The Indian government has granted an in-principle approval to two vaccines against Coronavirus, setting the stage for the roll out of the first phase of mass vaccination in the country.
The Subject Expert Committee (SEC) of the Central Drug Standards Control Organisation recommended grant of permission for restricted emergency use of Oxford –AstraZeneca’s vaccine, locally manufactured by Serum Institute of India (SII) as Covishield, as well as Bharat Biotech’s indigenous Covaxin vaccine.
The SEC’s recommendations will now be perused by the Drugs Controller General of India (DCGI), who will grant the final approval. The DCGI is expected to make a statement at 11am on Sunday.
However, neither the two companies nor the government has clarified as to what data was appraised before the approval was recommended to DCGI. Bharat Biotech’s multi-centre Phase-III trial that began mid-November is underway and involves a two-dose regimen 28-days apart. It is not clear yet if the regulator will continue evaluation of clinical trials being carried out by Serum and Bharat Biotech.
The SEC had met on Thursday to appraise Serum Institute’s proposal seeking approval for Covishield, which has been developed and manufactured in India using a master seed from Oxford University-AstraZeneca. SEC approved Covishield for restricted use with certain conditions, which included among others providing a factsheet to those getting the shot and an informed consent form, sources said.
On Saturday, the SEC met again to deliberate on Bharat Biotech Limited’s Covaxin. Curiously, SEC has recommended Covaxin for restricted use on grounds of abundant precaution and in public interest, especially in the context of the mutant strain of Coronavirus that was confirmed by authorities in the United Kingdom over two weeks ago.
Along with recommendations for these two vaccines, the SEC also recommended grant of permission to Ahmedabad-based Cadila Healthcare Ltd. for conduct of Phase-III trials of their vaccine, funded by the Department of Biotechnology.
Accelerated approval for new medicines and drugs is granted following the New Drugs and Clinical Trials Rules, 2019, framed under the Drugs and Cosmetics Act, 1940. The Rules provide a relaxation for skipping Phase-III clinical trials or allow appraisal of limited data.
If the new drug or vaccine shows ‘remarkable efficacy’ with a defined dose in the Phase-II clinical trial and if there are ‘unmet medical needs of serious and life threatening diseases in the country’, then the rules provide a room to recommend 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 crore Indians. The foremost priority among these 30 crore would be given to an estimated one crore healthcare workers and about 2 crore frontline workers belonging to the various police forces, armed forces, municipal workers and volunteers involved in disaster management. Those above 50 years of age and persons with comorbidities below the age of 50 would comprise the remaining 27 crore.
The Centre had asked state governments to create a database of healthcare workers and share it by the end of first week of December.
Data sought by SEC
During an earlier meeting, Serum Institute submitted interim safety data from Phase II/III clinical trials that are underway in India together with interim safety and efficacy results of Phase II/III and Phase III clinical trials done in the United Kingdom.
SII’s vaccine has been developed and manufactured with a master seed from Oxford/AstraZeneca. The SEC had sought updated safety data of the Phase II/III clinical trials in the country along with immunogenicity data from the clinical trial in the UK and India.
Meanwhile, SEC had asked Bharat Biotech to present 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 it is made from a weakened version of a common cold virus (adenovirus), which causes infections in chimpanzees, and it that has been genetically changed so that it is impossible for it to replicate in humans, the University of Oxford had said.
The vaccine type is known as a viral vector type since it uses a harmless virus as a carrier to deliver the genetic material of a pathogen into cells to create an immune response.
In the pre-clinical trials done on monkeys, the vaccine was effective in stopping the Coronavirus infection from progressing to pneumonia. The vaccine protected the monkeys from pneumonia and other serious symptoms but it did not kill the virus.
Bharat Biotech’s BBV 152 has developed an inactivated virus vaccine. This involves a heat killed or dead virus that is used to generate an immune response. The company has used this platform in the past to manufacture Rabies, Japanese Encephalitis and Rotavirus vaccines.