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'Covaxin Efficacy Determined Only 14 Days After Second Dose', Vaccine Maker Issues Clarification
Writer: Navya Singh
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India, 5 Dec 2020 11:17 AM GMT
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The clarification came soon after Haryana's Health Minister Anil Vij, who was a volunteer of vaccine trials, said that he has tested positive for novel Coronavirus.
India's indigienous vaccine, Covaxin, has been designed to be effective against Coronavirus if a person takes two doses, Hyderabad-based Bharat Biotech said in a statement today, December 5, adding that the "efficacy can be determined 14 days after the second dose".
The clarification by the pharmaceutical firm came soon after Haryana's Health Minister Anil Vij, who was a volunteer of vaccine trials, said that he has tested positive for novel Coronavirus.
"Safety is our primary criteria in vaccine development," Bharat Biotech assured.
"Covaxin clinical trials are based on a 2-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days post the 2nd dose," the Hyderabad firm said in an official statement. One of the three Covid vaccine candidates being tested in India, Covaxin - in its third phase of trials- will be administered to "26,000 subjects across 25 sites", the statement read.
"The phase 3 trials are double blinded and randomised, where 50 per cent of subjects will receive vaccine and 50 per cent of subjects will receive placebo," it added.
The Health Ministry in a statement mentioned: "The antibodies against the infection build up in a human being only after a specific number of days pass after the second dose of the vaccine is taken. This is a two-dose vaccine. The minister in question has taken only one dose of the vaccine."
Bharat Biotech is also carrying out clinical trials for Covaxin in the United States and the United Kingdom. The firm has conducted over 80 clinical trials, across 18 countries in the last two decades.
"Bharat Biotech has supplied more than 4 billion doses, to more than 80 countries, with an excellent track report of safety, The phase-3 trials of Covaxin is the only efficacy trial being conducted in India for COVID-19 vaccines, to determine its suitability to the diverse Indian population," the firm said in a statement.
On Friday, December 4, Prime Minister Narendra Modi said that experts are hopeful that India will receive a vaccine against the deadly virus in just few weeks.
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