In a year that has found a seesaw between astonishing gains and brutal setbacks on Covid-19, few moments were as sobering as the revelation last month that a coronavirus variant in South Africa dampened the effect of one of the world’s strongest vaccines .
The finding – from a South African trial of the Oxford-AstraZeneca shot – revealed how quickly the virus managed to evade human antibodies, ending what some researchers described as the world’s honeymoon with Covid-19. vaccines and the hope of returning to the pandemic.
As countries adapt to the frightening bliss, the story of how scientists discovered the dangers of the variant in South Africa put the spotlight on the global vaccination tests that were indispensable to warn the world.
“Historically, people would have thought that a problem in a country like South Africa would remain in South Africa,” said Mark Feinberg, CEO of IAVI, a non-profit scientific research group. ‘But we’ve seen how fast variants are popping up all over the world. Even affluent countries need to pay close attention to the developing landscape around the world. ”
After an afterthought in the vaccination race, these global trials saved the world from sleepwalkers in year two of the coronavirus, unaware of the way the pathogen can blunt the body’s immune response, scientists said. They also hold lessons on how vaccine manufacturers can combat new variants this year and correct long-term health inequalities.
The deck is often up against drug trials in poorer countries: drug and vaccine manufacturers move to their largest commercial markets, often avoiding the cost and uncertainty of testing products in the south worldwide. Less than 3 percent of clinical trials are held in Africa.
Yet the emergence of new varieties in South Africa and Brazil has shown that vaccine manufacturers cannot afford to wait years, as in the past, before testing whether shots made for rich countries also work in the poor.
“Failure to identify and respond to what is happening in a supposed continent is having a significant impact on global health,” said Clare Cutland, a vaccine scientist at the University of the Witwatersrand in Johannesburg. “These results have emphasized to the world that we are not dealing with a single pathogen sitting there and doing nothing – it is constantly mutating.”
Despite the fact that the Oxford vaccine is minimally protected against mild or moderate cases caused by the variant in South Africa, it is likely that the patients will become seriously ill, preventing the increase in hospitalizations and deaths. Laboratory studies have yielded a mix of hopeful and worrying results on how much the variant interferes with Pfizer and Moderna’s shots.
Nevertheless, vaccines are testing updated booster shots. And countries are trying to isolate cases of the variant, which according to the South African trials could possibly also re-infect humans.
Last March, long before scientists struggled over variants, Shabir Madhi, a veteran vaccine specialist at the University of the Witwatersrand, began to push vaccine makers to have him tested.
Aware of how long Africa regularly waits for life-saving vaccines, such as a decade ago for swine flu shots, Dr. Madhi is rapidly investigating how Covid-19 vaccines work on the continent, including in people living with HIV. He hoped the world would have no excuse to postpone approvals or supplies. Different socioeconomic conditions and health conditions can alter the vaccine’s performance.
“I’m sure I can get money,” he emailed the Oxford team on March 31 last year, saying, “It’s important to evaluate HIV.”
Oxford agreed, and the Bill and Melinda Gates Foundation contributed $ 7.3 million, confirming its role as a core of efforts to send vaccine trials to the global south.
The trial nevertheless had to face problems that larger studies with better resources in the United States and Europe did not. First, dr. Madhi’s team eliminates several test plots because they did not have enough freezers or generators, which is essential in a country where frequent power outages can threaten precious doses.
Even once the researchers closed websites and relied on clinics with experience in conducting HIV studies, the trial became almost undone. Test results showed that almost half of the earliest volunteers at the time they were vaccinated were infected with the virus, and declared their results invalid.
“We had a limited amount of funding, and a limited number of vaccines,” Dr. Cutland said. “We were very concerned about the fact that the trial was completely derailed.”
At another trial site, all three pharmacists contracted Covid-19, leaving out the only person who could prepare the shots. Nurses during the trial lost siblings to the disease. The staff was so overwhelmed that when the vaccine drivers called from abroad, the phones sometimes rang and rang.
The force of the pandemic in South Africa – 51,000 people died and up to half of the population was possibly infected – almost overturned the trial. But it was also part of the vaccine producers: more cases means faster results.
The team of dr. Madhi withstood the storm and worked for 12 hours, adding patches on the spur of the moment to ensure volunteers were not already infected. In May, he asked Novavax, then a well-known American company with Trump administration, to conduct a trial there as well. Novavax agreed, and the Gates Foundation kicked in $ 15 million. However, the trial was only registered several months later.
Novavax said the trial took time to set up. But the delay also reflects what scientists have described as the pressure on U.S.-backed vaccine makers to focus their efforts within the United States. There are studies that are the best way to unlock coveted approvals from the Food and Drug Administration, the world’s medicine agency for gold.
And vaccine manufacturers tend to know their biggest markets best.
“Companies have the most experience in clinical trials in parts of the world that represent their commercial markets,” said Dr. Feinberg said.
For experimenters who made providing the world a centerpiece of their strategies, the trials were a blessing. Novavax showed that the effectiveness of the vaccine was only moderately impaired by the variant in South Africa. Johnson & Johnson, who also had a South African trial, showed that its vaccine is protected against hospitalization and death.
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“You have your fishing line in the water – and by the time we were there, the virus had developed,” said Dr. Gregory Glenn, president of research and development at Novavax, said. “It is invaluable to us and the world.”
In a recent laboratory study, the Oxford-AstraZeneca vaccine ill-protected hamsters exposed to the variant, even though the animals’ immune response was somewhat weaker. The human trial in South Africa was too small to say definitively whether the vaccine could prevent serious diseases. But the finding that it provides minimal protection against lighter matters was in itself discouraging, as the shot is the backbone of the development of much poorer countries.
In South Africa, the results have improved the plans to give the Oxford vaccine to health workers. Despite offering trials, the country failed to utilize it in early purchase agreements, which delayed inventory. Only a fifth of the 1 percent of people there have been vaccinated, raising fears of another spate of deaths and further mutations.
If HIV research has laid the foundation for vaccine trials in South Africa, some scientists hope that an explosion of global studies in the pandemic to pharmaceutical companies will show that other countries also have the infrastructure to conduct large-scale trials.
To that end, the Coalition for Epidemic Preparedness Innovations, a Gates-backed group, is encouraging companies to hold further Covid-19 vaccine trials in poorer countries.
“People tend to go for what they know,” said Melanie Saville, the coalition’s director of research and development. “But capacity is increasing in low- and middle-income countries, and we need to encourage developers to take advantage of it.”
South Africans presented in large numbers for the trials. Most mornings, dr. Anthonet Koen, who ran a site in Johannesburg for the Oxford and Novavax trials, opened her doors at 6am, when the participants had been standing outside for two hours.
On December 11, dr. Koen on that the pandemic is increasing: after weeks without a case, two people in the trial tested positive. Then more and more, every day. Health officials announced the discovery of the variant a week later. The dutiful placement of the trials has given scientists what they almost never have: an outdoor lab to look at a vaccine and a variant in real time.
Since the results of Oxford were announced last month, dr. Koen said volunteers were trying to comfort her: “I get a lot of messages of sympathy, and ‘I’m sorry,'” she said.
As long as the vaccine and other serious diseases occur, even in cases of the variant, the world can live with the virus, scientists said. But the trial in South Africa nevertheless emphasized the need to eradicate the virus before mutating further. Without it, scientists said, the world could have been blind to what was to come.
“We would expect this variant not to be the end of the story,” said Andrew Pollard, the Oxford scientist responsible for its trials. “Once the population has a good immunity to the current variants, the virus must survive to survive.”