The World Health Organization (WHO) has issued an emergency use listing for India’s Covaxin vaccine against COVID-19.
The jab “is extremely suitable for low – and middle-income countries due to easy storage requirements”, the United Nations’ health agency said in a statement on Wednesday after its Strategic Advisory Group of Experts found it last month to have 78 percent efficacy after two doses spread over four weeks.
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“This emergency use listing expands the availability of vaccines, the most effective medical tools we have to end the pandemic,” said Mariangela Simao, WHO’s assistant director-general for access to medicines and health products.
“But we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory,” she added.
Glad to see one more vaccine, #Covaxin, being granted @WHO emergency use listing. The more products we have to fight #COVID19, the better, but we must keep up the pressure to deliver #VaccinEquity & prioritize access to vulnerable groups who are still waiting for their 1st dose. https://t.co/wCgtSSNvJ1
— Tedros Adhanom Ghebreyesus (@DrTedros) November 3, 2021
Covaxin is the first vaccine completely developed and manufactured in India to receive WHO approval.
To date, the health agency has granted emergency approval to the vaccines made by AstraZeneca and its partner, the Serum Institute of India; Pfizer-BioNTech; Moderna; Johnson and Johnson; and the Chinese pharmaceuticals Sinopharm and Sinovac.
Nearly 29 percent of people in India have received at least one dose of Covaxin and more than 23 percent of people have received two jabs, according to Our World in Data.
Vaccines approved by the WHO can be used as part of the UN-backed COVAX effort to distribute COVID-19 jabs and to share doses with poorer countries.
WHO’s emergency use licensing for Covaxin should also mean that millions of Indians immunised with the shot will be allowed to travel internationally by countries that recognise vaccines authorised by the WHO, including Britain, European Union members and Canada.
Covaxin was developed by Indian company Bharat Biotech in partnership with the Indian Council of Medical Research, the government’s apex research body.
Bharat Biotech welcomed the WHO approval and said it “validates the international safety and quality standards of Covaxin”.
The Emergency Use Listing approval by WHO validates the international safety and quality standards of COVAXIN®. Bharat Biotech is motivated to mitigate the worldwide pandemic. #Indianinnovationglobalvalidation #indiasfirstindigenouscovidvaccine #covid19 #covaxin @WHO pic.twitter.com/zN7wefyP5U
— BharatBiotech (@BharatBiotech) November 3, 2021
While an expert group convened by the WHO said there was insufficient data about the vaccine’s safety and efficacy in pregnant women, studies are being planned to address those questions.
India’s drug regulator authorised Covaxin in January, months before extensive testing in people had been completed, prompting concern from health experts that the shot was given the nod prematurely.
Bharat Biotech published results in July showing the vaccine was about 93 percent effective in preventing severe COVID-19 and roughly 65 percent effective against infection with the more contagious Delta variant of the coronavirus.
Despite India’s repeated endorsement of its homegrown vaccine, Bharat Biotech has faced problems scaling up production.
In July, India’s health ministry said the company was making 25 million doses of the vaccine on average each month and expected to increase monthly production to 58 million doses.
The company says it is aiming to reach an annual capacity of 1bn doses by the end of 2021, or more than 80m shots each month, but has not responded to questions about its current capacity.
Bharat Biotech said several other countries, including Brazil, the Philippines, Iran and Mexico, had also authorised its COVID-19 vaccine.