With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots here.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the CDSCO will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine, official sources said.
The process of granting emergency use approval for Bharat Biotech's COVID-19 vaccine 'Covaxin' may take time as its phase 3 trials are still underway, while Pfizer is yet to make a presentation.
"Going by this, Oxford vaccine 'Covishield' is likely to be the first to be rolled out in India," a source said.
Serum Institute of India (SII) last week also had submitted some additional data required by the Drug Controller General of India (DCGI), the sources said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Amid fears about the mutated variant of SARS-CoV-2 detected in the UK, government officials recently said that it will have no impact on the potential of emerging vaccines that are being developed in India and other countries.
Bharat Biotech, Serum Institute of India (SII) and Pfizer had applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their COVID-19 vaccines early this month.
The subject expert committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on December 9 had sought additional safety and efficacy data for COVID-19 vaccines of SII and Bharat Biotech after deliberating upon their applications.
The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation as the company had sought more time for making a presentation before the committee.
The Pfizer vaccine has already been approved by several countries including the UK, the US, and Bahrain.
While considering SII's application, the SEC had recommended that the firm should submit an updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA.
As for Hyderabad-based Bharat Biotech, "after detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration", the SEC had said.
The Pune-based SII, the world's largest vaccine manufacturer, has made a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
The SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from the DCGI, officials recently had said.
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