The Government of India has granted approval in principle to two vaccines against Coronavirus
, setting the stage for the deployment of the first phase of mass vaccination in the country.
The Subject Matter Expert Committee (SEC) of the Central Organization for the Control of Medicines Standards recommended the granting of permission for the restricted emergency use of the Oxford-AstraZeneca vaccine, manufactured locally by the Serum Institute of India (SII) as Covishield as well as the indigenous Covaxin vaccine from Bharat Biotech.
The SEC’s recommendations will now be examined by the Comptroller General of Drugs of India (DCGI), who will grant final approval. The DCGI is expected to make a statement at 11 a.m. Sunday.
However, neither the two companies nor the government have clarified what data was evaluated before DCGI was recommended for approval. The multicenter Phase III trial of Bharat Biotech that began in mid-November is ongoing and involves a two-dose regimen 28 days apart. It is not yet clear whether the regulator will continue to evaluate the clinical trials Serum and Bharat Biotech are conducting.
The SEC had met on Thursday to evaluate the Serum Institute’s proposal for approval for Covishield, which has been developed and manufactured in India using a master seed from the University of Oxford-AstraZeneca. The SEC approved Covishield for restricted use under certain conditions, including but not limited to providing a fact sheet to those who received the vaccine and an informed consent form, the sources said.
On Saturday, the SEC met again to deliberate on Covaxin from Bharat Biotech Limited. Interestingly, the SEC has recommended Covaxin for restricted use for reasons of great caution and in the public interest, especially in the context of the mutant strain of Coronavirus That was confirmed by the UK authorities more than two weeks ago.
Along with the recommendations for these two vaccines, the SEC also recommended the granting of permission to Ahmedabad-based Cadila Healthcare Ltd. to conduct phase III trials of its vaccine, funded by the Department of Biotechnology.
Accelerated approval of new drugs and drugs is granted following the New Drugs and Clinical Trials Rules of 2019, framed in the Drugs and Cosmetics Act of 1940. The Rules provide relaxation to skip Phase III clinical trials or allow for evaluation of limited data.
If the new drug or vaccine shows ‘remarkable efficacy’ with a dose defined in the phase II clinical trial, and if there are ‘unmet medical needs for serious and life-threatening diseases in the country’, then the rules provide space to recommend the approval .
The approval paves the way for the first phase of mass vaccination against the infection. In the first phase, the government has planned to inoculate 30 million Indians. The top priority among these Rs 30 million would be given to approximately one million million health workers and around 2 million front line workers belonging to the various police forces, armed forces, municipal workers and volunteers involved in the management disaster. Those over 50 and people with comorbidities under 50 would comprise the remaining Rs 27 million.
The Center had asked state governments to create a database of healthcare workers and share it by the end of the first week of December.
Data requested by the SEC
During a previous meeting, the Serum Institute presented interim safety data from the phase II / III clinical trials being conducted in India along with interim safety and efficacy results from the phase II / III and phase III clinical trials. III made in the UK.
The IBS vaccine has been developed and manufactured with an Oxford / AstraZeneca master seed. The SEC had sought updated safety data from phase II / III clinical trials in the country along with immunogenicity data from the clinical trial in the UK and India.
Meanwhile, the SEC had asked Bharat Biotech to submit safety and efficacy data from the ongoing phase III clinical trial in the country for further consideration.
What are these vaccines?
The Oxford vaccine is called ChAdOx1 nCoV-19 and is made from a weakened version of a common cold virus (adenovirus), which causes infections in chimpanzees, and which has been genetically modified to make it impossible for it to replicate in humans. the University of Oxford had said.
The type of vaccine is known as a type of viral vector, as it uses a harmless virus as a carrier to transport the genetic material of a pathogen into cells to create an immune response.
In preclinical trials in monkeys, the vaccine was effective in stopping the Coronavirus infection of progression to pneumonia. The vaccine protected the monkeys from pneumonia and other serious symptoms, but did not kill the virus.
BBV 152 from Bharat Biotech has developed an inactivated virus vaccine. It is a killed or heat-killed virus that is used to generate an immune response. The company has used this platform in the past to make vaccines against rabies, Japanese encephalitis, and rotavirus.
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