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Pfizer and Biontech, the pharmaceutical industry, have announced that they may seek approval from U.S. and European regulatory agencies for emergency use of their Covid-19 vaccine within the next month, after the results final trials showed that the vaccine’s success rate was 95% and that there were no serious side effects, according to “Sky News Arabia”. .
The efficacy of the vaccine has been found to be stable across different age groups and ethnicities, which is a promising sign, given that the disease affects the elderly and some groups, including people with dark skin, more that others..
The success rate of the vaccine that Pfizer, the US and its German partner, Biontech, have been working on is the highest of any vaccine tested in late clinical stages to date, and experts say it’s a big success in the race to end the pandemic..
Biontech CEO Ugur Shaheen told Reuters TV that the US Food and Drug Administration may allow emergency use of the vaccine before the end of the first half of December or the start of the second half of the month..
He indicated that it was possible to obtain conditional approval from the European Union in the second half of December.
“If all goes well, I can expect to get approval in the second half of December and start distribution before Christmas, but only if things go well.”“.
Pfizer said 170 volunteers in the trial, which included more than 43,000, had been infected with Covid-19, but 162 of them were given a placebo vaccine, meaning the vaccine’s effectiveness is 95% . Of the ten who were severely infected with Covid-19, one received the vaccine.
Enrico Pucci, biologist at Temple University in Philadelphia, said: “For the first time in human history: a large-scale clinical trial of a vaccine is conducted in less than a year to find out the sequence (genome) of the virus, and more, it is based on a completely new technology.“.
Shaheen said an application would be submitted Friday to obtain the US permit for the emergency use of the vaccine..
A knowledgeable source said the U.S. Food and Drug Administration’s vaccine advisory committee plans to meet in principle on December 8-10, but those dates are subject to change..
The final analysis of the trial comes just a week after initial results showed the vaccine to be over 90% effective. Moderna released preliminary data on its vaccine on Monday showing 94.5% efficacy.
The Pfizer / Biontech vaccine was found to be 94% effective in people over 65, which experts have called very important at a time when the virus is spreading around the world with record cases..
Andrew Hill, Visiting Fellow in the Department of Pharmacology at the University of Liverpool, said: “This is the evidence we needed to make sure those most at risk were protected“.
Better-than-expected results for both vaccines have rekindled hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc on the economy and daily life..
Pfizer said it plans to produce up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021..
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