Covaxin – 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, pre-publication 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 25,800 volunteers between the ages of 18 and 55, according to government data Phase I trials involved 375 participants between the ages of 18 and 55.
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.