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Coronavirus: Pfizer and BioNtech to Seek Emergency US Approval ‘Within Days’ Following Better Than Expected Test Results
Pfizer and BioNtech announced Wednesday that their Covid-19 vaccine had achieved 95 percent efficacy in their final clinical trials. The two companies said there was sufficient data to meet the requirements of the US drug regulator and that they would submit an application for emergency use. authorization “in a few days”. Last week, the two companies said interim results from phase three trials showed their efficacy level to be above 90 percent, which the scientists said was above expectations. Get the latest insights and analysis from our Global Impact newsletter on the Another American company using similar genetic technology, Moderna, also announced Tuesday that its vaccine is 94.5% effective, raising hopes that other vaccines are also effective. reported an efficacy rate of 92, but scientists say it is based on only 20 cases of Covid-19 in trials, too small a number to reach a firm conclusion. The results of the study mark an important step in this historic eight-month journey to present a vaccine capable of helping end this devastating pandemic, “said Albert Bourla, Pfizer President and CEO.” We continue to advance at the speed of science to collect all the data collected so far and share it with regulators around the world. ” Pfizer, a US company, and the German company BioNTech were the first to publish data from their large-scale clinical trials for the experimental vaccine, saying they expect it will produce up to 50 million doses this year, covering 25 million people. By the end of next year, they hope to produce up to 1.3 billion doses. Vaccines will be critical to alleviating the global pandemic, which has so far caused more than 55 million confirmed cases and more than 1.3 million deaths worldwide. The coronavirus vaccine developed in China induces a rapid immune response The United States has been particularly hard hit, with more than 1,000 deaths from coronavirus every day. Millions have lost their jobs amid partial lockdowns designed to contain the spread of the deadly virus. The World Health Organization and regulators like those in the US and China had originally called for vaccines to be at least 50% effective, so the latest vaccine Study results have far exceeded expectations, but expectations persist. Vaccine safety and distribution concerns, including access for developing countries. The Covax global collaboration has responded by raising more than $ 2 billion from the richest nations to buy vaccines for the poorest countries. Pfizer said the efficacy of the candidate vaccine was consistent across ages, genders and ethnic groups. Its efficacy among those over 65, the most vulnerable group, was 94 percent. Among the 43,000 volunteers in the trial, there were 170 confirmed cases, 162 of which came from the placebo group. The team said 10 serious cases were reported in the trials. , with nine of them in the placebo group and one in the vaccinated group. They said the study had not raised major safety concerns. In a subgroup of 8,000 participants where side effects were seen, the only serious ones were fatigue and headache. The result places the vaccine, which uses a genetic material known as mRNA to trigger an immune response, in the first position to obtain approval for emergency use. from the US Food and Drug Administration. Coronavirus: the cold and harsh challenge of vaccine delivery The Chinese government has already approved the emergency use of vaccines that are still in the phase of three clinical trials. Although scientists are delighted with the results of the Pfizer and Modena trials, they say it is important to see how Pfizer shares rose 2.86 percent to $ 36 in pre-market trading on Wednesday after the announcement. The United States government has already secured a $ 1.95 billion agreement with Pfizer and BioNTech to provide 100 million doses at no cost. for the American public, with a concession to acquire an additional 500 million. More from South China Morning Post: * Pfizer Coronavirus Vaccine Over 90% Effective, Says US Drug Maker Diseases * Coronavirus: Vaccine Hopes Rise With Promising Pfizer-BioNTech Trial Results * Fosun expects to launch BioNTech and Pfizer’s Covid-19 vaccine in China at the same time as the US and Europe, says Guo Guangchang This article Coronavirus: Pfizer and BioNtech to seek US emergency approval ‘in about days’ after better-than-expected test results first appeared on the South China Morning Post For the latest news from the South China Morning Post, download our mobile app. Copyright 2020.
