NEW DELHI: Ahmedabad-based Zydus Cadila is set to apply for emergency use authorisation of its Covid vaccine candidate, still under the phase 3 efficacy trials, within next few days and it could soon be the fourth available vaccine against coronavirus in India.
If the regulatory approvals come through, the vaccine, being called ZyCoV-D now, will be the first DNA vaccine, licensed for use in humans.
“We are looking to submit the data by the end of May and eventually look for an approval,” company MD Sharvil Patel said in response to queries by this newspaper.
Incidentally though, the company has not published or released results from its phase 1, 2 trials showing safety and immunogenicity of the vaccine though it was submitted to the drug regulator before the last stage trials were started last month.
The company did not reply to our query on why isn’t it making the crucial data public, but Patel insisted that the phase 3 trials of vaccine will be truly representative of the efficacy of the vaccine against many of the known variants as different variants have surfaced in the ongoing wave of the Covid pandemic.
“So, the trial outcomes will have more representative efficacy data than any other vaccine,” he said.
The vaccine, which is to be administered intradermally and in three doses, is being tested in over 28,000 plus volunteers, aged 12-99 years as per the phase 3 trial protocol submitted to the clinical trial registry of India.
Patel, meanwhile, said that the company hopes to supply 5 crore doses by the end of this year. “We are also looking at further scaling up and are also exploring tech-transfers and partnerships,” he said.
Though the hope of another Covid vaccine being available for India, grappling with acute shortage of vaccines while in the middle of a raging pandemic, comes as a welcome news, experts stressed on the need of maintaining due scientific rigour and processes.
“Vaccines need to come with assurance of efficacy and safety and in the absence of clinical trial data to support the same will lead to vaccine hesitancy and lack of trust,” said public health researcher Oommen john.
Health policy expert and bioethicist Anant Bhan pointed out that the country is seeing a spate of emergency use authorisations, but it is extremely important that India continues to ensure that there is quality oversight, and transparency regarding decision making.
“While presumably the regulator has access to phase 1, 2 data, it is crucial for these to also be publicly available. This is important for confidence in the process,” he said.