Corona vaccine update: The Central Drug Standard Control Organization (CDSCO) has said that a COVID-19 vaccine candidate must show at least 50 percent efficacy during phase III clinical trials for it to be widely implemented. However, it will be necessary to generate adequate data that inform about the potential risk of improved respiratory disease (ERD) associated with the vaccine, said the Central Medicines Standard Control Organization (CDSCO) in its draft ‘Regulatory Guidelines for the development of vaccines with special consideration for COVID -19 Vaccine ‘. Also read – ‘World-class service provider, left an indelible mark’: Tributes come from political circle on Suresh Angadi’s disappearance
“To ensure that a widely implemented COVID-19 vaccine is effective, the primary efficacy endpoint estimate for a placebo-controlled efficacy trial must be at least 50 percent…,” the guidelines said. Also read: reassess the COVID situation, focus on micro-containment zones: PM Modi to CM of the 7 most affected states
Speaking at a press conference on Tuesday, Dr. Balram Bhargava, director general of the Indian Council for Medical Research, said that all vaccines against respiratory viruses are not 100 percent effective. Also read: Update on the coronavirus: a low level of this nutrient can increase the risk of death in patients with COVID-19
“There are three things to a vaccine: first the safety, second the immunogenicity and third the efficacy. The WHO says that if we can get more than 50 percent effective, that’s an accepted vaccine. For respiratory viruses, we never get 100% effective. Our goal is to be 100% efficient, but we could get 50-100%. “
According to CDSCO guidelines, since it is possible that a COVID-19 vaccine “could be much more effective in preventing moderate to severe COVID-19 compared to mild”, the possibility of promoting efficacy trials should be considered. for formal hypothesis testing in severe COVID. -19 full stop.
Regardless, moderate-to-severe COVID-19 should be assessed as a secondary endpoint (with or without formal tests of hypothesis) if it is not assessed as a primary endpoint, the guidelines said.
Establishing the safety and efficacy of the vaccine in individuals with SARS-CoV-2 + ve is critical, they added.
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