Even as India kickstarts its nationwide Covid vaccination campaign, a new controversy has erupted over the approval to use Bharat Biotech’s indigenously developed Covaxin, whose efficacy data is still awaited.
Concerns are being raised about granting emergency use authorisation to Covaxin, an indigenously developed vaccine manufactured by Bharat Biocon, even though the third phase of its trial isn’t completed and its efficacy data is not yet available. In fact, the authorization was granted “in clinical trial mode”, which raises even more questions.
There are at present two vaccines that are being offered; Covishield developed by a team from Oxford University in association with pharma major Astra Zeneca, and Covaxin, an indigenously developed Covid vaccine manufactured by Bharat Biocon in association with the Indian Council of Medical Research (ICMR). However, unlike Covishield where trial data and efficacy studies are available, in case of Covaxin they are missing. In fact, the Third Phase of the vaccine trial is currently underway; the first dose has been administered and the second dose is yet to be administered. Yet the Indian government has granted emergency authorization to Covaxin. Scientists and medical professionals are asking why the vaccine is being rushed through without following proper procedure?
Now, All India Drug Action Network (AIDAN) has written to the government demanding an explanation for what it means when authorization is granted “for restricted use in clinical trial mode.” The letter says, “There is no official communication providing details about how restricted emergency use in clinical trial mode will be implemented.” The letter also asks the government to ensure that Bharat Biotech’s ‘protocol for rollout’ is shared in the public domain. AIDAN also raises concerns over the ambiguity between full license and restricted use license.
The entire letter may be read here:
Malini Aisola, Co-Convenor of AIDAN told NDTV, “There will be more vaccines in the pipeline. The regulators should not have taken a hasty decision.”
Meanwhile, in a statement released, the All India Peoples Science Network (AIPSN) said, “AIPSN expresses shock and urges Central Government, State Governments and Regulatory authorities to ensure Covaxin is not deployed without clinical trial data being made public.” It has further urged, “All doses of Covaxin distributed to states so far be held in stock by them and not administered till greater clarity is given by the government or till CDSCO/SEC approval conditions are amended based on efficacy data from Bharat Biotech-ICMR as promised.”
AIPSN expresses shock and urges Central Government, State Governments and Regulatory authorities to ensure Covaxin is not deployed without clinical trial data being made public @CDSCO_INDIA_INF @drharshvardhan @PMOIndia @MoHFW_INDIA https://t.co/9auPenexiT pic.twitter.com/HWKMtbUzjT
— AIPSN (@gsaipsn) January 15, 2021
In an exclusive interview to India Today Dr. Krishna Ella, CMD, Bharat Biocon, attempted to allay fears about Covaxin saying, “I’m ready to take the vaccine. I’ll make my grandson part of the program.” He admitted that while the efficacy data wasn’t available as the third phase of the trial was still ongoing, it will be available soon. “By March, I will have efficacy data,” said Dr. Ella. He asserted that all procedures laid down by law were followed to obtain the emergency use license.
Interestingly, the Ministry of Health and Family Welfare (MoHFW) admits that license is only granted after the drug regulator examines efficacy data. In a series of tweets, the MoHFW said, “The safety and efficacy data from clinical trials of vaccine candidates are examined by our country’s drug regulator before granting the licenses.” It added, “Yes, the vaccines introduced in India are as effective as other countries. Various phases of vaccine trials are undertaken to ensure their safety and efficacy.”
Are the vaccines introduced in India as effective as the ones introduced in other countries?
Yes, the vaccines introduced in India are as effective as other countries. Various phases of vaccine trials are undertaken to ensure their safety and efficacy. (7/21)
— Ministry of Health (@MoHFW_INDIA) January 15, 2021
But therein lies the problem. The efficacy report of Covaxin is not ready yet. Then why did the government grant it emergency approval? In fact, the government appears to be indirectly promoting the home-grown vaccine. In a tweet from its official account, the GoI said, “India has time & again guided the world towards a better tomorrow. Now in these testing times, from developing & manufacturing our own vaccines, India is on the way to yet again ‘save humanity’, this time against the COVID-19 infection.”
India has time & again guided the world towards a better tomorrow. Now in these testing times, from developing & manufacturing our own vaccines, India is on the way to yet again ‘save humanity’, this time against the COVID-19 infection. #MyGovMorningMusings pic.twitter.com/gP7IDsZRrc
— MyGovIndia (@mygovindia) January 16, 2021
On Tuesday, while addressing the media, Dr VK Paul, Member (Health), NITI Aayog further tried to allay fears about Covaxin saying, “Both the vaccines (Covishield and Covaxin) have been authorized for emergency use and there should be no doubt about their safety. They have been tested on thousands of people and side-effects are negligible. There is no risk of any significance.”
Prime Minister Narendra Modi kickstarted the vaccination campaign on January 16 in New Delhi amidst much fanfare:
Today is a historic day for all of us as we enter a decisive phase in this fight against COVID-19. Join PM @narendramodi in the pan India rollout of the vaccination drive at 10:30 AM. Watch live: https://t.co/lNixPPWHIW #LargestVaccineDrive pic.twitter.com/hpWshKWev5
— MyGovIndia (@mygovindia) January 16, 2021
In the first phase frontline and healthcare workers are to be vaccinated. Vaccination is said to be voluntary and is likely to be offered next to the elderly and people with major comorbidities.
Once again, highlighting the “Indianness” of the vaccine, Modi said, “Ordinarily it takes years to develop a vaccine. But we have developed two made-in-India vaccines in such a short span of time.” This is strange considering that the Covishield vaccine is developed by a team from Oxford University in association with pharma major Astra Zeneca and that only clinical trials were held in India (along with many other places across the world).
Meanwhile, according to a report in The Telegraph, it appears people won’t really have a choice as to what vaccine will be administered to them. The report says, “The Union health ministry has not explained the criteria adopted to decide how the 11 million doses of Covishield and 5.5 million doses of Covaxin that have been ordered to initiate the vaccination campaign would be split between the states or between the hospitals within a state.” It reports that there are fears that “the home-grown vaccine, which is yet to prove its efficacy, is being sent to public institutions that have fewer opportunities to question the decision.”
It, therefore, appears that choice might just be an illusion and the vaccine taker’s privilege is likelier to determine what vaccine is administered to them.