New Delhi: The inactivated vaccines being developed for Covid 19 are safest and its adverse reactions are lesser, according to Bharat Biotech compares.
Bharat Biotech said, in a series of frequently asked questions (FAQs) for its trials, that BBV-152 is a whole-virion inactivated SARS-CoV-2 vaccine.
The inactivated vaccine compares favourably with other vaccine platforms like mRNA-based vaccine, DNA-based vaccine, vector-based vaccine, or live attenuated vaccines, one report says.
About 755 participants have been vaccinated in phase 1 & 2 clinical trials, it said. No serious adverse events have been reported from the vaccine in phase 1 and 2 clinical trials.
It said vaccination with BBV-152B may protect the participants only after 14-days post-second dose of vaccination.
The participants should follow precautions to avoid SARSCoV-2 infection up to 14-days post-second dose.
Since the participants are vaccinated before the results of the RT-PCR and the ELISA tests are known, there is a chance that the participants with asymptomatic SARS-CoV-2 infection may enter the study, and later show Covid-19 symptoms.
Also, the participants—who are very recently infected with SARS-CoV-2just before the first dose of vaccination, and have viral loads below the limit of detection (LoD) of the RTPCR test kit, may not be detected by RT-PCR—later show the Covid-19 symptoms.
Since every participant has an equal chance of getting placebo and 50 per cent of the participant will get it, they may get SARS-CoV-2 infection/Covid-19 any time after vaccination.
In the event of successful evidence of efficacy during the interim analysis, participants who received placebo may get vaccination at the end of the study, after approval from the regulatory authorities, Bharat Biotech said.
Following approval, first Health care workers, Front line workers will receive vaccine. It will take at least 6 months for elderly (more than 65 years to receive the vaccine).
It will take a minimum of 6-12 months for a person under the ages of 60 to receive a vaccine, due to limited supply.
"If you participate in this trial, this vaccine will most likely get licensed within a few months. And if you received a placebo, we will contact you and give you the vaccine, thus giving you priority access to the vaccine (even if you are below 60 years)," it said.
IANS report with edits