Which is positive news for the world, the University of Oxford and AstraZeneca became the first Covid-19 vaccine manufacturers to publish the results of end-stage clinical trials in a scientific journal on Tuesday, clearing a key hurdle. in the global race to develop safe and effective medicines. for the new coronavirus.
The study published in the respected medical journal Lancet confirmed that the vaccine works in an average of 70% of cases, with an efficacy of 62% for those who receive two full doses and 90% for those who receive half and then the full dose.
The results are the “first full peer-reviewed efficacy results” published for a Covid-19 vaccine, The Lancet said.
“ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be effective against symptomatic COVID-19 in this interim review of ongoing clinical trials,” the scientific journal stated in its review.
The researchers say that the vaccine protects against the disease in 62% of those who received two full doses and in 90% of those who initially received half the dose. However, independent experts have said that the second group was too small (2,741 people) to judge the possible value of that approach and that more evidence is needed.
This news comes during a series of positive events that have raised hopes that the launch of vaccines could help start to curb a pandemic that has killed more than 1.5 million people and affected societies around the world.
Britain on Tuesday became the first country in the Western world to start immunizations, using a rival vaccine developed by Pfizer-BioNTech after approving it for general use last week.
Initial data from Astra and Oxford last month appeared positive, but raised concerns about how much protection the injection would offer after trials produced two different results from two dosing regimens. The partners said their vaccine was 90% effective when given half a dose before a full-dose booster, and that two full doses showed 62% efficacy.
It was later learned that the lower dose was the result of a manufacturing discrepancy and was only tested in a younger group. Astra CEO Pascal Soriot said in an interview last month that the company would set up an additional test, probably global, to verify the 90% result. The company said Tuesday that it is still deciding whether to conduct an additional study.
The results, based on advanced trials of 11,636 people in the UK and Brazil, were reviewed after 131 participants contracted Covid-19. Of these, 30 were in the group that received the vaccine and 101 in the control arm, which equates to an efficacy rate of 70%, according to data from The Lancet.
While the vast majority of the 175 serious adverse events were considered to be unrelated to Covid-19 or the control vaccines, one case of the neurological disorder transverse myelitis could be related to the injection, according to the paper.
AstraZeneca said it would be up to regulators to decide, based on the data, whether people would receive two full doses or half doses followed by a full dose. It has started submitting the data to regulators around the world for early approval and is ready to begin delivering hundreds of millions of doses, the company said in a statement. The drugmaker said it is also seeking an emergency use list from the World Health Organization to accelerate delivery of the vaccine to low-income nations.
The Oxford-Astra data will be analyzed around the world, and many countries will have the vaccine to protect their populations. The vaccine will cost a fraction of the price set by Pfizer and its partner BioNTech SE, and another injection from Moderna, which showed 95% efficacy. The Astra shot should also be easier to deploy, with storage temperatures between two and eight degrees Celsius, compared to minus 70 for the Pfizer shot.
The results come when the UK launched the first vaccine in the Western world. The Pfizer-BioNTech injection was approved in Britain last week and, starting Tuesday, will be administered to people over 80 and people in nursing homes, including workers, before being rolled out more widely in the coming months. The jab could also be approved in the US as early as this week and in the EU before the end of the year.
The news of the vaccine’s efficacy is a welcome development for India as, according to experts, Oxford vaccine is logistically feasible for distribution in urban and rural areas of the country, as it can be stored between two and eight degrees Celsius, which is an ideal temperature. for being kept in cold rooms in the field.
The Oxford vaccine is being manufactured by the Serum Institute of India in Pune and is in the phase three clinical trial of the Oxford Covid-19 vaccine, Covishield.
On December 7, Serum became the first indigenous company to submit an application to the Comptroller General of Drugs of India (DCGI) seeking an emergency use authorization for Oxford COVID-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the general public.
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