A GSK lab in London.
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The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline For use in adults over 60 years of age.
The approval, the first worldwide by a regulatory body of an RSV vaccine, is a decisive victory for GSK in a race against drugmakers. Pfizer and modern to bring to market a vaccine that targets respiratory syncytial virus.
GSK shares rose nearly 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 effort to reduce the “significant burden” of RSV.
The company will now focus on ensuring eligible seniors in the US can access the vaccine “as quickly as possible,” he said. GSK will also work for regulatory review and approval of the vaccine in other countries.
London-based GSK, during an earnings presentation last week, said it has “millions” of doses of the RSV vaccine ready to ship.
The company plans to meet with the vaccine advisory committee of the federal Centers for Disease Control and Prevention in June to discuss potential vaccination schedules for the US, according to that presentation.
GSK’s opportunity is also getting closer to 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 injection would help countries combat the upcoming RSV season in the fall.
The USA suffered from an unusually severe 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 keep the spread of RSV low.
RSV usually causes mild, cold-like symptoms. But every year, the virus kills between 6,000 and 10,000 older people and a few hundred children under the age of 5, according to the CDC.
The FDA said the approval of GSK’s vaccine was based on data from a phase three trial in older adults.
In March, an independent panel of FDA advisors recommended the shot based on trial results, which found the vaccine to be nearly 83% effective in preventing RSV lower respiratory illness. Illness was defined as two or more symptoms including shortness of breath, wheezing, coughing, increased mucus production, crackles, low oxygen saturation, or need for oxygen supplementation.
The independent panel unanimously said that GSK’s vaccine efficacy data was sufficient.
But the advisers also pointed to possible safety concerns related to a nervous system disorder, Guillain-Barré syndrome, that could be linked to the shot.
A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving the GSK vaccine, according to an FDA information document. She was hospitalized for six months before being released.
The document said the woman was the only case of Guillain-Barré syndrome out of more than 12,000 people who received the injection.
GSK said in February that there is insufficient evidence to confirm that the woman received Guillain-Barre as a result of the GSK shooting.
But the FDA said at the time that it considers the case to be related to the GSK vaccine.
On Wednesday, the agency said it will require GSK to conduct a study to further assess the risk of Guillain-Barré syndrome and another side effect seen in a clinical trial in which the RSV shot was co-administered with a flu vaccine. .
Guillain-Barré syndrome is a rare disorder 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 long-lasting effects.
The rate of Guillain-Barré syndrome is typically one to two cases per 100,000 people each year in the US, according to the National Organization for Rare Disorders.
The FDA flagged the disorder as a potential safety concern with Pfizer’s RSV vaccine for older adults.
Two people developed Guillain-Barre syndrome after receiving a shot from Pfizer in a late-stage clinical trial involving more than 20,000 vaccines.
Pfizer said in February that it will conduct a safety study to further evaluate Guillain-Barré syndrome if the FDA approves its vaccine.
The pharmaceutical company hopes to get that 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 during the first half of this year.
