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FDA meticulously re-analyzes raw data … UK prepares for review before application
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(New York = Yonhap News) Correspondent Kang Gun-taek = British government approves use of new vaccine against coronavirus infection (Corona 19) by US pharmaceutical company Pfizer and Germany’s Bioentech on 2 (local time) ). Questions arise.
Although Donald Trump’s US administration launched an “ Operation Warp Speed ” project and launched an all-out battle for rapid vaccine development and deployment, their own companies’ vaccines were also lost in the UK for first emergency approval.
In this regard, the New York Times (NYT) reported that there were differences in the vaccine approval review process between the two countries.
In the case of US regulators, the newspaper reported that the statutory data was carefully reanalyzed to prove the results of pharmaceutical companies’ clinical trials, such as scrutiny of thousands of documents. He explains that he not only reads the reports issued by pharmaceutical companies, but looks at the clinical trial data one by one.
“The FDA is one of the few regulators that actually looks at the raw data,” said Stephen Han, director of the Food and Drug Administration (FDA). She said.
On the other hand, according to the NYT, regulators in the UK and Europe rely more on the analysis of pharmaceutical companies rather than on control of raw data.
However, it’s hard to say that the UK’s COVID-19 vaccine review process was insufficient. The Pfizer-Bioentech vaccine examined “unprecedented” raw data, including direct review of more than 1,000 documents, the UK government said.
Both the US and the UK seek advice from outside expert groups, who appear to have moved more quickly and flexibly on the British side in the process.
The FDA, which received an application for emergency use approval from Pfizer on the 20th last month, plans to hold its first advisory board meeting on the 10th, but a group of experts in the UK has already met. for more than 40 hours to review data, including data review.
“We must prepare and prepare to climb the mountain,” said Jun Lane, head of the MHRA, who recommended that the British government approve the Pfizer vaccine. “We have already started preparing since June”. .
“We were at base camp when the results of the first clinical trials arrived on November 10 (Pfizer),” Lane said.
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2020/12/03 04:45 sent
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