Coronavirus update: India Inc joins race to make drugs and vaccine
With the Covid-19 research consortium easing approvals to speed up research and development, the public and the private sectors are focusing on diagnostic kits, repurposed or new drugs, and vaccines against the virus that has sickened 415 and killed 7.
Pharmaceutical major, Zydus Cadila, is running pre-clinical animal trials for two vaccine candidates, which act completely differently. “In another four to six weeks, we should have the results of the animal trials. One of the vaccines uses recombinant (relating to or denoting an organism, cell, or genetic material formed by recombination) DNA technology and the other uses reverse genetics technology (a line or phrase explaining). Depending on the results of the pre-clinical trials, we will decide which to take forward and apply for approvals from the drugs controller accordingly,” said Pankaj Patel, chairman, Zydus Cadila.
To create vaccines through recombinant technology, the DNA encoding an antigen that can produce an immune response against the virus is inserted into a bacterial or mammalian cell. Within the cell, the antigen gets expressed and is then purified to form the vaccine.
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Reverse genetic technology can be used to create a virus that had weakened potency but is similar enough to the circulating strain to produce an immune response.
“The vaccines are in different stages of development. There are two or three Indian companies and a large number of research groups working on them. However, currently, they are not looking at funding support; rather, they need support for getting through the regulatory framework,” said Renu Swarup, secretary, department of biotechnology.
Pune-based Serum Institute of India (SII) has started animal trials of a vaccine candidate developed in collaboration with a US biotechnology company, Codagenix. The team hopes to get the results of the animal trials in the next two months and then go for approvals for human trials.
“The artificially developed vaccine virus strain is identical to the original virus and can generate a robust immune response. Our initial data suggests that it will render protection to maybe 60 to 70% of those vaccinated, the rest might still get the disease. We intend to apply for clinical trial and imports of certain strains of the virus to the Drug Controller General of India (DCGI) next month,” said Adar Poonawalla, chief executive officer of SII.
Codagenix uses the viral sequencing data to develop a weakened virus that can trigger an immune response against disease, according to its website.
“We are working very closely with the Serum Institute of India for vaccine development against Nipah. The next follow-up will be on Covid-19,” Dr Balram Bhargava, director general, ICMR, said in a recent media briefing.
Globally, there are two vaccines that have begun phase-1 clinical trials in humans and 42 others are in the pre-clinical phase, according to the World Health Organization.
The two vaccine candidates that are currently in the Phase 1 trial have been developed by the company, CanSino Biologics, in collaboration with Beijing Institute of Biotechnology and Moderna, in collaboration with the National Institute of Allergy and Infectious Diseases.
Another vaccine candidate developed by the US company, Inovio Pharmaceuticals, is also likely to go into human trials in a couple of months.
“Another vaccine developed by Inovio pharmaceuticals is also likely to go into human trials soon. But it will take time for any vaccine to hit the markets. The phase 1 human trial is done in a small number of people to check whether the vaccine candidate is toxic. The phase 2 trial will establish the immune response it generates. And phase 3 will test whether it protects against the disease in a large population. All this has to be done before the product can be submitted to regulators for approval,” CEPI vice-chair, Dr Gagandeep Kang, had told HT. The Coalition for Epidemic Preparedness Innovations (CEPI) is also supporting vaccine development efforts against Covid-19.
As for drugs, several companies and labs in India are working towards developing or repurposing existing anti-viral drugs that might work against the disease.
“People are looking at various antivirals, chloroquine and zinc for Covid-19 therapy. Then there will be plenty of herbal molecules and somebody needs to test them. The test can either be done in a live virus, which would only be at the National Institute of Virology, or in a protein, which lots of people are trying right now. With the genome sequence available, a lot of people are also doing in-silico (on a computer) work,” said Dr Anurag Agarwal, director Institute of Genomics and Integrative Biology, and one of the members of the science and tech group set up by the principal scientific advisor.
To promote more research, on Friday an empowered committee for Covid-19 allowed all national laboratories to carry out clinical testing for Covid-19 and all BSL-3 (biosafety levels) and BSL-3+ facilities to culture the virus for research purposes.
A combination of two anti-HIV medicines -- lopinavir and ritonavir – which the Indian drug regulator has allowed for restricted use has been shown to have no benefit in severe Covid-19 cases, according to a study of 199 people in China.
Now, the search is on for repurposing other antiviral medications. The drug major, Cipla, has tied up with Hyderabad-based CSIR-Indian Institute of Chemical Technology (IICT) for repurposing three molecules, remdesivir, favipiravir and baloxavir.
Remdesivir was originally developed to treat Ebola virus; favipiravir and baloxavir are anti-virals approved for influenza A and B.
“These are drugs that already have FDA approvals for a particular disease and can now probably help in treating Covid-19. When there is a situation like this, there isn’t enough time to conduct all necessary trials. So to expedite the process, we can get approvals and ethical clearance to use such drugs on the people who have severe infection and the evidence from the limited number of patients can be used to decide whether the drug is effective. All over the world, people are looking at repurposing several antivirals and anti-malarial drugs for Covid-19,” said Dr G Narahari Sastry, senior scientist at IICT.