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The vaccine developed by Bharat Biotech has been controversial after the Indian government cleared its use without concrete data.

Coronavirus vaccine developer Bharat Biotech has warned people with low immunity and other medical conditions, including allergies, fever, or bleeding disorder, to consult a doctor before getting vaccinated – and if possible avoid the vaccine.

The company said on Tuesday that those who receive its Covaxin injections should disclose their health, any medications they are taking and any history of allergies.

He said serious allergic reactions in people vaccinated can include difficulty breathing, swelling of the face and throat, rapid heartbeat, rash, dizziness and weakness.

The Indian manufacturer’s directive came three days after India launched what the government calls “the world’s largest immunization program.”

However, the vaccine developed by Bharat Biotech has been the subject of controversy after the country’s pharmaceutical regulator authorized its use without concrete data showing its effectiveness in preventing COVID-19.

A man rides his motorbike past a parked bus of Indian company Bharat Biotech outside his office in Hyderabad [File: Reuters]

On January 4, the regulator approved the emergency use of two vaccines, one developed by the University of Oxford and UK manufacturer AstraZeneca, and the other by Bharat Biotech.

The drug regulator has taken the plunge without publishing information on the effectiveness of the Indian vaccine.

Bharat Biotech has yet to release data on the effectiveness of its vaccine, but said it is following clinical trial guidelines.

The regulator maintains the vaccine is safe and has given approval believing it may be more effective in combating a new variant of the coronavirus found in the UK.

The regulator and the company said efficacy data will be released after late clinical trials end.

Most hospitals in India inoculate the AstraZeneca vaccine to healthcare workers. But the turnout, especially at hospitals using the Bharat Biotech vaccine, has been relatively low, health officials said.

Hospitals in New Delhi that administered the Bharat Biotech vaccine have seen many doctors hesitate to be vaccinated.

Tens of thousands of people have received the vaccine in the past three days after India started vaccinating healthcare workers over the weekend.

India vaccinated 148,266 people on Monday, bringing its total to 381,305, the health ministry said. Indian authorities hope to give vaccines to 300 million people by July 2021.

Beneficiaries are to include 30 million doctors, nurses and other frontline workers, followed by 270 million people over the age of 50 or with illnesses that make them vulnerable to COVID-19.

The vaccination campaign began at a time when coronavirus infections have dropped sharply and much of life has returned to normal.

India comes second after the United States for the number of confirmed cases at 10.5 million. The country ranks third in the number of reported deaths, behind the United States and Brazil, with more than 152,000 deaths.


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