NEW DELHI (AP) – The World Health Organization issued an emergency license for the emergency use of a coronavirus vaccine developed in India on Wednesday, giving confidence for a vaccine that has been approved by the country’s regulatory authorities well ahead of the completion of expanded safety and efficacy trials.
The UN health agency said it has authorized the use of the drug Covaxin, made by the Indian company Bharat Biotech. The promotion makes Covaxin the eighth COVID-19 vaccine to receive the WHO green light.
“This Emergency Use List expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Dr Mariangela Simau, WHO Deputy Director General for Access to Medicines.
Covaxin was developed by Bharat Biotech in collaboration with the Indian Medical Research Council, the highest government research body. The vaccine is made using a killed coronavirus to induce an immune response and is given in two doses.
The WHO said the vaccine is about 78% effective in preventing severe COVID-19 and is “extremely suitable” for poor countries due to simpler storage requirements.
An expert group convened by WHO stated that there is insufficient data on the safety and efficacy of the vaccine in pregnant women; studies are planned to address these issues.
The Indian regulator authorized Covaxin in January, months before the completion of comprehensive human trials, prompting fears among medical experts that the injection was being given prematurely.
Indian Prime Minister Narendra Modi received the first two-dose vaccine in March. By mid-October, more than 110 million vaccine injections had been injected, making Covaxin the second most commonly used COVID-19 vaccine in India after the AstraZeneca vaccine.
Despite India’s repeated endorsements of its own vaccine, Bharat Biotech faced challenges in increasing production. In July, India’s health ministry said the company produces an average of 25 million doses of vaccine each month and expects monthly production to rise to 58 million doses.
The company says it intends to achieve an annual capacity of 1 billion doses by the end of 2021, or more than 80 million doses per month, but did not answer questions about its current capabilities.
Bharat Biotech said several other countries, including Brazil, the Philippines, Iran, and Mexico, have also approved the COVID-19 vaccine. Before India suspended exports, footage made by Bharat Biotech was sent to Myanmar, Paraguay and Zimbabwe as grants, as well as to Mauritius and Iran in commercial deals, Indian Foreign Ministry figures show.
The Brazilian Federal Attorney’s Office is investigating possible violations in the contract of the Ministry of Health for the purchase of 20 million doses of covaxin.
To date, the World Health Organization has issued an emergency authorization for vaccines produced by AstraZeneca and its partner, Serum Institute of India, Pfizer-BioNTech, Moderna Inc., Johnson & Johnson, and Chinese pharmaceutical companies Sinopharm and Sinovac.
WHO-approved vaccines can be used as part of the UN-backed COVAX effort to expand COVID-19 vaccines and transfer doses to poorer countries. The initiative desperately needs more vaccines after it missed its targets and drastically cut the number of doses to be delivered by the end of the year.
Anna Marriott, health policy manager at Oxfam, said WHO’s approval of the Indian drug Covaxin should “silence those who claim that the expertise and knowledge to develop and manufacture life-saving drugs and vaccines does not exist in developing countries.”
She encouraged Bharat Biotech to freely share their vaccine recipe and know-how so that more manufacturers around the world can produce it. Less than 1% of the world’s coronavirus vaccines are sent to poor countries.
“Today’s vaccine apartheid between rich and poor countries has been created by the monopolies of companies such as Pfizer and Moderna, which consistently prioritize obscene profits before saving lives, and we urge Bharat Biotech not to follow in their footsteps,” Marriott said in a statement.
The WHO emergency use of covaxin license should also mean that millions of Indians immunized with the vaccine will be allowed to travel internationally to countries that recognize WHO-approved vaccines, including the UK, European Union member states and Canada.
Cheng reported from London.