With the election approaching, trump has made an effort to promote the new crown therapy and vaccine

There are only two months left before the US presidential election on November 3. The trump administration seems to be using the Federal Food and drug administration to speed up the approval of treatments and vaccines as a result of its fight against the epidemic and as a bargaining chip in the election. < / P > < p > on Sunday, local time, FDA issued an emergency authorization for the use of convalescent plasma in the treatment of hospitalized patients with new crown. “This is what I’ve been looking for for for a long time, and this is great,” trump said at the day’s briefing

plasma therapy novel coronavirus pneumonia is a method of extracting blood components rich in antibodies from patients with newly recovered pneumonia. Peter marks, director of FDA’s Center for biological products evaluation and research, said inpatients under 80 who received plasma treatment within three days of diagnosis and who did not receive ventilator treatment benefited the most. Compared with patients receiving low antibody plasma, their survival rate increased by 35% after 30 days of transfusion. According to a paper published earlier this month by the Mayo Clinic cited by FDA, the mortality rate of patients receiving high-level antibody plasma treatment within three days after diagnosis was 8.7% at seven days after transfusion, while that of patients receiving low antibody plasma treatment within four days or more after diagnosis was 11.9%. But the results have not been published in peer-reviewed journals. However, there are still some risks. More research is needed and plasma “should not be considered a new standard for the treatment of patients,” the statement of authorization for emergency use of the therapy said. < / P > < p > so far, among the new crown drugs, only redcivir developed by Gillette Company has been authorized by FDA for emergency use. The company said on August 10 that it had applied to the FDA for full approval of radcivir. For its < / P >, it is regarded as the regulatory process of trump. On Saturday, he criticized the FDA on twitter for making it more difficult to declare vaccine and treatment trials just to postpone the publication of the results until after the election. < / P > < p > < p > citing three people familiar with the matter, the Financial Times said the trump administration was considering bypassing conventional standards and quickly introducing vaccines from the UK before the election. This means that the FDA will grant emergency use authorization to the vaccine developed by AstraZeneca and Oxford University in October. < p > < p > according to the U.S. regulation, the vaccine needs to be tested by 30000 people to reach the authorization threshold. Currently, only 10000 volunteers have been recruited for the AstraZeneca study. Larger trials involving 30000 volunteers will be conducted after the completion of the small-scale trials. < / P > < p > according to data published in the lancet on July 20, the new crown vaccine produced a strong immune response in an early human trial involving more than 1000 people. < / P > < p > < p > according to the financial times, speeding up the approval process and providing vaccines before the election may allow trump to claim that he has successfully controlled the new epidemic. But this will further undermine public confidence in vaccine safety. As of noon on August 24, Beijing time, data from Johns Hopkins University showed that 5.7 million people in the United States had been infected with the new coronavirus, of which 176000 died. In his speech after accepting the nomination last week, presidential candidate Biden, Trump’s rival, criticized that the epidemic situation in the United States should be worse than that in any other country, but trump still lacks planning: “the tragedy we are in today is that things should not be as bad.” Michael Caputo, a spokesman for the FDA’s Department of health and human services, said all claims that the government would issue authorization for emergency use of vaccines before the election were “absolutely wrong.”. The government hopes to develop a vaccine by the first quarter of 2021. “I’ve never been informed that this goal has changed It is irresponsible to claim that authorizing the public to use unsafe or ineffective vaccines is to undermine the president’s response to the epidemic. ”