On Jan. 3, the Indian government granted emergency use authorization for the COVID-19 vaccine Covaxin developed by Bharat Biotech International Ltd. Indian news media praised the move, calling it the pride of the nation.
Covaxin was researched and developed by Bharat Biotech in collaboration with India’s National Institute of Virology and the Indian Council of Medical Research, using the same technology platform as China’s vaccines.
The institute and the council provided the virus strain in May last year, and in July commenced phase 1 and phase 2 clinical trials, which were carried out in 12 Indian hospitals selected by the council.
The results of the phase 1 clinical trials, which were published in the British journal The Lancet Infectious Diseases, showed that there was a good immune response to the vaccine in non-human primates. The phase 3 clinical trial began in November, and data were collected on 25,800 people in 22 Indian hospitals. It is expected to be completed next month.
However, the Drugs Controller General of India and the Central Drugs Standard Control Organization on Jan. 3 accepted the recommendations of an expert committee and granted advance approval for emergency use.
Many Indian experts and academic organizations, headed by the nation’s most famous virologist, Gagandeep Kang, objected to the decision.
Lawmaker Shashi Tharoor, a senior member of the opposition Indian National Congress party, also voiced his disagreement.
Paul Griffin, director of infectious diseases at the University of Queensland in Australia, said that he had never heard of any precedent of approving emergency use of a vaccine before completion of its phase 3 clinical trial.
As of Feb. 4, the Indian Ministry of Health and Family Welfare had been notified of 25 hospitalizations and 19 deaths of people who had received the vaccine, but Minister of Health and Family Welfare Harsh Vardhan said that the deaths were not causally related to COVID-19 vaccination and that any adverse reactions to the vaccine were minor.
Taiwan’s most experienced pharmaceutical company, Adimmune Biotech Corp, held its phase 1 clinical trial, led by professor Chang Shan-chwen (張上淳) at National Taiwan University Hospital, but discontinued the project after finding that the vaccine did not produce a satisfactory immune response. Adimmune and its research team are to be commended for their honest attitude.
On Jan. 26, US pharmaceutical firm Merck announced, for the same reason, that it had discontinued a vaccine research project it had been conducting in cooperation with France’s Pasteur Institute.
It should be noted that Merck is a well-known company with a long history and experience of making and selling vaccines, while the Pasteur Institute was the first institute in the world to engage in vaccine research.
The Food and Drug Administration has recommended that the government should purchase 10 million doses of the Taiwan-made vaccine that will definitely not proceed to its phase 3 clinical trial.
Minister of Health and Welfare Chen Shih-chung (陳時中) should give serious thought to his administrative and legal responsibilities. He should consider conducting a public opinion poll on people’s willingness to accept a Taiwan-made vaccine.
An even better idea would be to use the real-name mask rationing system for the public to register their willingness to accept locally made vaccines, to find out how many people would be willing to do so, and only then decide how many doses of which vaccine to order.
Hsieh Yen-yau is a retired professor of internal medicine at National Taiwan University College of Medicine.
Translated by Julian Clegg
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