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During the clinical trial of the new corona vaccine developed jointly by the American pharmaceutical company Pfizer and BioNTech of Germany, a total of 6 subjects died. However, the cause of death was not related to the vaccine. The US FDA recognized the Pfizer vaccine as safe. However, yesterday (9) it was reported that British medical personnel experienced an allergic reaction after the injection. Experts hope that when FDA committee members meet today (10) to discuss whether to urgently authorize the Pfizer vaccine, this incident will be put on the agenda.
The US political news website Politico reported that the US Food and Drug Administration (FDA) announced vaccine-related documents on the official Pfizer website on Day 8. In addition to certification The initial statement that the vaccine is 95% effective, also revealed for the first time that 6 volunteers died during the clinical trial. Four of the dead belonged to the control group administered placebo. There were 2 deaths in the vaccine-administered test group, but none of their deaths were related to the vaccine itself.
The document also revealed that there was one seriously ill patient with the new crown in the experimental group and three seriously ill patients in the control group. The FDA noted that after the first dose of the vaccine, the protective effect reached 88% and after the second dose, the effectiveness of the vaccine increased to 95%. Therefore, the FDA determined that the Pfizer vaccine was effective, “with no particular safety concerns.”
However, after the UK started mass vaccination with Pfizer on the 8th, it was reported yesterday that 2 members of medical staff had allergic reactions and must receive treatment, forcing the Medicines and Healthcare Products Regulatory Agency (MHRA ) to make urgent recommendations. , Urged people with a history of “severe allergic reactions” not to get the Pfizer vaccine.
The US FDA will meet today to decide whether to grant emergency authorization for the Pfizer vaccine. If approved by the FDA, US Health Secretary Alex Azar said on the 6th that the FDA will authorize the Pfizer vaccine in a few days.
However, US media CNBC reported that Moncef Slaoui, the top director of the Trump administration’s crown research and development program for new vaccines and therapies, said yesterday that he expected the allergic incident in the UK to be listed today in the FDA’s agenda. “Decision”, but the American expert in infectious diseases William Schaffner believes that the allergic reaction of people after vaccination should not be the key to authorize or not the vaccine. He said that this is a problem that the competent authority deals with “frequently”.
Schaffner said that if the FDA does not include this topic on today’s agenda, it is still possible in the coming days to discuss with the CDC’s Advisory Committee on Immunization Practices, which will allow the committee to make recommendations for the use of vaccines in the future.
The FDA declined to respond to whether UK allergies will be on today’s agenda, but the spokesperson noted that there are indeed links on today’s agenda that will review vaccine safety.
(Zhongshi News Network)
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