Emergency Use Authorisation of COVID-19 Vaccines

The world, in general, and India, in particular, have arrived at a unique moment in biomedical history, in the middle of a most unusual pandemic. Our part in it, India’s epidemic, began in March, and nine months later, in December, three vaccines are under consideration with the Drugs Controller General for emergency use authorisation (EUA). Such speed could not be predicted in the past, but dire need is the mother of invention. The three are: one Indian (Covaxin, inactivated coronavirus with unique adjuvant; Bharat Biotech), one foreign (BNT162b2, Spike protein messenger RNA in lipid nanoparticle envelope; Pfizer-BioNTech), and one India-made foreign vaccine (Covishield, Spike protein RNA gene’s reverse transcripted DNA in vector virus, chimpanzee adenovirus type 5, replication disabled; Serum Institute of India).

The biotechnology behind all three is cutting edge, state of the art. The Covaxin adjuvant enhances both antibody and T-cell responses. Inactivated virus as vaccine is a conventional idea, and theoretically safe from any serious adverse reaction. Although mRNA has been in use to tailor personalised anti-cancer immunity, never before has it been used in a vaccine against an infectious disease. A vector-mediated DNA vaccine is not a new idea, but is unprecedented in a vaccine candidate that has reached human trials. These biologics are a testament to the great advances in human understanding and skills in science.