Bharat Biotech, SII approach DCGI for using COVID vaccine on those using blood thinners

New Delhi, Jan 28: ICMR chief Balram Bhargava on Thursday said COVID-19 vaccine manufactures--Bharat Biotech and Serum Institute--have approached the country's drugs regulator to make changes in the fact sheet to permit the use of the vaccine on people using blood thinners.

Responding to a query during a press conference, he clarified that there is no contraindication in administering COVID-19 vaccines to those who are on blood thinners such as aspirin and clopidogrel.

The relative contraindication regarding blood thinners is mentioned in the fact sheet of both the vaccines, Covaxin and Covishield, he said.

"Both the companies have written to the DCGI regarding changing this point and that will happen very soon," Bhargava said.

Oxford COVID-19 vaccine 'Covishield' manufactured by the Serum Institute of India (SII) and indigenously developed 'Covaxin' of Bharat Biotech have been approved by the Drugs Controller General of India (DCGI) for restricted emergency use in the country.

Elaborating further, the ICMR Director General said there are two categories of blood thinners. The first one is 'antiplatelets' such as aspirin and clopidogrel, which is not a problem at all, he said.

"The second category is anticoagulants like heparan, and these patients have a tendency to bleed much higher. The only worry is, there can be local hematoma or swelling can occur where the injection site is. Therefore, it is a very relative contraindication. The anticoagulants can be stopped for one or two days before giving the vaccine.

"But as for blood thinners like aspirin and clopidogrel, there is no contraindication and that will be corrected in the fact sheet as soon as the drugs controller will give permission for the same," Bhargava added.