The five healthy volunteers, who received an injection of the Covid-19 vaccine from Bharat Biotech International Limited at Sola Civil Hospital in Ahmedabad of Gujarat, have not complained of any health problems so far, a senior doctor said on Friday. During the phase 3 clinical trials of Covaxin, the first dose of the injection was administered to all five volunteers, including one woman.
Dr. Parul Bhatt, the hospital’s medical superintendent, said the second dose will now be administered after 28 days. “Volunteers who have been vaccinated have not yet complained of any health problems / symptoms. Today more will be vaccinated, ”Bhatt told the ANI news agency.
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The large-scale phase 3 trials of Covaxin, which is being developed by Hyderabad-based company Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR), will recruit more than 26,000 volunteers from 25 trial sites across the country.
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Vaccine candidates should be tested in animal models first for safety and immune response. In humans, a small phase 1 trial is performed to verify the safety of the compound, while in phase 2, trials are conducted to see the immune response and the dose at which the vaccine should be administered. Large-scale phase 3 trials are conducted to see how many serious infections or diseases the vaccine prevents in a given population.
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“In the first phase, we have planned to cover 1,000 healthy volunteers. They must be in the age group 18 to 60 and have no history of coronavirus infection. Anyone who meets the criteria can come up to us and sign up as a volunteer, “Bhatt had said Thursday, according to PTI.
He said that hospital doctors participating in the clinical trial will keep in contact with the volunteers by phone to monitor their health after the vaccine is administered. The main doctor had said that volunteers will be called to the hospital at regular intervals for follow-up tests and procedures, including blood tests and oxygen level.
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“All this exercise will continue for 12 months. We will also give a contact number to the volunteers in case they need any urgent intervention. The hospital will provide the necessary treatment in case of any complication, “he added.
The Sola Civil Hospital in Ahmedabad is among 130 centers across the country selected for the phase three trials of Covaxin, said HG Koshia, commissioner of the Gujarat Food and Drug Control Administration (FDCA). Bharat Biotech had announced last week the start of the third phase of trials, being the first candidate in India to reach this stage.
Four vaccine candidates from around the world have announced preliminary reports: trial data from Pfizer and Moderna in the US and Sputnik V in Russia show that their vaccines were around 95% effective in preventing Covid- 19, while AstraZeneca-Oxford University said its vaccine could be up to 90%. % effective with a particular half dose first and a full dose later. ZyCovD, which has been developed by the Indian pharmaceutical company Zydus, is also in advanced stages of human trials.
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