Serum Institute gets nod for Oxford varsity trials in India

Grant Boone
August 5, 2020

The approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr VG Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on COVID-19. The human trial phases consist of Phase 1 for safety, Phase 2 for efficacy and dosing, and Phase 3 for efficacy in a huge group of tens of thousands of people.

SII has collaborated with AstraZeneca to manufacture the Oxford vaccine and it had submitted an application to DCGI on July 25 seeking permission to conduct clinical trials.

Globally, the World Health Organisation (WHO) is tracking around 140 candidates vaccines, of which around two dozen are in various phases of human clinical trials. The approval was given to SII to carry out the trials after it submitted a revised proposal of the trials.

The observer-blind, randomized controlled study aims to determine the safety and immunogenicity of "Covishield" on healthy Indian adults.

It is pertinent to note that COVISHIELD (SII-ChAdOx1 nCoV-19) vaccine contains the replication-deficient simian adenovirus vector ChAdOx1, containing the structural surface glycoprotein (Spike protein) antigens of SARS-CoV-2.

"The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone", said Thomas Triomphe, Global Head of Sanofi Pasteur.

"While we do not know today which vaccine will work best in the end, Europe is investing in a diversified portfolio of promising vaccines, based on various types of technologies", said European Commission President Ursula von der Leyen.

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Immunogenicity or the amount of immune response generated by a vaccine is at the crux of this research.

The European Union has reached an agreement with French pharmaceutical giant Sanofi for the supply of 300 million doses of the potential coronavirus vaccine, the bloc's executive arm announced on Friday. Every volunteer will be administered two doses.

Antibody immunity, on the other hand, peaked after four weeks and remained high by day 56, indicating that it may well last for even longer.

Russian vaccines: Russia is planning to launch a nationwide vaccination campaign in October.

During the study, participants who received the vaccine had detectable neutralising antibodies, which have been suggested by researchers as important for protection.

However, later ICMR clarified that quickening clinical trials was only meant to cut unnecessary red tape.

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