SEOUL – A leading global vaccination expert has praised international bodies, regulatory agencies and pharmaceutical companies, noting that protocols adopted pre-Covid-19 have enabled the compression of vaccine rollouts, which would normally take a decade, down to a single year.
But though Dr Jerome Kim was upbeat about a global vaccination drive that is proceeding with unprecedented speed on an unprecedented scale, he was cautious, in an exclusive interview with Asia Times, about predicting when – or even if – the world would exit the Covid-19 crisis.
Kim is the director-general of the Seoul-based International Vaccine Institute. The IVI, originally set up under UN Development Program auspices, has the mission of discovering, developing and delivering safe, effective and affordable vaccines to developing nations. Among its member bodies is the World Health Organization, or WHO.
The uneven pace of Covid-19 vaccinations from country to country is itself a risk, Kim said – particularly given that the world lacks a single, central mechanism to track virus mutations. Amid this blind spot, and with variants already appearing, his nightmare scenario is a potential mutation that could be immune to vaccines.
This means a high-stakes race is now underway between mankind’s vaccination drive and Covid-19’s ability to mutate.
De-risking the vaccine scene
Despite widespread criticism of national and global agencies and pharmaceutical companies, the Covid-19 pandemic met with a vastly accelerated vaccine response – thanks to groundwork laid during previous pandemics.
A number of fearsome diseases – such as Ebola – have passed before there was a need for mass vaccinations, Kim said. This customarily made it economically risky for companies to embark upon the long research, development and approval processes vaccines require.
To overcome this problem, the Coalition for Epidemic Preparedness Innovations (CEPI) was conceived in 2015 and established in 2017 with funding from the Gates Foundation. CEPI funds companies, research institutes and universities to find vaccines for emerging infectious diseases.
This allowed companies to create “platform vaccines” which needed minimal tweaking when Covid-19 made its shock appearance. “The platforms could be switched from Zika or MERS to Covid,” Kim said.
Another issue was financial assurance.
“From the vaccine manufacturing perspective we were very lucky as CEPI organized the first grants of billions within weeks of the publication of Covid’s sequences,” Kim said. That enabled companies and research institutes “to move with less consideration of the risks.”
Separate cash tranches were forthcoming from Washington.
“Last March and April the US entered with US$18 billion with ‘Operation Warp Speed,’” Kim said. That enabled a number of companies not in the CEPI program, such as Sanofi and Pfizer, to proceed. It also prompted pharmas that had never developed vaccines, such as Innovio and Moderna, to enter the space.
“The US government said, ‘We will help fund research by buying a vaccine if you are successful,’” Kim said. “If you are a company, this is what you want to hear.” These moves, he added, replicated the kind of incentives Washington usually offers for the development of a new missile.
As prior platform vaccines were known to regulatory authorities, their trial processes could be fast-tracked by National Regulatory Agencies (NRAs) such as the US Food and Drug Administration (FDA) and the EU’s European Medicines Agency (EMA).
“What the EMA and the FDA said was, ‘We have seen the platform is safe, so go ahead and test,’ and that allowed [pharmaceutical companies] to really move,” Kim said. “The idea was to accelerate all aspects in coordination with regulatory bodies as the data was being generated.”
The acceleration enabled was unprecedented. Moderna, for example, started trials of its Covid-19 vaccine only two months after China released the DNA sequence of the virus, Kim noted.
An unprecedented fast track
Moreover, the WHO was willing to accept data supplied by “stringent” NRAs. The WHO certifies NRAs into various tiers, with the FDA and EMA being two examples of the gold standard.
“This is the first use of extensive emergency use approvals by the US or the WHO,” Kim said. “By and large it has been relatively efficient … if the WHO gives its seal of approval, counties around the world will be comfortable.”
Getting the WHO’s nod is critical, given that a “trailer full of paperwork” used to be required for vaccines to be approved. These dossiers are now stored in electronic files, but the amount of processing required remains massive enough to overpower NRAs in many nations.
Still, the fast-track system is not perfect. Nations whose NRAs are not as highly rated as “stringent” cannot mount the fast track for WHO approval.
The process as it stands “works fine for vaccines from Western countries,” Kim said. However, “it has taken longer for the Chinese and Russian vaccines … we don’t have a read from the WHO on the Chinese and Russian vaccines.”
But the overall process of getting vaccine researched, developed, trialed, approved and distributed has been telescoped: What would normally be a 10-year process was slashed to about one year, Kim estimated.
