Vaccine security: 'No one is safe until everyone is safe'


The second batch of AstraZeneca Covid-19 vaccines via the Covax Facility arrived in Kuala Lumpur on May 21, 2021. Covax was instrumental in helping many countries access Covid-19 vaccines in a more equitable way. — Pharmaniaga via Unicef

A phrase that was often quoted throughout the 2nd Vaccine Cooperation Forum in the Indo-Pacific Region held earlier this month (December 2022) was that “no one is safe anywhere until everyone is safe everywhere”.

As amply demonstrated by the Covid-19 pandemic, one small virus has the ability to wreck havoc across the world in a matter of months, thanks to our global inter-connectivity.

And while national borders can, and were, shut down to a large extent for prolonged periods during the pandemic, no country could be entirely closed off due to individual needs for essential imported materials, e.g. food, healthcare or energy supplies.

The near-collapse of many national healthcare systems from dealing with the overwhelming number of Covid-19 patients during the early part of the pandemic meant that, along with trying to find effective treatment, prevention from getting infected was paramount.

As is known by now, various vaccines for Covid-19 were developed in a record amount of time.

Some were based on well-known vaccine platforms, e.g. protein vaccines where part of the virus is delivered into the body to stimulate the immune response, and some on newer platforms that were being researched and developed before the pandemic hit, e.g. mRNA (messenger ribonucleic acid) vaccines.

And while no vaccine could claim to prevent the transmission of the SARS-CoV-2 virus, they all could prevent severe disease and death from Covid-19 to a significant extent.

This was particularly essential to help relieve the overwhelming strain on healthcare systems worldwide, and to ensure that the vast majority of those who did get infected would only suffer mild or moderate illness – or even none for some people.

But while the development of the Covid-19 vaccines was a crucial milestone, another big issue for many countries was actually getting hold of sufficient supplies for their populations.

Challenges and adaptations

Gavi founding president and Cepi special advisor Dr Tore Godal giving the keynote speech at the forum. Listening is Dr Azizah (right). — TAN SHIOW CHIN/The Star
Gavi founding president and Cepi special advisor Dr Tore Godal giving the keynote speech at the forum. Listening is Dr Azizah (right). — TAN SHIOW CHIN/The Star

International Vaccine Institute deputy director-general Dr Ahn Wartel noted that collaborations between national governments, supranational organisations, academia and industry were able to produce and distribute the Covid-19 vaccines in a record-breaking time.

“But that shining process was soon marred by the darker mishandling of any equitable global distribution of those vaccines.

“This disparity was also exacerbated because developing nations frequently lacked the necessary infrastructure to store, distribute and use the vaccines,” she said.

For example, Laos Health Ministry Mother and Child Health Center Vaccine Preventable Disease Division head Kongxay Phounphenghack shared that storage and transportation for the vaccines that required ultra-cold conditions were a challenge for his country.

Fortunately, with the help of international organisations like the World Health Organization (WHO) and neighbours like Cambodia, which donated refrigerated trucks to Laos, they were able to manage the logistics of getting the vaccines out to their communities.

He noted that another important element in the process was human resources, as people had to be trained on how to store and administer the new vaccines, as well as to act within the limited timeframe available to give them.

Both Dr Wartel and Phounphenghack were speaking at the panel session on Vaccine Security during the Vaccine Cooperation Forum held in Seoul, South Korea.

Also speaking during the session was Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) senior principal assistant director and Biologics Section head Dr Azizah Ab Ghani.

Sharing the point of view of a drug regulatory agency, she noted that such agencies had to adjust the way they worked in order to adapt to the pandemic situation.

“Some countries use emergency-use authorisation to bring in unregistered vaccines to be used for the public, but this is not allowed in Malaysia due to our current laws.

“Therefore, Malaysia implemented conditional fast-track registration to provide expedited access to vaccines or therapeutic products for use during the pandemic, without compromising the aspects of quality, safety and efficacy, using a risk-based approach.”

Two important elements of this pathway are reliance and recognition.

“Reliance means some work from trusted authorities will be taken into account and given significant weight in the assessment of the vaccine, while recognition is the acceptance of the regulatory decision of another regulator or other trusted institution.

“This is a smarter way to avoid duplicate work and ensure fast access to the vaccine,” she explained.

Dr Azizah also pointed out the importance of adapting post-marketing regulatory processes for the Covid-19 vaccines, as adjustments to dosages and the opening of more manufacturing facilities were being made even as the vaccines were being distributed.

This was to ensure that quality and safety were still being maintained, without disrupting the rollout of the vaccination process.

She shared that national regulatory bodies, both regionally and worldwide, worked closely together to align their requirements and processes, e.g. in terms of authorisation, approach to clinical trials, communication and regulatory agility.

Relying on relationships

Pre-established relationships were an important factor in vaccine procurement and distribution globally, as pointed out by US State Department Global Covid-19 Response and Health Security deputy coordinator Laura Stone.

Speaking during the forum’s second session on Vaccine Partnerships in the Indo-Pacific Region, she said: “As we (the United States) were delivering around the world and establishing production and delivery partnerships, the partnerships tend to be based on established relationships.

“One of the things we found out during the pandemic: it was really hard to start from scratch.

“Things tended to revert to established relationships, even if they were not necessarily the establish- ed relationships we would have preferred.”

As a small nation with no current capacity to manufacture vaccines, Brunei certainly had to rely on its existing international relationships to help procure vaccines for its population during the pandemic.

