Although the AstraZeneca AZD1222 COVID-19 vaccine trial remains on hold in the United States, its full speed ahead for the underlying Oxford-created vaccine in the UK and India. For example, the COVID-19 vaccine, known as ‘Covishield’ in India, will start next week at Sassoon General Hospital in Pune in the State of Maharashtra, according to a comment from Dr. Muralidhar Tambe, professor and head of the medical school this past Saturday. The “Oxford” vaccine has been considered one of the most promising of all the leading vaccine candidates.
COVID-19 in Maharashtra
Maharashtra lies in the western peninsular region of India taking up a significant portion of the Deccan Plateau. With 123 million inhabitants, it represents the second most populated state in India.
The Phase 3 trial testing the “Covishield’ vaccine commences at Sassoon General Hospital next week, reports The Hindu. Apparently the hospital is already enrolling volunteers for the study. Manufactured by perhaps the busiest vaccine manufacturer in the world, the Serum Institute of India, the plan is to administer the vaccine to approximately 150 to 200 volunteers at the Sassoon General Hospital site.
AstraZeneca & SII
Although the investigational drug isn’t known as AZD1222 in India, AstraZeneca secured the rights to the Oxford vaccine and has partnered with Serum Institute of India for the production of the experimental vaccine called Covishield there. The original name of this vaccine candidate is ChAdOx1 nCoV-1.
A couple weeks ago, the trial was put on pause due to a reported serious adverse event in the UK. By September 11, regulators in India, the Drugs Controller General of India (DCGI) put a pause on the study in the world’s second most populous nation and seventh richest nation as measured by GDP. Although considered a potential “vaccine car crash” in the U.S., in the UK and India that trial resumed; the DCGI issued permission to resume on September 15.
‘AZD122 Car Crash’ in the USA?
The story is different in the United States. With the vaccine still on hold, some investor-focused publications pen an increasingly cynical picture. For example, Keith Williams writing for Seeking Alpha, an investor portal and news platform, suggests in “COVID-19 Car Crash” that given growing problems with American public confidence generally this latest incident during the Phase 3 trial triggers a call for “more clarity for public confidence.”
Under Operation Warp Speed under the Trump Administration, there was a big push (and a lot of money spent) to do everything possible to develop a safe and effective vaccine before the end of the year. Of course, that mandate is still relevant but a marked change in the public mood and overall tone dampers enthusiasm for expedited vaccines.
With the latest polls implicating a growing skepticism for the COVID-19 vaccines, pharmaceutical sponsors are aligning with the call for more transparency. In the meantime, at least the perception of political interference can do great damage to public confidence in America.
Sassoon General Hospital & BJGMC Linked to Johns Hopkins
Pune’s Sassoon General Hospital, a large state-run hospital, includes over 1,500 beds; its attached to the B.J. Medical College and a Nurses training school. This hospital goes back to David Sassoon, a Jewish philanthropist from Mumbai who made a generous donation to construct the hospital back in 1867.
The hospital includes a well-respected childcare center and orphanage. Society of Friends of Sassoon Hospitals is connected to the hospital as well. This group was formed by a group of Pune citizens for the welfare of poor patients of Sassoon Hospitals. The Sassoon General Hospital includes 21 outpatient clinics and links to multiple NGOs in the community.
The Byramjee Jeejeebhoy Government Medical College (BJGMC) is among the top 10 medical schools in India. BJGMC has an active clinical research program and is partnered with Johns Hopkins for joint research efforts. In fact, the BJMC Clinical Research site is the India arm of the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU)—see the link.
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