AIDAN has greatly surprised India’s biotech recommendation for the vaccine for clinical trial mode. In view of the muten strain, the plea for sanction of trial has got much more confused. AIDAN has said about this that, due to lack of data on the efficacy of the vaccine, a very worrying situation has arisen.
Appealing to DCGI to bring the unproven product for use in the general public and the lack of transparency, it should once again reconsider the SEC’s recommendation to grant REU approval to covicin.
Let us tell you that, before the publication of print, data of about 755 participants was available in the first and second phase trials conducted on humans only. AIDAN states that based on whatever decision the SEC took, the data revealed by the test should be made public immediately. In such a situation, on what basis did the SET recommend biotech vaccine from India for REU approval and clinical trial?
Asked for clarity, is it going to affect the new stand of vaccine virus or not? It is only being speculated that this vaccine may be effective against mutations of the virus. No data on the apparent efficacy of this claim has been revealed so far. Surprisingly, what scientific reasoning prompted SEC experts to approve the vaccine so fast?
Regarding the Covishield vaccine, AIDAN states, ‘It is also important to know the impact dose estimates for this vaccine dose in regimen and the dosing schedule. Talking about the interest of transparency and public welfare, we also want to understand on what basis the regulator has taken such decisions. Importantly, there has been a lack of information on the UK MHRA’s review of Estrogenica and the Oxford vaccine ‘.
Interim data for the second and third stages of the Serum Institute / ICMR for safety and immunity have also not been available. If this was not reviewed at the time of the process of data regulatory approval revealed by the test, it may not serve the purpose of the study to assess vaccine candidates in the Indian population.