Bharat Biotech, the manufacturer of Covaxin, has submitted its phase-3 clinical trial to the Central Drug Standards Control Organisation, claiming nearly 78% efficacy of its Covid-19 vaccine, which is currently being used for mass vaccination in India.
An expert panel under the CDSCO on Tuesday reviewed the data, news agencies claimed quoting unnamed sources, but there was no confirmation from the Union Health Ministry on whether the home-grown vaccine received the final approval from the Drugs Controller General of India.
The Hyderabad-based firm claimed that the indigenous vaccine demonstrated 77.8% efficacy in the final trial conducted on 25,800 subjects.
“The Covid-19 Subject Expert Committee of the CDSCO on Tuesday reviewed the data and accepted it. Their recommendations have been sent to the DCGI now,” PTI reported
Releasing the interim results from phase-3 trials in April, Bharat Biotech and ICMR claimed that Covaxin demonstrated an overall interim clinical efficacy of 78% and 100% efficacy against severe Covid-19 disease.
It is to be noted in the absence of the phase-3 clinical trial data is Covaxin’s biggest stumbling block for getting the World Health Organisation certification.
In the absence of the WHO recognition, those travelling abroad are now advised to take the Covishield jab to get a Covid-19 vaccination certificate.
Bharat Biotech is expected to attend a “pre-submission” meeting on July 23 with the WHO as a part of the process to get the Emergency Use Listing for the made-in-India shot.
Though the meeting will not be a detailed review of the product, the vaccine-maker will have an opportunity to submit a summary on the overall quality of the jab.
It is also to be ntoed that Eleven people who received the AstraZeneca-Oxford Covid-19 vaccine have developed a rare neurological disorder called Guillain-Barre syndrome, clinicians in India and England have reported in two separate studies.
While seven cases were reported from a medical centre in Kerala, where about 1.2 million people were administered the AstraZeneca Covid-19 vaccine, known as Covishield in India, four were reported from Nottingham, UK, in an area in which approximately 700,000 (7 lakh) people received the jab.
In Guillain-Barre syndrome (GBS), the body’s immune system mistakenly attacks part of its peripheral nervous system the network of nerves located outside of the brain and spinal cord.
The two studies, published in the journal Annals of Neurology on June 10, describe an unusual variant of GBR characterised by prominent facial weakness.
The frequency of GBS from the areas where the cases were reported was estimated to be up to 10 times greater than expected, the authors of the two studies said.
In recent developments US Pharma giant Pfizer is in the final stages of an agreement with India to supply anti-Covid-19 vaccines, CEO Dr Albert Bourla said on Tuesday, observing that the domestically manufactured vaccines would be the backbone of vaccinating the Indian people.
Addressing the 15th edition of the India-US Bio Pharma & Healthcare Summit being organised by the US-India Chamber of Commerce, Dr Bourla also said that Pfizer has made a specific plan that the mid and low-income countries, which includes India, will receive at least two billion of such doses.