State ministers and government officials have given conflicting dates for when the coronavirus vaccine will be available in Pakistan, with estimates ranging from as early as March to the first quarter of 2022.
The Correspondent sat down with Professor Hasan Abbas Zaheer, the primary coordinator of the AJM Pharma and CanSinoBIO vaccine trials that are being conducted in Pakistan, to understand when Pakistanis can expect vaccines to be delivered.
Established in 2009, China’s CanSino Biologics Inc—abbreviated as CanSinoBIO—has worked extensively in vaccine development. Having worked previously on the Ebola vaccine, the company is now hard at work countering another pandemic—for which it is developing the Ad5-nCoV or Convidecia vaccine, currently undergoing Phase III trials in Pakistan.
Can you tell us about the progress of the CanSinoBIO vaccine trial, and how it is being conducted?
We are currently implementing Phase III trials of the CanSinoBIO coronavirus vaccine in Pakistan. This is a global clinical trial and Pakistan was the first country to launch this trial on September 22, 2020. This week we are going to complete the recruitment target of the volunteers, which was 18,000.
The recruitment was done in five premier medical research institutes: Shifa International Hospital in Islamabad; University of Health Sciences, and Shaukat Khanum Memorial Hospital in Lahore; and Agha Khan University, and Indus Hospital in Karachi. These five centers are being managed by the principal investigator which is the National Institute of Health. The other two key partners in this project are CanSinoBIO, which is the manufacturer of the vaccine, and AGM Pharma private limited, which is the representative firm of CanSinoBIO in Pakistan. In Pakistan, we have almost completed the 18,000 recruitments.
In Pakistan, we have almost completed the 18,000 recruitments. we will be releasing our preliminary results within 10 days. However, the clinical trial itself will continue for another year, in which we will follow up on the 18,000 volunteers.Professor Hasan Abbas Zaheer
The role of AJM Pharma is to ensure smooth implementation and facilitation of the clinical trials in Pakistan. During these last five months, the technical experts from CanSinoBIO from China have been present in Pakistan. Technical experts from another Chinese firm, which is a clinical research organization (CRO), have also been present in Pakistan. This global CRO firm is ensuring the smooth implementation of the trials in other countries as well, which include Mexico, Argentina, Russia, and Chile.
In all five countries, the trial is actively progressing. In Pakistan, we have almost completed the 18,000 recruitments. While in other countries, 15,000 volunteers have been recruited.
In Pakistan, we will be releasing our preliminary results within 10 days. However, the clinical trial itself will continue for another year, in which we will follow up on the 18,000 volunteers. At the end of one year, we will be assessing and analyzing our detailed results, and then we will have them published in a reputable medical journal.
Can you tell us the results of this trial so far?
With almost 18,000 volunteers, we have not recorded a single case of vaccine related serious adverse effects. There were, however, minor side effects, like low grade fever, body aches. and irritation at the local site of the injection. But nothing serious at all; not only in Pakistan, but in in the other four countries as well. As far as safety is concerned, we are very satisfied with the performance of this vaccine. The main purpose of this trial is now to judge the efficacy of this vaccine which we are in the process of evaluating.
When will we be getting the CanSinoBIO vaccine in Pakistan?
AGM Pharma has already applied to the Drug Regulatory Authority of Pakistan (DRAP) for the grant of emergency approval use of this vaccine. This application is under process, and next week when we will have our preliminary results, we will share them with DRAP, and we hope we will get a favorable response. On the basis of approval from DRAP, the government will consider granting us approval and will negotiate the import of the vaccine with our principals, which is CanSinoBIO.
There are other companies that have also applied to DRAP for emergency use approval. We have to keep in mind that Pakistan is a very big country—220 million people—so I think one or two companies will not be enough to take care of the immunisation needs of the country. So, I think we would have to select more than one manufacturer.
We have heard that India has developed a vaccine at a very cheap price, while the Pfizer vaccine is very expensive—which some companies in Pakistan are already procuring. Do you think the government will have to give subsidies on the vaccine to make it affordable?
First of all, India has not developed its own vaccine, India has acquired the vaccine already developed by Oxford-AstraZeneca. But the important thing is, India has the infrastructure required to manufacture a vaccine. The Serum Institute of India has entered into a collaboration with Oxford-AstraZeneca, and they are manufacturing that vaccine in India; this brings down the cost substantially. This was possible because India already has this manufacturing capacity and they have a very good research development base.
So, I think now is a good time for Pakistan to be thinking in those terms and to focus on the vaccine manufacturing sector. There is no reason why we can’t do it; we have the technical expertise available, and if the government prioritises this sector, we should, in due course of time, be able to manufacture vaccines. We have a huge need for routine and commonly used vaccines. So, the market is there in Pakistan, the export potential is also there, and the expertise is there as well, but we need to develop the required infrastructure.
I think now is a good time for Pakistan to focus on the vaccine manufacturing sector. There is no reason why we can’t do it.Professor Hasan Abbas Zaheer
As far as the cost of the vaccine is concerned, the SinoPharm vaccine the government is going to acquire is going to provided free of cost to the priority groups—which include health workers as well as the elderly population. Let’s see what the policy is for the rest of the population.
In CanSinoBIO’s application to DRAP, we have asked for approval for rolling out the vaccine through the public sector, and to make it available for commercial use for those who can afford it. There are a lot people who would not prefer to go to public sector institutes to get immunised; they would like to just buy it off the shelf or go through some other institutes at their own convenience.
There is no reason the government should provide this vaccine free of cost to everyone, because there are a lot of people who can afford to buy this vaccine. In those cases, the government should not foot the bill—they should provide it to those who cannot afford it. I think we should have a liberal policy, and give permission to more than two or three manufactures to make their vaccines in Pakistan in the public sector and the private sector.
What will be the exact cost of the vaccine?
Every country has a different policy, but if you keep in mind the government has fixed the cost of one diagnostic COVID-19 test at Rs 6,500 per test per person, the cost of the vaccine will be much lower than that—maybe 10% or 15% of that cost. The vaccine is very cheap compared to the test.
Will the immunity from the vaccine last for a lifetime or will it last for a limited amount of time?
I’m not sure I have the answer to that; only time will tell. The vaccine has been developed at a very rapid pace across the world and we are currently focusing on this season. Hopefully in the near future, this pandemic will go away. Until that time, we need to make our population secure. Once this vaccine is rolled out, researchers will be able to determine how long its effectiveness is. Maybe it will have to be boosted up every season.
When exactly will Pakistan get coronavirus vaccines?
This is something the government will decide. They have already decided to import 1.1 million vaccines from SinoPharm. We are not sure when exactly they will be arriving in Pakistan, but the government has to take these decisions quickly. The coronavirus vaccine is a scarce commodity with a huge global demand—many countries have already made advanced bookings of vaccines that are yet to be delivered—so we cannot afford to delay. I think the DRAP should quickly process these applications, and decide on manufacturers as well as the quantities.
The coronavirus vaccine is a scarce commodity with a huge global demand—many countries have already made advanced bookings of vaccines that are yet to be delivered—so we cannot afford to delay.Professor Hasan Abbas Zaheer
They should also make plans on how to roll out these Pakistan. Pakistan is a very big country; it will be a huge challenge even if the vaccine is available today. Providing it to the public would not be easy. Even western countries, with all their resources, are having trouble in getting it to their populations.
Lastly, has SinoPharm conducted clinical trials in Pakistan?
No, not yet. They plan to do it, but they are planning on doing Phase I trials in a couple of centres with a very small number of volunteers. However, every country doesn’t have to do their own clinical trial; they can use the results of clinical trials of the same vaccine done in another country.