On Sunday, the Drugs Controller General of India VG Somani had given his approval to the emergency use of Oxford-AstraZeneca’s Covishield and Bharat Biotech’s Covaxin. However, the decision has been criticised in the political as well as scientific communities.
The main target of the issue is Covaxin, whose Phase III details are yet to be released. Regardless, the Expert Committee had granted “permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of mutant strains”. The government is saying that while they won’t use Covaxin in a larger capacity, it will be used in an emergency when Covishield is either not up to mark or unavailable. They add that the indigenously developed Covaxin is also effective against the mutant strain.
Independent scientists ask the government as to how the latter can claim that the vaccine is effective against the mutant strain when there is no published data regarding it. Bharat Biotech, while having furnished hopeful numbers in its first and second phase, has not yet given any data on Phase III. It is especially concerning how the Centre could grant emergency use authorisation for such a candidate. There are no peer-reviewed journal articles since the Indian Council of Medical Research hasn’t even published anything on it.
Moreover, the use of language also perplexes many experts. They claim that the use of “clinical trial mode” makes no sense. The fact of the matter is that administering Covaxin as a viable candidate is unethical at this point as the efficacy data is yet to be released. The experts believe that data comes first, depending on which the approval is provided. Besides, the language of the SEC recommendation is different for Covishield and Covaxin, with the wording being complicated for the latter.
Moreover, a Central Drugs Standard Control Organisation official has claimed that the inclusion-exclusion criteria applicable for volunteers (as is in the case of a clinical trial) will be applicable for the general population in the case of Covaxin.
The official also claimed that the Bharat Biotech is liable if the beneficiaries suffer from an adverse event. However, there are doubts about whether such a claim could be backed up since the entire situation is right now very murky. Even more concerning is the fact that the people will have to sign an informed consent before taking Covaxin, which is a glorified clinical trial at this point. The common people are misled using fancy terms and clinical jargons. Union Health Minister’s tweet clarifies the same, and adds that the people will be “tracked, monitored as if they are in trial”. That should surely inspire confidence among the people.
While, the Oxford vaccine — produced in India by the Serum Institute — is safer compared to Covaxin, it still has problems. According to experts, the SII has proposed a Phase II/III study not recognised in other parts of the world. The description of the study indicates that it is a study for safety and immunogenicity and not clinical efficacy. The DCGI statement shows that they relied on the AstraZeneca data for the efficacy, which according to the UK regulator stands at 70%. However, they add that for the doses in India, it is about 62%, which is fine as long as it is over 50%.
The experts opine that as of this moment, India is no different from Russia or China, who hid data, erased transparency in a bid to fast track their vaccines.