USFDA decision on Covaxin has no impact on policies in India: V.K. Paul

‘Our regulator has approved this vaccine. We have enough data on safety and efficacy,’ he says

A medical staff seen collecting blood samples for sero survey in New Delhi. File

The rejection by the USFDA (United States Food and Drug Administration) of the emergency use application of Bharat Biotech’s Covaxin has no impact on the policies in India, NITI Aayog member (Health), Dr. V.K. Paul said at a Union Health Ministry press conference on Friday.

“Every country has its parameter for approval of vaccinations for its population despite the world sharing a common scientific framework for approval. India also follows its own regulatory process for approval that is tailor-made for our population. It’s their decision, it should be respected. Our regulator has endorsed this vaccine and there is no impact on use of Covaxin in our national programme,’’ he stated, noting that Covaxin phase-3 clinical trial data would be published in the next 7-8 days.

“We expect that the Covaxin manufacturers will be able to comply with the regulators’ requirement. Our regulator has approved this vaccine. We have enough data on safety and efficacy,’’ he asserted.

Dr. Paul stressed that doctors should not insist on prescribing Liposomal Amphotericin-B. Standard Amphotericin-B could be used in otherwise healthy people without pre-disposed kidney condition to treat mucormycosis. “This would ensure that we have a robust availability of this drug,’’ he pointed out.

Next sero survey

With the Health Ministry saying on Friday that India was now showing indications of an improving COVID-19 scenario, Dr. Paul said the Indian Council of Medical Research (ICMR) was preparing for a national survey. “The ICMR will begin work for next sero survey this month. But if we want to protect our geographies, we won’t have to depend on national sero survey alone, we’ll have to encourage States for sero surveys too,’’ he observed.

Suggestions to reduce the gap between the two doses of Covishield and non-requirement of vaccination for those who have recovered from COVID-19 “are welcome.” “Revisions can be made as per data analysis and consultations,’’ he added.

In a release on Friday, the Union government said reports on keeping the vaccine wastage below 1% was unrealistic and undesirable.

“Each dose saved means vaccinating one more person. India is using the COVID-19 Vaccine Intelligence Network (Co-WIN) with the inbuilt eVIN (Electronic Vaccine intelligence network) system, a digital platform, which not only registers the beneficiaries but also tracks the vaccines and facilitates real-time monitoring of storage temperatures across 29,000 cold chain points across the country,’’ it stated.

‘Open vial policy’

The vaccines being used now did not have an ‘open vial policy’ i.e., they have to be used within a stipulated time once a vial was opened. The vaccinator was advised to mark the date and time of opening each vial and all opened vaccine vials should be used/discarded within four hours of opening.

“Several States have organised COVID-19 vaccination in such a way, that not only is there no wastage but they are able to extract more doses from the vial and thus show a negative wastage. Hence, the expectation that vaccine wastage should be 1% or less is not at all unreasonable. It is reasonable, desirable and achievable,’’ said the release.

Further, all the States/ UTs have been advised that each vaccination session was expected to cater to at least 100 beneficiaries. However, in the case of remote and sparsely populated areas, a State could organise a session for a lesser number of beneficiaries while ensuring that there was no vaccine wastage. A session may be planned only when adequate beneficiaries were available, it stated.