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The Covaxin-WHO EUL saga

Manufacturers will need to cover all bases from the start, as the regulatory process will only get more stringent and competitive

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The WHO issued the much-awaited Emergency Use Listing (EUL) to Bharat Biotech’s Covaxin on 3rd November. The vaccine has not yet been approved for pregnant women, as ‘available data on vaccination of pregnant women with the (Covaxin) vaccine are insufficient to assess vaccine  safety or efficacy in pregnancy’, as per a WHO statement. Studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry.

Earlier on the same day, India’s CDSCO extended Covaxin’s shelf life from the current six to 12 months. And on 1st November, Covaxin, along with Chinese firm Sinopharm’s BBIBP-CorV, was ‘recognised’ by Australia’s vaccine regulator, the Therapeutic Goods Administration (TGA), for the purpose of establishing a traveller’s vaccination status.

Underlining the importance of this decision, at a time when the WHO EUL was still in the pipeline, PM Narendra Modi tweeted his thanks to his Australian counterpart H E Scott Morrison calling it “an important step forward in the post-COVID partnership” between the two countries.

These announcements will come as vindication for Bharat Biotech’s management, but the process has deep learnings for all stakeholders.

Additional data requests and clarifications have marred the Hyderabad-based vaccine maker’s journey from its 19th April application for an EUL to its grant on 3rd November. The latest ask, as per media reports quoting company sources, was for additional information including reportedly immunogenicity data for over 60-year-olds, as well as gender-wise split data on immunogenicity and efficacy of the vaccine. While other nations have been accepting Covaxin on a reciprocal basis, the WHO explained that asking for additional data and clarifications was part of its routine assessment guided by the recommendations of the Strategic Advisory Group of Experts on Immunization (SAGE).

A series of tweets from the WHO in mid-October explained that the timeframe for the WHO EUL 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 that 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 an EUL to the vaccine.

While the WHO was “aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the COVID-19 Emergency Use Listing,” it reiterated that they “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 has also gone on record to state that Bharat Biotech/Covaxin was not singled out. A PTI report dated 29th October quotes Dr Mariangela Simao, Assistant Director General, Access to Medicines and Health Products as saying that the agency’s process was ‘transparent,’ that they had “daily conversations” with the company for clarifications on data required, and Bharat Biotech had been submitting data on the EUL of Covaxin “regularly and very quickly” to a technical committee.

Reiterating that the WHO “trusts” the Indian industry that manufactures high-quality vaccines, Dr Simao made the point that another Indian COVID-19 vaccine (Serum Institute of India’s Covishield) was approved in 30 days. Additional clarifications were also sought on the two Chinese vaccines as part of the approval process. One received an EUL a month after the first technical advisory group meeting, while the second got an EUL after six weeks.

In the 3rd November release, Dr Simao noted that this EUL expands the availability of vaccines but also cautioned that “we must keep up the pressure to meet the needs of all populations, giving priority to the at-risk groups who are still waiting for their first dose, before we can start declaring victory.”

WHO’s SAGE noted that Covaxin is extremely suitable for low- and middle-income countries due to easy storage requirements, an indication of the vital role of such jabs in ramping up supplies to the WHO’s COVAX initiative.

However, Dr Bruce Aylward, Senior Advisor to WHO Director General Dr Tedros Adhanom Ghebreyesus, had flagged more serious concerns, saying “there were a number of inaccuracies in the way the issue was presented.”

Manufacturers will need to cover all bases from the start, as the regulatory process will only get more stringent (and competitive). Today, there are reportedly as many as eight COVID-19 vaccines under WHO EUL consideration. Therefore, regulators can afford to up the ask, to keep pace with evolving understanding of this pandemic’s progress. Manufacturers across the globe must, thus, be allowed time and allocated resources to keep pace with the latest global procedures and data requirements, in real time for rolling reviews.

More importantly, the vaccine sector will have to re-set its expectations. Regulators cannot make exceptions, even in the midst of a health crisis. While geo-political reasons might delay the process, hard data will stand the test of time.

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