Zydus to seek approval for its COVID-19 vaccine next week
What's the story
Zydus Cadila, the Gujarat-based drug firm, will next week apply for the emergency use authorization (EUA) of its COVID-19 vaccine in India, company sources told the media, adding it has apprised the government of its intention. If and when approved, the vaccine, named ZyCoV-D, will become the world's first DNA vaccine against the coronavirus and the fourth jab to get the nod in India.
Details
Data from Zydus's phase three trial is nearly ready
Data from the company's latest clinical trial is now almost ready, a source told PTI. "Zydus Cadila has told the government that it could apply for emergency use authorization for ZyCoV-D vaccine in the next seven-eight days," news agency ANI quoted a government source as saying. Zydus had enrolled more than 28,000 volunteers for their phase three trial, according to a top government official.
Details
It is reportedly the first COVID-19 vaccine with 3 doses
What makes this vaccine distinct from other jabs approved around the world is it is a DNA vaccine, implying it contains such genetic material that will instruct the human cells to produce coronavirus antigen. It is also reportedly the first vaccine with a three-dose regimen. The second and third doses are required to be given 28 and 56 days after the first, respectively.
For children
It could be India's first approved jab for children
Zydus's phase three trial also included children aged between 12 and 18 years. Hence, if this vaccine gets the due approval from the Drugs Controller General of India (DCGI) - it could go on to become the country's first approved jab for the below 18 population. Bharat Biotech is also notably carrying out trials on children, but they are still in an initial phase.
Other details
It does not require ultra-cold temperatures
ZyCoV-D has been supported by the central government's National Biopharma Mission (NBM) under the aegis of the Biotechnology Industry Research Assistance Council, a public sector undertaking. Reports say the vaccine can be stored at two to four degree Celsius and does not require cold chains, which will potentially make its transportation to remote areas of the country easier and cheaper.
Quote
'We are very proud of their work,' government official says
The Indian government has praised Zydus's efforts in giving India its second indigenous COVID-19 vaccine. "We expect they will submit the results very soon...We are very proud of their work," Dr. VK Paul, who is overseeing the country's COVID-19 fight, told ANI.
Production capacity
Zydus could provide about 5 crore doses by December
However, even if Zydus earns the go-ahead from India's top drug regulator, it would not be a huge addition to India's ambitious inoculation program, in terms of volume. That is because of the company's relatively limited manufacturing capacity. The government says the firm could provide around five crore vaccine doses between this August and December.
Vaccination in India
Nearly 16% Indians are partially vaccinated
India has three approved coronavirus vaccines - COVAXIN, Oxford-AstraZeneca's Covishield, and Russia's Sputnik V. More than 26 crore vaccine doses have been administered in India, however, only 3.5% of the population is fully vaccinated. That's partly because India's most prevalent vaccine has a dose gap of at least 12 weeks. The government aims to inoculate all Indian adults by the end of this year.
Situation
Third wave likely in 6 to 8 weeks, expert warns
India 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 60,000 over the past few days. However, a new wave of COVID-19 could hit India within the next eight weeks, AIIMS chief Dr. Randeep Guleria has warned.