Regulatory Assessment of COVID-19 Vaccines in the Indo-Pacific: Australian support to PNG

Welcome to Season 2 of Contain This and Episode 29. 

This week we discuss an essential step in the journey of the COVID-19 vaccine. We bring you insights on how the experts at Papua New Guinea’s Pharmaceutical Services Standards Branch were supported to assess the safety and efficacy of COVUD-19 vaccines in the last few months prior to the first doses arriving in their country.

In this episode, we spoke with Adjunct Professor John Skerritt who heads the Therapeutic Goods Administration within Australia’s Department of Health, Vali Karo, the Acting Manager and Mary Keurih, the product registration technical advisor at the Pharmaceutical Services Standards Branch within PNG’s Pharmaceutical Services Standards Branch. 

We hope you enjoy the episode.

For more information about the Indo-Pacific Centre for Health Security, visit our website indopacifichealthsecurity.dfat.gov.au/vaccine-access.

Connect with us on Twitter via @CentreHealthSec and @AusAmbRHS.

Transcript

OPENING
Vali Karo
It's very important for us to continue that relationship, especially with a reputable international regulatory authority, like TGA. And learn as much as we can and also with other reputable national regulatory authorities. Because for them they've done the hard yards in terms of assessment, they've   assessed products that are already on the market. And for us, it wouldn't be a good idea to reinvent the wheel or go back, given the resources that we have.

INTRODUCTION
Robin Davies

Welcome to Contain This. I’m Robin Davies, the head of the Australian Government’s Indo-Pacific Centre for Health Security. 

In the past three months, COVID-19 vaccine doses have arrived in our region. However the journey of how a vaccine arrives in your arm is not simply a story of a factory, vials, an aeroplane and freezer. It also involves many hours of research during vaccine development, government approvals, and ongoing monitoring for safety after the vaccine is administered.

Today we are looking at one essential step in the process. How are regulators in our neighbouring countries making important decisions about which COVID-19 vaccines should be approved in their countries?

We are pleased to be able to bring you insights on how the experts at the Papua New Guinea’s Pharmaceutical Services Standards Branch were supported in the last few months prior to the first COVID-19 vaccine doses arrived in their country.

Our Centre, funded through the Regional Vaccine Access and Health Security Initiative, enabled the Therapeutic Goods Administration, the body within Australia’s Department of Health which regulates medicines, medical devices, biologics and by-products, to assist the regulator during this process. 

We first asked Adjunct Professor John Skerritt, who heads the TGA, to explain how relationships have been built with regulators in the region over the last five years.

John Skerritt 

So we've had a relationship with DFAT for about the last four or five years. It was recognized, I guess, going back in the mid 2000s, mid 2000s, that a major barrier to getting new medicines for communicable diseases such as malaria and TB, was actually the countries didn't have well developed regulatory systems. And so there might be a new medicine, but it's much more effective for a particular type of tuberculosis that was not getting into developing countries, especially developing countries at the lower end of incomes, because the regulatory systems didn't have a capacity to be able to review those products in a timely manner. And so therefore, the people were not getting access to it. 

On the other hand, the more developed countries that are becoming middle income economies still were facing challenges as some of the technologies and products such as gene technologies and so on and tissue products were becoming more sophisticated. So whether it was the poorer countries in the region, or the middle income countries in the region, they both expressed the need for partnership with Australia, and so DFAT funded that partnership and built on some long standing relationships. But it was the funding provided a mechanism for face to face and also remote interactions to help build the capacity of those countries. 

At the same time, there was a separate initiative in the Pacific, a lot of the Pacific countries were procuring the lowest cost product for a lot of a medicines to treat things such as diabetes, high blood pressure, and so on. And yet either the quality of what they were buying, all the way in which those products were stored, or both meant that often the medicine had broken down. So you might have a medicine for someone with diabetes. So by the time it reached someone in Tonga, had actually broken down and was effectively not doing what it should do. And so we established a partnership with over a dozen Pacific Island countries, where we could test those medicines in our laboratories and see whether certain sources of certain ones have broken down and therefore whether they should be discarded, and also whether particular suppliers should be avoided for that, for that reason. 

Robin Davies

DFAT has two existing programs with the TGA. The Regulatory Strengthening Program focuses on seven countries in Southeast Asia and is targeted at improving regulatory systems for medicines, mostly to do with infectious diseases. 

