Combating coronavirus: India aims for first Covid-19 vaccine by August 15
Covaxin is being developed in partnership with Hyderabad-based company Bharat Biotech India.
Doubt and derision over vaccine nationalism have greeted India's ambitious but unrealistic August 15 deadline for the development of a Covid-19 vaccine when science states that a safe and effective jab would take longer to produce. The plan sounds brazen and the date assumes significance as the country celebrates independence from British rule on that day. The government, however, could be using the opportunity to trumpet its self-reliance agenda while it battles the pandemic on one front and deals with tensions with China on the other.
The project has the strong backing of the Modi government and is a public-private venture between Bharat Biotech, the government-run Indian Council for Medical Research (ICMR) and National Institutes of Virology. Covaxin, the vaccine candidate in question cleared animal trials last week and the government has roped in leading health institutions to expedite clinical trials among humans, it is learnt.
In a letter sent to 12 premier health institutions on July 2, ICMR, the country's premier health agency has asked them to help expedite trials "without a lapse" for an early rollout of the vaccine.
"You have been chosen as clinical trial site of the BBV152 Covid vaccine. In view of the public health emergency due to Covid-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrollment is initiated not later than July 7, 2020," ICMR Director-General Balram Bhargava said in the letter.
"Therefore, you are advised to treat this project on highest priority and meet the given timelines without a lapse," the letter added.
The All India Institute of Medical Sciences (AIIMS-New Delhi), AIIMS-Patna, Nizam Institute of Medical Science - Hyderabad, Post Graduate Institute of Medical Sciences - Rohtak, King George Hospital - Visakhapatnam, are among the sites that will conduct the trials.
This is the India's first homegrown vaccine for Covid and Hyderabad-based Bharat Biotech did not set a time frame for its launch. However, a strain of vaccine nationalism was evident in the ICMR note that read: "This is the first indigenous vaccine developed by India and is one of the top priority projects which is being monitored at the top-most level of government." A copy of the letter is with Khaleej Times. The letter laid emphasis in bold on top-most level of government.
Bharat Biotech's BSL-3 high-containment facility for the manufacture of the inactivated polio vaccine will now be used for the Covid-19 vaccine. Other Indian pharma companies are also in the fray along with 130 global pharma companies. On Friday, Zydus Cadilla, another Indian firm, said its vaccine candidate had cleared animal trials.
Serum Institute, a Pune-based firm, and the largest producer of vaccines by doses, is in partnership with the Oxford Vaccine Group for a vaccine. The company said it would be ready with millions of doses in September if trials go well and the dose is well tolerated by humans.
Bharat Biotech's Covaxin is an "inactivated vaccine" developed from an Indian strain of the coronavirus that was isolated by NIV.
Officials with the World Health Organization and the Gavi Vaccine Alliance, in earlier interviews to this newspaper, had said a vaccine could take a year to develop as it would have to go through rigorous tests for efficacy and safety involving thousands of volunteers.
Broadly, there are four types of vaccines. The live version uses a weakened form of the virus to trigger antibodies. Inactivated vaccines, on the other hand, use a dead version of the virus.
Toxoid vaccines, as the name suggests, use toxins made by viruses to produce immunity; subunit, recombinant, polysaccharide, and conjugate vaccines use proteins or other chunks of the virus.
Typically, vaccines candidates must clear three phases of human trials. Phase 1 trials test the vaccine's safety and determines side effects over a period. Phase 2 trials explore if the formula works in larger groups and is safe to use. Phase 3 trials take longer and thousands of volunteers are given doses of the jab with more monitoring for side effects. - email@example.com
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