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Author : Dr K Aggarwal , President CMAAO, With input from Dr Monica Vasudev
India
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New Delhi, November 24, 2020 :
India may grant Pune’s Serum Institute of India (SII) with the emergency use authorisation of Oxford and AstraZeneca’s coronavirus vaccine if the British-Swedish pharmaceutical company gets such an approval from the UK government, Niti Aayog member Vinod Paul noted on Saturday. The Oxford vaccine is already in its third and final phase of clinical trials in India, and if all things go as planned, the COVID-19 vaccine may be ready for distribution by January or February 2021. Earlier this week, the Oxford-AstraZeneca vaccine produced a strong immune response in older adults, raising hopes that it can protect the age groups most at risk from the virus.
The drugmaker AstraZeneca announced that an early analysis of some of its late-stage clinical trials showed that its vaccine was 70.4 percent effective on average and potentially up to 90 percent effective in preventing Covid-19. It is the third major vaccine developer to announce promising results. An early analysis of data from late-stage clinical trials found that AstraZeneca’s vaccine was either 62 percent or 90 percent effective, depending on the manner in which the doses were given.
Unlike some other leading vaccine candidates, the AstraZeneca offering can be quickly produced in vast quantities, will cost only a few dollars per dose and is easy to store for long periods. That could substantially expand the number of countries and people that have access to the vaccine. The varying effectiveness of AstraZeneca’s vaccine reflected differences in how doses were administered in the late-stage trials. In the dosing plan that was 90 percent effective, study participants were given a half-dose of the vaccine and then, a month later, a full dose. The vaccine was less effective when people were given a standard full dose upfront, followed a month later by another full dose. On average, the vaccine was 70 percent effective. The analysis, which looked at data from participants in Britain and Brazil, did not turn up any serious safety issues that were confirmed to be related to the vaccine. It had come under global scrutiny after AstraZeneca temporarily paused its trials in September after a participant in Britain developed a neurological illness.
Oxford and AstraZeneca said they would submit the trial data to regulators in Britain, the European Union and Brazil and would seek emergency authorization to start distributing the vaccine in those places. British and European Union regulators have been conducting so-called rolling reviews of the vaccine, which could hasten the authorization process.
Fewer than 2,800 participants in the clinical trials received the smaller first dose that yielded such strong results. That is a much smaller sample size than in Pfizer and Moderna’s trials.
The AstraZeneca vaccine uses a weakened version of a chimpanzee adenovirus as a delivery vehicle to ferry coronavirus genes into human cells. That trains the immune system to fight future attacks from the actual coronavirus.
The data released came from AstraZeneca’s Phase 2/3 clinical trial in Britain and its Phase 3 clinical trial in Brazil. The participants were randomly assigned to receive either the coronavirus vaccine or a meningitis vaccine as a control, followed by a booster shot of the coronavirus vaccine, the meningitis vaccine or a placebo about four weeks later. Professor Pollard said the Oxford scientists hoped to submit the results for publication in a peer-reviewed journal within 24 hours.
A vaccine deploying the technology behind AstraZeneca’s candidate has never won approval. But the approach has been studied before, notably in a small 2018 study of an experimental vaccine against the virus that causes Middle East respiratory syndrome, or MERS. That virus is related to SARS-CoV-2, the novel coronavirus that causes Covid-19.
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