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[Reuters]- The United States Food and Drug Administration (FDA) approved the emergency use of a new coronavirus vaccine developed by the American pharmaceutical giant Pfizer and the German pharmaceutical company Biontech on the 11th, and the first vaccination will finally begin in the United States. ..
The following is a summary of the current situation in the competition for the development of the new coronavirus vaccine.
Pfizer and Biontech are at the forefront of development competition. The two companies were the first in the world to publish full data on late-stage clinical trials on November 18, and the British government first approved emergency use on November 3. Subsequently, it was approved in Canada on the 9th and in the United States on the 11th.
The European Pharmaceutical Agency (EMA) also plans to complete the licensing exam by the 29th, and India is rushing the exam.
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The American pharmaceutical company Moderna is out of the group and pursues the Pfizer-Biontech coalition. On November 30, the data from the latest clinical trial was released in full, showing an effectiveness of 94.1%. The FDA’s Expert Advisory Committee will consider the pros and cons of emergency use on the 17th of this month and the EMA on January 12 of next year.
AstraZeneca, a major British pharmaceutical company, published interim data for a late-stage study on November 23 for a vaccine developed jointly with the University of Oxford, and is currently seeking permission from the British government. In the interim data, the mean efficacy was 70%, while the efficacy of the group of subjects who received half the full dose the first time and the full dose the second time reached 90%.
It is not clear how the authorities will view that data. The Indian government is speeding up the review, but is also demanding more data. Astra Zeneca is also in talks with EMA.
Johnson End Johnson (J&J), a major US pharmaceutical and daily necessities company, plans to release clinical trial data within this year or early next year, and if the effect is confirmed, plans to apply for a license from FDA by the end of February next year. J&J has reduced the number of subjects from 60,000 to 40,000 on the 9th of this month, and there is a possibility that the results can be summarized earlier.
Novabax, an American biopharmaceutical, is conducting late-stage clinical trials in the UK and plans to publish data in the first quarter of next year. The late trials will begin in the United States later this year.
However, French pharmaceutical giant Sanofi and British pharmaceutical giant Glaxo Smith Klein were forced to pull out of the competition for vaccine development. On the 11th of this month, it was revealed that the immune response of the older subjects was insufficient in each test, and a new test will begin in February of next year.
The World Health Organization (WHO) has stated that it ideally wants to ensure at least 70% effectiveness. The minimum effectiveness line established by the FDA is 50%. In other words, in clinical trials, it is a condition that the number of cases of infection in subjects who received placebo (counterfeit medicine) has reached twice that of vaccinated subjects. EMA can also accept lower efficiency.
The Pfizer-Biontech Coalition vaccine will be administered based on the release of data from the latest study, but Russia and China have given the public a vaccine that is still in the middle of the latest study.
Russia announced on November 24 that its homemade “Sputnik V” vaccine was 91.4% effective in preliminary data from the latest study. However, the inoculation already started in August and 100,000 people have been inoculated so far.
In July, China launched an emergency vaccine use program for medical workers and people at high risk of exacerbation, and by mid-November, at least three types of vaccines had been administered to about 1 million people. Of these, two types were developed by China Biotechnology (CNBG) under the umbrella of the Chinese Pharmaceutical Group (Sinofarm), and one type was developed by the China Department of Technology (Sinobac).
Sinobac said on Nov. 18 that its vaccine, Coronabac, was found to have produced a rapid immune response in medium-term trials, and that interim data for term trials may be available later this year.
The Butantan Institute in Sao Paulo, Brazil, aims to fill and label one million vaccines a day before starting coronabac in the state on January 25 of next year.
The United Arab Emirates (UAE) also revealed on 9 this month that a late-stage study conducted in the country yielded preliminary results showing that one of the CNBG vaccines is 86% effective.
