Covaxin in its Phase I trials induced immunity and has shown no serious side-effects as per the interim findings of the trials. Covaxin is one of the three vaccines being considered for emergency use authorisation in India.
The vaccine showed only induced neutralising antibody and it was well-tolerated among all doses groups with no adverse events, the data showed.
The side effects which showed were predominantly mild and moderate which can be resolved without any medication. According to a report, the most common adverse event is pain at the injection site but was spontaneously resolved.
A patient who vaccinated on July 30 had fever and headache five days later. This effect was classified as ” serious adverse event” but he also later tested positive for COVID-19. Bharat Biotech and two other firms have applied for emergency use approval for Covaxin and it can only be granted after completing all phases of trials and its analysis of its results. The vaccine to be safe and effective to be granted for emergency use.
Earlier this month, Bharat Biotech request was not cleared by a committee of health experts as they demanded more data of vaccine’s efficacy and safety. Bharat Biotech has still not released that efficacy data, even though it is required for emergency use approval.
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.
Another vaccine Covishield also didn’t get approval and according to the centre this does not mean that these 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 told news agency Reuters.
The centre has also released guidelines for the management of adverse events. On Tuesday the government admitted that post-immunisation there is always “the possibility of an adverse event.”
Covaxin needs to be stored at temperatures between two and eight degrees Celsius and is compatible with all national immunisation program cold chain requirements. This vaccine might have an upper hand over Pfizer vaccine which is supposed to be kept at -70 degree Celsius. Such low temperature will be difficult to attain in India’s climate.
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.