Bharat Biotech, SII asks DCGI to change Covaxin, Covishield fact sheet on blood thinners respectively
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New Delhi: India's drug regulatory body has received requests from both Pune based Serum Institute of India and Hyderabad-based Bharat Biotech to make necessary changes in the vaccine fact sheet to allow people using blood thinners to get inoculated against Covid-19, Indian Council of Medical Research (ICMR) said on Thursday.
The Drugs Controller General of India (DCGI) has given restricted emergency use approval to SII's vaccine Covishield and Bharat Biotech's Covaxin.
"There is no contraindication in administering COVID-19 vaccines to those who on blood thinners such as Aspirin and Clopidogrel. Both the pharma companies have written to the DCGI regarding changing this point and that will happen very soon," Dr Balram Bhargava, Director General of Indian Council of Medical Research (ICMR) said.
Bhargava was responding to a query during a press briefing of the Union Health Ministry today.
While clarifying a query about contraindication in administering COVID-19 vaccines to people on blood thinners, the ICMR DG said that relative contraindication regarding blood thinners are mentioned in the factsheets of both the vaccines -- Covaxin and Covishield.
Bhargava said there are two categories of blood thinners--anti-platelets and anti-coagulants.
ICMR chief added that for blood thinners like aspirin and clopidogrel, there is no contraindication and that will be corrected in the fact sheet once the drug regulator would give permission for the same.
"Anti-platelet medicines like aspirin and clopidogrel, are not a problem at all. The second anticoagulants like heparan are for patients whose tendency to bleed is much higher. The only worry is, these (patients) can suffer local hematoma or local swelling at the site of the injection. It is a very relative contraindication. These anticoagulants can be stopped for one or two days before giving the vaccine," Bhargava said.
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