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FDA批准辉瑞(PFE.US)RSV疫苗用于老年人 拟于今年三季度上市

The FDA approved the Pfizer (PFE.US) RSV vaccine for the elderly and is scheduled to be marketed in the third quarter of this year

Zhitong Finance ·  Jun 1, 2023 14:50

The Zhitong Finance app learned that the US Food and Drug Administration (FDA) approved the respiratory syncytial virus (RSV) vaccine Abrysvo developed by Pfizer (PFE.US) on Wednesday. The vaccine can protect adults aged 60 and above from respiratory syncytial virus. Respiratory syncytial virus is a common pathogen that causes thousands of elderly deaths and hospitalizations each year. Pfizer said in a statement on Wednesday that it expects to go public in the third quarter of this year before the RSV popularity season. The US Centers for Disease Control and Prevention (CDC)'s Independent Advisory Committee will meet on June 21 to make recommendations on the use of the vaccine.

A few weeks before Pfizer's vaccine was approved, the FDA approved a similar vaccine against RSV produced by GlaxoSmithKline (GSK.US). The FDA's two authorizations in just one month represent a historic milestone in public health, after decades of failed efforts to develop a vaccine for the virus.

RSV causes mild symptoms similar to colds in most people, but older people have a higher risk of severe illness. According to the US Centers for Disease Control and Prevention (CDC), the virus causes the death of 60 to 10,000 elderly people every year, of which 60,000 to 160,000 are hospitalized.

RSV is also spreading at the same time as COVID-19 and influenza viruses. At the end of last year, the shared burden of these three viruses put tremendous pressure on the US health care system. Two new RSV vaccines introduced by Pfizer and GlaxoSmithKline may help ease that pressure this fall.

The Pfizer vaccine is a single dose of 120 micrograms. Clinical trial results show that the vaccine is about 67% effective in preventing lower respiratory diseases with at least two conditions or symptoms, and for lower respiratory diseases with three conditions or symptomsprophylaxisThe effectiveness is approximately 86%.

The FDA's independent advisory board approved Pfizer's vaccine in February. But several members of the team expressed concerns about the vaccine's safety. Two participants in the Pfizer clinical trial developed Guillain Barre syndrome after being vaccinated. Guillain Barre syndrome is a rare neurological disorder with symptoms ranging from brief weakness to paralysis. The FDA believes the two Guillain Barre cases may be linked to the vaccine. The agency has asked Pfizer to conduct a post-approval safety study to monitor the disease.

Pfizer has also developed a vaccine to protect newborns from RSV. The FDA's advisers backed the vaccine at a meeting earlier this month. The FDA is expected to make a final decision on the vaccine in August.

The translation is provided by third-party software.


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