Bharat Biotech Submits Data 'Regularly, Very Quickly': WHO Official on Covaxin

Covaxin vaccine. Image used for representational purposes.

(Photo: FIT)

The World Health Organisation (WHO) on Thursday, 28 October said that India's Bharat Biotech has been submitting information required for Emergency Use Listing (EUL) of Covaxin "regularly and very quickly" to a technical committee that helps the global health agency in assessing the vaccine, reported news agency PTI.

The technical committee is likely to recommend Covaxin to WHO, this coming week.

The UN body said this at a press briefing in Geneva, and asserted that it trusted India's vaccine manufacturing industry, that produces "high quality" vaccines.

Bharat Biotech had on 19 April submitted EOI (Expression of Interest) to WHO for Emergency Use Listing (EUL) of its COVID vaccine – Covaxin.

WHO Seeks Additional Information to Bharat Biotech

At a meeting held on Tuesday, 26 October, a technical advisory committee of the health agency has asked "additional clarifications" from Bharat Biotech to perform a "final risk benefit assessment" before listing it for emergency use.

Answering questions from journalists on why there is a delay in providing EUL for Covaxin, when Chinese vaccines Sinopharm and Sinovac were approved for EUL, although they didn't have enough data, Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products, WHO said Bharat Biotech has been submitting data regularly and very quickly. However, they submitted that last set of data on 18 October, she said.

She added that their technical advisory team would reconvene on 2 November for the final risk benefit assessment of Covaxin, before deciding on the approval.

Simao further said that WHO is in touch with Bharat Biotech, daily via calls and video conferences to apprise the company on what additional information it needs to submit to the technical advisory group.

In a veiled reference to Serum Institute of India (SII) she said it took nearly 30 days to approve their Covishield vaccine.

"So, this is not about moving quicker with one or another vaccine...We really trust the Indian industry. India produces different majority of vaccines in the world, high quality vaccines. We are right now at the last stage of the assessment by this external advisory group and we hope to have a final recommendation to the WHO next week."

Simao said, as quoted by PTI

'Processes Followed by WHO for EUL of Vaccines Are Transparent'

Asserting that the process used by WHO for approving a vaccine for EUL is very transparent, she said that there are "no secrets" involved besides confidential information. The procedures followed at WHO, she said, was independent of which country was manufacturing the vaccine.

Explaining the process followed by the global health agency, she said, soon after the manufacturer submits all the required data, it is given for assessment to an external technical advisory group, which would comprise experts from six different nations.

The experts then take note of all data gathered by WHO, and those provided by the manufacturer and then take a call on providing EUL for the vaccine. Usually, WHO also inspects the manufacturer, but incase of Bharat she said, it was not required.

Simao further added that the two Chinese vaccine manufacturers too were asked for additional information and the entire process was followed. While one Chinese vaccine was given EUL a month after the first technical advisory meeting, the other she said was accorded EUL six weeks after the meet.

Besides, Bharat Biotech, she said that WHO was assessing eight other vaccine candidates now. WHO has so far given EUL for Serum Institute of India's AstraZeneca Covishield vaccine, COVID vaccines made by Pfizer-BioNTech, Johnson & Johnson-Janssen, Moderna, and Sinopharm.

It Will Take a Bit of Time for Us to Ensure Vaccine Is Fully Safe: WHO

Responding to questions on the same issue, Dr Bruce Aylward, Senior Advisor to WHO Director General Dr Tedros Adhanom Ghebreyesus, said at a stressful situation like the pandemic, they wanted to use and share only accurate information. "We just want to highlight, be on the record, that there were a number of inaccuracies in the way the issue was presented," he said, as per PTI.

Assuring that all the processes of WHO is transparently available in its website, he said, that their entire organization was committed to finishing the process as soon as possible.

However, he said, the time period required for EUL of a vaccine completely depended on the manufacturer and the speed with which they submit "complete information" required by the independent expert teams that access the vaccine.

Further, he added that it was important for them to ensure that vaccines are safe and are of the good quality. "That would take a bit of time, however it is in the interest of global safety," he said.

Due to the travel restrictions imposed across the world, Soumya Swaminathan, WHO's Chief Scientist said people are stressed if the vaccines they have received has not been given EUL by WHO or any other main stringent regulatory agency.

She further stressed that the emergency committee which monitors International Health Regulations held a meeting again this past week and highlighted their earlier recommendation that countries should not mandate vaccination status or selective vaccination status as the only criteria for allowing entry into their respective nations.

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

(With inputs from PTI)