Pharmaceutical company AstraZeneca might be granted an emergency use authorization by the Food and Drug Administration (FDA) for a COVID-19 vaccine, according to a new report.
The vaccine, being developed by AstraZeneca and Oxford University, could receive authorization as early as October, the Financial Times (FT) reported.
“The Trump administration is considering bypassing normal US regulatory standards to fast-track an experimental coronavirus vaccine from the UK for use in America ahead of the presidential election, according to three people briefed on the plan,” FT reported. “One option being explored to speed up the availability of a vaccine would involve the US Food and Drug Administration awarding ’emergency use authorisation’ (EUA) in October to a vaccine being developed in a partnership between AstraZeneca and Oxford university, based on the results from a relatively small UK study if it is successful, the people said.”
But Fortune reported that “AstraZeneca says it has held no discussions with the U.S. government about emergency authorization for the COVID-19 vaccine it is manufacturing.”
That vaccine is still undergoing late stage human clinical trials in several sites around the world, including in the U.K. and the U.S., making a rapid approval under the criteria the U.S. Food and Drug Administration has established so far a long shot.
Other vaccines are in the testing stage, as well. The world’s largest COVID-19 vaccine study in the world began early this month, with the first of 30,000 Americans volunteering to take the shots. The experimental vaccine, developed by the National Institutes of Health (NIH) and Moderna Inc., is in phase three of the development process, which includes tests at clinical sites across the country.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” NIH Director Dr. Francis Collins said in a statement. “The launch of this phase-3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”
Meanwhile, Russia said last week that it had approved a vaccine for COVID-19, becoming the first nation in the world to mark the achievement.
President Vladimir Putin, who announced the approval of the vaccine, said one of his two adult daughters has already been inoculated. Putin also said the vaccine underwent all tests to show its effectiveness, although Russian officials offered no data to back up his claim. The approval was granted by Russian health officials after just two months of human testing, Reuters reported.
“A vaccine against coronavirus has been registered for the first time in the world this morning. I know that it works quite effectively, it forms a stable immunity,” Putin said on state TV. “I repeat, it has passed all the needed checks. … We must be grateful to those who made that first step very important for our country and the entire world.”
But scientists warned that the vaccine never underwent Phase 3 trials, which involve thousands of patients and usually lasts for months.
“Fast-tracked approval will not make Russia the leader in the (vaccine) race, it will just expose consumers of the vaccine to unnecessary danger,” Russia’s Association of Clinical Trials Organizations said Monday, urging government officials to postpone clearing the vaccine without completed advanced trials.
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