AstraZeneca partner sticks to two full dosing regimens in COVID trials in India

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* Half dose, full dose could complicate IBS vaccine distribution

* SII considers factors beyond efficacy to be crucial in vaccination decisions

* SII considers affordability, ease of storage and transport as key

By Abhirup Roy and Euan Rocha

PUNE, Dec. 1 (Reuters) – Serum Institute of India, which has partnered with AstraZeneca to make its COVID-19 vaccine, will continue to test a full two-dose regimen of the vaccine despite a less than half and complete success rate dosing regimen in the pivotal trials, a senior executive told Reuters.

The British drugmaker has said its COVID-19 vaccine could be up to 90% effective if given in a half dose followed by a full dose, but some scientists have questioned the robustness of this result because only a few thousand people have received this diet in advanced stage trials in the UK. Global trials have shown that the vaccine’s effectiveness rate is 62% if the full dose is given twice, as was the case for most of the participants in studies in Britain and Brazil. AstraZeneca said it was likely to conduct an additional global trial to assess the lower dosage regimen. which is currently conducting trials in India to test the safety of the AstraZeneca vaccine as well as the immune response it elicits, does not intend to change them to include the half-dose-full regimen, according to the Dr Suresh Jadhav, Executive Director of SII.

“Anything beyond 50% will always be a plus, a plus,” Jadhav said in an interview on Monday, referring to efficiency rates. He added that changing the dosing regimen now would delay trials.

A combination of two different measures could also complicate rapid distribution efforts, according to Jadhav, who has worked on vaccines for more than four decades.

“When it comes to a common dose, it becomes very easy. Whether it’s the first or the second, it’s the same vaccine, the same dose,” he said.

Over the weekend, SII said it plans to apply for an emergency use license for the vaccine in India within the next two weeks. The 62% efficacy rate on the larger two full-dose trial of AstraZeneca is above the 50% that U.S. regulators consider the minimum required to consider a drug for emergency clearance.

SII, based in Pune, in the west of the city, is the world‘s largest vaccine manufacturer by volume. Beyond AstraZeneca, it has also partnered with other companies to potentially manufacture their images, notably the American biotechnology company Codagenix; his rival Novavax and the Austrian Themis.

But in the global race to develop vaccines to beat the pandemic, AstraZeneca’s vaccine is one of the pioneers despite having lower efficacy rates than some competitors. drug manufacturers Pfizer (NYSE 🙂 PFE.N and Moderna said their coronavirus vaccines were 95% and 94.5% effective respectively, but AstraZeneca’s drug is cheaper and easier to transport because it can be stored for long periods of time at temperatures normal refrigerator.

These benefits are particularly important for many developing countries and, therefore, for SII. As part of a deal reached in June, AstraZeneca authorized SII to deliver one billion doses of its vaccine to dozens of low- and middle-income countries.

Most of the countries that are part of the COVAX initiative, which has been set up to provide COVID-19 vaccines to the poorest countries, have indicated that they will accept and use a proven vaccine, if it shows efficacy. by more than 50%, according to Jadhav.

Adar Poonawalla, CEO of SII, said accessibility, scalability, and ease of storage and transport are key factors for India and other emerging economies as they seek to decide on purchases of large-scale vaccines.

“A vaccine that cannot penetrate and be given to a large population to provide high vaccination coverage, you might as well not give it at all,” Poonawalla told Reuters.

“If it’s not affordable and logistically transferable, even though it’s 110% efficient, what’s the point?”

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