The Subject Expert Committee (SEC) has permitted Bharat Biotech to unblind all phase-3 trial participants above 45 years and offer the vaccine to those who received a placebo. The reason: vaccines (including Covaxin) are already available under the immunisation programme, and therefore all the eligible age groups should be unblinded for vaccination.
Considering that recruitment and complete vaccination of all trial participants has been achieved, the drug regulator has to take a decision on the number of cases required for licensing — currently available cases (which is likely to be more than 43), second endpoint of 87 cases or 130 cases as originally planned, for which the … Continue reading Should Covaxin trial continue till 130 cases are recorded?
While it is unclear if pre-existing antibodies to adenovirus vector will affect vaccine efficacy, it is possible that repeated vaccination using adenovirus-based vaccine either as a booster or as annual vaccination, if the need arises, will result in reduced efficacy due to vector immunity.
Interim results of Phase-1 and Phase-2 trials of an inactivated SARS-CoV-2 vaccine carried out in China show that the vaccine is well tolerated, safe, and produced neutralizing antibodies at 14 days after booster vaccination. Over 90% receiving the vaccine developed neutralizing antibodies. Interim results of Phase-1 and Phase-2 trials of an inactivated SARS-CoV-2 vaccine carried out … Continue reading Interim results of phase-1-2 trials find inactivated coronavirus vaccine is safe