Oxford Vaccine Commences Phase 3 Study Moving to Sassoon General Hospital in Pune

Sep 21, 2020 | AstraZeneca, AZD1222, ChAdOx1 nCoV-19, COVID-19, India, Leading Sites, News, Oxford, Site Success, Site Watch, Vaccine

Oxford Vaccine Commences Phase 3 Study Moving to Sassoon General Hospital in Pune

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.

According to some reports, this coastal state has recorded 1.21 million cases. With nearly 7 million, Pune has recorded 263,715 COVID-19 cases.   

‘Covishield’

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.

The Hindu reported that Phase 2 clinical trials were conducted at Bharti Vidyapeeth Medical College and KEM Hospital, both in Pune.

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.

Temporary Halt

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

Lead Research/Investigator

Dr. Muralidhar Tambe (BJGMC)

Call to Action: Those sponsors interested in learning more about Sassoon General Hospital/BJGMC should see the contact link

0 Comments

Pin It on Pinterest