East-West, North-South divide
At present, Kim is watching a “multiple-track process” unfold as countries worldwide execute vaccination programs at various speeds. In the lead, Kim sees Bahrain, Israel, the UEA, the UK and the US. Behind them are the EU and India and then comes East Asia.
Many have been puzzled by the EU’s lack of speed, and the political tug of war underway between the EU and the UK.
“The EU might like to be aggressive, but supply issues are a problem as the US and the UK made major upfront commitments to purchase,” Kim explained. “Companies issue their vaccines in a serial of when orders were received.”
An East-West divide is also apparent. East Asian countries contained the virus far more effectively than the EU, UK and US – but as a result, took a less urgent approach toward vaccine purchases.
“The pandemic threat was much lower here, so there was definitely less urgency,” Kim said. “If you look at some surveys, Korean adults are saying 50% will take vaccines, and 30-40% are saying, ‘We’ll wait and see.’ It is not so much vaccine resistance, there is just not the urge to take it – you can go out to a restaurant here.”
But the biggest divide is not East-West, is it between the global North and the global South. Kim notes “big gaps” in the speed of inoculations, between prosperous countries and low-income Africa and low- and middle-income Latin America, Kim said.
It is in the developing world where the global Covax (“Covid-19 Vaccines Global Access”) initiative comes into play. Though 190 countries are members of the globally-funded initiative, 92 countries are getting Covax-supplied vaccines at low or no cost.
Overall, “it looks like we will be able to supply above 25% of anticipated vaccinations for all countries by the end of 2021,” Kim said. “This is remarkable – we have never seen the introduction of new vaccines in advanced economies and low- and middle-income countries.”
For comparison, Kim cited rotavirus, a form of acute diarrhea that once killed hundreds of thousands of children worldwide.
Within two years of a vaccine’s introduction in 2006, the disease had been eradicated in the US. But that was not the case elsewhere: 60% of children globally have still not been vaccinated as the total annual production is slightly more than 100 million doses.
The comparison with Covid-19 vaccines is stark.
Surging supply
According to UNICEF, some 2 billion Covax doses will be distributed by the end of 2021. Thus far, the initiative, which has approved 14 different vaccines, has shipped more than 32.8 million doses.
Worldwide, Kim expects approximately 13 billion doses of vaccines will be needed to inoculate the entire 7.8 million-strong global populace against Covid-19.
Counter-intuitively, he is as worried about middle-income as low-income countries, as the former will not benefit from the free supplies given by Covax to the latter. A different concern is the capabilities of low-income countries to safely store and distribute incoming vaccines.
Yet with so many shots being developed and churned out worldwide, there may be oversupply. UNICEF anticipates an excess in 2022, basing its prediction on manufacturers’ estimates. Kim, however, sounds a note of caution.
“If you look at companies that make WHO-approved vaccines, it is something like 12 billion doses,” he said. But even that amount would be enough to inoculate most of the world.
“Imagine the scale of this effort,” Kim said. “We have proved they work, now we need the billions of doses, made by qualified and well-regulated manufacturers worldwide… bio-pharmaceuticals are much more complicated to make than drugs.”
Amid this multiple-phase rollout, “vaccine diplomacy” is underway with China, Russia, the United States and “The Quad” supplying, or pledging to supply, less fortunate countries. Kim disapproves of putting politics before pragmatism.
“In a setting where vaccines are in good supply, this would not be a bad thing,” he said. “But in a setting where vaccines are limited and we want to distribute to countries most in need, it is a bad thing.”
And there remain areas of the pandemic that are neither bright, nor even transparent.
Eerie unknowns
“One of the great unknowns is what is happening in parts of the world without good monitoring,” Kim warned. “Explosive outbreaks are what generate viral mutations … being able to characterize and identify the virus and its variants and making sure vaccines work is very important.”
So far, vaccines are holding the line.
“Now, it looks like vaccines work less well – but still work – against the variants,” he said. “It is those variants that we don’t know about that could threaten the success of vaccination programs.”
Problematically, no single global agency exists that oversees data on variants.
“The WHO has a system for collecting information on ‘flu, and the US CDC does the same,” Kim said. “For Covid-19, right now, there is an informal group based on flu surveillance – but there are gaps and it is not officially sanctioned.”
He suggested that a well-funded body, such as the US government or the Gates Foundation, should incentivize labs around the world to submit samples of variants to a central core lab which would test to see if the mutations can be inactivated by the various vaccines.
Even that master program would need to be preceded by capacity building of lab facilities in multiple geographies. These labs would have to be able to collect swabs, collate samples and break down genetic sequences.