The Pacific Medicines Testing Program has a different focus. It involves 12 Pacific island countries and TGA tests medicines on behalf of countries to ensure they are of good quality. The target medicines are mostly for non-communicable diseases, for example for heart disease and diabetes.

It's currently being relaunched as the Pacific Pharmaceutical Laboratory Testing Program, and will now include personal protective equipment and COVID-19 treatments, and will also offer assistance to Timor Leste.

Adjunct Professor Skerritt says the people-to-people connections have been one of the important early outcomes of the two programs.

John Skerritt

Everything's built, everything's built on relationships.  

And then the fact that we had this technical working relationship more recently meant, but when COVID came along, we'd already established partnerships with many of the Southeast Asian countries that were in scope, and also many of the Pacific island nations. There were established face to face relationships and from both sides. So if we have a question, say of the Thais or a question of the people in PNG, or, or a question, say, of Indonesians, we can pick up the phone, we can email each other because we've met with work together and asked them as a degree of trust. 

But there's also a degree of understanding of each other systems, facilities resources, and it enables us to be realistic. So we're not here about trying to say copy and clone the Australian regulatory system into a country like Vanuatu, a country like Cambodia, or even a country like Indonesia. Our resources will be different, whether it be training, whether it be money, whether it be physical infrastructure, and then we've got to understand that and have systems where countries can still play a role, they can have the final say about where the products are appropriate or not. And we can work with them and support them, but it can be relevant to the resources that they have and their requirements at the time.  

Robin Davies

The aim of the Australian Government providing technical assistance in this way has been focused on taking a whole of regulatory systems approach to build each country’s capacity to improve access to high quality, safe and effective medicines and medical products for the diagnosis, treatment and prevention of diseases. The programs also recognise how important it is to build relationships and trust to encourage open and free-flowing communication and information exchanges.

John Skerritt

We have to respect that, for example, about approving a medicine or approving a vaccine it's a country’s sovereign decision whether or not they approve of a product and also how they deploy the product. So for example, there's a lot of interest in Papua New Guinea at the moment as to whether vaccines should be used and which vaccine should be used in different age groups. Now, that is the Papua New Guinea's sovereign and final decision. Our role is to be as open as possible and share what information and knowledge we have. But to recognize that we're not there to tell them what to do. It's for them to make the final decision of how they want to proceed with a particular product. 

Robin Davies

Vali Karo is the Acting Manager for the Pharmaceutical Services Standards Branch which is the body within the Ministry of Health that supports pharmaceutical and medical product registration in Papua New Guinea, also known as the country’s national regulatory agency or ‘NRA’. He has been involved with setting up the relationship with Australia’s Therapeutic Goods Administration over the last five years.

Vali Karo 

For us, we are young in terms of development as an NRA, we haven't   come to the level of maturity, when you compare us with TGA. So, I mean, that's, that's where we come in. So we need every assistance that's available to us to   capacity build ourselves and RSP is the opportunity to provide it. And we took that opportunity and   rode on that one.

Vali Karo 

Even before the vaccine came onto the scene, there was, when the pandemic   commenced, I think TGA took the initiative to, to come to us and ask us whether, if there was anything,  they could help with regard to the pandemic, what the pandemic was creating so they were open to us, and then when the vaccine came, then it just fell into place. But otherwise, the openness was there, the communication was there already, even before the vaccine came, anyway. 

Robin Davies

Mary Keurih is the product registration technical advisor at PNG’s Pharmaceutical Services Standards Branch. She has built relationships with various TGA staff during workshops that aimed to strengthen all regulatory functions including manufacturing inspection, licensing, compliance as well as assessment and registration of medicines.

Keurih says the model where work plans were drawn up during the workshops led to improvements being made to internal processes following further exchange of information and ongoing support from TGA.

Mary Keurih 

The course itself was very good. We have learned a lot and we were able to identify what needs to be put into the SOP. Yes, yes, we were having a very good relationship with those officers from the TGA. So it was good. And we feel free. So any questions that we saw needs clarification, we just send an email to them. And they were able to answer it on a spot. Yes. Like immediately. So it was it was really good.

Robin Davies

During 2020, Australia started to plan how it was going to support the COVID-19 vaccine rollout. Our experience in the Indo-Pacific region led the Australian Government to realise that our neighbours would need comprehensive end-to-end support; from procuring doses to delivery and cold storage advice.

On the regulatory aspects, the Therapeutic Goods Administration was the natural partner for the Department of Foreign Affairs and Trade’s new Regional Vaccine Access and Health Security Initiative.

