Pfizer Inc and BioNTech could obtain emergency clearance in the United States and Europe for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said. The vaccine’s effectiveness has been shown to be consistent across ages and ethnicities – a promising sign given that the disease has disproportionately injured the elderly and some groups, including blacks. The U.S. Food and Drug Administration could authorize emergency use by mid-December, BioNTech chief executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be obtained in the second half of December, he added. “If all goes well, I could imagine that we get the approval in the second half of December and start deliveries before Christmas, but really only if everything goes well,” he said. The success rate of the vaccine developed by US drugmaker and German partner BioNTech was well above what regulators had said to be acceptable. Experts said it was a significant achievement in the race to end the pandemic. Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving more than 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people with severe COVID-19, one had received the vaccine. “A first in the history of mankind: less than a year between the sequence of the virus and the large-scale clinical trial of a vaccine, which is based on a completely new technique”, declared Enrico Bucci , biologist at Temple University in Philadelphia. . “Today is a special day.” Sahin of BioNTech said that U.S. Emergency Use Authorization (EUA) would be sought on Friday. An FDA advisory committee tentatively plans to meet on Dec. 8 and 10 to discuss the vaccine, a source familiar with the situation said, though the dates may change. The FDA did not respond to requests for comment. The final analysis of the trial comes a week after initial results showed the vaccine to be over 90% effective. Moderna Inc on Monday released preliminary data for its vaccine showing an efficacy of 94.5%. “We now have two safe and highly effective vaccines that could be cleared by the Food and Drug Administration and ready for distribution in a matter of weeks,” said US Secretary of Health and Human Services Alex Azar. The Moderna vaccine will likely be cleared within seven to 10 days of Pfizer receiving the EUA, US officials said, with states ready to begin distribution within 24 hours. Better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, raised hopes of ending a pandemic that has killed more than 1.3 million people and destroyed savings and everyday life. The news was especially welcome with the virus once again raging around the world, setting records for new infections and hospitalizations almost daily. The Pfizer-BioNTech vaccine has been shown to be 94% effective in people over 65, a particularly high-risk group. .
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