more than 20,000 vaccine recipients.
Pfizer said in February that it would conduct a safety study to evaluate Guillain-Barre syndrome if the Food and Drug Administration approved its vaccine.
The drug company hopes to get that approval later this month.
No cases of Guillain-Barre syndrome were identified during a clinical trial of the RSV Moderna vaccine.
Moderna plans to file for approval by the US Food and Drug Administration (FDA) during the first half of this year.