The Coronavirus COVID-19 pandemic is the defining global health of this decade and the greatest challenge we have faced since World War 2.It has caused a havoc across the globe. The world is fighting against the pandemic since it’s first outbreak in Wuhan,China. Its now high time to find out a vaccine and different Countries and firms are in a race to come up with a cure.
Along with 10 more countries , India has got its first indigenous vaccine to start human trial.
Bharat Biotech, a Hyderabad based firm,has got the approval from Drug Controller General of India(DGCI) to start phaseI and phase II clinical trials of its vaccine prototype, COVAXIN.
The vaccine has been produced by Bharat Biotech in collaboration with Indian Council of Medical Research(ICMR) and National Institute of Virology(NIV) .
Lets see some of the queries that can pop up into our minds:
- What does the Vaccine Contain?
COVAXIN is an inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3(Bio-Safety level 3) high containment facility.
2. When will the trials start?
On July 2 , a letter which has been sent out by ICMR DG reads :
“You have been chosen as a clinical trial site of the BBV152 Vaccine. In view of public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of clinical trial and ensure that the subject enrollment is initiated no later than 7th July”
This confirms that trial will start on or before july7 . But CTRI(Clinical Trials Registry- India) says that date for first enrollment is 13th July as per a tweet
3. When it will be launched?
ICMR is planning to launch this vaccine within 45 days that is by 15th August as per the letter says: ” It is envisged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clincal trials. BBIL is working expeditously to meet the target, however final outcome will depend on the cooperation of all clinical trial sites involved in this project”
4. Is it possible to complete all the phases of vaccine testing within 15th August?
Clinical development of a vaccine is a three phase process. Phase I is for safety ,where small groups of people recieve the trial vaccine. Phase II is for preliminary data collection on antibody production and in Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Now, all these steps actually takes a lot of time to complete . If done in a cautious way and improvised way then Phase I and Phase II can be combined and still would take a year of time atleast to complete it.Experts have questioned how all three phases can be conducted within a month and a half.
“This should not be done at the cost of efficacy and safety”, said Dr Shashank Joshi, Dean of the Indian College of Physicians.
Dr Anant Bhan, Researcher,Global Health, Bioethics and Health policy also put forward his thought as “I would find it very surprising if it is done. Even the most ambitious companies in the world that are in more advanced stages of development for their COVID-19 vaccines have a longer frame. Even having all the trial results, with safety and efficacy data, by August 15 is difficult. This raises sever questions”.
So we can see that even though ICMR has put into words about the date of release of COVAXIN, it will be very diificult to do so.