None of the participants in the Covishield vaccine trial carried out by the Directorate of Public Health (DPH) and Preventive Medicine and the Rajiv Gandhi Government General Hospital (RGGGH) have had any side effects till now, Health Minister C. Vijayabaskar said.
In a reply to a question on reports that a participant in the phase-3 Covishield trial conducted at the Sri Ramachandra Institute of Higher Education and Research (SRIHER) has sent a legal notice to the Pune-based Serum Institute of India alleging an adverse event, he said the department would examine the issue.
“The safety of the vaccine is being tested by the DPH and the RGGGH, while its immunogenicitiy is evaluated at the private university. There have been no complaints and no side effects among the participants in the trial carried out by the DPH and the RGGGH. They had received the first dose of the vaccine and are under our observation. None of them have had any side effects,” he told reporters shortly after inaugurating a 120-bed ward at RGGGH on Saturday.
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Clinical trials of Covishield vaccine were launched at the RGGGH and the SRIHER with the Director of Public Health appointed as the principal investigator. An official of the DPH said as per protocols, SRIHER should directly inform the Serum Institute of India in case of adverse effects in any of the participants. “We have received no official information from them,” he said.
As preparation for the vaccination trials, the Health Minister said two to three preliminary discussions, including one on cold chain activity, were held.
New ward at RGGGHADVERTISEMENT
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Mr. Vijayabaskar said in a first of its kind in the country, a 120-bed ward for patients, who had co-morbidities and tested positive for COVID-19, has been established at the RGGGH. “This includes the departments of nephrology, urology, oncology and cardiology,” he said. RGGGH has treated 26,762 COVID-19 patients.