Covaxin is a candidate for an indigenously developed coronavirus vaccine (archive)
New Delhi:
Covaxin, which is one of three coronavirus vaccine candidates being considered for emergency use authorization in India, induced an immune response and did not record any serious adverse events, the company said Wednesday night when publishing the results of phase I trials.
The vaccine “induced (a) a neutralizing antibody (an immune response)” and was “well tolerated in all dose groups with no serious vaccine-related adverse events,” Hyderabad-based Bharat Biotech, which developed the vaccine in association with the ICMR, it 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 injection site pain, which resolved spontaneously.” added.
The company said a patient vaccinated on July 30 had a fever and headache five days later. Although this was originally classified as a “serious adverse event,” it later tested positive for COVID-19.
Approval for the emergency use of a drug, which is what Bharat Biotech (and two other companies) have requested, can be granted if there is sufficient evidence to suggest that the drug is safe and effective. Final approval is granted only after completion of testing and complete data analysis.
Earlier this month, a committee of health experts did not approve Bharat Biotech’s request for emergency use and asked for more data on the efficacy and safety of the vaccines. The company has not yet released the efficacy data, which is necessary for the emergency use request to be granted.
These data are the result of a combined analysis of three phases of clinical trials. Covaxin is currently in Phase III trials with more than 22,000 volunteers at 18 sites across the country.
However, the center has stressed that this does not mean that the vaccines have been rejected.
“It is standard practice for the government to hold several meetings. The process is expected to take a week or two,” Serum Institute sources told Reuters news agency, seeing that Covishield was also not authorized.
The center has also published guidelines for managing adverse events, admitting Tuesday that there is always “the possibility of an adverse event” after immunization.
The candidate vaccine, which must be stored at temperatures between two and eight degrees Celsius, is compatible with all cold chain requirements of the national immunization program.
This means that it will have an advantage (if approved) over the Pfizer vaccine that must be kept at -70 degrees Celsius, making transport and storage difficult in a country as diverse as India.
Last week, Suchitra Ella, joint managing director of Bharat Biotech, was quoted by the ANI news agency as saying that Covaxin could be available by the first quarter of 2021.
India has reported more than 99.3 billion cases of COVID-19 since the pandemic began in December last year. Of these, more than 1.44 lakh are virus-related deaths and around 3.32 lakh are active cases.
The center has already published guidelines for a coronavirus vaccination campaign that will begin with healthcare and frontline workers (and people over 50.
With input from ANI, Reuters
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