It is important to gather all necessary information before recommending a vaccine: WHO

New Delhi, October 23, 2021:

At a time when India is looking forward to the Emergency Use Listing of indigenously developed Covid-19 vaccine Covaxin from Bharat Biotech, the World Health Organisation (WHO) has said that it is important that it gathers all the necessary information before recommending the vaccine to the world.

Dr Mike Ryan, executive director of WHO Health Emergencies Programme, in a video released by WHO in its Twitter account, said, “It is really important that we gather all of the necessary information not only on the vaccine itself, but on the manufacturing processes, and all of that because we are recommending to the world that this vaccine is safe, effective and has been produced using the highest quality standards.”

He was answering a question on whether there will be a definitive answer on Covaxin’s EUL by October 26, though he did not seem to have specifically addressed the matter of the particular vaccine.

Dr Soumya Swaminathan, chief scientist with WHO on October 17, in her personal Twitter account, said, “The technical advisory group will meet on October 26 to consider EUL for Covaxin. WHO has been working closely with Bharat Biotech to complete the dossier. Our goal is to have a broad portfolio of vaccines approved for emergency use and to expand access to populations everywhere.”

Ryan, on October 21 said that WHO is very clear that it wants all countries to recognise EUL vaccines that have been given an Emergency Use Listing by the WHO advisory process. Those companies who put their vaccines forward, first of all, they have to request and respond and say, we want our vaccine to be put through EUL. Then they have to provide documentation on the whole process, the efficacy studies and the manufacturing process.

“Sometimes that requires visits to look at and examine the manufacturing practices and all of that has to come together into the dossier that is presented within this advisory group mechanism and then it is from there that WHO can make recommendations. It is a hugely important task and it is extremely involved and measured and the outputs of this process have been of very high quality right the way through this pandemic,” he added.

On October 18, WHO in its Twitter account said, “We are aware that many people are awaiting for WHO’s recommendation for Covaxin to be included in the Covid-19 EUL, 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 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,” it added.

“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 added that WHO is expecting one additional piece of information from the company which is expected to be submitted soon.

Later during the week, Union health minister Mansukh Mandaviya also discussed the EUL process for Covaxin with WHO Director-General Tedros Adhanom Ghebreyesus. Government of India officials have been expecting EUL approval from WHO for the vaccine in the last few months. PharmaBiz