U.S. FDA to delay emergency authorization of AstraZeneca vaccine until next year: Report
Arirang News
2020-12-10
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'한국 첫 도입 계획' 아스트라제네카 백신 FDA 승인 늦어질 듯
The U.S. may reportedly delay the approval of AstraZeneca's COVID-19 vaccine until next year,... citing a lack of data from the British pharmaceutical company.
This may also delay the roll out of the vaccine in South Korea.
Lee Seung-jae reports.
When South Korea's health ministry announced its vaccine deal for 44 million people earlier this week,... the first vaccines to be administered were to be those from the U.K. firm, AstraZeneca.
However,... that plan may have taken a hit... as the U.S. FDA is reportedly delaying the approval of AstraZeneca's vaccine in America until next year.
According to the New York Times,... a lack of communication between the British drugmaker and the FDA may slow the approval process.
According to an official at the FDA,... commissioner Dr. Stephen Hahn was "stunned" by AstraZeneca's failure in September to disclose a halt to their trial.
The source added it was a part of a pattern of communication blunders by the drugmaker that damaged AstraZeneca's relationship with regulators,... raising doubts about whether its vaccine will stand up to intense public and scientific scrutiny.
The report also says that while AstraZeneca repeatedly said it hoped to roll out the vaccine in the U.S. as early as October,... the company hasn't even finished enrolling people in its U.S. clinical trials.
It added the trial was grounded for nearly seven weeks,... because AstraZeneca was slow to provide regulators with evidence the vaccine was not associated with neurological symptoms that had appeared in two clinical-trial participants.
The delay is a massive blow to Washington's roll out plans,... as it was expected to account for a substantial portion of the U.S. supply.
With the U.S. government pledging more than one billion dollars to finance the development and production of vaccines,... AstraZeneca was set to supply the country with 300 million doses if it proved effective.
This would make up as much as 60-percent of the U.S.'s entire vaccine purchase.
With uncertainty surrounding AstraZeneca's vaccine approval,... South Korea may also be faced with a similar situation,... despite the government's plan to begin its vaccination program sometime in February or March.
Lee Seung-jae, Arirang News.
The U.S. may reportedly delay the approval of AstraZeneca's COVID-19 vaccine until next year,... citing a lack of data from the British pharmaceutical company.
This may also delay the roll out of the vaccine in South Korea.
Lee Seung-jae reports.
When South Korea's health ministry announced its vaccine deal for 44 million people earlier this week,... the first vaccines to be administered were to be those from the U.K. firm, AstraZeneca.
However,... that plan may have taken a hit... as the U.S. FDA is reportedly delaying the approval of AstraZeneca's vaccine in America until next year.
According to the New York Times,... a lack of communication between the British drugmaker and the FDA may slow the approval process.
According to an official at the FDA,... commissioner Dr. Stephen Hahn was "stunned" by AstraZeneca's failure in September to disclose a halt to their trial.
The source added it was a part of a pattern of communication blunders by the drugmaker that damaged AstraZeneca's relationship with regulators,... raising doubts about whether its vaccine will stand up to intense public and scientific scrutiny.
The report also says that while AstraZeneca repeatedly said it hoped to roll out the vaccine in the U.S. as early as October,... the company hasn't even finished enrolling people in its U.S. clinical trials.
It added the trial was grounded for nearly seven weeks,... because AstraZeneca was slow to provide regulators with evidence the vaccine was not associated with neurological symptoms that had appeared in two clinical-trial participants.
The delay is a massive blow to Washington's roll out plans,... as it was expected to account for a substantial portion of the U.S. supply.
With the U.S. government pledging more than one billion dollars to finance the development and production of vaccines,... AstraZeneca was set to supply the country with 300 million doses if it proved effective.
This would make up as much as 60-percent of the U.S.'s entire vaccine purchase.
With uncertainty surrounding AstraZeneca's vaccine approval,... South Korea may also be faced with a similar situation,... despite the government's plan to begin its vaccination program sometime in February or March.
Lee Seung-jae, Arirang News.
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