Zydus Cadila seeks approval for world’s first DNA Covid vaccine

Zydus Cadila, a homegrown healthcare and pharmaceutical company, has appealed to the Drug Controller General of India for an emergency use authorization (EUA) for ZyCoV-D, its plasmid DNA vaccine against Covid-19.

If certified, this would be the world's first Covid-19 DNA vaccine.

The vaccine, which was trialled in late-stage human clinical trials encompassing over 28,000 participants, has thus far been found to have a primary efficacy of 66.6 %. This means that it was effective to lessen symptomatic cases of Covid-19 in those who got the vaccine by nearly 67% to the ones who didn't receive a vaccine.

Despite the fact that this efficacy is lower than that of most other Covid vaccines approved in India, ZyCov-strength D's rests in its potency against the Delta version of the virus, according to Zydus Cadila managing director Dr Sharvil Patel.

“The trial was conducted at 50 different clinical sites across the country during the peak of the second wave of Covid-19, reaffirming vaccine efficacy against a new mutant strain, the Delta strain,” Patel said at a press briefing on Thursday evening.

The firm is testing the vaccine against other variants of interest and concern and will determine whether to "upgrade" the vaccine based on the results and whether these other forms become more infectious or virulent.

Reportedly, In India, about 27.61 crore people have received at least one dose of vaccination, with the majority of them receiving Covishield from the Serum Institute of India. On June 30, a little more than 28.61 lakh injections were provided, although vaccines have averaged almost 55.6 lakh doses each day in the 10 days since the new vaccination policy went into effect on June 21.

Zydus Cadila also examined ZyCov-D's safety and potential to elicit an immunological response in a trial involving 1,000 teenagers aged 12 to 18. Yet, it is unclear whether the corporation is pushing for approval for this age range at this time.

Further, the company has been investigating the prospect of utilising a two-dose regimen of ZyCov-D, claiming that this dosing regimen elicited an immunological response "equal" to a three-dose regimen.

According to the company's interim review of its clinical trial data, two doses of ZyCov-D may be adequate to prevent severe disease and death, but three doses may be required to prevent moderate Covid symptoms.

This preliminary investigation looked at 79 to 90 RT-PCR verified positive Covid-19 instances, according to Patel.

Zydus Cadila intends to produce 100 million-120 million doses of ZyCov-D each year, enough for up to 40 million people to receive three doses. Patel states that the company's new vaccine manufacturing plant will be operational by the end of July.

By December, the business aims to have delivered 50 million doses of ZyCov-D to India. This is consistent with the Centre's previous statement to the Supreme Court, which stated that ZyCov-D will account for 50 million of the 1.35 billion doses to be provided to India between August and December of this year.

ZyCov-D operates on a “plasmid DNA” platform, which incorporates a genetically altered version of a plasmid, a type of DNA molecule. Plasmid DNA, like mRNA vaccines, contains code for spike protein, which allows the SARS-CoV-2 virus to infect cells and cause sickness. This is expected to aid the body's immunological response.

Furthermore, the vaccine is also distinct in its delivery technique, as it employs a device that does not require the use of a needle to administer the vaccination solution into the body.

According to Patel of Zydus Cadila, DNA vaccines are “inherently non-infectious, because they lack any viral vectors associated with toxicity, and hence they pose the least danger to vaccine-enhanced diseases due to the lack of infectious agents in them.”