New Delhi: India’s indigenous Covid-19 vaccine candidate, Covaxin, has been recommended for restricted emergency use authorisation by the subject expert committee appointed by India’s drug watchdog —Central Drugs Standard Control Organisation (CDSCO) — despite not having released any efficacy data.
Officials told ThePrint the subject expert committee clearance means Covaxin can be included in the government’s vaccination drive, as long as any adverse events following immunisation are reported within a stipulated time period. The SEC was appointed by the Central Drugs Standard Control Organisation to advise and make recommendations to the government regarding Covid-19 vaccines.
The vaccine, produced by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology, Pune, has courted many controversies since it first began human trials on 29 June, the emergency use authorisation being the latest.
ThePrint explains everything you need to know about Covaxin — from how it works to its various controversies.
Also read: What next as govt expert panel gives conditional nod for Covid vaccines Covaxin and Covishield
How it works
Covaxin is made of an inactivated vaccine, meaning the vaccine is made up of the virus that has been killed and can no longer cause infection. When injected into the body, immune cells can still recognise the virus, even though it is inactivated, which is what triggers an immune response.
The vaccine was made by the NIV by isolating an Indian strain of the virus.
Trial results so far
On 22 December, Bharat Biotech published data from its phase 2 trials with a follow-up on its phase 1 trial, on a non-peer reviewed website.
The data showed that the vaccine was safe with no serious adverse effects having been observed. The study also “hypothesized” that T-cell and B-cell immunity generated from the vaccine “may persist until at least 6-12 months after the second vaccination dose.”
The study also said that an evaluation of safety outcomes would require a large-scale phase 3 trial.
Bharat Biotech was granted permission to conduct phase 3 trials on 25,800 volunteers on 23 October — making it the country’s largest ever efficacy trial.
On 22 December, the company announced that it had crossed the half-way mark after recruiting over 13,000 volunteers.
The vaccine became a source of controversy after a letter, signed by ICMR chief Balram Bhargava, came to light on 2 July. In the letter, he asked principal investigators to conclude all trial phases for a rollout by 15 August.
The ICMR later denied having set a deadline, saying, “Our internal communication is being misinterpreted. We only said that we envisage to have a vaccine by 15 August and it is not a deadline.”
On 28 December, ThePrint reported that Bharat Biotech advised principal investigators (PIs) to encourage volunteers by telling them that enrolling in the phase three trial could give them immunity against Covid-19.
“It may take many months for the subjects above the age of 50 years to be immunised for Covid-19 vaccine,” said the document given to the PIs, which added, “Hence, it will be advisable to participate in the Phase 3 Efficacy Trial for Covaxin and get vaccinated to protect yourself against Covid-19.”
On Saturday, the SEC recommended that the vaccine be given restricted emergency use access despite not having released any efficacy data — meaning, so far, any data proving the vaccine’s efficacy has not been published in the public domain, including any results of an interim analysis.
Bharat Biotech first applied for EUA on 7 December, and was asked by the government’s expert panel, appointed by the Drugs Controller General of India, to return with additional data from its ongoing phase 3 trial on several occasions.
Also read: Bharat Biotech ‘thousands of volunteers short’ for ongoing Covaxin Phase 3 trials
As reading the article, I have assumption that it is not made by India but copied for Oxford-Astrazeneca vaccine and can cause serious health issues, that can show up after sometime.
Chinese and Indian companies should be stopped and fined for copying other companies products where original companies have spent millions to create the product and only to find that a Indian company has copied their product and registered it with their name on it.
Covaxine is the safest vaccine and have been fully tested on Indians unlike other vaccines. News media should carefully analyse and post such important subjects. It is because of such news people never came forward to get vaccinated and now we are in a mess. Don’t blame the PM if everyone cannot do their bit.
Very biased and poorly written article where the choice of words and language is unscientific and based on a clear agenda and motivation.
No issues then you can take the vaccine.
What you have mentioned as “controversies” are no controversies at all! There is no need for a vaccine data to be published in peer reviewed journals as peers cannot conduct experiment on the same; what is wrong with setting a deadline for certain results to be given by certain date Aug 15 in this case; what is wrong with encouraging volunteers…The Pfizer vaccine which has charted a course which “Tge Print” admires is making people faint!
There are vested interests, including certain paid media, that are working against three Indian researchers. The cost of producing a single dose has been brought down to less than 1 USD. This cannot be digested by the the big pharma conglomerates. They don’t like the runaway success of the Indian manufacturs. But they will have to finally accept it, whether they like it or not. Period.
this article simply draws a straw man….. it seems an attempt to undermine the indigenous efforts and give an advantage to competing vaccines .. let more details come out..
there are many vaccines with inactivated viruses… probably author herself must have been vaccinated with one of those ….. ha ha ha
Why is it controversial? Are you American?
Haven’t you read the article ? It’s clearly written they did not conduct the Phase 3 trials but got the clearance.
Now the question , why are you acting like an anti national by supporting an untested vaccine to be used on Indians? People will lose trust on every vaccine if some adverse side effect appears.
Mr Gupta, didn’t u know that the government has given emergency use option for the vaccine. And this has been done with many other vaccines too! Where is the controversy?? Infact the other vaccines have resulted in death of many ppl. So, all vaccines are controversial. Shame on certain idiots who in the name of journalistic freedom write half truth and utter nonsense, and ppl such as you research less and believe all that is written as the cosmic truth! Educated! Hahaha
Its deactivated virus vaccine, not inactivated.
Such vaccines are traditional proven methodology deemed generally safe. Both Russia Sputnik V and all China’s vaccines used deactivated virus.
In fact, China had already vaccinated 5Mils Chinese for emergency usage like frontline medical workers.
But due to COVID is well contained in China, trial 3 has to be tested in overseas like Brazil, Turkey, Emirates, etc., making data collection very difficult and delaying.
However, this does assured China’s clinical field data collected are genuine proven by 3rd party nation, unlike US Pfizer in full opacity.
So its strange that India with 10millions reported cases, it has failed to recruit even 25,000 for Trials 3.
There might be untold trouble side effect in the vaccines that delay, or people simply don’t have confidence with often adulterated fake India drugs and risky drug trials on uninformed people.
You’re confusing China with India.
Chinese companies have a reputation of producing fake medicines, fake electronics and even a fake republic.
India’s pharma industry is world renowned.
Hope you get your 5c on an Indian new website from Xi Jinping the Pooh.
Go home paki
Pfizer vaccine is an mRNA, means it only uses a part of the virus’ for generating the immune response, unlike the inactivated/deactivated vaccines these are multitudes of order safer the other vaccines you mentioned. Also, the western ones tier-3 data is in peer reviewed and in public domain, so stop peddling lies you Chinese troll.
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