AstraZeneca partner adheres to two full dosing regimens in COVID studies in India

PUNE (Reuters) – Serum Institute of India, which is partnering with AstraZeneca to produce its COVID-19 vaccine, will continue to test a two full doses of the injection despite showing a lower success rate than a schedule with a half and full dose in crucial processes, a top executive told Reuters.

The British drug company has said that its COVID-19 vaccine can be up to 90% effective when given as a half dose followed by a full dose, but some scientists have questioned the robustness of that result, as only a few thousand people got that regime in late-stage British trials.

The worldwide studies showed that the efficacy of the injection was 62% when the full dose was given twice, as in most study participants in studies in Great Britain and Brazil. AstraZeneca has said it is likely to conduct an additional global trial to evaluate the lower-dose schedule. According to Dr. at SII.

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

According to Jadhav, who has been working on vaccines for more than four decades, a combination of two different measures could also complicate rapid distribution efforts.

“If it’s a very common dose, it gets very easy. Whether it’s the first dose or the second, it’s the same vaccine, the same dose, ”he said.

Last weekend, SII said it planned to apply for an emergency use permit for the vaccine in India in the next two weeks.

The 62% efficacy rate in AstraZeneca’s broader two full dose study is above the 50% that is the minimum required by US regulators to consider a drug for an emergency authorization.

SII, based in the western city of Pune, is the largest producer of vaccines in the world by volume. In addition to AstraZeneca, it is also partnering with other companies to potentially manufacture their shots, including US biotech company Codagenix; its rival Novavax and Themis from Austria.

But in the global race to develop vaccines to beat the pandemic, AstraZeneca’s vaccine is at the forefront, despite lower efficacy than some rivals.

US drug makers Pfizer and Moderna have said their coronavirus vaccines have efficacy rates of 95% and 94.5%, respectively, but AstraZeneca’s drug is cheaper and easier to transport because it can be stored at normal refrigerator temperatures for long periods of time.

Those benefits are especially important to many developing countries and thus to SII. As part of a deal outlined in June, AstraZeneca has licensed 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 was set up to provide COVID-19 vaccines to poorer countries, have indicated that they would accept and use a proven vaccine if it showed more than 50% efficacy, Jadhav said . .

Adar Poonawalla, the CEO of SII, said affordability, scalability, and ease of storage and transportation were key factors for India and other emerging economies in making decisions about large-scale vaccine purchases.

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

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

Reporting by Abhirup Roy and Euan Rocha; edited by Carmel Crimmins

Source link