The Ministry of Science and Technology on Sunday said that the development of a potential coronavirus vaccine “is unlikely to be ready for mass use before 2021”, but later edited the press release to remove the specific line.
This cast doubt on the Indian Council of Medical Research’s timeline to launch a coronavirus vaccine by August 15. Health experts have raised concerns and questions on the clinical research agency’s letter to all 12 hospitals and medical institutions to speed up the trial process of Bharat Biotech’s Covaxin and to launch it by next month for public use. Several vaccine candidates are at various stages of development around the world to tackle the coronavirus pandemic.
The press release said that there were more than 100 vaccine candidates in the world currently, of which 11 were in human trials. “None of these vaccines is unlikely to be ready for mass use before 2021,” it added. The new press release does not mention this.
It stated that India’s vaccine candidates – Covaxin and ZyCov-D – marks the “beginning of the end” of the pandemic.
Covaxin was approved this week for Phase I and Phase II clinical trials. To launch it by August 15 would involve either skipping or rushing through the Phase III trial, which tests the efficacy of the vaccine on a large number of participants and takes the longest time to complete. Each phase can last months, if not years, and although regulators globally have been fast-tracking trials on medicines and vaccines to treat the infection, the timeline proposed in the letter is said to be unprecedented.
Medical experts expressed concern the trials would compromise patient safety and ethics. However, the ICMR on Saturday claimed that the letter was meant to “cut unnecessary red tape” and “speed up recruitment of participants”.
World Health Organization chief scientist Soumya Swaminathan has also said that the development of a potential coronavirus vaccine must show efficacy and safety, adding that the completion of its trials could take six to nine months.