Table 2.
Theme | Extracts from the news |
---|---|
Development of covaxin | “ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine,” |
Study in four different animals and good immunogenic response serum was able to neutralise all the viruses | |
Covaxin was evaluated in animals on Schedule and reported to be safe and immunogenic | |
Launch of covaxin | “Making the vaccine feasible for public use will take a year or more” |
“It is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials” | |
Concerns regarding early launch of covaxin | “If a person is vaccinated, the body will take 28 days to produce antibodies. It is impossible to provide confirmed data by then” |
“Number of people, trials be completed and analysed by August 14 members of the independent DSMC. Unrealistic timeline of August 15” | |
Justification for early launch of Covaxin | Council said, process is exactly in accordance with globally accepted norms important for ICMR to expedite clinical trials with a promising indigenous vaccine |
Permission for trials of new vaccine | DGCI allowed the company to conduct the first and second stages of the vaccine’s human trials |
Research ethics | “We have to explain the research protocol before the ethics” |
“A vaccine trial completed in little over a month, efficacy pre-decided” | |
Some hospitals selected for clinical trials caution against ‘impossible’ timeline | |
Process of vaccine development in general | The CDSO has allowed phase I and II human clinical trials of Covaxin, making it the country’s first Covid-19 vaccine to get this approval |
Phase l less than 100. Phase II commences where 100 to 300 people are enrolled to test efficacy and understand side effects. Phase III 3,000 participants for approval process after which it is rolled out | |
“vaccine development takes time due to the phases involved” | |
Advance human clinical trials of covaxin | According to the Clinical Trials Registry-India, the Phase-I and Phase-II clinical trials of the covaxin will be carried out on 1,125 participants across 12 hospitals |
Bharat biotech trials of the vaccine are scheduled to begin across India this month | |
Dosage schedule | “One of the most important things of this phase is to check how long the immunity stays. This allows to determine how often a person will have to get re vaccinated” |
Reported be in “two doses and delivered to patients in a fortnight interval this month” during the human trial phase | |
Fake news | ‘Bharat Biotech VP taking corona vaccine clinical trial is fake’ |
‘routine procedural blood drawn for testing all production staff’ | |
Cost of covaxin | ‘Socially inclined organisation and a company that is focussed on public health too early to make any statement regarding the price.’ |
Outcome of vaccine trials | “Vaccine development is characterised by a high failure rate - often 93% between animal studies and registration of a product” |
‘COVAXIN™ is an inactivated vaccine developed on a vero-cell platfor. Inactivated vaccines have a well-proven and accepted track record’ | |
Production of new alternate vaccine | ‘CDSO, granted approval to ZydusCadila to initiate phase I and II human clinical trials in India for its potential COVID-19 vaccine’ |
Trial for a new alternate vaccine | ‘Zydus has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in this month across multiple sites in India’ |
‘While, pharma major ZydusCadila became the second Indian company to get the DCGI approval for human clinical trials of its vaccine ZyCoV-D’ |
CDSO=Central drug standard control organization, DCGI=Drug Controller General of India, DSMC=Data safety monitoring committee, ICMR=Indian Council for Medical Research, GMP=Good Manufacturing Practice, BBIL=Bharat Biotech International Limited