Yet Sub-Saharan Africa, South Asia and Latin America cannot fund a lab network. “We need criteria for sampling and sequencing, like in a centralized lab in Central America,” Kim said.
Living with Covid or exiting Covid?
Conventional wisdom has it that herd immunity is achieved in communities with 60-70% immunity, achieved either through prior exposure or vaccination.
That outcome is looking feasible in countries with fast-paced vaccination programs. There, Kim expects a return to some normality – such as socializing and mass audience activities, like performances and sports – by the end of year. All eyes will be on the experience of the UK and US.
“If the US gets to 70-80% of vaccinations by the end of summer, and the UK too, if they are successful, other countries will want to do it,” said Kim. “That will be a huge benefit going into 2022.”
Even so, containment measures – such as testing stations and provision of PPE – cannot be ditched in the near term.
“We will need to identify variants and provide PPE and other things,” he said. “It is really critical that we are not generating variants that could be dangerous to countries that have put in place effective vaccination programs.”
For similar reasons, countries racing ahead with vaccinations should not declare victory too swiftly.
“As you ramp up vaccinations, hospitalizations and illnesses start to drop,” he said. “But even if you have half the population of the US vaccinated, you still have 150 million people at risk, and what if a variant comes into a football game or a super church?”
Another area where a return to normalcy is unclear is international travel.
Rebooting travel?
Vaccine passports are already being mooted in various countries, but homologation questions are unanswered.
“The question is, can these be verified? How does one country delegate authority to enter information into a system that is secure and verifiable?” Kim asked. “I guess the EU could do that, but between the EU and US, we would both have to accept each other’s version of the passport.”
A complicating factor is that every country has national regulations for data privacy and medical information. “Getting countries to agree is really critical, unless IATA can find a way to independently verify,” Kim said.
In fact, the IATA – the International Air Travel Association – has developed and trialed a global travel pass in the form of an app that verifies test and vaccination information. But it is not yet accepted by governments.
“Right now, countries don’t have policies for what to do with people with vaccination certificates,” Kim said. “If you come to Korea with a certificate you will still be put into 14-day quarantine; if you go to the US without one, you won’t get quarantined at all!”
The IATA does not predict air travel returning to 2019 capacities until 2024.
Still, among high-income nations, Kim expects these barriers to be hurdled. He cautiously predicts that Australasia, East Asia, Europe and North America will start seeing travel between each other, and through global transit hubs in the Middle East, at the end of 2021.
But these travel “bubbles” will not cover the globe, and it is unclear what protocols for higher risk areas will be established. “What will be the requirements be to go to Africa?” Kim wondered.
Can mankind crush Covid-19?
The broader question is whether, with so many vaccines coming online, Covid’s days are numbered. Prior experience is encouraging.
“Typically, when you develop a vaccine, it works for a long, long time,” Kim said. “Almost no vaccines have been thwarted by the development of resistance.”
This raises the question as to whether Covid-19 could be wiped out like measles – “which is essentially eliminated in the US” – or could survive as an endemic disease like influenza – “which is drifting and shifting its genome over time,” Kim mused.
In the early months of the pandemic, there were few observed changes in Covid-19, but now countries are experiencing third or fourth waves. These waves “generate substantially more mutants,” Kim observed.
There is a common belief that viruses, in order to preserve themselves by not wiping out their host populations, become more infectious but less deadly over time.
Worryingly, this is not proving to be the case with Covid-19.
Doomsday scenario
Covid-19’s “British” variant is both more infectious and more deadly than the Wuhan original, Kim said, and the British variant is not the most dangerous.
“The Brazilian variant was able to go into a town where we thought there was herd immunity, but now it is killing hundreds,” Kim said. “So herd immunity is not what we thought.”
And Kim does not fear the Brazilian variant the most: That would be the South African mutation.
Unsurprisingly, it is mutations that represent Kim’s nightmare scenario.
“If we fail to provide vaccines to parts of the world where we suspect major outbreaks, or get big countries with political problems, where even 40% vaccinations are not possible … these are mutant generators,” he said.
Currently, vaccines are holding their own, even if efficiency levels are reduced. This raises two questions: Will vaccines continue to maintain efficacy? And will the speed of vaccinations outpace the speed of viral mutations?
“Assuming there are no new variants resistant to current vaccines, I would say we can achieve elimination, like measles in the US, which required 90% vaccination rates,” Kim said. “It’s a race between vaccinations and the development of mutations.”