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, the company said Wednesday evening as it released results of Phase I trials.
The vaccine “induced (a) neutralising antibody (an immune response)” and was “well-tolerated in all dose groups with no vaccine-related serious adverse events,” Hyderabad-based Bharat Biotech, which developed the vaccine in association with the ICMR, said in its statement.
“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,” it added.
The company said 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 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 for use) over the Pfizer vaccine that needs to be stored at -70 degrees Celsius, making transportation and storage a difficult proposition in a country as diverse as India.