New Delhi: The Narendra Modi government’s expert panel has rejected the proposal by Dr Reddy’s Laboratories to evaluate Russia’s Covid-19 vaccine in a Phase III clinical trial. It has instead recommended a Phase II trial, which is held among a smaller number of participants.
Dr Reddy’s had proposed to test Sputnik V vaccine, which has been found to produce an immune response with no serious adverse effects, in Phase III clinical trial.
The move came after the Russian Direct Investment Fund (RDIF), Moscow’s sovereign wealth fund, tied up with the Indian drug maker last month to supply 100 million doses of Sputnik V in India after receiving the necessary regulatory clearances.
The Hyderabad-based drug maker then presented Phase III clinical trial protocol before the government’s subject expert committee (SEC) along with overseas Phase I and II clinical trial data. It also submitted the non-clinical toxicity data before the panel, which shows the safety profile of the vaccine candidate.
The SEC advises the apex drug regulator, the Drug Controller General of India, on applications seeking approvals for new drugs, vaccines, and clinical trials.
However, after “detailed deliberation”, the panel has asked the firm to revise and submit the protocol for consideration again for Phase II and III trial as the data submitted was generated through a “small” sample size.
Under Phase II trial, 100 to 300 people are enrolled to test efficacy and understand side effects whereas Phase III trials — for which the company had sought permission — generally enroll over 1,000 participants.
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No data on Indian subjects yet
The SEC took the decision at a meeting on 5 October. The minutes of the meeting were made available on the Central Drugs Standard Control Organisation’s (CDSCO) website.
The CDSCO is the health ministry arm that regulates the quality of drugs and vaccines in the country.
The committee noted that the safety and immunogenicity data in overseas Phase I/II studies is “small” and there is “no data available on Indian subjects”.
The committee recommended that “the firm should follow the regulatory requirements and conduct Phase II/III clinical trials in the country with proper monitoring for humoral and cell mediated immune response”.
Humoral is a reference to B cells, which produce antibodies and must be secreted by an effective vaccine candidate, whereas cell mediated response produces T cells but no antibodies.
Humoral immunity is the one that secretes antibodies to fight against antigens, whereas cell-mediated immunity secretes cytokines, and not antibodies, to attack the pathogens. Cytokines are a kind of proteins that mediate and regulate immunity and inflammation in the body.
First registered Covid vaccine
Sputnik V is an adenovirus vector-based vaccine that was registered by the Russian Ministry of Health on 11 August.
According to the Sputnik V website, it became “the first registered Covid-19 vaccine on the market”.
A vector-based vaccine is one where a part of the coronavirus is inserted into another virus and delivered to the body, following which the inserted coronavirus part, usually the spike protein molecule, is discharged. The body then recognises this as a foreign pathogen and mounts an immune response.
The vector used here is the human adenovirus, a group of respiratory viruses that cause common cold and flu-like illnesses in humans and animals.
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pls start the medicine too whom who already test positive atleast so we can save the live of one n than we know the results on that time only it’s effective or not bcoz already we wasted the too much time to know the vaccine wil effect or not.
Noow start giving VACCINE to all. Delay will result TO more harns. Economy will come to order. Start tomorrow. If 2nd trial is success.. 3rd is definite. Don’t delay