The COVID-19 vaccine rollout began in Papua New Guinea on March 30 with 8,000 doses produced by AstraZeneca’s European manufacturers.

Before this milestone, the Branch worked with the TGA to share technical safety and efficacy assessments based on the vaccine’s clinical trial results, adverse reaction profiles and other information that assists NRAs make product approval decisions. 

Mary Keurih
 
We had the experts from TGA going through those assessments, and from the assessment, will we learn, we learn from those assessment, we also ask questions, like in terms of trying to identify what are the what are the important parameters that we should be considering in the assessment of quality, safety and efficacy, and which they had to go through even we had to ask questions, repeating questions twice, but they still go through it. So it was good in that way. 

It's strengthened, and it gives us the confidence to do the assessment. So what they did was they sent us the assessment reports. And those assessment reports are confidential, which it came through this Australian High Commission and it was delivered to us. And we went through those assessments. And from the assessments, seeing the actual assessment, we can also pick up how the assessments are done. And we also learn from it. And it was it was a good opportunity as well, like we learned from this, this approval of AstraZeneca vaccines. And if there's going to be a vaccine that is going to be coming into PNG, the officers can do the assessment, given the exposure to those assessments that were carried out by TGA. We have learned from it and have the confidence in that assessment itself. So we can be able to do the assessment. 

And also they have also sent emails as well. So those questions that we feel that we need to get more answers from it, we feel free, we just send an email for them. And also, we asked if they can organize a training for us. So they did conduct several trainings, covering quality, covering clinical, non-clinical, and even the risk management. So they were able to learn through it. 

Even some of the questions like, for example, with this blood clot, we were asking them the questions as well, like, have you pick up from your area when you were rolling out the vaccines? So we feel free to ask questions like, if any, any areas that we heard from the news, or from the other national regulatory authority of other countries, we feel free to ask those questions for TGA. And they were able to respond to them, if they have the questions. If they don't have the question [answers], they said, We will look for that information and provide to them. We feel free, we were given the opportunity, it gives us the technical know-how, during that assessment, and we build that confidence as well of doing the assessment.
 

Robin Davies

Given the ability of the COVID-19 virus to mutate and the need for regulators to support governments in adapting their public health responses, assistance under the Vaccine Access Initiative will continue beyond vaccine approvals.

Vali Karo welcomes the support.

Vali Karo 

It's very important for us to continue that relationship, especially like with an reputable international regulatory authority, like TGA. And learn as much as we can and also for with other reputable national regulatory authorities. Because for them they've done the hard yards in terms of assessment, they've   assess products that are already on the market. And for us, it wouldn't be a good idea to reinvent the wheel or go back, given the resources that we have. So, I mean, those are the   arrangements, we want to   take advantage of, just piggyback on what they've already done, and we can take it and then expedite the product registration process. In the case of the vaccine, it is a new, like Mary said, it's a new biological, so, you would expect continuing areas to come about and it makes it more complex in the sense that because it's a virus then it   mutates, so that gives us added problems as well. So we would very much rely on on the expertise of any reputable NRA is to collaborate with them and then for them to provide it provided advice at the most convenient time.

Robin Davies

Australia’s hope is that the investment in health system strengthening to respond to COVID-19 will flow into infectious disease resilience for the region. 

Vali Karo says PNG is actively working to ensure improved treatments are delivered to its citizens.

Vali Karo 

We are working very closely with the, with the programs, TB, malaria, HIV, HIV AIDS. And, like I mentioned that the.... At the beginning, this initiative, the main goal was to combat the challenges, challenges of emerging and existing infectious diseases, not only in Australia, but for the for the region as a whole. So that's one of those takeaways from the initiative that was launched. So, like I was saying, we make it our priority to work with the programs to make sure that the safety, not only the safety, but the quality and efficacy of the medicines  , should come as a priority to us. I think we also we've also worked together with other partners like World Vision now in terms of testing the quality of the medicines yet at the lab level as well and if there is a need, we can also utilize the arrangement that TGA is with us to test those medicines to ensure that those medicines that are circulating around on the market I know the desired quality.

Robin Davies

In this episode we have been joined by the head of Australia’s Therapeutic Goods Administration, Adjunct Professor John Skerritt. From Papua New Guinea’s Pharmaceutical Services Standards Branch we heard from Acting Manager Vali Karo and product registration technical advisor, Mary Keurih.