Consultant infectious diseases physician and Brunei Health Ministry Covid-19 Vaccine Technical Committee member Dr Riamiza Natalie Momin shared: “Our size is our limitation in terms of direct procurement.

“So bilateral and multilateral cooperation has facilitated our access to Covid-19 vaccines from Asean member states, and there was a real show of goodwill from other partner countries during a time of need when vaccine supplies were really low, e.g. from Singapore, China, Australia and Japan – and we are very thankful.

“We were also able to benefit from the Asean Covid-19 Relief Fund, as well as the Covax Facility.”

Covax, known in full as Covid-19 Vaccines Global Access, is co-led by Gavi, the Vaccine Alliance; the Coalition for Epidemic Preparedness Innovations (Cepi); and WHO.

Its aim is to ensure that all participating countries, regardless of income level, have equal access to Covid-19 vaccines.

It does this by acting as a platform to support the research, development and manufacturing of a wide range of Covid-19 vaccine candidates, as well as negotiating their pricing.

Stone noted that: “For the US, it would have been nearly impossible to navigate many of the physical delivery issues, as well as the legal challenges, if we had not been able to go through an organisation like Covax.”

Singapore, which is another small nation with limited negotiating power for direct procurement, also does not have a domestic vaccine manufacturing company.

However, National Healthcare Group deputy group CEO (Education & Research) Dr Benjamin Seet noted that as a regional biomanufacturing hub, Singapore has attracted a number of pharmaceutical companies that have set up a variety of facilities in the country.

These range from research and development labs, to fill-and-finish facilities.

He pointed out that as a small country, their domestic vaccine needs are very small.

This means that any domestic vaccine manufacturing capacity will always exceed demand.

Therefore, Singapore will have the capability to help meet regional vaccine needs through collaboration with regional and international networks and organisations when needed.

Keeping the momentum going

The Asean Leaders’ Declaration on AVSSR was adopted at the 35th Asean Summit in November 2019, just one month before the SARS-CoV-2 virus emerged in Wuhan, China. — AFP
The Asean Leaders’ Declaration on AVSSR was adopted at the 35th Asean Summit in November 2019, just one month before the SARS-CoV-2 virus emerged in Wuhan, China. — AFP

While most of the world is moving back to normal routines with the general attitude of “living with Covid-19”, the threat of another global outbreak – whether from a known pathogen or a new one – is still ever present.

As Korean Foreign Affairs Vice Minister Cho Hyundong said in his opening remarks during the forum: “While continuing our joint efforts to put an end to Covid-19, we need to take full advantage of our current cooperation to strengthen preparedness against future health crises.”

US Ambassador to South Korea Philip S. Goldberg agreed, saying during his welcoming speech: “Too often, we’ve seen resources flood health systems during emergencies, only to see those resources dry up once the immediate threat’s over.

“If we’re able to build true resilience against the challenges of the 21st century, we must break this cycle of panic and neglect.”

Korea’s Foreign Affairs Ministry, the US State Department and Australia’s Foreign Affairs and Trade Department were the hosts of the forum.

Indeed, Dr Sunate Chuenkitmongkol shared that one of the current challenges faced by the Asean Vaccine Security and Self-Reliance (AVSSR) initiative is to maintain the high level of enthusiasm member states showed for the initiative during the early part of the pandemic.

The deputy director for Thailand’s National Vaccine Institute, which advocated for the adoption of AVSSR, presented on the initiative during the session on Vaccine Security.

Although talks on AVSSR began in 2014, it was only in November 2019 that the Asean Leaders’ Declaration on AVSSR was adopted at the 35th Asean Summit – coincidentally, just a month before the emergence of the SARS-CoV-2 virus in Wuhan, China.

Dr Chuenkitmongkol said that while there are five strategies in the AVSSR Strategic and Action Plans 2021-2025, the ones of current focus are Strategies II, III and IV.

These are the establishment of a vaccine strategic procurement and regional stockpiling mechanism, the establishment of a regional platform for information sharing and knowledge exchange, and the creation of a vaccine workforce/stakeholder training programme respectively.

For the first, she shared that there will be a meeting held next April (2023) to tackle the creation of an Asean pooled procurement conceptual framework.

And while regional training programmes are being developed, Asean member states have been able to participate in programmes run by other stakeholders such as the Global Training Hub for Biomanufacturing.

Established by WHO in February (2022) in South Korea, this Hub aims to provide training on vaccines and biologics manufacturing for low- and middle-income countries.

In fact, NPRA senior principal assistant director and Centre for Compliance and Quality Control GMP section head Mohd Nasrul Mohamad Noor shared that Malaysian representatives had participated in the Hub’s training programme in July (2022).

He said this while participating virtually in the panel session on Vaccine Partnership.

Malaysia, along with Indonesia, are among the Asean member states that are ramping up their domestic vaccine manufacturing capabilities.

Dr Chuenkitmongkol noted though that vaccine security does not necessarily mean that each country has to produce its own vaccines, but that they can access suitable and affordable vaccines of assured quality whenever they need it in a timely, sustainable and uninterrupted manner.

According to Stone, the challenge now is to establish health and vaccine partnerships that can be relied upon for future pandemics.

“We certainly need to establish some kind of vaccine security and diversify production.

“We also need continued political and financial commitment to this development, to training, to sustainable production and to information sharing.”

She also noted that: “We do need to coordinate amongst our various efforts in terms of vaccine partnerships to ensure that we’re not competing against each other, and that these are truly sustainable long-term efforts.”

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