India's Foremost Science Academy Calls ICMR's August 15 Vaccine Deadline 'Unfeasible'
- by Virginia Carter
- in World Media
- — Jul 7, 2020
Currently, more than 140 vaccines are undergoing various stages of development across the globe.
The bid underscores India's urgent require for a way to halt the coronavirus, which has sickened far more than 6,97,000 persons and killed in excess of 19,600 in the Asian country - the world's 3rd-biggest outbreak.
Responding to a specific question whether Phase-3 trial can be skipped for making the vaccine available for public use in light of the pandemic, Dr. Swaminathan said: "Any vaccine must demonstrate efficacy and safety in a sizable number of participants".
However, experts cautioned against rushing the process for developing a vaccine as the Indian health authorities and companies seem to be following only the fast-tracking of vaccine development for diseases of pandemic potential.
On July 2, the day that ICMR director-general Balram Bhargava wrote to doctors envisioning a mid-August launch, Francis Collins, a top American biomedical researcher testifying in a US Senate hearing, explained how even at high speed, a vaccine is expected only in early 2021.
She also added that the World Health Organization, along with the GAVI and the CEPI, is in dialogue with Secretary, DBT, and five Indian vaccine manufacturers to provide any kind of support and facilitate advancing the candidates to trials. These include the two Indian vaccines, Covaxin and ZyCov-D, which are among the 11 vaccine candidates that are now going through human trials. Indian manufacturers account for 60% of vaccine supplies made to UNICEF. Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. All of them must be tested, through the various phases, in collaboration with the DBT and the ICMR, and till we see results from these trials, we can not predict which of them will be successful.
"The academy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impact of unforeseen magnitude on citizens of India", it added. For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 can not be initiated and the candidate vaccine must be discarded.
The science organisation also voiced concern about the article published by the Ministry of Science and Technology which had earlier mentioned that the vaccines may not be ready till 2021, but later deleted the sentence from the official release.
"In light of the public health emergency. and urgency to launch the vaccine, you are strictly advised to fast-track all approvals related to the initiation of the clinical trial.no later than July 7".
"While issues raised in public domain by commentators are welcome, the best of India's medical professionals and research scientists should not be second-guessed for their professionalism", the council said.
The Vigyan Prasar article said it could take anywhere between 15 to 18 months before licenses are issued for the vaccine while the PIB story did not set a date.