Inactivated vaccines are safest with lesser adverse reactions, amongst all vaccine platforms such as an mRNA-based vaccine, DNA-based vaccine, vector-based vaccine, or live attenuated vaccines, Bharat Biotech has said. In a series of frequently asked questions (FAQs) for its trials, Bharat Biotech said BBV-152 is a whole-virion inactivated SARS-CoV-2 vaccine. Amongst all the vaccine platforms such as an mRNA-based vaccine, DNA-based vaccine, vector-based vaccine, or live attenuated vaccines, etc., the inactivated vaccines are safest, and hence, the adverse reactions are lesser.
It said about 755 participants have been vaccinated in phase 1 & 2 clinical trials. No serious adverse events have been reported to be related to 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. Hence, the participants should follow the below precautions to avoid SARSCoV-2 infection up to 14-days post-second dose of vaccination.
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, and later show the Covid-19 symptoms.
Since there is also an equal chance of getting a placebo for every participant, 50 per cent of the participant will get the placebo, and they may get SARS-CoV-2 infection/Covid-19 any time after vaccination.
Bharat Biotech said in the event of successful evidence of efficacy detected during the interim analysis, participants who received placebo may be provided with vaccination at the end of the study, after getting due approval from the regulatory authorities.
It said that whenever a vaccine gets approval first Health care workers, front-line workers will receive the vaccine. It will take at least 6 months for the 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.
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