India may have to tie up with more than one vaccine manufacturer to ensure that every one in the country receives protection against the coronavirus disease (Covid-19) when a vaccine becomes available, Union heath minister Dr Harsh Vardhan said on Sunday, and stressed the need for making sure that the most vulnerable groups get it first.
“Considering the large population size of India, one vaccine or vaccine manufacturer will not be able to fulfil the requirements of vaccinating the whole country. Therefore, we are open to assessing the feasibility of introducing several Covid-19 vaccines in the country as per their availability for the Indian population,” the minister said.
“All Covid-19 vaccines currently in India are in the phases 1, 2 or 3 of trials with results awaited. Adequate safety and efficacy data is required for emergency use authorization vaccine approval for ensuring patient safety. Further course of action will be based on data generated,” he added, responding to people’s queries on his social media accounts as part of the fifth episode of his Sunday Samvaad (dialogue).
Dr. Harsh Vardhan clarified that since it is anticipated that supplies of a Covid-19 vaccine would be available only in limited quantities in the beginning, its administration will have to be prioritised. Of several different types of vaccines being tested, some may be suitable for a particular age group and may not be for others.
“Prioritization of groups for vaccination will be based on two key considerations, first is occupational hazard and the risk of exposure to infection; second is the risk of developing severe disease and risk of increased mortality,” the health minister said. “The Covid vaccines currently under trial in India are two-dose and three-dose vaccines. While Serum Institute and Bharat Biotech’s vaccine candidates are two-dose vaccines, Cadila’s is a three-dose vaccine candidate. For other vaccines in preclinical stages the dosing is being tested,” he said.
According to the website of the World Health Organisation (WHO), there are currently more than 100 Covid-19 vaccine candidates under development, with scientists, businesses and global healthcare providers racing to find a safe and effective vaccine.
In India, Bharat Biotech International Limited has developed an inactivated whole virion candidate vaccine (BBV152) for Sars-CoV-2, the virus that causes Covid-19. Cadila Healthcare Limited has developed a DNA vaccine for which pre-clinical toxicity studies were conducted in small animals: mice, rats, rabbits and guinea pigs.
Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce the AstraZeneca-Oxford vaccine candidate in India, for which it is conducting Phase 2/3 trials.
The Central Drugs Standard Control Organisation (CDSCO) has granted test license permission for manufacture of Covid-19 vaccine for preclinical test, examination and analysis to the seven manufacturers in India.
These are Serum Institute of India in Pune, Cadila Healthcare in Ahmedabad, Bharat Biotech in Hyderabad, Biological E Ltd. in Hyderabad, Reliance Life Sciences Private Limited in Mumbai, Aurobindo Pharma Limited in Hyderabad, and Gennova Biopharmaceuticals Limited, Pune
Experts say that more than a vaccine, it is Covid-19 appropriate behaviour that will help prevent the transmission of the respiratory disease.
“The vaccine is far from being available right now, as we really do not know when will it be available and more importantly, how effective it will be. If you look at the influenza vaccines, the efficacy that we get is about 50%. Even after 21 years the vaccine against Hepatitis C, which is an RNA-based virus like Covid-19, is not very effective. So, it is too early to predict about the Covid-19 vaccine at this stage,” said Dr GC Khilnani, former head of pulmonology, All India Institute of Medical Sciences, Delhi.
“Developing antibodies is one thing, more important is to know whether those antibodies can actually protect against the infection, which gets known after phase 3 trial data is generated. Phase-3 trial will be crucial but it takes longer for phase 3 trial results to be out; it cannot be expedited. Changing behaviour to make it Covid-19 appropriate is the key, especially with winters coming,” he added.
Currently, the key component of the planning for Covid vaccine procurement is the cold chain and other logistics that need to be planned to ensure that no glitches take place in vaccine delivery even at the last mile, the health minister added.
In another development, Dr Harsh Vardhan disclosed that Feluda,a low-cost indigenously developed test that can detect the coronavirus disease (Covid-19) within an hour, is expected to be available for use in the next few weeks. Feluda is said to be nearly as accurate as the gold standard reverse transcription-polymerase chain reaction (RT-PCR) test.
“While I cannot put an exact date on the availability, we should expect this test within the next few weeks,” the minister said on Sunday Samvaad.
The paper strip test has been developed by the Council for Scientific and Industrial Research- Institute of Genomics and Integrative Biology (CSIR-IGIB) and has been approved by the Drug Controller General of India for commercial launch. The kit has already been validated by the Department of Atomic Energy’s National Centre for Biological Sciences, Bengaluru.
The test is named after a fictional detective created by the late Satyajit Ray, although it is also an acronym for FNCAS9 Editor-Linked Uniform Detection Assay. It has been developed by senior scientists Dr Debojyoti Chakraborty and Dr Souvik Maiti at CSIR-IGIB.
Based on tests performed on over 2,000 patients during the trials at IGIB and on testing in private labs, the test showed 96% sensitivity and 98% specificity. This compares favourably to ICMR’s current acceptation criteria of RT-PCR kit of at least 95% sensitivity and at least 99% specificity. Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate) whereas specificity is the ability of the test to correctly identify those without the disease (true negative rate).
“It has similar accuracy as RT-PCR because it is based on the same PCR concept except it is done on simple machines, not expensive real time PCR ones. The detection system is CRISPR based,” said Anurag Agrawal, director, CSIR-IGIB, Delhi.
Feluda uses CRISPR gene-editing technology to identify and target the genetic material of Sars-CoV2. CRISPR, which is short for Clustered Regularly Interspaced Short Palindromic Repeats, is a gene-editing technology that can be used to detect a specific snippet of DNA from a sequence.