NEW DELHI: The clinical trial of the indigenously developed Covid-19 vaccine candidate Covaxin will be conducted in three phases, AIIMS director Randeep Guleria told reporters on Monday.
Guleria, addressing the media, also said that the transmission of the virus in the national capital, barring certain areas, seems to have hit its peak.Here is look at the what AIIMS director said on India’s Covid vaccine, mortality ratio and cases in DelhiVaccine trial in three phasesThe trial of India’s vaccine candidate Covaxin will be conducted in three phases by AIIMS.
Phase 1 vaccine trial will be conducted on healthy people aged 18-55 years who have no co-morbidity. The samples of 375 people will be studied in this phase.
The minimum time required for Phase 1 trial results to come out will be four to six weeks. Pregnant women will not be allowed to be a part of the trial in the first phase.
“In the first phase, we see the safety of the vaccine which is of primary importance and the dose range is also calculated,” the Guleria said.
Phase 2 vaccine trial will be conducted on healthy people aged 12-65 years. This phase will study samples from 750 people.
In the second phase, “we see how immunogenic it is and that is subsequently followed by phase III, which involves a larger population to assess its efficacy and therapeutic benefit”, Guleria said.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.
Phase 3 trial will be conducted to test the efficacy and effectiveness of the vaccine.
Already, around 1,800 people have registered for the trial at AIIMS. Anybody willing to participate in the trial can send an email to Ctaiims.email@example.com, or an SMS to or call to 7428847499, Rai said.
Last week on Saturday, the country’s leading medical institute had announced that it has given its approval for conducting human clinical trials of Covaxin vaccine candidate starting from Monday. The vaccine candidate has been developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology.Vaccine should be ready by end of 2020 or early next year, if everthing goes as per plan: AIIMS DirectorAsked when a vaccine would be available, Guleria said — “So, predicting exactly when the vaccine is going to be ready is a difficult business. But then say if everything works out ideally, then by the end of the year or early next year, we should be in a position to say that we can start manufacturing. But then there are lot of ifs and buts in that.
“We are very good in mass production. Even if a vaccine comes from any part of the world, India will be involved in its production because 60 per cent or more of the vaccines of the world are being made in India,” the AIIMS-Delhi director said.
“Launching of vaccine depends on its overall trial, we will have check the effectiveness of the vaccine for at least 6 months. By end of this year or early next year, there are chances that we will have a vaccine,” said Dr Sanjay Rai, head of community medicine department AIIMS.Certain areas of Delhi have hit peakCertain areas in Delhi, the AIIMS director said, seems to have reached a peak in terms of the number of coronavirus cases.
However, there are certain areas where the cases are still increasing and they are yet to reach their peak.
Guleria added that in certain areas the cases are continuing to rise and it is feared that local community transmission is taking place in these areas. Guleria also added that there is not much evidence of community transmission of Covid-19 happening at the national level.
The national capital witnessed a rapid increase in the number of cases during the last month. However, in the last few weeks, the numbers have steadily come down, indicating that the worst seems to be over for the city.
As of July 20, there were over 16,000 active cases in the capital. The city has seen 1,22,793 cases since the outbreak of the virus. A total of 3,628 people have succumbed to the virus.’Mortality rate much lower than many adversely affected countries’Further, the AIIMS director said that the mortality rate in India is much lower than in European countries like Italy and Spain and even in the United States.
“If you look at the data from Southeast Asia, not just India, the mortality rate is much lower than what happened in Italy and Spain or what is happening in the United States,” he was quoted as saying by news agency ANI.
The Union health ministry on Sunday said that India’s case fatality ratio is “progressively falling” is currently at 2.49%, which is one of the lowest in the world.
There are 29 states and union territories with a case fatality rate (CFR) lower than India’s average, with five of them having a CFR of zero and 14 having fatality rate of less than 1 per cent.MostHighlighted