On 1 July, Zydus Cadila announced that it has applied to the Drug Control General of India (DGCI) for emergency use authorisation of its COVID-19 vaccine, ZyCoV-D.
If approved, the 3 dose covid vaccine, ZyCoV-D, will become the world's first plasmid DNA COVID vaccine to be given authorisation.
According to a statement released by the company, the interim results of the phase 3 trials shows the vaccine has an efficacy of 66.6 percent in preventing symptomatic illness and a 100 percent efficacy when it comes to moderate illness.
This is also the first time that a COVID vaccine has been tested on children between the ages of 12 and 18 in India.
What Do We Know About the Phase 3 Trials?
Zydus Cadila hasn't yet released peer reviewed data of their vaccine's phase 2 and 3 clinical trials.
Speaking at a press conference, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, they were aiming to release the data within the next 4 to 6 months.
From the information released so far, this is what we know about the phase 3 trials.
It is a double blind placebo trial.
The trial involved 28000 participants in 50 clinics across the country.
Around a 1000 of them were children between the ages of 12 -18.
Interim results of the trial have found the vaccine to have 66.6 percent efficacy against symptomatic illness.
No moderate or severe cases of covid were observed in the vaccine sub group of the trial.
Some FAQs About the Vaccine, Answered
What is the recommended gap between the three doses?
Speaking at the press conference, Dr Sharvil Patel said that the 3 dose vaccine will be administered with a gap of 28 days and 56 days respectively.
He also added that their 2 dose vaccine (also in the works) is to be taken with a gap of 28 days.
How is the vaccine administered?
According to the company, the Zydus vaccine is administered using the The PharmaJet® is a jet injector capable of delivering the vaccine without needles.
When will ZyCoV-D be available in India?
No clear timeline has been presented for the availability of the vaccine for use.
According to Dr Patel, although it is too soon to say, the company aims to start scaling up production by the end of this month, and that they hope to roll out the first batch in 45 -60 days.
Zydus Cadila has also said that they plan to produce 10 to 12 crore doses annually.
Can pregnant and lactating women take the vaccine?
As per the government's latest recommendation, pregnant and lactating women have been encouraged to take the available COVID-19 vaccines.
This includes all the vaccines approved for emergency use in the country.
When asked about conducting safety and efficacy clinical trials on pregnant and lactating women, Dr Patel said that although it is needed, no such plans have been made by the company for the near future.
He also added that although they don't have the data now, they hope to release internal data regarding the safety and efficacy of the vaccine in participants who might have become pregnant during the clinical trials.
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