Updated: Jan 24
India's covid vaccine roll out drive has begun on the 16th of January. Indian drug regulator has granted the emergency use authorization or accelerated approval for two vaccines, Serum Institute of India developed Covishield and Bharat Biotech’s Covaxin.
The Serum Institute of India collaborated with Swedish drugmaker AstraZeneca to natively manufacture Covidshield which was developed by Oxford University and AstraZeneca.
2. India's Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR).
While you can see that both the vaccine are manufactured in India, only Covaxin makes it to my article headline. There are two reasons for this.
One, I read somewhere that blog titles should be less than18 characters to be picked by the search engines and earn readership.
Two, While both of them are being produced indigenously not both were formulated here.
IS EMERGENCY USE AUTHORISATION, AN APPROVAL IN HASTE?
For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials. This is a painfully long process, designed to ensure that medicine or vaccine is absolutely safe and effective.
In emergencies, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals if there is sufficient evidence to suggest its efficacy.
The point worth your notice here is, India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined.
I think nobody in the Central Drugs Standard Control Organisation, CDSCO thought of an extraordinary situation like this to hit the country which would demand an astounding solution. Fair enough
So, When both the vaccines got this hastened approval, why do I say one is trustworthy and the other is not?
Phase II and III testing of covidshield was carried across 17 centers in India, with the last leg wrapped up in early December. There is sufficient efficacy data on it, as this vaccine has been a part of the UK's vaccination drive.
Covaxin has been approved before it even completed its phase three trials. This concern of mine was seemingly addressed by the CDSCO with the notion that Covishield would be rolled out for general use and that Covaxin would be deployed in “clinical trial mode” for “restricted use” in “emergency cases”, as a matter of “abundant precaution.
THE BACKUP VACCINE-
Let me unravel these terms and conditions before you.
Clinical trial mode-There is no such definition of clinical trial mode I could find, later got to know there isn't such a mode in drug testing.
Going by the Press release statement of CDSCO, "The vaccination exercise is underpinned by the principles of people’s participation -Jan Bhagidari ", I assume they mean the first to receive Covaxin make the candidates in this Clinical trial mode.
Restricted use in emergency cases- The first lot to get vaccinated, under the government’s plan, would be 30 million healthcare and frontline workers. Since generating immunity against Covid-19 requires two doses of the vaccine, a total of 60 million doses would be required to vaccinate them.
Serum Institute has claimed it has a stockpile of over 50 million doses and will soon have the capacity to produce as many as 100 million doses by March. According to the current plan, around 300,000 people are likely to be vaccinated daily – thus Serum seems well-equipped to meet India’s current demand.
The government has procured 11 million doses of Covishield and 5.5 million doses of Covaxin.
These numbers are speaking to me. Why did the Government procure such outstanding volumes of a vaccine which supposedly is the emergency option, when the forefront vaccine is claiming its availability, awaiting procurement.
Abundant precautions- Ideally, people have to be informed about the known and potential benefits and risks of such a vaccine, and the “extent to which such benefits or risks are unknown”, and that they have a right to refuse the vaccine.
The Union health secretary Rajesh Bhushan, in a press briefing on January 12 asserted that Health workers would not have a choice between Covaxin and Covishield stating “No country offers beneficiaries such choices,”
Bottom line, Covid warriors have to hold their armors tight to their chests.
CONCLUSION- QUESTION HERE IS NOT EFFICIENCY BUT EFFICACY.
I am in no manner an expert in immunology and vaccination to draw a comparison between the two. Nor am I trying to do that. And I believe Government doesn't assume the 1.7 billion population, all, to do their own research.
So again I ask – where is the efficacy data of Covaxin?
Indeed, the Government produced testimonials of "49 eminent scientists and doctors collectively" ensuring the safety of both vaccines.
The letter, on the wall of the Ministry of Health's Twitter, only intends to drive the blues of the people who have "vested interests" in proving against the vaccine. The letter itself doesn’t bother with clinical trial data, transparency, or public accountability.
The letter states “reprehensible utterances are causing huge credibility crisis for the Indian scientific community who have devoted their lifetimes to make India a name to reckon with in export of vaccines”
I certainly know I don't have "vested interests". Now is it safe for me to presume the Government is putting its Self Reliant- Aatmanirbhar agenda ahead of my scrutiny?