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The British government announced on Friday (27) that it asked the Medicines Regulatory Authority (MHRA) to examine the Covid-19 vaccine developed by the AstraZeneca laboratory in partnership with the University of Oxford.
“We have officially asked the health regulator to evaluate the Oxford / AstraZeneca vaccine and determine if it meets strict safety standards,” Health Minister Matt Hancock said in a statement. If approved, it will be an “important step in producing a vaccine as soon as possible,” he added.
MHRA has already initiated an ongoing review to determine whether the Oxford vaccine meets its strict standards for safety, efficacy and quality.
The UK government says there is no reason for anyone to worry about the vaccine’s clinical trial data and that any questions about the safety and efficacy of the immunizer will be cleared up with independent evaluation by the regulatory agency.
The vaccine called ChAdOx1 Distribution is already planned for Brazil between December 2020 and January 2021: the federal government will invest R $ 1.9 billion to produce 100 million doses.
- 4 of the 11 vaccines in the final phase of testing have already shown efficacy rates; see comparison
An undated photo released Nov. 23 shows a vial of the University of Oxford’s Covid-19 vaccine – Photo: John Cairns / Oxford University / AFP
On Monday (23), the vaccine developers announced that, based on the results of clinical trials conducted in the UK and Brazil, the combination of a half dose with a full dose ended up being more effective in protecting against the disease, 90% . In contrast, the effectiveness in participants who received the two full doses was lower, 62%.
Oxford scientists could not explain the reason for the difference.
Mene Pangalos, executive vice president of AstraZeneca, said on the same day that half of the dose given to part of the vaccine volunteers was a “fluke.”
“The reason we have a half dose is chance,” Mene Pangalos, head of non-cancer research and development at AstraZeneca, told Reuters.
On Thursday (26), the director of the pharmaceutical AstraZeneca said that the vaccine should undergo an “additional study” to re-evaluate the effectiveness of applying a half dose combined with a full dose of immunization.
- The greater effectiveness of the half dose of the Oxford vaccine has not yet been definitively explained; scientists look for answers
Lab admits Oxford Covid-19 vaccine should undergo further testing
Experts question the data
AstraZeneca’s test results were criticized by national and international scientists, who raised several questions.
At the heart of the concerns is the fact that the most promising test result, 90% effective, comes from subgroup analysis, a technique that many scientists say can lead to incorrect readings.
Business transparency was also criticized.
“The half dose was a mistake, and what is worse, it was only given to young volunteers. The company tried to cover up the fact,” wrote Brazilian microbiologist Natália Pasternak on a social network.
Additionally, Oxford / AstraZeneca did not disclose important parts of the study, such as the number of Covid-19 cases in the group that was 90% effective, noted epidemiologist Denise Garrett, vice president of the Sabin Vaccine Institute.
