Wednesday, June 23, 2021
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Karnataka awaits revised fact sheet to increase Covaxin usage


The vaccine has been used only on healthcare workers so far.

Armed with the Phase 3 results of Covaxin that have shown an interim vaccine efficacy of 81%, the Health Department is waiting for a revised fact sheet from the Drugs Controller General of India (DCGI) to increase the usage of this vaccine across the State.

As of now, Karnataka has utilised just 9,008 (2.5%) of the total 3,56,340 doses of Covaxin it has received. With a shelf life of six months, this stock is set to expire in May. Given this, the Health Department is now working on increasing its usage. There has been a huge demand for vaccination since the second phase was rolled out.

This vaccine, developed by the Indian Council of Medical Research (ICMR) in partnership with Bharat Biotech International Ltd. (BBIL), was dispatched to the State during the first phase of vaccination in January and has been used only on healthcare workers so far.

While the State has seen 21 serious adverse events following immunisation (AEFI) so far, all were post Covishield vaccination. No AEFI has been reported in the State after Covaxin administration.

Arundathi Chandrashekar, State Mission Director, National Health Mission (NHM), told The Hindu on Friday that the department was waiting for a revised fact sheet from the DCGI before distributing Covaxin to more districts. “We will wait for a week for the fact sheet. However, after that even if we do not get the revised fact sheet, we will expand its usage from mid-March. We will utilise the stock before it expires,” she said.

She said the initial apprehensions about Covaxin’s efficacy have been cleared now as the ICMR, two days ago, announced that the interim efficacy as 81%. “The confidence level about this vaccine among people has increased now. Also, Prime Minister Narendra Modi took Covaxin on the first day of the rollout of the second phase. We are planning to distribute it to more districts, including Bengaluru, soon,” she said.

Blood thinner issue

The official pointed out that the ambiguity over the use of Covaxin for those on blood thinners still exists. “However, cardiologists say that people on blood thinners can also safely take this vaccine. So, we are waiting for the revised fact sheet,” she said.

Meanwhile, C.N. Manjunath, nodal officer for labs and testing in the State’s COVID-19 expert committee and director of Sri Jayadeva Institute of Cardiovascular Sciences, said he had spoken to ICMR Director General Balram Bhargava about the need to get the DCGI’s clarification on the safety of Covaxin for those on blood thinners.

“Covishield is considered safe for people taking blood thinners. Likewise, scientifically there should not be any contraindication for taking Covaxin also. However, a consent form needs to be signed before taking Covaxin,” he said. “The fact sheet of Covaxin mentions that this vaccine is relatively contraindicated for people on some type of blood thinners. I have asked the ICMR Director General to get this issue clarified in a revised fact sheet.”

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