The US FDA Released the New Corona Vaccine Analysis Report Developed by Germany and the United States – In Line with Emergency Use Authorization Standards

Original Title: US FDA Released New Corona Vaccine Analysis Report Developed by Germany and the United States – In Line with Emergency Use Authorization Standards

American food and drugsadministrationThe Agency (FDA) published an analysis on the 8threportHe said clinical research results show that the new German biotechnologythe companyAnd the united statesPfizerPharmacistLimited liability companyThe new jointly developed corona vaccine complies with FDA regulations for emergency use.AuthorizationStandards.

according to”financial worldThe Daily reported that the 53-page report issued by the FDA on the same day confirmedPfizerThe results of a trial released by the pharmaceutical company in November: The new corona vaccine developed by it is 95% effective in preventing symptomatic infection by the new corona virus. The report indicated that the new corona vaccine meets the criteria for authorization for emergency use.

The phase 3 clinical trial of this vaccine was launched on July 27 of this year, and so far 44,000 subjects have been recruited worldwide. The FDA report analyzed the health data of 19,000 test recipients.

According to the report, there is evidence that the new corona vaccine is given 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 between 1 and 2 days after vaccination, such as injection site pain, 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 data in the report shows that the majority of the subjects are white, most of whom are under the age of 55.

The Washington Post stated that this report is preliminary information provided by the FDA prior to approving the new corona vaccine. The FDA will conduct a “vaccine and related biologicsproductadvisoryCommittee”(VRBPAC)meetingAnd vote on whether this vaccine can effectively prevent people over 16 from contracting the new coronavirus. After the meeting, the FDA will decide whether to approve the emergency use authorization for the vaccine.

According to Reuters,PfizerPharmaceuticals and Modena Biotechnology of the United States submitted an emergency use authorization application for the new corona vaccine in the United States in late November. Both vaccines are mRNA (messenger ribonucleic acid) vaccines. The new corona vaccine developed by the latter will be next weekto acceptFDA review.

The UK regulatory agency is also reported to havecompanyThe new jointly developed corona vaccine was approved and vaccination started on day 8. Currently, the vaccine is also under review in the European Union.

(Source: China News Network)

(Responsible editor: DF524)