Context
Ahmedabad-based ZydusCadila has applied to Central Drugs Standard Control Organisation (CDSCO), the national drugs regulator, seeking emergency use authorisation (EUA) for ZyCov-D, its Covid-19 vaccine.
- If approved by the regulator, ZyCov-D will be the world’s first DNA vaccineagainst infection with SARS-CoV-2.
About the ZyCov-D vaccine
- ZyCov-D is a “plasmid DNA”
- It uses a genetically engineered, non-replicating version of a type of DNA molecule known as a ‘plasmid’.
- The plasmids used in the vaccine are coded with the instructions to make the spike protein of SARS-CoV-2.
- Vaccination gives the code to cells in the recipient’s body, so they can begin making the spiky outer layer of the virus.
- The immune system is expected to recognize this as a threat and develop antibodies in response.
- ZyCov-D will be given in three doses, with an interval of 28 days between the first and second and second and third shots.
- No needle is used to deliver the vaccine, instead, a spring-powered device delivers the shot.
- ZyCov-D has been developed with the support of the central government’s Department of Biotechnology and the Indian Council of Medical Research (ICMR).
Safety concerns
- Safety concerns to integrate into cellular DNA or cause auto-immune diseases.
Emergency Use Authorization
- In the current pandemic situation, it may not be possible to have all the evidence that a drug regulator would normally require for approving a drug, vaccine, device or test.
- When there is a declared emergency, the regulator, in India’s case the DCGI, can take a call whether it is worth releasing a drug or vaccine that is not fully tested for efficacy and safety.
- If there is evidence to suggest it may benefit patients, then the regulator is well within its rights to issue an emergency use authorisation to a medical product to make it widely available for use.
Vaccines approved under the EUA
- The process for using the EUA is less clearly spelt out in India, but the DGCI has also been issuing EUAs based on clinical trial data.
- In January, the DCGI approved the first two vaccines
- Covishield, produced by Pune-based Serum Institute of India under licensing agreement from AstraZeneca
- Covaxin, manufactured by Bharat Biotech
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