WHO authorizes Indian-made COVID vaccine, months into use

New Delhi, Nov 4 (BNA): The World Health Organization (WHO) on Wednesday granted emergency use authorization for a coronavirus vaccine developed in India, providing reassurance to the loop that regulators in the country have allowed long before the completion of advanced safety and efficacy testing.

The United Nations health agency said in a statement that it had allowed Covaxin, which was supplied by India’s Bharat Biotech. The Associated Press (AP) reported that the measure makes Covaxin the eighth COVID-19 vaccine to receive the go-ahead from the World Health Organization.

“This list of emergency uses expands the availability of vaccines, which are the most effective medical tools we have to end the pandemic,” said Dr Mariangela Simao, WHO’s Assistant Director-General for Access to Medicines.

Covaxin was developed by Bharat Biotech in partnership with the Indian Council of Medical Research, a top government research body. The vaccine is made using a killed coronavirus to stimulate an immune response and is given in two doses.

The World Health Organization said the vaccine was found to be 78 percent effective in preventing severe COVID-19 and was “highly appropriate” for poor countries due to its much easier storage requirements.

An expert group set up by the World Health Organization said there was insufficient data on the vaccine’s safety and efficacy in pregnant women; Studies are planned to address these questions.

India’s drug regulator allowed Covaxin to be used in January, months before extensive testing on people was completed, raising health experts’ concern that the syringe was given a premature nod.

Indian Prime Minister Narendra Modi took the first of the two-dose vaccine in March. By mid-October, more than 110 million doses of the vaccine had been administered, making Covaxin the second most widely used vaccine for COVID-19 in India after AstraZeneca.

Despite India’s repeated endorsement of a homemade vaccine, Bharat Biotech has faced problems in increasing production. In July, India’s health ministry said the company was making an average of 25 million doses of the vaccine each month, and monthly production was expected to increase to 58 million doses.

The company says it aims to reach an annual capacity of 1 billion doses by the end of 2021, or more than 80 million doses each month, but it has not responded to questions about its current capacity.

Bharat Biotech said several other countries, including Brazil, the Philippines, Iran and Mexico, have also allowed the COVID-19 vaccine. Data from India’s foreign ministry shows that before India temporarily halted exports, Bharat biotech shots were sent to Myanmar, Paraguay and Zimbabwe as grants, and to Mauritius and Iran as part of trade deals.

Brazil’s Federal Prosecutor’s Office is investigating possible irregularities in the Ministry of Health’s contract to purchase 20 million doses of Covaxin.

So far, the World Health Organization has given emergency approval for vaccines made by AstraZeneca and its partner, the Serum Institute of India, Pfizer-BioNTech, and Moderna Inc. , Johnson & Johnson, and the Chinese pharmaceuticals Sinopharm and Sinovac.

Vaccines approved by the World Health Organization can be used as part of the UN-backed COVAX effort to distribute COVID-19 vaccines and share doses with poor countries. The initiative is in dire need of more vaccines after failing to achieve its goals and significantly reducing the number of doses expected to be delivered by the end of the year.

Anna Marriott, Oxfam’s director of health policy, said WHO’s licensing of India’s Covaxin should “silence those who have claimed that expertise and expertise in developing and manufacturing life-saving medicines and vaccines is lacking in developing countries.”

Bharat Biotech called for the vaccine recipe and knowledge to be shared freely so that more manufacturers globally can produce it. Less than 1% of the world’s coronavirus vaccines went to poor countries.

“Today’s vaccine apartheid between rich and poor nations was created by monopolies of companies like Pfizer and Moderna who have consistently put outrageous profits before saving lives, and we urge Bharat Biotech not to follow in their footsteps,” Marriott said in a statement.

The WHO’s emergency use authorization for Covaxin should also mean that millions of vaccinated Indians will be allowed to travel internationally by countries that recognize WHO-licensed vaccines, including Britain, members of the European Union and Canada.

MI