The stage is set for the biggest vaccine rollout in India’s history with the Drugs Controller General of India formally approving two vaccines for restricted use under emergency conditions: Covishield by the Serum Institute of India (SII), and Covaxin by Bharat Biotech.
Though other vaccine candidates are in the fray too, these two set a precedent for how future COVID-19 vaccines will be evaluated and administered.
India has been long known as a manufacturer of vaccines but less so as one that can develop from scratch, test and then provide it to the world.
India being as Pharmacy of the world:
- India is largely considered as the global hub for cheap and generic medicines. It is therefore pertinent for this production and supply of generic medicines to continue in order to address major health crisis in poor, least developed, and developing nations.
- The pandemic offers an unprecedented opportunity to establish those credentials, but already a key step of establishing the vaccine’s efficacy in the Indian population before rollout has been side-stepped.
- Vaccines by Bharat Biotech and Serum Institute of India (SII) were formally approved by the Central Drugs and Standards Committee (CDSCO) on Sunday.
- This allows the vaccines Covishield from SII and based on the Oxford AstraZeneca vaccine, and Covaxin from by Bharat Biotech to be offered to healthcare workers and frontline workers in India.
Highest risk personnel will be given the vaccine for free:
- The Health Ministry has said 3 crore such personnel, considered at highest risk for COVID-19, will be given the vaccine for free.
- It isn’t yet known which vaccine will be made available to these personnel though multiple officials say rollouts can begin in less than a fortnight.
- Both the approvals accorded are for “restricted use in emergency situation” and in the case of Bharat Biotech the approval wording notes it is in “public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.” What these conditions are were not specified.
- Covaxin has been developed based on an inactivated Sars-CoV-2 strain cultured at the National Institute of Virology, an ICMR body.
- Because it was a whole virus (and therefore, more of it would be exposed to the immune system) the chances that it would mount a response against a variety of mutant virus types or strains were higher.
- The Indian data furnished by the companies only attest to the vaccine’s safety and its evoking some immune response.
- However, this pandemic has revealed multiple instances of therapies and interventions from convalescent plasma therapy to a slew of antivirals that seemed to work well under idealised lab conditions but did not measurably protect in real-world hospital conditions.
How do Covishield and Covaxin work?
- Covishield is the Indian variant of AZD1222, the vaccine developed by AstraZeneca and University of Oxford. Pune-based Serum Institute of India (SII) developed and manufactured Covishield through a licence from AstraZeneca and Oxford.
- It is a “non-replicating viral vector” vaccine, which means it makes use of another weakened and genetically modified virus, in this case a common cold chimpanzee virus to help the body develop immunity against the coronavirus.
- The vaccine carries just the code to make the spike protein (the spike on the virus’s surface). The body’s immune system is supposed to recognise this protein as a threat, and work on building antibodies against it.
- Covaxin, developed by Hyderabad-based Bharat Biotech in collaboration with the National Institute of Virology, uses a different platform.
- It is an “inactivated” vaccine, which means it uses the killed SARS-CoV-2 virus, which has no potential to infect or replicate once injected and just serves to boost an immune response.
- Covaxin is expected to target more than just the spike protein — it also aims to develop an immune response to the nucleocapsid protein (the shell of the virus that encloses its genetic material).
Concerns regarding untested vaccine:
- Some scientists have expressed concern about the basis for the approval to Covaxin, given that it does not seem to adhere to the regulator’s own requirements for clearing a vaccine in this pandemic.
- The concern from approving an untested vaccine is that it makes it nearly impossible to conduct a proper phase-3 trial.
- It will be unethical to expect volunteers to participate in a trial where there is only a 50% chance of being administered the actual vaccine, when they have the option of the real dose elsewhere.
- Both SII and Bharat Biotech, given the pace of recruitment and potential pool of volunteers, would have been able to generate much more data within mere weeks.
- So, it is hard to imagine why an emergency use authorisation of these vaccines was hurried through.
- Opacity marks the government’s communication strategy in a country where distrust of vaccines remains in spite of years of vaccination programmes and elimination of grave diseases. The government neglects this at the country’s peril.
India makes about 60% of vaccines globally and many countries are eagerly waiting for it to begin shipping doses. It has formally approved the emergency use of two vaccines as it prepares to begin giving jabs in January.
India plans one of the world’s biggest inoculation, seeking to immunise about 300 million people by July.
When it comes to vaccine making, India is a powerhouse. It runs a massive immunisation programme, makes 60% of the world’s vaccines and is home to half a dozen major manufacturers, including Serum Institute of India – the largest in the world.
Yet vaccinating a billion people, including hundreds of millions of adults for the first time, against Covid-19 is going to be a daunting and unprecedented challenge.