In a press release by the company, Zydus Cadila has announced that it has begun human trials of its COVID-19 vaccine. This is the second Indian pharmaceutical company to start testing a vaccine in India, the biggest producer of generic drugs and vaccines in the world.
The company announced that it has begun giving its potential coronavirus vaccine to healthy volunteers in the first and second phases of human clinical trials across multiple sites.
Zydus has already manufactured and stockpiled clinical GMP batches of the vaccine candidate that are required for the clinical trial. It plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects.
One of the centers that will be testing the vaccine is in Ahmedabad.
.@ZydusUniverse’s Chairman Pankaj Patel says the pharmaceutical firm’s Phase 1 and 2 trials of its #COVID19 vaccine will be complete within 3 months, adding that a vaccine could be available at the end of 2020 #StreetSignsAsiahttps://t.co/th4kGXaBjJ
— CNBC Int'l PR (@cnbcipr) July 7, 2020
According to the data provided by the Clinical Trial Registry of India (CTRI), which provides details about ongoing trials in the country, the phase-1 where the safety of the vaccine will be evaluated will be completed under 84 days. The second phase evaluating safety and efficacy with the help of placebo will also be completed in an additional 84 days.
Just this month the company also announced that its plasmid DNA vaccine candidate (ZyCoV-D) had received permission from the Drug Controller General of India (DCGI) permission to initiate Adaptive Phase I/II human clinical trials in India.
— PIB in Maharashtra 🇮🇳 (@PIBMumbai) July 7, 2020
The DNA vaccine was developed at the company’s Vaccine Technology Centre in Ahmedabad, India and have successfully completed the preclinical phase before it got the approval for the human trials.
In a press release, the company announced that in the pre-clinical phase, the vaccine was found to elicit a strong immune response in multiple animal species. The vaccine was tested in animals like mice, rats, guinea pigs and rabbits.
The vaccine generated a strong antibody response. When these antibodies were tested in virus neutralization assay, the were able to neutralize the wild type of coronavirus.
The preclinical data also suggested that there were no safety concerns observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration.
The company also added that it has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe.
In the absence of no vector response and any infectious agent, the vaccine could be easily mass produced with minimal biosafety requirements, if it works in humans.
This is the second vaccine in India to begin human trials. The first was Covaxin, by Bharat Biotech that began its human trial just last month.
COVAXIN™, India's 1st indigenous Covid-19 vaccine, developed by Bharat Biotech successfully enters human trials.
— BharatBiotech (@BharatBiotech) June 29, 2020
“The two candidates have got their sites ready and they are doing their clinical study on approximately 1,000 human volunteers, each at different sites,” Balram Bhargava, the director-general of the Indian Council for Medical Research (ICMR), said in a press briefing on Tuesday.
Two indigenous Indian Candidate vaccines have got clearance to start early phase human trials this month. Approximately 1,000 human volunteers are participating in clinical trials for each of this two indigenous vaccine: DG, @ICMRDELHI
— PIB India (@PIB_India) July 14, 2020
More than dozen other Indian Pharmaceutical companies are developing a vaccine for coronavirus in India right now, according to ICMR.
The Indian government is going at a very fast pace to approve a coronavirus vaccine as soon as possible. This has been met with disapproval by many of the scientists both in India and in other countries.
A letter written by the ICMR Director General that was leaked on Friday, on Twitter, suggests that the first vaccines could be rolled out by 15 August. Critics are saying that would leave far too little time for proper testing. The Indian Academy of Sciences has even gone on to say that this timeline is “unreasonable and without precedent.”
Now if you read closely this letter from ICMR you'll find a tone of order by ICMR.
We can't order researchers to have all phases of clinical trials before 15 Aug! pic.twitter.com/2MkPCyEY61
— Chirag Patil (@lordchirag) July 7, 2020
The ICMR Director General wrote the letters to the hospitals designated to be involved in the Covaxin studies.
“It is envisaged to launch the vaccine for public health use latest by 15 August 2020 after completion of all clinical trials,” it said.
The Director General asked the hospitals to fast-track all approvals for the vaccine and be ready to enroll participants “no later than 7 July 2020,” adding that “noncompliance will be viewed very seriously.”
Experts all over India have said that it is foolish to think studies could show a vaccine to be safe and effective in less than 2 months.
— scroll.in (@scroll_in) July 9, 2020