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According to local media on the 9th, Adrian Hill, head of research and development for the AstraZeneca vaccine, said: “If the FDA waits for the clinical trial to finish, the vaccine will not be available in the United States until the middle of next year.” Said.
“I hope the FDA will see data on this vaccine, including all data available in January 2021,” said Hill’s director, asking for speedy approval. He also indirectly criticized the FDA, saying, “It is too late for the value of this highly efficient vaccine to be used on a large scale and easily distributed.”
Hill’s comment came after the New York Times (NYT) reported that “the AstraZeneca vaccine is losing trust in the FDA” and that approval within the year was impossible.
AstraZeneca clinical trials in the US recruited only about half of the participants (30,000) required by the FDA. The fact that the clinical trial was suspended for 7 weeks until the end of October appears to have affected the FDA because no evidence was presented to the FDA that the neurological symptoms of the two clinical trial participants were not related to the vaccine. .
AstraZeneca explained to the NYT that, given the comments it received from the FDA, it hopes it will not get federal approval until it gets the clinical results from the US.
AstraZeneca’s Phase 3 clinical results announced on 23rd last month also became a problem. At the time, the company announced that the average preventive effect of the vaccine was 70%, but later revealed that the low-dose delivery method, which showed a 90% preventive effect, was a coincidence.
The AstraZeneca vaccine, a method of delivering a viral antigen gene in another virus that does not harm the human body, can be stored at normal refrigerator temperature and has attracted attention for its low price of $ 4 per serving.
“It is not enough to approve the low-dose regimen without a clear explanation of why the low-dose regimen worked better,” said Montsef Slawi, executive director of the White House vaccine development project ‘Ultra-Rapid Operations’. He said he would request permission to use.
According to the industry, approval is expected to be available in mid-February. However, it is expected to be approved within a year in the UK and India, NYT said.
