An illustration of Dr. Gagandeep Kang with vaccine vials in the background. Photos: Twitter and Reuters
New Delhi: India’s method of giving the green light to two COVID-19 vaccine candidates is not only mired in a questionable process and curious choice of words, but it could also have far-reaching effects on the way they look. vaccines, Gagandeep Kang said.
The Indian authorities approved during the last weekend (January 1 and 2) two vaccines for administration. The first was ‘Covishield’, developed at the University of Oxford with AstraZeneca and the second, ‘Covaxin’ from Bharat Biotech.
In an interview with India Times, Kang, who is he vice president of the board of Coalition for Innovations in Epidemic Preparedness and a professor in the Wellcome Trust Research Laboratory at Christian Medical College in Vellore, has said that she is quite confused by both approvals.
While controversy has surrounded the Bharat Biotech vaccine since it was first announced, Kang says that even the approval process followed for the AstraZeneca-Oxford vaccine is confusing.
From the moment vaccines began to be tested around the world, Kang has been widely featured on Indian media channels, including on The wire – seeking to shed light on a process that would otherwise be unknown to most, with interviews and explanatory pieces.
Language
In his latest interview, Kang expresses utter dismay at the language used by the Comptroller General of Drugs of India (DCGI) when announcing the approval of the two vaccines. DCGI heads the department of the Central Drug Standards Control Organization that deals with drug and vaccine approvals.
“I can understand what they are saying about the Covishield vaccine and then they have this very complicated language for the Covaxin vaccine. The DCGI has actually cited that language, but their approval for both vaccines is identical, ”Kang said.
He also said that approval of a vaccine (in this case, Covaxin) in a “clinical trial mode” is something he has not seen before in a career spanning several decades.
The wireVasudevan Mukunth, has also highlighted that the language used by DCGI Dr. VG Somani in his announcement of January 3 “is not found in the New Rules of Clinical Trials and Medicines of 2019”.
Somani announced that the expert panel reviewed the safety and immunogenicity data of the two candidates “for the granting of permission for restricted use in emergency situations of public interest as an abundant precaution, in clinical trial mode, to have more options of vaccination, especially in case of infection by mutant strains ”.
In the interview, Kang expresses his surprise at how a vaccine that is already in clinical trial could be approved for use in the same way.
Questions also arise about the legal position of recipients of such a vaccine, considering that trial participants are different from those who sign up to receive a vaccine.
Data and efficiency
Even the very limited data available on the exact basis of the approval of the two vaccines has not been transparent, Kang said.
While vaccine developers such as Pfizer, Moderna, Gamlaya, and AstraZeneca have been submitting data to regulators in each country, they have simultaneously been submitting the same findings to peer-reviewed journals for publication. Therefore, Kang cites, the Indian Council for Medical Research (ICMR), the lead body in India’s medical response to COVID-19, is well prepared to release the Covishield data, and how it helped the regulator get to approve them, alone. daily.
“He has already done that for many articles that he has published, such as the one on hydroxychloroquine, the observational study they had and many others,” Kang said.
In the absence of data reflecting the efficacy of Covaxin, Kang questions how the “vaccine required two doses” was concluded, especially considering that the phase 3 trials determining efficacy only began in November 2020.
Kang also points out that what India is labeling a ‘phase 2/3’ study in the Covishield case is actually a phase 2 study elsewhere in the world.
The DCGI statement, Kang says, is completely dependent on the source of the vaccine, namely AstraZeneca, for the data. “They have said that they seek 70% efficiency [Somani actually said the efficacy was 70.42%] which is more or less what the UK regulator did even though we know that in the dosing schedule [a full two-dose regimen] proposed for India and tested for India, the actual effectiveness is approximately 62%. That’s fine as long as it exceeds 50%, ”he says.
Somani, in particular, did not clarify the intervals between Covishield’s shots in his ad.
In particular, for Covaxin, there are no such numbers. The science of wire had reported Bharat Biotech’s claim of 60% efficacy within days of starting phase 3 trials. The company has not followed up this claim with actual trial data.
Trust
The overwhelming lack of transparency on fronts ranging from how approvals were decided, who decided them, how vaccines will affect health and other parameters among beneficiaries, has dented an essential bridge that must exist between consumers, manufacturers and the authorities in the country. process – trust.
“How are we different from Russia and China? I really don’t have an answer if someone asks me that question, ”says Kang. The Russian Sputnik V vaccine was approved in a swift and questionable process.
The gray of the approval process, Kang feels, is a feather in the hat of those who have been anti-vaccination (often with disastrous consequences).
“You are basically giving people who are against vaccines and against science a weapon that they can use. It’s tremendously hard to think why experts would think this is a good way to go, ”he says.
