ICMR Says COVID-19 Vaccine Likely To Have 50-100% Efficacy
Drugs Controller General of India released draft guidelines for Covid-19 vaccine on Monday. The 39-page document lists several safety protocols that companies have to follow, including developing adaptive trial designs.
The vaccine against coronavirus disease (Covid-19) is likely
to be anywhere between 50 to 100% effective, according to the director-general of
the Indian Council of Medical Research (ICMR).
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¡°All the vaccines for respiratory viruses are not 100% effective. The World Health Organisation (WHO) says that there are three things key for a vaccine: safety (how safe it is for human use), immunogenicity (whether it is able to provoke body¡¯s immune response) and its efficacy (how effective it is against the virus),¡± said director general, ICMR, Dr Balram Bhargava.
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¡°And WHO says even if we get 50% efficacy that is more than acceptable. So for respiratory viruses we will never get a vaccine with 100% efficacy. We are obviously aiming at 100% efficacy but we may get anywhere between 50 to 100%,¡± he added.
According to TOI, Drugs Controller General of India released draft guidelines for COVID-19 vaccine on Monday. The 39-page document lists several safety protocols that companies have to follow, including developing adaptive trial designs.
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As per the guidelines, the vaccine that will go for approval must elicit superior immune responses compared to no vaccination against COVID-19. An individual who gets the vaccine should be protected from re-infection for at least a year.
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The regulatory approval for the vaccines will come through only if companies demonstrate 50 per cent efficacy in the primary endpoint or more than 30 per cent efficacy in the secondary endpoints. This means a vaccine has to either prevent or decrease the severity of the disease in at least 50 per cent of people vaccinated.
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"To ensure that a widely deployed COVID-19 vaccine is
effective, the primary efficacy endpoint point estimate for a
placebo-controlled efficacy trial should be at least 50 per cent, and the
statistical success criterion should be that the lower bound of the the appropriately alpha-adjusted confidence interval around the primary efficacy
endpoint point estimate is (greater than) 30 per cent," the guidelines
stated.
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Meanwhile, the regulatory body also clarified in the guidelines that persons who have been infected with the SARS-CoV-2 virus in the past should be included in vaccine testing, as long as they do not have acute COVID-19 or other acute infectious illnesses.