Covaxin, which is one of three coronavirus vaccine candidates being considered for emergency use authorisation in India, induced an immune response and registered no serious adverse events, interim findings of Phase I trials have revealed.
The vaccine induced a neutralising antibody (an immune response) and was well-tolerated in all dose groups with no vaccine-related serious adverse events, the data showed.
After the first vaccination, local and systemic adverse events were predominantly mild or moderate in severity and resolved rapidly, without any prescribed medication. The most common adverse event was pain at the injection site, which resolved spontaneously.
A patient vaccinated July 30 had a fever and headache five days later. Although this was originally classified as a “serious adverse event”, he later tested positive for COVID-19.
Emergency use approval of a drug – which is what Bharat Biotech (and two other firms) have applied for) can be granted if there is sufficient evidence to suggest the drug is safe and effective. Final approval is granted only after completion of the trials and analysis of full data.
Earlier this month a committee of health experts did not clear Bharat Biotech’s emergency use request, and asked for more data on vaccine efficacy and safety. The company has yet to release efficacy data, which is needed for the emergency use request to be granted.
This data is the result of a combined analysis of three phases of clinical trials. Covaxin is currently in Phase III trials with over 22,000 volunteers at 18 sites across the country.
However, the centre has stressed that this does not mean the vaccines have been rejected.
“It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks,” sources within the Serum Institute, which saw Covishield also not cleared, told news agency Reuters.
The centre has also released guidelines for adverse event management, admitting Tuesday that there is always “the possibility of an adverse event” post-immunisation.
The vaccine candidate, which needs to be stored at temperatures between two and eight degrees Celsius, is compatible with all national immunisation program cold chain requirements.
This means it will have an edge (if approved ) over the Pfizer vaccine that must be kept at -70 degrees Celsius, making transportation and storage difficult in a country as diverse as India.
Last week Suchitra Ella, the joint managing director of Bharat Biotech, was quoted by news agency ANI as saying Covaxin could be available by the first quarter of 2021.
India has reported over 99.3 lakh COVID-19 cases since the pandemic began in December last year. Of these, over 1.44 lakh are deaths linked to the virus and around 3.32 lakh are active cases.
The centre has already released guidelines for a coronavirus vaccination drive that will begin with frontline and health care workers (and people over the age of 50.
With input from ANI, Reuters