The phase 1 results for Covaxin are now in the Lancet. Covaxin is the inactivated vaccine by Bharat Biotech, India.
Covaxin – BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel).
The study was conducted at 11 hospitals across India in healthy adults aged 18–55 years. Participants were randomly assigned to receive either one of three vaccine formulations (3 μg with Algel-IMDG, 6 μg with Algel-IMDG, or 6 μg with Algel) or an Algel only control vaccine group.
Safety summary:
- The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events.
- The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]).
- All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose.
- One serious adverse event of viral pneumonitis was reported in the 6 μg with Algel group, unrelated to the vaccine.
Article link: https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30942-7/fulltext#sec1
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