India’s Bharat Biotech has submitted data on Covaxin’s EUL “regularly and very quickly” to a technical committee that hopes to have a final recommendation to the WHO next week, a senior global agency official said on Thursday. health, noting that the UN body “trusts” the Indian industry to manufacture high quality vaccines.
Hyderabad-based Bharat Biotech, which developed Covaxin, had submitted an EOI (expression of interest) to the World Health Organization on April 19 for the vaccine’s emergency use list (EUL).
A UN health agency technical advisory group that met on Tuesday asked Bharat Biotech for “further clarification” for Covaxin to conduct a final “risk-benefit assessment” for the use list emergency vaccine.
“Let me say that Bharat submitted data regularly and very quickly, but they submitted the last batch of data on October 18,” said Dr Mariangela Simao, Deputy Director General, Access to Medicines and Health Products. at the WHO, during a press conference. press briefing in Geneva.
She was responding to a question about the delay in granting the emergency use list to Covaxin when Chinese vaccines Sinopharm and Sinovac were approved even “with a lack of data”. Simao said that when the technical advisory group met on October 26 to discuss the EUL for Covaxin, it asked Bharat Biotech for further clarification. The Technical Advisory Group will meet again on November 2 for the final risk and benefit assessment of Covaxin EUL.
She said the WHO was in contact with Bharat Biotech and had “daily conversations”, calls and meetings “clarifying what additional data is needed” to submit to the technical expert group.
âLet me clarify and without wanting to mention any particular manufacturer, but saying that we evaluated an Indian manufacturer earlier in the year and it took 30 days,â she said, referring to Serum Institute of India which manufactures the AstraZeneca Covishield vaccine. .
âSo it’s not about going faster with one or the other vaccineâ¦ We really trust the Indian industry. India produces a different majority of vaccines in the world, high quality vaccines. We are currently in the final stage of evaluation by this external advisory group and hope to have a final recommendation to WHO next week. Hope this is understood correctly. She said it is important to stress that the process used by WHO to publish the Emergency Use List is a very transparent process and that there is “no secrets” involved, at the exception of confidential information.
âEverything else, the procedures used by WHO, are independent of the country that makes the vaccine,â she said, adding that the process was based on the best international standards available.
Simao also noted that sometimes the WHO has to inspect the manufacturer, if it has not carried out an inspection in recent times.
âThis was not the case with Bharat. We didn’t need to inspect Bharat, âshe said, adding that once the manufacturer has finished submitting all data to WHO, it is submitted for evaluation by a technical advisory group. external, which includes experts from six different nationalities and they review all the data that has been collected by the WHO, provided by the manufacturer to recommend the emergency use list.
She noted that in the case of the two Chinese vaccines as well, the group had requested further clarification and that the whole process had been followed to evaluate the Chinese vaccines. One of the Chinese vaccines was released on the emergency use list a month after the first technical advisory group meeting, while the second vaccine received the EUL after six weeks, she said.
Simao noted that currently, including Bharat Biotech’s Covaxin, the WHO is evaluating eight vaccine candidates.
She said Bharat Biotech started continuous submission on July 6. “We are treating this as a very urgent matter and we have teams working seven by seven on the subject.” Responding to the question about Covaxin, Dr Bruce Aylward, Senior Advisor to WHO Director-General Dr Tedros Adhanom Ghebreyesus, said that in “the stressful situation we are all working in this pandemic in which it is so important that we are specific about the information we use and share. And we just want to point out, for the record, that there were a number of inaccuracies in the way the problem was presented. He added that the actual information on the dates and process of the EUL is all available transparently on the WHO website.
âWe have been committed within the organization from the highest level, under the leadership of the CEO, to moving these processes forward as quickly as possible. But let’s be very clear, the timeline for EULing of a vaccine is 99% dependent on the manufacturers, how quickly, how comprehensively they can provide data to independent groups that are evaluating for the WHO. We just want to be very, very clear on this point. Aylward added that the WHO’s job is to save as many lives as possible and as fast as possible. This includes making sure that no product goes unused.
As the organization does everything, he said, âwe need the manufacturers, the regulators, the others we work with to make sure they have the information they need to make these decisions. . We have to make sure that the products are safe, effective and made with the right quality. And it takes a little while, but it is in the interests of global security. WHO Chief Scientist Soumya Swaminathan said that one of the reasons for the high level of stress experienced by people who have received vaccines that are not yet approved, whether by the WHO or by one of the other major strict regulators, is “because of the travel restrictions that have been imposed.” She reiterated that the emergency committee reviewing the International Health Regulations met again last week and highlighted its previous recommendations that countries should not use vaccination status or selective vaccination status as the only one. entry criteria for travel.
Covaxin and AstraZeneca from Bharat Biotech and Covishield from the University of Oxford 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-Janssen, Moderna and Sinopharm for emergency use.