The subject expert committee (SEC) committee of the Indian drug regulator has recommended the approval of Zydus Cadila's three-dose COVID-19 vaccine, ZyCoV-D, for emergency use authorization (EUA), according to a report. Also, the committee has sought additional data from Zydus about the 2-dose regimen of the vaccine.
Citing sources, CNBC-TV18 tweeted about that the SEC's recommendation on Friday. If ZyCoV-D receives the EUA, it will become only the second indigenously-developed COVID-19 vaccine to be cleared for administration. The vaccine was developed by Zydus Cadila (listed as Cadila Healthcare Ltd) in association with the Department of Biotechnology and the Indian Council of Medical Research.
Seeking Emergency Use Approval
As of now, only four COVID-19 vaccines have received the nod—Bharath Biotech's Covaxin, Covishield, Russian-made Sputnik V, and Moderna (from the US). A EUA will also make ZyCoV-D the only DNA vaccine in the world to be approved for use against the SARS-CoV-2 virus.
The company—which is based in Ahmedabad—had applied for EUA from the Central Drugs Standard Control Organisation (CDSCO) on July 1 for ZyCoV-D. This was on the basis of an efficacy rate of 66.6 percent in a late-stage trial involving over 28,000 volunteers across the country in over 50 centers.
Also, the trial involved around 1000 volunteers between 12-18 years of age, making it the first COVID-19 vaccine trial in India to include the age group. According to Zydus, the vaccine was found to be safe in children. The drugmaker stated that it has also analyzed a regimen of the vaccine involving two doses of 3 mg each; for which additional data has been asked for by the SEC.
Different from the Rest
#CNBCTV18Exclusive | Subject Expert Committee recommends EUA for ZyCoV-D; Cadila Health’s 3-dose COVID vaccine, sources tell us.
— CNBC-TV18 (@CNBCTV18Live) August 20, 2021
Zydus application claims efficacy of 66.6%. SEC is of a view that Zydus needs to submit additional data for 2-dose vaccine. pic.twitter.com/OH9hI0Z79c
What makes ZyCoV-D unique is that it is a plasmid DNA vaccine. It uses a non-replicating and a non-integrating plasmid carrying a 'gene of interest'. Therefore, the DNA sequence introduced will match that of the novel coronavirus. It produces the spike protein—the structure that the SARS-CoV-2 virus uses to invade cells—in order to induce immune responses. Without vector response and with the absence of an infectious agent, the Zydus DNA platform makes the manufacturing of the vaccine easy with minimal requirement for biosafety(BSL-1).
Additionally, ZyCoV-D is an intradermal vaccine (i.e) it does not require a needle for delivery. A spring-powered device caller PharmaJet delivers the contents of the vaccine as a thin jet that penetrates the skin; ensuring painless delivery. It can be stored at 2-8 C and at 25 C for a period of up to three months.
The vaccine is said to have demonstrated efficacy of 66.6 percent against symptomatic cases of COVID-19 and 100 percent in moderate cases. Zydus also said that no severe cases or deaths due to the disease occurred following the administration of the vaccine's second dose.
