Controversy over the nondisclosure of the disease outbreak in the corona19 vaccine clinical trial by an Indian pharmaceutical company

(New Delhi = Yonhap News) Correspondent Kim Young-hyun = Despite the possibility of side effects that arose during the clinical trial of a new vaccine against coronavirus infection (Corona 19) being developed by an Indian pharmaceutical company, it is controversial because it does not disclose it and forces the follow-up work. .

According to the Economic Times of the Indian Economics magazine on the 22nd, a participant in his 30s suffered a serious illness in the first phase of a Corona 19 vaccine clinical trial in August conducted by a local Barat Biotech company.

An official said: “This participant developed symptoms of viral pneumonia after receiving the vaccine and was hospitalized and released a week later.”

However, at that time, neither Barat Biotech nor the Indian authorities disclosed the facts.

Subsequently, Barat Biotech continued with clinical trials and recently entered phase 3.

This is different from the fact that multinational pharmaceutical companies AstraZeneca and Johnson & Johnson (J&J) temporarily suspended clinical trials due to concerns about side effects after the disease was discovered among clinical trial participants in September and October.

After that, Barat Biotech made a statement late on the 21st and explained the situation when the media reports about clinical side effects came out.

The company said: “We reported the facts to the drug regulatory authority within 24 hours of the occurrence of the situation.”

However, the experts pointed out that if a problem was found in the course of a clinical trial, it should have been disclosed immediately and the related trial should have been discontinued.

Currently in India, another pharmaceutical company, Zydus Cadillac, is developing its own vaccine. The Serum Institute, known as the largest vaccine company in the world, has participated in a vaccine development project at AstraZeneca and the University of Oxford.

Dr Redis, a local pharmaceutical company, is preparing a clinical trial for the Russian ‘Putnik V’ vaccine.

Meanwhile, India’s Ministry of Health and Family Welfare announced that the cumulative number of confirmed corona19 cases as of the morning of the 22nd was 9,095,000,806, an increase of 45,000,209 from the previous day.

As of mid-September, the number of people infected per day, which peaked at nearly 100,000, has recently dropped from 20,000 to 40,000.

The cumulative death toll that day was 13,227, an increase of 501 over the previous day.

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2020/11/22 15:06 sent