NEW DELHI: No vaccine for respiratory diseases it is 100% effective and those that are 50-100% effective can be approved for use against the Covid-19 pandemic, Indian Council of Medical Research (ICMR), Dr. Balram Bhargava, CEO, said even when adding that maximum efficacy will be sought.
“No vaccine for respiratory diseases is 100% effective. The WHO says that a vaccine must have three things: safety, immunogenicity (the ability of a foreign substance to trigger a immune response) and efficacy. The WHO has said that a vaccine with 50% efficacy can be accepted. Our goal is 100%, but the efficacy of the vaccine would be between 50 and 100%, ”said Bhargava.
the Oxford Vaccine Candidate it has shown promise in the early stages of the UK trial. The trials showed that the vaccine is safe and capable of inducing an immune response. Regulatory authorities say that locally developed candidates also have potential, as they are simpler compositions and safety has been guaranteed.
The comment comes a day later drug regulatorThe Central Drugs and Standard Control Organization issued a draft guidance note for Covid-19 vaccines suggesting that researchers do not necessarily look for a candidate’s preventive ability and settle for one that protects a person from developing a serious infection. .
In a draft of the regulatory guidance note on vaccine development, the drug regulator said it plans to approve Covid-19 vaccines that can provide immunity to at least 50% of participants in Phase 3 clinical trials. now, trials of leading vaccine candidates have yielded more encouraging results, particularly with the administration of a second injection.
“To ensure that a widely implemented Covid-19 vaccine is effective, the primary efficacy endpoint for a placebo-controlled efficacy trial must be at least 50%,” said CDSCO in its draft regulatory guidelines for the development of vaccines, with special consideration for Covid. -19 vaccine issued on Monday.
The CDSCO draft is in line with the guidelines established by the WHO and the US FDA.
Currently, there are three vaccines that are undergoing human trials in India, while the one developed by Russia will likely apply for testing permits soon as well. The most advanced of these vaccines in human trials are Serum Institute of Indiathe vaccine, which was developed jointly by AstraZeneca and Oxford University and is currently undergoing phase 3 trials in India. The other two vaccines in human trials are the Bharat Biotech candidate developed with ICMR and that of Zydus cadila.
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