India is submitting biotech data 'very early, routine': WHO on Covaxin

United Nations: India’s Bharat Biotech is submitting data on Covaxin’s EUL “regularly and very quickly” to a technical committee, a top global health agency official said on Thursday, which expects a final recommendation to the WHO next week. The UN body “trusts” the Indian industry manufacturing high quality vaccines.

Hyderabad-based Bharat Biotech, which has developed Covaxin, submitted the EoI (Expression of Interest) to the World Health Organization on April 19 for the Emergency Use List (EUL) of the vaccine.

A technical advisory group of the United Nations health agency that met on Tuesday has sought “additional clarification” from Bharat Biotech for Covaxin to conduct a final “risk-benefit assessment” for the vaccine’s emergency use list.

“I would say that India is submitting data regularly and very quickly, but they submitted the last batch of data on October 18,” said Dr Mariangela Simao, assistant director general of Access to Medicines and Health Products at WHO. Press conference in Geneva.

She was responding to a question on the delay in giving Covaxin an emergency use list, while the Chinese vaccines Sinopharm and Sinovac were also approved “with a lack of data”. Simao said that when the technical advisory group met on October 26 to discuss the EUL for Covaxin, he sought additional clarification from Bharat Biotech. The Technical Advisory Group will meet again on 2 November for the final risk-benefit assessment of the Covaxin EUL.

She said the WHO is in touch with Bharat Biotech and has “daily interactions” and calls and meetings “to clarify what additional data is needed” to submit to the technical expert group.

Referring to Serum Institute of India, which manufactures the AstraZeneca Covishield vaccine, he said, “Let me clarify and without mentioning any specific manufacturer, but adding that we have assessed an Indian manufacturer in the first year and it took 30 days.” ” .

“So it’s not about going fast with one or the other vaccine… We really trust the Indian industry. India produces a wide variety of vaccines in the world, high quality vaccines. This is in the final stages of evaluation by the external advisory group and we expect a final recommendation to the WHO next week. I hope this is well understood.” He said it is important to highlight that the process the WHO uses to issue an emergency use list is a very transparent process and does not involve “no secrets” except for any confidential information.

“Everything else, the processes that WHO uses are independent of which country is manufacturing the vaccine,” she said, adding that the process is based on the best international standards available.

Simao also noted that sometimes the WHO is required to inspect the manufacturer, if it has not inspected in the most recent term.

“This was not the case for India. We didn’t need to inspect India,” she said, adding that once the manufacturer has completed submitting all the data to the WHO, it is put up for evaluation by an external technical advisory group, Which includes experts from six different nationalities and looks at all the data collected by WHO, provided by the manufacturer in the Recommendation for Emergency Use List.

He said that even in the case of the two Chinese vaccines, the group had sought additional clarifications and the entire process was followed to assess the Chinese vaccines. One of the Chinese vaccines was issued an emergency use list a month after the first technical advisory group meeting, while the second vaccine was given the EUL after six weeks, she said.

Simao said that at present, WHO is assessing eight vaccine candidates, including Bharat Biotech’s Covaxin.

It said Bharat Biotech had started rolling submissions on July 6. “We are considering this as a very urgent matter and we have seven to seven working teams on the subject.” Responding to Covaxin’s question, Dr. Bruce Aylward, Senior Advisor to WHO Director-General Dr Tedros Adhanom Ghebreyesus, said that “In the tense situation we are all dealing with in this pandemic, it is so important that we are accurate in information.” That we use and what we share. And we just want to highlight that, on record, there were many mistakes in the way this issue was presented.” He said that the actual information about EUL dates, procedure is transparently available on the WHO website.

“We are committed from the very top of the organization under the Director General to move these processes forward as quickly as possible. But let’s be very clear, the timeline for EUL of a vaccine is 99% up to the manufacturers, the speed, the completeness with which they Independent groups can get the data that the WHO evaluates for. We want to be very clear on that point.” Aylward said that the WHO’s job is to save as many lives as possible and as soon as possible. This includes ensuring that no product goes unused.

While the organization does everything, he said, “we need manufacturers, regulatory agencies, other people we work with to make sure they have the information they need to make those determinations. What is required is that products are safe and effective and are produced of the right quality. And it takes a while, but it is in the interest of global safety.” WHO Chief Scientist Soumya Swaminathan said that for people who have received vaccines, which have not yet been approved by the WHO or any of the other main stringent regulatory agencies, one reason for the high amount of stress is “due to restrictions on travel which has been installed.” She reiterated that the emergency committee reviewing international health regulations met again last week and outlined its previous recommendations that countries should not use immunization status or selective immunization status as the sole criteria for entry to travel. should do.

Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield are the two widely used vaccines in India.

WHO has so far approved Covid-19 vaccines from Pfizer-BioNtech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Jensen, Moderna and Sinopharm for emergency use.


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