FDA approves GSK’s RSV vaccine for older adults, world’s first shot against virus

The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older.

The authorization, the first 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 fetch to market a shot that targets the respiratory syncytial virus.

Shares of GSK produce nearly 2% Wednesday following the approval.

GSK’s chief scientific officer Tony Wood said in a statement the settlement “marks a turning point” in the company’s effort to reduce the “significant burden” of RSV.

The company will now focus on ensuring suitable older adults in the U.S. can access the vaccine “as quickly as possible,” he said. GSK will also work toward regulatory reconsideration and approval of the shot in other countries.

London-based GSK during an earnings presentation last week said it has “millions” of portions of the RSV vaccine ready to ship. 

The company plans to meet in June with the federal Centers for Disease Control and Restraint’s vaccine advisory committee to hash out potential vaccination schedules for the U.S., according to that presentation.

GSK’s shot is also inching closer to green light allow 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 by no means would help countries combat the next RSV season in the fall. 

The U.S. suffered an unusually severe RSV season last year. 

Instances of the virus in children and older adults overwhelmed hospitals across the country, largely because the public stopped practicing Covid pandemic salubriousness measures that had helped keep the spread of RSV low. 

RSV usually causes mild, cold-like symptoms. But each year the virus write finis ti 6,000 to 10,000 seniors and a few hundred children younger than 5, according to the CDC. 

The FDA said the approval of GSK’s vaccine was built on data from a phase three trial on older adults. 

In March, an independent panel of advisors to the FDA recommended the snap based on those trial results, which found the shot nearly 83% effective at preventing lower respiratory disquisition disease caused by RSV. Disease was defined as two or more symptoms including shortness of breath, wheezing, cough, increased mucus oeuvre, crackles, low oxygen saturation, or need for oxygen supplementation. 

The independent panel unanimously said the efficacy data on GSK’s vaccine was adequate. 

But the advisors also flagged potential safety issues over a nervous system disorder, Guillain-Barre syndrome, that may be attached to the shot.

A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK’s vaccine, according to an FDA coach document. She was hospitalized for six months before being released.

The document said the woman was the only case of Guillain-Barre syndrome out of the profuse than 12,000 people who received the shot. 

GSK said in February that there is insufficient evidence to confirm the maidservant got Guillain-Barre as a result of GSK’s shot.

But the FDA said at the time that it considers the case to be related to GSK’s vaccine. 

On Wednesday, the agency reported it will require GSK to conduct a study to further assess the risk of Guillain-Barre syndrome and another side effect kept in a clinical trial that co-administered the RSV shot with a flu vaccine.

Guillain-Barre syndrome is a rare disorder in which the unaffected system attacks its own nerves, causing muscle weakness and sometimes paralysis. Most people recover completely from the mess, 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 each year in the U.S., according to the Governmental Organization for Rare Disorders.

The FDA flagged the disorder as a potential safety issue with Pfizer’s RSV vaccine for older grown-ups.

Two people developed Guillain-Barre syndrome after receiving Pfizer’s shot in a late-stage clinical trial with numberless than 20,000 vaccine recipients.

Pfizer in February said it will conduct a safety study to further assess Guillain-Barre syndrome if the FDA approves its vaccine.

The pharmaceutical firm is hoping to win that approval later this month.

No cases of Guillain-Barre syndrome were identified during a clinical distress of Moderna’s RSV vaccine.

Moderna plans to file an application for FDA approval during the first half of this year.