Everything you need to know about Covaxin's safety
Would the government approve Covaxin if it wasn't a make in India?
Covaxin and Covishield, both the vaccines have been the talk of the town for quite some time now. World's biggest vaccine drive began in India on January 16 and lakhs of people have already been vaccinated since then.
The efficacy of Covaxin, produced by Bharat Biotech, was questioned heavily post its approval. The questions raised spoke about the emergency authorisation of the vaccine before the completion of Phase 3 trials. However, senior officials have assured of its efficacy based on the results produced by its Phase 1 and 2 trials.
Vaccine manufactured by Pfizer and BioNTech is said to have an efficacy of 95 per cent. Whereas, Covaxin and Covishield efficacy is far from less if compared to that of Pfizer vaccine. Covaxin is 60 per cent efficient, whereas Covishield is said to be 70 per cent effective.
Pfizer, being the most efficient vaccine in the market, has reported over 29 deaths in Norway. Fortunately, neither Covaxin nor Covishield has proven to be fatal yet. However, the Phase 3 trials of Covaxin did report severe side-effects. Some also reported breathing problems after taking the first shot of Covaxin in Bhopal.
Despite undergoing all phases, Pfizer has proven to be unsafe for several, which is why the repercussions of passing Covaxin for use without the Phase 3 trials could be calamitous.
Earlier this month after several experts questioned the passing of Covaxin for emergency use, the government clarified saying it is a secondary vaccine and should be utilised only in case of a sudden surge in cases.
However, Covaxin is already being used to vaccinate people across India, despite the drastic decline in coronavirus cases.
Bharat Biotech has advised people not to take 'Covaxin' if they have allergies, fever, bleeding disorder, immune-compromised, or are on medicines, blood thinners that affect the immune system. In fact, in a sheet for recipients and caregivers, the company mentioned that even pregnant and nursing women should not take the vaccine.
This announcement came following deaths of 29 people in Norway after receiving the first dose of Pfizer vaccine.
After two days of immunisation across the country, there were 500 adverse reactions reported.
Despite two reported fatalities, the government claimed that vaccination was not an underlying cause of death.
Bharat Biotech said in case of any Serious Adverse Events (SAV), medically recognised standards of care, in government-designated and authorised centres/hospitals, will be provided to the vaccine recipients.
Compensation for such cases will be paid for by Bharat Biotech International Limited, only if SAV was proven to be causally related to the vaccine. The ICMR will determine the amount of compensation for such adversities.
We were wondering if Covaxin wasn't a make in India product, would the government still approve emergency use without the Phase 3 trials?
(With inputs from IANS)