WHO chief Tedros Adhanom Ghebreyesus discussed the issue of the emergency use listing of Bharat Biotech’s COVID-19 vaccine Covaxin and resumption of supplies of the Serum Institute of India-manufactured AstraZeneca vaccine to the COVAX facility among other topics during a telephonic conversation with Health Minister Mansukh Mandaviya.
“Had a call with @mansukhmandviya, India's Health Minister, to discuss #India's ongoing #COVID19 vaccination programme; the need for a global pandemic agreement; digital health; & traditional medicine. We welcome India's support to strengthen WHO, incl. via flexible, sustainable financing,” Mr. Ghebreyesus tweeted on October 19.
The WHO Director-General said that he also discussed with Mr. Mandaviya vaccine equity issues: “the resumption of SII/AstraZeneca vaccine supplies to #COVAX; the Covaxin Emergency Use Listing process; and technology and license sharing through C-TAP.” COVID-19 Technology Access Pool (C-TAP) was launched in May last year for facilitating timely, equitable and affordable access of COVID-19 health products by boosting their supply.
Mr. Mandaviya had also tweeted that he had a “detailed interaction” with the WHO chief, accompanied by other senior officials of the global health agency “on various issues related to health, including pandemic management and WHO reforms.
“DG WHO lauded the mammoth efforts undertaken by the Indian government for #COVID19 vaccination,” Mr. Mandaviya tweeted.
The cumulative number of Covid vaccine doses administered in India crossed 99 crore on October 19 and as the country is close to administering 100 crore doses. According to official figures, around 74.45% of India's eligible adult population has been administered at least one dose of the Covid vaccine and around 30.63% have received both doses.
On October 18, WHO said it is expecting one additional piece of information from Bharat Biotech regarding its COVID-19 vaccine COVAXIN and emphasised that it has to thoroughly evaluate to ensure vaccines are safe and “cannot cut corners” before recommending a vaccine for emergency use.
“We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the #COVID19 Emergency Use Listing, but we cannot cut corners - before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective,” the global health organisation had said in a tweet.
“Bharat Biotech - the manufacturer of Covaxin - has been submitting data to WHO on a rolling basis and WHO experts have reviewed these data. WHO is expecting one additional piece of information from the company today,” it said.
WHO said the timeframe for its Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for the WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries.
“When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine,” it said.
On October 17, World Health Organisation Chief Scientist Soumya Swaminathan had said in a tweet that the technical advisory group at the World Health Organisation will meet on October 26 to consider the Emergency Use Listing for Covaxin.
Bharat Biotech had submitted EOI (Expression of Interest) on April 19 for its vaccine. The WHO said it began rolling data of the vaccine on July 6. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process.
According to the WHO, submissions to the global health body for prequalification or listing under the emergency use procedure are confidential. If a product submitted for assessment is found to meet the criteria for listing, WHO will publish the results widely.
Duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer and on those data meeting WHO criteria, according to the agency.
Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India. The Covishield vaccine, which has been developed by AstraZeneca, is manufactured in India by Pune-based Serum Institute of India.
India will resume export of surplus COVID-19 vaccines in the fourth quarter of 2021 under the ‘Vaccine Maitri' programme and to meet its commitment to the COVAX global pool.
The government had stopped export of COVID-19 vaccines after the second wave of the pandemic hit the country in April this year. India has exported over 66 million vaccine doses to nearly 100 countries through grants, commercial shipments and the COVAX facility.
