Zydus has received approval from Indian regulatory authorities to begin human studies for its Covid-19 vaccine, India's approval for Zydus comes days after Bharat Biotech, a private company, obtained a similar green light for human studies for its vaccine.
- Zydus will begin testing more than 1,000 subjects this month at multiple locations in India. The company also plans to increase its production capacity so that the vaccine meets Indian and global demand.
- A commercial vaccine against Covid-19 has not yet been approved, but more than a dozen out of more than 100 candidates worldwide are currently being tested in humans, and some have shown potential in trials with one early stage.
- As we know the number of coronavirus infections in India surpassed 600,000 on Thursday, resulting in 17,834 deaths as authorities struggle to contain the pandemic and ease the blocking rules. Only the United States, Brazil and Russia reported more cases than India.
The Central Drug Control Organization (CDSCO) has also authorized Bharat Biotech India (BBIL) to conduct human clinical trials for “Covaxin”, a Covid-19 vaccine developed in the country. Testing is expected to begin across India in July.
- The candidate vaccine was developed by BBIL in collaboration with the National Institute of Virology (NIV). NIV isolated a strain of the new coronavirus from an asymptomatic Covid-19 patient and transferred it to BBIL in early May.
- The company then used it to develop an “inactivated” vaccine, a vaccine that uses the killed virus, at its high containment facility in Hyderabad.
- Covaxin then underwent preclinical testing on animals like guinea pigs and mice to see if it was safe before the company approached CDSCO for permission to proceed to human trials.
- The CDSCO, has granted BBL approvals for phase I and II clinical trials. This brings India closer to finalizing a nationally developed Covid-19 vaccine at a time when the country's cases continue to increase.
- The first phase, usually done in a small group, tries to determine what dose of vaccine is safe to use, if it is effective in building your immunity to the virus, and if there are any side effects.
- The second phase is carried out in a group of hundreds of people who fit the description of those for whom the vaccine is intended, using characteristics such as age and gender. This phase tests the effectiveness of the vaccine in the population group studied.
- Vaccines, like most new drugs, are said to follow a four-step testing process, starting with preclinical testing and ending with phase III studies in thousands of patients.
- After regulatory approval, the company should continue to monitor the use of its vaccine in patients and submit post-marketing surveillance details, which check for long-term adverse reactions.
- BBIL plans to begin Phase I and II testing in July, but is unsure of the overall schedule for testing and obtaining final approval.
Other Indian companies working on a candidate vaccine for Covid-19 include Zydus Cadila, the Indian Whey Institute and, earlier this month, Panacea Biotec. Although Panacea is still in the preclinical stage
- Covaxin has reached a more advanced test stage than two other candidate vaccines that BBIL is developing through global collaborations; one in collaboration with Thomas Jefferson University and the other with the University of Wisconsin-Madison and the manufacturer of FluGen vaccines.
- The two candidates are currently in the preclinical stage, according to the World Health Organization's Covid-19 vaccine outlook project.
- However, it is far behind in the global race. The favorite is AstraZeneca, whose candidate ChAdOx1-S from the University of Oxford is already in phase III.
- Serum Institute has an agreement to manufacture this vaccine. Moderna is about to begin phase III trials for its LNP-encapsulated mRNA vaccine candidate with the United States National Institute of Allergy and Infectious Diseases.
- In addition to Covaxin, which is not listed among the vaccines being tried globally, at least six other candidates are in Phase I/II trials and another five are in Phase I trials globally.
- Globally, Zydus Cadila's DNA plasmid and measles vector vaccines as well as Serum's codon deoptimised live attenuated vaccine, which it is developing with Codagenix, are still in the pre-clinical stage, according to WHO.