Coronavirus Vaccine: SII Will Start Phase III Trials In Mid-October! Will India Get the COVID-19 Vaccine By December 2020?

Prime Minister Narendra Modi announced in his Independence Day speech: India has 3 vaccines. Pune-based Serum Institute of India was the first to produce a vaccine developed by Oxford University. The second one was jointly developed by Bharat Biotech‘s Covaxin and ICMR. The third is ZycovD developed by Zydus Cadila.

At a Union Health Ministry briefing on the prevailing coronavirus situation in the country, an ICMR official stated that three vaccines are undergoing clinical trials in India.

Balram Bhargava, Director General of the Indian Council of Medical Research, said: Bharat Biotech and Cadila have completed phase I trials. Serum Institute of India has completed phase second-B3 trials and will begin phase three trials after clearance (with 1,500 patients at 14 locations).

On Tuesday, the Minister of State for Health Ashwini Choubey informed Rajya Sabha that the phase I clinical trial showed the “superior safety” of two candidate vaccines developed by Bharat Biotech in cooperation with Cadila Healthcare Ltd and ICMR, and their immunogenicity trials are in the progress.

Asked about the current state of the COVID-19 vaccine / clinical trial program conducted by the Medical Research Council of India (ICMR) and other private research centers in the country, Choubey said that the second phase of clinical trials is ongoing.

Choubey further informed that discussions about cooperation on recombinant vaccines developed in Russia are ongoing. However, formal research has not yet begun.

The Serum Institute of India (SII) and ICMR have collaborated to produce two global vaccine candidates. The first is a non-replicating viral vector vaccine called ChAdOx1-S developed by the University of Oxford/ AstraZeneca. This vaccine is undergoing phase three clinical trials in Brazil.

Choubey said that ICMR has initiated Phase II/III bridging studies at 14 clinical trial sites. In Chennai, the National Institute for Research in Tuberculosis is the lead institution.

Choubey further informed that ICMR and SII have also cooperated to develop a glycoprotein subunit nanoparticle adjuvant vaccine developed by Novavax in the United States.

The final trial will start in the second half of October after that SII produces the vaccine. He said that the trial is being led by ICMR- The trial is being led by ICMR-NARI (National AIDS Research Institute), Pune.

Explaining two indigenously developed vaccine candidates. Choubey stated that Bharat Biotechnology International Co., Ltd. has developed SARS-CoV-2 inactivated whole virion candidate vaccines using virus isolates provided by the ICMR-National Institute of Virology (NIV), Pune.

The candidate vaccine has been characterized on ICMR-NIV, and then safety and tolerability studies have been conducted in small animals such as mice, rats, and rabbits. Phase I clinical trials and parallel studies on large animals have been completed.

He said: The trial shows that the candidate vaccine has excellent safety. Immunogenicity testing is in progress. Phase two clinical trials are in the progress.

Besides this, Cadila Healthcare Ltd has developed ZyCov-D (a DNA vaccine) whose pre-clinical toxicity studies were conducted in small animals such as rabbits, mice, rats, and guinea pigs.

The vaccine has been found to be immunogenic, effective, and safe. Cadila has collaborated with ICMR to conduct parallel preclinical studies in large animals.

He said: Although the industry and government are doing their best to provide an effective and safe vaccine for coronavirus infection as early as possible; it is hard to comment on the exact timetable given the several complicated pathways involved in vaccine development.

Other Indian companies involved in coronavirus vaccine development are Premas Biotech, Epygen Biotech, Biological Evans, Gennova, Mynvax, Luxmatra Innovations. The minister announced that all candidates are in the pre-clinical development stage.

 On Tuesday, the U.S company stated that according to an agreement with the Serum Institute of India, Novavax Inc is doubling its COVID-19 vaccine production capacity to 2 billion doses.

This year in August, Novavax signed an agreement with the Serum Institute, the world’s largest vaccine manufacturer, to produce at least 1 billion doses of its vaccine candidate for low- and middle-income countries and India. As part of the expanded agreement, the Serum Institute of India will also produce the antigen component of the vaccine soon, which is called NVX-CoV2373.

The US company’s vaccine is currently in the mid-term test stage. An early test revealed that the vaccine can produce high levels of antibodies against the deadly coronavirus.

The number of coronavirus cases in India has exceeded the 490,010 marks on Tuesday. More than 49,30,220 cases have been reported in the country, including 9,90,065 active cases, 38,59,412 discharged/cured/migrated patients and 80,780 deaths.

Hope we get the COVID-19 vaccine by December 2020!