(Fighting New Coronary Pneumonia) The US FDA released the analysis report of the new crown vaccine developed by Germany and the United States: it meets the emergency use authorization standards

　　China News Agency, Houston, December 8th. The US Food and Drug Administration (FDA) released an analysis report on the 8th, saying that clinical research results show that the new crown vaccine jointly developed by German Biotech and Pfizer Pharmaceutical Co., Ltd. meets FDA The prescribed emergency use authorization standards.

　　According to the Wall Street Journal, the 53-page report issued by the FDA on the same day confirmed the results of a trial disclosed by Pfizer in November: The new crown vaccine developed by it was effective in preventing symptomatic new crown virus infection by 95%. .

The report stated that the new crown vaccine meets the criteria for emergency use authorization.

　　The Phase 3 clinical trial of this vaccine was launched on July 27 this year and has so far recruited 44,000 subjects worldwide.

The FDA report analyzed the health data of 19,000 test recipients.

　　According to the report, there is evidence that the new crown vaccine is administered in two doses, three weeks apart, and begins to protect the human body after the first dose.

　　According to the report, 70% of the subjects experienced side effects 1 to 2 days after vaccination, including soreness at the injection site, fatigue, headache, joint pain, fever and other symptoms.

　　The report also said that this vaccine is effective for people of different ages, weights and races.

However, the report data shows that most of the subjects are white, most of whom are under 55 years of age.

　　The Washington Post stated that this report is preliminary information provided by the FDA before approving the new crown vaccine.

The FDA will hold a "Vaccines and Related Biological Products Advisory Committee" (VRBPAC) meeting on the 10th and vote on whether this vaccine can effectively prevent people aged 16 and over from contracting the new coronavirus.

After the meeting, the FDA will decide whether to approve the emergency use authorization of the vaccine.

　　According to Reuters, Pfizer Pharmaceuticals and Modena Biotechnology in the United States submitted applications for emergency use of the new crown vaccine in the United States at the end of November.

Both vaccines are mRNA (messenger ribonucleic acid) vaccines.

The new crown vaccine developed by the latter will be reviewed by the FDA next week.

　　It is also reported that the British regulatory agency approved the new crown vaccine jointly developed by German and American companies last week, and started vaccination on the 8th.

Currently, the vaccine is also under review in the European Union.

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