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New Delhi: Bharat Biotech’s covid-19 Covaxin has been facing delays in getting World Health Organization’s (WHO) emergency use listing (EUL) since August. Covaxin despite being one of the most sought after covid-19 vaccines in India is yet waiting for a global approval.

Even as the US Centers for Disease Control and Prevention this week enlisted covaxin in the qualifying covid-19 vaccine candidates that meet its criteria for the exception, the vaccine still needs clearance from WHO for further processes of usage globally. The development meant that those who are vaccinated with both shots of covaxin and want to travel to the United States.

The UN health agency earlier this week asked for additional clarifications to conduct a final risk-benefit assessment for its global use. The WHO’s technical advisory group considered granting EUL to Covaxin in a meeting scheduled on Tuesday but did not come to a conclusion. Soumya Swaminathan, Chief Scientist at WHO said that if the Hyderabad based pharmaceutical company furnishes the data in time, then apex global health agency will convene a meeting on Wednesday, 3 November.

Public health experts have said that even though the vaccines is safe and efficacious the formal procedures are taking time for the approval. “Covaxin is one of the safest covid-19 vaccines available in the world which is developed on a safe and conventional platform. The efficacy data is already in public domain. The delay in getting the EUL from WHO may be because the company is very new in this process and they have also come up with new vaccine manufacturing plants. The WHO wants all the minute data regarding good manufacturing practices (GMP) to ensure that the pharmaceutical company will make quality vaccine before giving it a global go ahead," said Dr Naveen Thacker, president elect, international Pediatric Association and former civil society organization (CSO) representative to Gavi board, the Vaccine Alliance.

“May be there is some delay in examination of the new facilities. The company might be taking time in furnishing the required data which can only be sthe reason for delay else the vaccine is safe and effective," he said.

The delay has been impacting students and businessmen who want to travel to countries where a vaccination certificate for WHO-approved vaccines is mandatory. As on Monday over 12 crores doses of covaxin have been administered in India among different age group above 18. Also, WHO’s EUL is a prerequisite for supplying vaccines under the Covax Facility, a multilateral initiative aimed at fostering global access to covid vaccines. If done, the approval, will also place Covaxin in an important spot in the world map as it can be given to more and more countries.

“The WHO has a global responsibility and are very careful and thorough in reviewing and analyzing the data provided by the vaccine manufacturers. The Emergency Use Listing pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan with a focus on low- and middle-income country needs," said Lalit Kant, a scientist and former head of epidemiology and communicable diseases at the Indian Council of Medical Research (ICMR).

Kant explained that these data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

“At times, the WHO assessment includes on-site inspections of the production facility. For some of the inactivated vaccines, the WHO also reviews the virus inactivation procedures. The fact that WHO is seeking additional data indicates that there are some missing links," said Kant.

“Since the Drugs Controller General of India (DCGI) and its expert teams have already reviewed and accepted the data as satisfactory of all aspects of vaccine production and clinical trials provided by the Company, the delay is intriguing. Is the WHO looking at something that the DCGI missed?," argued Kant.

Covaxin, India’s first indigenously developed covid vaccine, has received EUAs from 14 countries and another 50 are in the process. In June, the drugmaker had said that its US partner, Ocugen, has received a recommendation from the US Food and Drug Administration to pursue biologics license applications (BLA) for Covaxin. Applications have to follow the BLA process, which is the standard for vaccines.

The WHO this week also said that that it cannot cut corners before recommending Bharat Biotech’s Covaxin for EUL. 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 WHO tweeted.

“The timeframe for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries," the UN health agency said in the series of tweet.

It further said, “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."

Meanwhile India’s cumulative covid-19 coverage on Friday breached 105 crores. Union health ministry said that more than 109.63 crore vaccine doses have been provided to States/UTs so far through government of India (free of cost channel) and through direct state procurement category. And More than 12.31 Crore balance and unutilized covid-19 Vaccine doses are still available with the States/UTs to be administered, the government said. the stock includes over 30% of the covaxin doses. At least 14,348 new coronavirus cases were reported in the last 24 hours.

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