Zydus applies for approval of its 3-dose, needle-free COVID-19 vaccine

(MENAFN- NewsBytes) Zydus Cadila, the Gujarat-based drug firm, has applied for the Emergency Use Authorization (EUA) of its COVID-19 vaccine to the Drugs Controller General of India (DCGI), the company said today. If and when approved, the vaccine, named ZyCoV-D , will become the world's first DNA vaccine against the coronavirus and the fifth jab to get the nod in India.

• Jab is 66.6% effective against symptomatic cases, Zydus says
• It could be India's first COVID-19 vaccine for children
• ZyCoV-D is a 3-dose, needle-free vaccine
• Vaccine is effective against the Delta variant: Zydus
• India has administered over 33 crore vaccine shots
• 20% Indians partially vaccinated, 4% fully inoculated
• India's coronavirus situation

ZyCoV-D has been found safe and effective in a late-stage trial involving more than 28,000 volunteers across India. Zydus said in a statement its vaccine is 66.6 percent effective against symptomatic cases of COVID-19 and 100 percent effective against moderate disease. "No severe cases or deaths due to COVID-19 occurred in the vaccine arm after administration of second dose of the vaccine," it stated.

The trial also included 1,000 subjects in the 12-18 year age group, according to the company, implying that an approval for ZyCoV-D could make it India's first permitted coronavirus vaccine for adolescents .

ZyCoV-D is a DNA vaccine. It contains such genetic material that will instruct the human cells to produce coronavirus antigen. It is also reportedly the first COVID-19 vaccine with a three-dose regimen. The second and third doses are required to be given 28 and 56 days after the first, respectively. Zydus says the vaccine can be applied through a "needle-free" system.

According to Zydus, its vaccine is effective against the Delta variant of the coronavirus, which drove India's deadly second wave . It said phase three trials were carried out through the outbreak of Delta variant. The study was done "during the peak of second wave of COVID-19 (in India), reaffirming the vaccine's efficacy against the new mutant strains especially the Delta variant," the company said.

Zydus may soon become the fifth jab to be approved in India and the second approved indigenous coronavirus vaccine. India has so far granted approvals to Oxford-AstraZeneca's Covishield, Bharat Biotech's COVAXIN, Russia's Sputnik V, and the US-made Moderna vaccine . India began its coronavirus vaccination program in January and has since administered over 33 crore vaccine shots.

Even though 20% of Indians have received at least one vaccine shot, just above 4% have been fully inoculated as yet. That's partly because India's most prevalent vaccine has a dose gap of at least 12 weeks.

India had faced the world's worst coronavirus outbreak over the past couple of months. Daily cases in the country had peaked at 4,14,000 in early May. The situation has since improved, with new infections hovering around 50,000 over the past few days. However, several experts have warned that a third wave could hit India by October.

MENAFN01072021000165011035ID1102373611

Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.