Another announcement was made by the Hyderabad based Bharat Biotech International Private Limited over the use of COVAXIN.
The Bharat Biotech said the India made COVAXIN for the Novel Coronavirus or COVID-19 infection should not be taken if suffering from allergies, fever, bleeding disorder, on blood thinners, immune-compromised or having any other medicines that affect the immune system.
The pharma company also advised minors, pregnant women and nursing women not to take the doses of COVAXIN.
Bharat Biotech said the Drugs Controller General of India (DCGI) had authorised the “restricted use of Covaxin under clinical trial mode.”
On the 19th of January, the Hyderabad based Bharat Biotech issued a fact sheet. The sheet read, “Individuals who are prioritised under the public health programme of the Health Ministry will be covered under this endeavour. Informing the individuals about the offer to vaccinate them with COVAXIN will rest with the respective government programme officials. Those offered Covaxin at pre-specified booths will have the option to receive or reject the administration of the vaccine.”
Bharat Biotech official said, “As with any new medicine, this vaccine will be closely monitored to allow quick identification of any new safety information.”
In addition, the company said side effects could be reported to toll free number 1 800 102-2245.
In the ongoing clinical trial of phase III, COVAXIN has shown to generate immunity following two doses given with a gap of two weeks.
In addition, in the two days of nationwide COVID-19 drive, over 500 adverse reactions were reported from across India.
Two deaths were also reported but the Union Government clarified that these were not related to vaccination.
Bharat Biotech said in case of any Serious Adverse Events (SAV), vaccine recipients would be provided medically recognised standards of care in Government designated and authorised centers/hospitals.
Compensation for serious adverse effects would be paid by Bharat Biotech International Limited and if the SAV is proved to be causally related to the vaccine.
The compensation amount would be determined by the Indian Council of Medical Research (ICMR) Central Ethics Committee.
