Hyderabad: The Hyderabad-based vaccine-maker, in a fact sheet for recipients and caregivers, said that even pregnant and nursing women should not take the vaccine.
People who have taken another Covid-19 vaccine or are suffering from any other serious health-related issues should also not take Covaxin.
Bharat Biotech reiterated that the Drugs Controller General of India (DCGI) had authorised the “restricted use of Covaxin under clinical trial mode”.
“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,” says the fact sheet that surfaced on Tuesday.
Company sources told IANS that the fact sheet was issued last week.
“As with any new medicine, this vaccine will be closely monitored to allow quick identification of any new safety information,” said Bharat Biotech. Side effects can be reported to toll-free number 18001022245.
The vaccine-maker said that in phase 1 and 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against Covid-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trial.
In phase 1 and 2 trials, 680 people were administered two doses each of Covaxin. The phase 3 clinical trial with 25,800 participants is on. The first dose was administered to them on January 6.
In the ongoing clinical trial, Covaxin has shown to generate immunity following two doses given four weeks apart, the firm said.
Covaxin, which Bharat Biotech developed in collaboration with the Indian Council of Medical Research and National Institute of Virology, and ‘Covishield’, developed by Oxford University and pharmaceutical company AstraZeneca and manufactured by Serum Institute of India at Pune, have been cleared by the DCGI for emergency use. Both the vaccines are in use during the nationwide immunisation programme launched on January 16.
The move to include Covaxin even before the publication of data from its phase 3 trial had come under criticism from some quarters. However, the regulator had defended the decision by saying that both the vaccines were totally safe.
Over 500 adverse reactions were reported from across the country during two days of immunisation. Two deaths were also reported but the government clarified that these were not related to vaccination.
Bharat Biotech said in case of any Serious Adverse Events (SAV), vaccine recipients will be provided medically recognised standards of care in government-designated and authorised centers/hospitals. Compensation for serious adverse event will be paid by Bharat Biotech International Limited and if SAV is proved to be casually related to the vaccine. The compensation amount will be determined by the ICMR Central Ethics Committee, it added.