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Covaxin & Covishield safe for those on aspirin, vaccine factsheets will be changed — ICMR chief

Bharat Biotech and Serum Institute of India have approached Drugs Controller General of India requesting a change in factsheets on their vaccines that rule them out for those on blood thinners.

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New Delhi: There is no problem in administering Covaxin and Covishield to people who are on blood thinners such as aspirin and clopidogrel, contrary to what currently appears in the factsheets of the two Covid-19 vaccines, Indian Council of Medical Research (ICMR) Director General Dr Balram Bhargava said Thursday.

Both Serum Institute of India (which manufactures Covishield) and Bharat Biotech (the developer and manufacturer of Covaxin), he added, have approached the drug controller to make relevant changes in the factsheets.

According to the Covaxin factsheet that is annexed to the consent form people have to sign before receiving the vaccine, those who are on blood thinners — drugs that impede blood coagulation, both within blood vessels and in case of a bleed — or have bleeding disorders cannot get the shot. For Covisheld, the factsheet asks potential recipients to inform their physicians in advance if they are on blood thinners, even though it is not directly contraindicated for people on blood thinners.

“See, it is about relative contraindication… both companies have written to the Drugs Controller General of India regarding this point (blood thinners) in the print sheet, for a change. That will happen very soon,” Dr Bhargava said in reply to a question from ThePrint at the Union Health Ministry’s Covid briefing.

“Anti-platelets such as aspirin or clopidogrel are not a problem at all. For anticoagulants like heparin, those patients may have a tendency to bleed. There may be a risk of developing a local hematoma. It is a relative contraindication,” he added, drawing a distinction between two kinds of blood thinners — those that act on platelets and those that act on blood-clotting factors.

The anticoagulant in such cases, he said, “can be stopped for one or two days”.

“There is no contraindication for aspirin and clopidogrel and that will be rectified in the factsheet very soon as soon as the drug controller gives permission,” he said.

According to a report of the National Non-Communicable Disease Monitoring Survey 2017-18, 17.4 per cent of Indians are on aspirin, one of the most commonly used blood thinners.

The present factsheet of Covaxin rules these people ineligible for the vaccine. Counted among those living with comorbidities, this group of patients is also likely to be among the priority groups in the coming phases of vaccination.


Also Read: Phase 2 of Covid vaccinations to begin after 60-70% of phase 1, but no date yet


Two states account for 67% active cases

India has shown a steady dip in daily positive Covid-19 cases and the number of active cases. Two states, Maharashtra and Kerala, currently account for 68 per cent of the total active cases. Kerala currently has 72,476 active cases and Maharashtra, 44,624.

India currently has less than 1.75 lakh active cases, of which Kerala accounts for 42 per cent, Maharashtra for 26 per cent, Uttar Pradesh and Karnataka for 4 per cent each, and West Bengal, 3 per cent.

For the first time now, Lakshadweep is also on India’s Covid-19 map. Health Secretary Rajesh Bhushan said: “Till about three weeks ago, Lakshadweep was free from Covid. The one positive case arrived there on ship from Kochi and then it spread to the close contacts of this person. Twenty-three close contacts were identified. All were tested and 14 were found positive. So these 15 have also been physically isolated and it has not spread further. There is no cause for worry on Lakshadweep.”

On walk-in vaccinations, Bhushan said it is possible only for people whose data has been fed into the CoWin app, a government portal released for the vaccination drive.

If someone is not part of the day’s roster at a vaccination centre, they can only get the vaccine if the appointed number of people for the day do not turn up on time, he added. He said states are free to increase the number of vaccination sessions scheduled.


Also Read: How effective are Covid vaccines? Delhi centres to test for antibodies before & after shot


 

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