The vaccine induced (a) neutralising antibody (an immune response) and was well-tolerated in all dose groups with no vaccine-related serious adverse events
New Delhi:
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, administered on an accelerated scheduled of two doses two weeks apart (rather than four), induced a neutralising antibody (an immune response) and was well-tolerated in all dose groups with no vaccine-related serious adverse events, a research document accessed by NDTV showed.
The document showed that 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 said it needed more data on vaccine efficacy and safety before clearing Covaxin for emergency.
However, the centre has stressed that this does not mean the vaccines have been rejected.
Vaccine efficacy data is the result of a combined analysis of the results of three phases of clinical trials. The results of a single phase (in this case Phase I) do not permit an assessment of the drug’s efficacy – which needs more extensive Phase III trials – the document accessed by NDTV stressed.
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.
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.
