CHENNAI: In a new development, the Tamil Nadu government on Wednesday gave its approval to the Indian Council of Medical Research (ICMR) to conduct trials in the State as part of its study on the efficacy of the Bacillre Calmette Guerin (BCG) vaccine in reducing COVID-19 mortality among the elderly.
The multi-site study is being conducted in conjunction with the National Institute for Research in Tuberculosis (NIRT). Chief Minister Edappadi K Palaniswami has given approval to the study, a press release from Health Minister C Vijayabasker said.
"Elderly persons, people with cardiac problems, diabetes, blood pressure and other problems are vulnerable to COVID. For the last 50 years, the BCG vaccine has been given for infants to protect against TB, and it is learned that it increases innate immunity. Also, it may reduce mortality and morbidity when administered to the 60 to 95 age group," the minister said in the release, adding that the trial would begin soon.
Explaining the contours of the study, Dr T S Selvavinayagam, director of Public Health said ICMR had identified persons who are COVID negative. “There is a test group and control group. One group will receive the vaccine to see if there is any protective effect,” he said.
However, on Twitter, the minister’s announcement of the study -- as a pilot programme raised concerns among experts. “BCG vaccine shall be administered on a trial basis for adults aged 60-95, ordered by Hon’ble @CMOTamilNadu... National Institute for research in Tuberculosis will start the pilot program soon,” the minister tweeted.
"Nobody has any experience in giving the live BCG vaccine to elderly people! Without proving safety, no program should be vaccinating elderly people. There is no direct evidence proving that BCG will reduce #COVID mortality," Dr Madhu Pai, an epidemiologist, and director of the McGill International TB Centre, said on Twitter, in response.
Dr Pai drew attention to the multiple randomised control trials underway in Netherlands, Australia, USA, and South Africa studying BCG’s efficacy against COVID.
Former TN director of public health Dr K Kolandaswamy also urged caution. "The BCG vaccine is not new to India and a majority of the population has received the vaccine. So, by now either they would have developed immunity by vaccination or by natural infection,” he said.
Noting that scientists were attempting to try a bacterial vaccine against a virus, he said such studies should not divert from the main focus. "The primary focus should remain on preventive and control measures, such as stressing on hand washing, surface disinfection, as well as testing and contact tracing,” he said.
Indian researcher Dr Anant Bhan said that announcements of such studies should be carefully worded so as to avoid raising public expectations.
"The research happening during COVID-19 is welcome, more so when it is conducted by government institutions such as ICMR. However, the studies should be based on solid science while also ensuring patient safety. The study should not cause a misconception among people that this is some breakthrough. It should be stressed that it is only a study and we will know only in due time if anything promising comes of it," Dr Anant Bhan told The New Indian Express.
State’s COVID-19 update
The State recorded 4,496 new COVID-19 cases and 68 deaths, including that of a 19-year-old girl from Kancheepuram, taking the tally to 1,51,820 and toll 2,167 on Wednesday.
Chennai alone recorded 1,291 cases and 23 deaths. Cases continue to spike in Chennai’s neighbouring districts of Kancheepuram, Tiruvallur and Chengalpattu.
According to the media bulletin issued by the Directorate of Public Health, Chengalpattu recorded 186 cases, Kancheepuram 163 and Tiruvallur 278 cases. Madurai, where cases have been on the rise, recorded 341 cases on the day. Meanwhile, among the deceased, four didn’t have any comorbidities.
A 19-year-old girl from Kancheepuram was the youngest among the deceased on Wednesday. The girl with Type I Diabetes Mellitus (TIDM) and Chronic Kidney Disease was admitted at Rajiv Gandhi Government General Hospital on July 10.
She tested positive on the same day. She died on July 14 due to acute respiratory distress syndrome, respiratory failure, COVID-19 pneumonia, sepsis, acute chronic kidney disease, diabetic ketoacidosis, TIDM.