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GSK laboratory in London.
Ole Scarf | Getty Images
the Food and Drug Administration Wednesday consent RSV vaccine production 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 during Show earnings It said last week it had “millions” of doses of the RSV vaccine ready to ship.
The company plans to meet in June with the federation Centers for Disease Control and PreventionThe 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 , European Medicines Agency He recommended that the company’s vaccine be approved by the European Union for Senior Citizens.
The shot will help countries battle the upcoming RSV season in the fall.
The United States suffered 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-sanitary measures that have helped keep the spread of RSV down.
RSV usually causes mild, cold-like symptoms. But every year the virus Kill From 6,000 to 10,000 seniors and a few hundred children under the age of 5, according to the CDC.
The FDA said approval of the GSK vaccine was based on Phase III data trial on the elderly.
In March, an independent panel of FDA advisors 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 the US Food and Drug Administration. 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 Food and Drug Administration She said at the time that she considered the condition 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 A rare disorder 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 an average Of Guillain-Barre syndrome is usually 1 to 2 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.
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