A concern often raised on medicines is now being brought up in the context of vaccines. How does a medical product that runs into regulatory issues internationally, continue to be safe for the domestic market?

The query comes up this time against the backdrop of weekend developments, where the World Health Organization (WHO) said it suspended supply of Bharat Biotech’s Covaxin through United Nation agencies. The WHO statement did add that the vaccine was effective and had no safety concerns, going by the data available with it. But that, however, did not stop the questions.

Vaccines are at the top of the pecking order, so to speak, followed by biologicals and pharmaceuticals, says a veteran regulatory-hand familiar with requirements in all three categories.

Without getting into specifics on Covaxin, the expert said that in a post-regulatory-approval scenario, companies face challenges when the scale of manufacturing increases and “deviations” begin to take place from the original commitment to the authority. These deviations may have been undertaken locally following a risk-based assessment that it did not affect the final safety and quality of the product, he said.

Timelines are difficult to predict, but depending on the deficiencies identified, the initial remedial process could take anywhere between two weeks and two months, the expert said. And that is provided the agency inspecting the plant approves of the measures initiated.

Facility upgradation

Neither the WHO or Bharat Biotech have outlined the exact nature of the problem. The WHO said its suspension was in response to the outcomes of a WHO post-EUL (emergency use listing) inspection (March 14–22) and “the need to conduct process and facility upgrade to address recently-identified GMP (Good Manufacturing Practices) deficiencies.”

The vaccine-maker did tell the WHO team that the improvement activities required of them would be “executed as soon as practical”. The corrective plan would have to be submitted to the Drugs Controller General of India (DCGI) and the WHO. The DCGI and the Indian Council of Medical Research (ICMR) have not made a public statement on the latest development on Covaxin. ICMR was a collaborator on developing the vaccine and over 30 crore doses have currently been administered in India. ​​

In fact, Bharat Biotech had pre-empted the WHO statement, giving an inkling of things to come. Announcing that it was temporarily slowing down production of Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies, the company said that it was going to focus on “pending facility maintenance, process and facility optimisation activities.”

Pointing out that the repurposed facilities were continuously producing last year, to meet the requirements of the health emergency, the company had said, “Certain highly sophisticated equipment which were required to enhance the process stringency were unavailable during the Covid-19 pandemic.” It, however, added, the quality of Covaxin was never compromised. “For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine,” the company said.

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