The FDA's approval is a victory for GSK in a race against Pfizer and Moderna to bring a shot that targets respiratory syncytial virus to the market.
In March, an independent panel of advisors to the FDA recommended the shot based on those trial results, which found the shot nearly 83% effective at preventing lower respiratory tract disease caused by RSV. Disease was defined as two or more symptoms including shortness of breath, wheezing, cough, increased mucus production, crackles, low oxygen saturation, or need for oxygen supplementation.
A 78-year-old woman in Japan was diagnosed with Guillain-Barre syndrome nine days after receiving GSK's vaccine, according to an FDAThe document said the woman was the only case of Guillain-Barre syndrome out of the more than 12,000 people who received the shot. GSK said in February that there is insufficient evidence to confirm the woman got Guillain-Barre as a result of GSK's shot.On Wednesday, the agency said it will require GSK to conduct a study to further assess the risk of Guillain-Barre syndrome and another side effect observed in a clinical trial that co-administered the RSV shot with a flu vaccine.in which the immune system attacks its own nerves, causing muscle weakness and sometimes paralysis.
Guillain-Barre syndrome after receiving Pfizer's shot in a late-stage clinical trial with more than 20,000 vaccine recipients.it will conduct a safety study to further assess Guillain-Barre syndrome if the FDA approves its vaccine.No cases of Guillain-Barre syndrome were identified during aModerna plans to file an application for FDA approval during the first half of this year.
México Últimas Noticias, México Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
FDA approves GSK RSV vaccineGSK's Arexvy, the first RSV vaccine approved for use in the U.S., gets the green light for older adults.
Leer más »
US FDA approves first RSV vaccine from GSKThe U.S. Food and Drug Administration has approved GSK Plc's respiratory syncytial virus (RSV) vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people.
Leer más »
FDA approves world's first RSV vaccine, a shot for adults ages 60 and upBREAKING: FDA approves the world's first respiratory syncytial virus, or RSV, vaccine made by pharmaceutical giant GSK.
Leer más »
FDA approves first vaccine for RSV, a moment six decades in the making | CNNAfter a 60-year scientific quest, the world has its first vaccine to protect against respiratory syncytial virus, or RSV -- and more are on the way.
Leer más »