- The Food and Drug Administration has approved GSK’s RSV vaccine for adults age 60 and older.
- The GlaxoSmithKline vaccine is now the world’s first fully approved vaccine that targets respiratory syncytial virus.
- The FDA’s decision is a victory for GSK in a tight race against drugmakers Pfizer and Moderna to bring an RSV vaccine to market.
- The shot will prepare the United States to fight the next season of RSV in the fall and winter.
A GSK laboratory in London.
Oli Scarf | Getty Images
The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use in adults 60 and older.
The approval, the first in the world 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 vaccine that targets respiratory syncytial virus. .
GSK shares rose nearly 2% on Wednesday after the approval.
GSK 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.
The company will now focus on ensuring that eligible seniors in the United States can access the vaccine “as quickly as possible,” he said. GSK will also work on regulatory review and shot approval in other countries.
London-based GSK in a presentation of results last week said it had “millions” of doses of the RSV vaccine ready to ship.
The company plans to meet with the federal government’s Centers for Disease Control and Prevention’s vaccine advisory committee in June to outline potential vaccine schedules for the United States, according to this presentation.
GSK’s shot is also closing in on approval in the European Union. Last week, the European Medicines Agency recommended that the company’s vaccine be approved by the EU for older people.
The shot would help countries tackle the upcoming RSV season in the fall.
Last year, the United States suffered an exceptionally severe RSV season.
Virus cases in children and the elderly have overwhelmed hospitals across the country, largely because the public has stopped practicing Covid pandemic health measures that had helped keep the spread of RSV at a low level.
RSV usually causes mild, cold-like symptoms. But each year, the virus kills 6,000 to 10,000 elderly people and a few hundred children under the age of 5, according to the CDC.
The FDA said GSK’s vaccine approval was based on data from a phase three trial in elderly people.
In March, an independent panel of FDA advisors recommended the vaccine based on the results of those trials, which found the vaccine to be nearly 83% effective in preventing lower respiratory tract disease caused by RSV. Illness was defined as two or more symptoms, including shortness of breath, wheezing, cough, increased mucus production, crackles, low oxygen saturation, or need for supplemental oxygen.
The independent panel unanimously said GSK’s vaccine efficacy data was sufficient.
But advisers also flagged potential safety concerns 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 vaccine from GSK, according to an FDA backgrounder. She was hospitalized for six months before being released.
The document says the woman was the only case of Guillain-Barré syndrome out of more than 12,000 people who received the shot.
GSK said in February there was insufficient evidence to confirm the woman had obtained Guillain-Barre as a result of the GSK shooting.
But the FDA said at the time it considered the case to be linked to GSK’s vaccine.
On Wednesday, the agency said it would ask GSK to conduct a study to further assess the risk of Guillain-Barré syndrome and another side effect seen in a clinical trial co-administered RSV with a vaccine against influenza.
Guillain-Barré syndrome is a rare disease in which the immune system attacks its own nerves, causing muscle weakness and sometimes paralysis. Most people recover fully from the disease, but some cases can be fatal or have lasting effects.
The rate of Guillain-Barré syndrome is typically one to two cases per 100,000 people each year in the United States, according to the National Organization for Rare Disorders.
The FDA flagged the disorder as a potential safety issue with Pfizer’s RSV vaccine for the elderly.
Two people developed Guillain-Barré syndrome after receiving Pfizer’s vaccine in a late-stage clinical trial with more than 20,000 recipients.
Pfizer announced in February that it would conduct a safety study to further evaluate Guillain-Barré syndrome if the FDA approves its vaccine.
The drug company hopes to get that approval later this month.
No cases of Guillain-Barré syndrome have been identified in a clinical trial of Moderna’s RSV vaccine.
Moderna expects to file for FDA approval in the first half of this year.