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Corona 19 vaccine developed jointly by British pharmaceutical companies AstraZeneca and the University of Oxford is expected to gain approval from the US Food and Drug Administration (FDA) only in the middle of next year due to issues such as efficacy. and security.
The AstraZeneca vaccine is the only Corona 19 vaccine that the Korean government has signed a pre-purchase contract.
The New York Times (NYT) on the 9th (local time) reported that “the FDA does not believe in the AstraZeneca vaccine” and “approval is not expected to be approved within the year due to repeated errors and delay in the trial process clinical”.
According to the NYT, AstraZeneca has not yet reached the standard number of FDA participants (30,000) in US clinical trials. This is because the clinical procedure was delayed after symptoms suspected of being a side effect appeared. of the vaccine in two clinical trial participants on September 6.
At that time, AstraZeneca temporarily suspended worldwide clinical trials, but did not notify the FDA. NYT reported that “the FDA was belatedly aware of the clinical suspension and was very disappointed by the opacity of AstraZeneca.” AstraZeneca has since failed to present immediate evidence to the FDA that the suspected side effects were not related to the vaccine, and the US trial was suspended for 7 weeks.
AstraZeneca’s intermediate clinical results announced on 23rd last month also became a problem. AstraZeneca revealed that some clinical participants accidentally administered only half of the second dose, which showed greater efficacy. “There is no clear medical explanation why the results of the low-dose regimen were better,” said Montsef Slawi, executive director of the White House vaccine development project team. “It is difficult to give approval in this state.”
Following the NYT report, an AstraZeneca official told NBC: “If the FDA expects clinical trials of the AstraZeneca vaccine to end completely, the vaccine will not be available in the US until the middle of next year.” . I hope, ”he urged.
The Korean government is in a position that even if FDA approval is delayed, it will not have a significant impact on domestic production and the timing of vaccine introduction. Lee Sang-won, director of epidemiological research and analysis at Defense Response Headquarters, said on the 10th: “The national vaccine detection system is different from that of the United States.”
Director Lee said: “We are not in a situation of concern because our country plans to obtain a vaccine through a different route (from the United States). We have already made certain agreements with AstraZeneca regarding production and use in Korea.” Additional.
Reporter Sun Han-gyeol [email protected]
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