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A coronavirus vaccine is one step closer after the government formally asked the UK drug regulator to evaluate the vaccine from the University of Oxford and AstraZeneca, giving millions hope.
But it comes after scientists defended the University of Oxford and AstraZeneca after questions were raised about the results of their vaccine trial.
The measure “marks an important first step for the vaccine to be approved for implementation” if it meets the necessary safety, efficacy and quality standards, the Department of Health and Social Care (DHSC) said.
The government said four million doses will be ready for the UK by the end of the year, with 40 million by the end of March 2021, out of a total order of 100 million.
It comes a week after the government formally requested the Medicines and Health Products Regulatory Agency (MHRA) to evaluate the Pfizer / BioNTech vaccine.
Health Secretary Matt Hancock said: “We are working tirelessly to be in the best possible position to implement a vaccine as soon as it is approved by the independent regulator MHRA.”
“We have formally asked the regulator to evaluate the Oxford / AstraZeneca vaccine, understand the data and determine if it meets rigorous safety standards.”
AstraZeneca said it will most likely conduct an additional global clinical trial to assess the efficacy of the jab after a surprising result found that 90% protection was achieved when people received a half dose followed by a full dose.
The pharmaceutical giant has acknowledged that the finding was the result of a dosing error, but said it did not expect any new tests to delay regulatory approval in countries like the UK.
American scientists questioned the lack of detail in the trial results released last week and the scientific director of the US Operation Warp Speed, the program to supply vaccines to the United States, told US journalists that the regimen a half dose was only given to people 55 years of age or younger. .
Scientists around the world hope to find vaccines that work in older people, the group most at risk for Covid-19.
The DHSC said the MHRA has already begun an “ongoing review” of the Oxford / AstraZeneca vaccine and that once the regulator receives all the safety, efficacy and quality data from the company, its scientists and physicians “will be ready to move forward. in their evaluation of the vaccine. “
The government said it has secured access to 100 million doses of the Oxford / AstraZeneca vaccine and 40 million of the Pfizer / BioNTech vaccine.
If approved, a vaccine could be released starting in December, Hancock said.
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