[ad_1]
Photo = Reuters
The new vaccine against coronavirus infection (Corona 19) developed jointly by the British pharmaceutical company AstraZeneca and the University of Oxford is expected to be approved by the US Food and Drug Administration (FDA) only in mid-September. next year. This is because the clinical trial process to verify efficacy and safety was not transparent. The AstraZeneca vaccine is the only officially announced Corona 19 vaccine that the Korean government has signed a pre-purchase contract.
On the 9th (local time), the New York Times (NYT) of the United States reported that “the FDA does not believe in the AstraZeneca vaccine” and that “it is expected that approval will not be obtained within the year due to repeated errors and delay in the clinical trial process “. The AstraZeneca vaccine has attracted attention because it is not difficult to store and distribute among corona 19 vaccines, and because a single dose is cheap at around $ 4.
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 trial procedure was delayed after symptoms suspected of being a drug appeared. Side effect 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 said: “AstraZeneca discussed urgent approval with the US FDA on September 8, two days after the suspension of the clinical trial, but did not reveal that a suspicious side effect had been raised. I was very disappointed with the opacity of AstraZeneca ”.
Since then, AstraZeneca clinical trials in the US have been suspended for 7 weeks. It was because the FDA could not provide evidence that the suspected side effects were not related to the vaccine. Meanwhile, there were cases where the first dose of vaccination failed to deliver the second dose. The NYT cited a source and reported: “In the UK, in July, a clinical participant showed symptoms suspected of neurological side effects, but this fact was not reported to the FDA.” AstraZeneca rebutted, saying, “I provided all the information to the FDA immediately.”
AstraZeneca’s intermediate clinical results announced on 23rd last month also became a problem. AstraZeneca revealed that some trial participants were accidentally given half the dose of the second dose, more effectively. “There is no clear medical explanation why the results of the low-dose regimen were better,” said Montsef Slawi, executive director of the US White House’s ultra-rapid operations team (Warp) of the vaccine development project. It is difficult to give ”.
Adrian Hill, who is overseeing the development of the AstraZeneca vaccine after the NYT report, told US NBC: “If the FDA waits for the clinical trials of the AstraZeneca vaccine to finish completely, the vaccine will not be available in the US until the middle of next year. ” He urged, “By that time, it is too late, so I hope the FDA will review the data within the next month and get approval quickly.”
The AstraZeneca vaccine is the only vaccine that the Korean government has completed a pre-purchase contract. The government is in a position that even if FDA approval is postponed, it will not significantly affect the timing of the introduction of national vaccines. Lee Sang-won, director of epidemiological research and analysis at Central Defense Response Headquarters, said on the 10th: “The national vaccine detection system is different from that of the United States.
Tae-ho Yoon, quarantine chief at Accident Response Headquarters, said: “It is not yet clear whether the FDA has officially postponed approval or raised concerns.” If there are no serious side effects, consider comprehensively the benefits of introducing the vaccine (FDA’s) It will be approved. ”
Reporter Sun Han-gyeol [email protected]
Ⓒ Hankyung.com prohibits unauthorized reproduction and redistribution
