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FDA thoroughly re-analyzes raw data … UK prepares for review prior to implementation
When the UK government approved the use of a new vaccine against coronavirus infection (Corona 19) by the US pharmaceutical company Pfizer and the German Bioentech the second (local time) for the first time in the world, the question arises : ‘Why is America one step behind?’
Despite the US administration of Donald Trump launching an “ Operation Warp Speed ” project and launching an all-out battle for the rapid development and dissemination of vaccines, even vaccines from their own companies were lost in the UK. for the 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 data from the law was carefully re-analyzed to test the results of clinical trials conducted by pharmaceutical companies, such as meticulously examining thousands of documents.
He explains that he does not just read the reports issued by the pharmaceutical companies, but analyzes the data from clinical trials one by one.
“The FDA is one of the few regulators that really looks at raw data,” said Stephen Han, director of the Food and Drug Administration (FDA). said.
On the other hand, regulators in the UK and Europe rely more on the analysis of drug companies themselves than on scrutiny of raw data, according to NYT.
However, it is difficult to say that the UK’s COVID-19 vaccine review process was insufficient.
The Pfizer-Bioentech vaccine analyzed “unprecedented” raw data, including a direct review of more than 1,000 documents, the UK government said.
Both the United States and the United Kingdom seek the advice of external expert panels, who appear to have moved more quickly and flexibly from the British side in the process.
The FDA, which received an emergency use approval application from Pfizer on the 20th of last month, plans to hold the first advisory committee meeting on the 10th, but a group of experts in the UK has already met for more than 40 hours to review data, including review of data.
“We have to brace ourselves and prepare to climb the mountain,” said Jun Lane, director of the MHRA, who recommended approval of the Pfizer vaccine to the UK government. .
“We were at base camp when the results of the initial clinical trials came in on November 10 (from Pfizer),” Lane said.
/ yunhap news
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