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India to analyze Oxford vaccine full dose data – health


The request for emergency approval of the coronavirus vaccine developed by the University of Oxford and the British pharmaceutical company AstraZeneca is based on clinical trials with two full doses, said an official from India’s drug regulator, adding that it could expect a decision in two weeks.

The Oxford-AstraZeneca vaccine has shown an efficacy of 62% when volunteers received two full doses of the vaccine, but 90% higher when the first was a medium dose, according to interim results from trials in the UK and Brazil. .

In India, the Serum Institute of India is conducting trials of the vaccine, which is also producing 1 billion doses of the injection.

The approach could be based on the fact that the Indian trials are being conducted with the two full doses; the entry in the Indian Clinical Trials Registry showed that they are both a 0.5ml injection. “The Indian trial has been using two full doses of the vaccine and that is the data that has been submitted for the emergency use authorization process,” said an official from the Office of the Controller General of Drugs of India (DCGI) , asking not to be named.

Since the half dose followed by a full dose regimen, which was initially administered by accident during UK vaccine trials, has been more effective, experts suggested that vaccine manufacturers could later propose additional studies in India and change the labeling. In any case, global standards require a vaccine to be at least 50% effective.

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DGCI is currently processing emergency use authorization applications for the Oxford-AstraZeneca vaccine and one developed by major US pharmaceutical company Pfizer and its German partner BioNTech. IBS presented data for the Oxford-AstraZeneca vaccine on Monday, while news of the Pfizer presentation came over the weekend.

Pfizer’s vaccine is the most advanced, having completed full clinical trials and showing 95% efficacy. Another American pharmaceutical company, Moderna, also announced that its vaccine was close to 95% effective.

“Once the data has been reviewed by the DCGI, it will be recommended for approval to a Committee of Experts on the matter,” said the aforementioned official, adding that the SEC is likely to meet in two weeks to make a decision on the matter.

In guidelines dated September 20, the Central Drug Control Organization (CDSCO) said that for any coronavirus vaccine to be considered effective, it must show an efficacy level of at least 50%. The bar is in line with what global regulators like the United States FDA and the World Health Organization have set.

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Experts have previously said that the reduced efficacy of the Oxford-AstraZeneca vaccine should not be considered of concern. “The results are good. Better than we expected when the WHO, FDA, and DCGI set the 50% efficacy point estimate criterion, which all arms of this trial have passed. All vaccine trials are different and are not direct comparisons between vaccines that claim to be 90, 95, 60 or 70% effective, ”said Dr. Gagandeep Kang, former executive director of the Institute of Translational Health Science and Technology , a DST organization.

Kang explained how the two full dose regimen could be applied even though it had a lower efficacy number. “Since the Indian trial is with two full doses of the vaccine, we can move to two full doses of the vaccine in the UK and Brazil and we should not move to a dose that we have not evaluated in India. Perhaps after the request is made to DCGI, they could propose additional studies in India, based on which they could request a labeling change, ”he said.

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