Zydus Cadila plans to get approval in mid-Might
A child runs past a mural depicting health care workers wearing face masks along a street in New Delhi, India on March 21, 2021.
Sajjad Hussain | AFP | Getty Images
India could soon get its second domestically developed coronavirus vaccine, even if a deadly second wave shows no signs of slowing anytime soon.
Drug company Cadila Healthcare, also known as Zydus Cadila, is conducting phase 3 clinical trials of its DNA-based vaccine candidate in 28,000 people, including those over the age of 75 and children between the ages of 12 and 18.
“We have completed the main recruitment for our third phase (study),” Managing Director Sharvil Patel told CNBC’s “Street Signs Asia” on Thursday.
He said the company expects the efficacy data from the Phase 3 trial to be released next month. After that, it will seek approval for an emergency from the Indian Medicines Agency in mid-May.
“In terms of safety and efficacy in our second phase (studies) as well as the ongoing phase three, we’ve seen very good safety data and strong immunogenicity data, comparable to most other vaccines out there,” said Patel.
India started its vaccination campaign in January, and as of Thursday, government data showed that more than 150 million doses had been administered. However, only about 25.8 million seconds were administered.
India is currently using the AstraZeneca vaccine known locally as Covishield and manufactured by the Serum Institute of India and Covaxin by Bharat Biotech.
New Delhi also recently approved the Sputnik V developed in Russia and approved overseas-made vaccines that have received emergency clearance from the agencies listed in the US, UK, European Union, Japan and World Health Organization-listed agencies.
Patel told CNBC that Zydus’ candidate uses technology that allows him to quickly modify the vaccine for mutated variants of the virus. The drug maker has a new facility that it plans to use to ramp up production once it has regulatory approval.
“Initially, we will start producing 10 million cans per month. As soon as we look over the next four to five months, we can double the capacity to 20 million cans per month,” said Patel.
1 in 3 new cases from India
In April alone, India reported more than 6.2 million cases and over 42,000 officially counted deaths – reports suggest the death toll may be undercounted.
The World Health Organization said in its weekly epidemiological update on the pandemic that India made up one of three cases reported worldwide last week. In its analysis, WHO said India had 157.4 new cases and 1.1 new deaths per 100,000 people.
On Thursday, data from the Indian Ministry of Health showed that there were 379,257 new cases. The death toll has risen this month, and the latest official figure says at least 3,645 more people have died within 24 hours.
Experts fear that a mutated variant of the coronavirus is responsible for the dramatic increase in some cases. The WHO said in its weekly update that reports suggest that there are several variants of the virus floating around in India.
The international community has pledged resources to help India tackle its second wave. The United States is sending more than $ 100 million worth of shipments “in the coming days” to ease pressure on India’s sprawling healthcare system.
The US will provide India with oxygen concentrators, oxygen generating units, personal protective equipment, vaccine manufacturing supplies, rapid diagnostic tests and therapeutics, and public health support, according to a White House statement on Wednesday.
Meanwhile, economists are revising their forecasts for India’s economic recovery in light of the second wave.
Rating agency S&P Global Ratings said the outbreak poses downside risks to GDP and increases the possibility of business disruption. A protracted outbreak “could cause us to revise our base assumption of 11% growth from fiscal 2021/2022, especially if the government is forced to reintroduce extensive containment measures,” S&P said.