ZyCoV-D plasmid DNA COVID vaccine efficacious, safe: Lancet on Phase 3 trials

Medical journal The Lancet published the Phase 3 trial findings of Zydus’ plasmid DNA COVID-19 vaccine on Friday. It stated that the “ZyCoV-D vaccine was found to be efficacious, safe, and immunogenic in a phase 3 trial”.

The journal stated that between January 16 and June 23, 2021, 33,194 individuals were screened, out of which 5,421 did not meet the screening criteria, leaving 27,703 to enroll for the trial. They were randomly assigned to receive the ZyCoV-D vaccine or a placebo. As per protocol, 81 cases were eligible and included in the efficacy analysis that found the ZyCoV-D vaccine to be 66.6 per cent efficient. Adverse events were similar in both the groups, and there was one death each in the groups, which the journal stated, were not considered to be related to the study treatments. 

Zydus, sharing the findings with the BSE, pointed out that the trial was conducted during the peak of the second wave of the COVID-19 infection. The second COVID-19 wave, the result of the Delta variant, was the deadliest in the country. “The efficacy of the vaccine stood at 66.6% at a time when Delta Variant of the SARS COV-2 virus was the prevalent strain across India,” it mentioned in the report. 

“The Plasmid DNA platform also allows generating new constructs quickly to deal with mutations in the virus, such as those already occurring,” the company added.

Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd said “We are pleased that the outcomes of the Phase III trial of ZyCoV-D have been peer reviewed and published in The Lancet. This attests to the compliance with the global best practices and stringent peer review parameters of clinical trials.” 

All about ZyCoV-D vaccine:

• ZyCoV-D is an intradermal vaccine
• It is administered in three doses, 28 days apart
• It is administered using the PharmaJet needle free system or a needle-free applicator
• The needle free system has been found to reduce local side effects
• ZyCoV-D needs to be stored at 2-3 degree Celsius
• It has also shown good stability at 25 degree Celsius for three months
• The thermostability of the vaccine will help in easy transportation and storage

In December last year, Prime Minister Narendra Modi had given the Emergency Use Authorisation for the supply of 1 crore doses of the ZyCoV-D vaccine. Zydus Cadila received an order to supply 1 crore doses to the government at a price of Rs 265 per dose, with the needle-free applicator at Rs 93 per dose, without GST. 

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