UK to infect healthy volunteers in vaccine research trial

In this Wednesday, Aug. 5, 2020 file photo, senior Clinical Research Nurse Ajithkumar Sukumaran prepares the COVID-19 vaccine to administer to a volunteer, at a clinic in London. (AP)
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Updated 20 October 2020

UK to infect healthy volunteers in vaccine research trial

  • Human challenge studies have been previously used to develop vaccines for diseases including typhoid, cholera and malaria

LONDON : UK researchers are preparing to infect healthy young volunteers with the virus that causes COVID-19, becoming the first to announce plans to use the controversial technique to study the disease and potentially speed up development of a vaccine that could help end the pandemic.
This type of research, known as a human challenge study, is used infrequently because some consider the risk involved in infecting otherwise healthy individuals to be unethical. But researchers racing to combat COVID-19 say that risk is warranted because such studies have the potential to quickly identify the most effective vaccines and help control a disease that has killed more than 1.1 million people worldwide.
“Deliberately infecting volunteers with a known human pathogen is never undertaken lightly,″ said Professor Peter Openshaw, co-investigator on the study. “However, such studies are enormously informative about a disease, even one so well studied as COVID-19.”
Human challenge studies have been previously used to develop vaccines for diseases including typhoid, cholera and malaria.
Imperial College London said Tuesday that the study, involving volunteers aged 18 to 30, would be conducted in partnership with the government’s Department for Business, Energy and Industrial Strategy, the Royal Free London NHS Foundation Trust and hVIVO, a company that has experience conducting challenge studies. The government plans to invest 33.6 million pounds ($43.4 million) in the research.
Governments around the world are funding efforts to develop a vaccine in hopes of ending the pandemic that has pummeled the international economy, shutting businesses and putting millions of people out of work. Forty-six potential vaccines are already in human testing, with 11 of them in late-stage trials — several expected to report results later this year or in early 2021.
The Imperial College partnership expects to begin work in January, with results expected by May. Before any research begins, the study must be approved by ethics committees and regulators.
While one or more vaccines are likely to be approved before then, the study will still be relevant because the world may need multiple vaccines to adequately protect different groups within the population, as well as treatments for those who continue to get sick, said Dr. Michael Jacobs, a consultant in infectious diseases at the Royal Free London NHS Foundation Trust who will take part in the research.
“I don’t think many people think that what we’re doing as scientists is searching for a silver bullet,” Jacobs said. “We’re going to need a whole raft of interventions in order to control this pandemic.”
Tens of thousands of volunteers around the world have already signed up to participate in more traditional trials of COVID-19 vaccines. Critics of challenge studies question the need to expose healthy people to the virus when the disease remains widespread and vaccine development is moving quickly.
In the first phase of the UK challenge study, researchers will expose 90 paid volunteers to the virus using nasal drops in an effort to determine the smallest level of exposure needed to cause COVID-19. Ultimately, the same model will be used to test the effectiveness of potential vaccines by exposing volunteers to the virus after they’ve received one of the candidate vaccines.
The research will be conducted at the Royal Free Hospital in London, which has a specially designed area to contain the disease. Volunteers will be monitored for at least a year to ensure they don’t suffer any long-term effects.
Kate Bingham, chair of the government’s Vaccine Taskforce, which is tasked with promoting development of a vaccine for COVID-19, said the project will improve understanding of the virus and help scientists make decisions about research.
“There is much we can learn in terms of immunity, the length of vaccine protection and reinfection,” she said in a statement.
Challenge studies are typically used to test vaccines against mild infections to avoid exposing volunteers to a serious illness if the vaccine doesn’t work. While the coronavirus causes only mild or moderate symptoms in most people and seems to be especially mild in young, healthy individuals, the long-term effects of the disease aren’t well understood, and there have been reports of lingering problems in the heart and other organs even in those who don’t ever feel sick.
In the US, the National Institutes of Health has downplayed the need for challenge studies given the speed with which vaccines are being developed, but it has taken preliminary steps to prepare for such research in case the approach eventually is required. Those steps include examining the ethics of a challenge study, and funding research to create lab-grown virus strains that potentially could be used.
But even if they are needed, “human challenge trials would not replace Phase 3 trials” of COVID-19 vaccines, according to a September statement from NIH that called the standard, rigorous studies its priority.
In July, the NIH’s vaccine working group published a paper in The New England Journal of Medicine pointing out the risks of doing a challenge study with a virus that so far has no good treatment and is wildly unpredictable, occasionally killing even some young, otherwise healthy people.
But 1Day Sooner, which advocates for COVID-19 challenge trial volunteers, praised the decision and called on the government to build a testing center.
“We are glad the UK government is embracing the altruism of the thousands of our British volunteers who want these studies,” the group said in a statement. “Challenge trials will be key to making multiple safe and effective COVID-19 vaccines available for the whole world, including those in low-income countries bearing the brunt of this pandemic.”
Danica Marcos, 22, a recent university graduate now doing volunteer work with homeless people, is hoping to take part.
“So many people (are) struggling right now, and I want this pandemic to be over,” she told The Associated Press. “Every day that goes on, more cases are going on, more people are dying. And if this vaccine trial could mean that this period of trauma for the whole world will be over sooner, I want to help. I want to be a part of that.”


French youth of Arab origin mistrust secularism, national symbols, finds poll

Updated 6 min 12 sec ago

French youth of Arab origin mistrust secularism, national symbols, finds poll

  • Arab News en Francais/YouGov survey of French citizens of Arab origin found a wide generational gap in attitudes to secular values
  • Older respondents identified more closely with French national symbols, but tended to feel stigmatized for their faith

LONDON: Young people of Arab origin in France are less likely to hold secular values and are more distrustful of national symbols than their elders, an Arab News en Francais survey conducted in partnership with British polling agency YouGov has found.

Attitudes to secularism appear to differ substantially among those aged between 18 and 24, which constituted 15 percent of the 958 people surveyed, compared with other age groups.

More than half (54 percent) of all those polled said they believe religion plays a negative role in politics, while a smaller 46 percent of 18-24-year-olds said this was the case.

Likewise, on the subject of laws restricting the wearing of religious clothing, 38 percent of all respondents said they favor such rules, while 29 percent of 18-24-year-olds approve.

Asked whether they would be prepared to defend the French model of secularism in their country of origin, 65 percent of respondents said they would compared with just 56 percent of 18-24-year-olds.

Even among the 25-34 age group, adherence to the values of secularism is noticeably stronger than among the younger cohort, with 55 percent saying religion plays a negative role in politics.

The trend generally continues with age. Among those over 45, about 50 percent said they are in favor of laws limiting the wearing of religious symbols.

Observers have asked whether such negative perceptions of secularism among young French citizens of Arab origin can be equated with growing radicalism.

Some scholars of Islam have established a link between countries which have adopted a more “incisive” secularism and the number of citizens who traveled to Syria to join Daesh.

William McCants and Christopher Meserole of the Brookings Institution believe the political culture of France and Belgium, where religious symbols are restricted, combined with massive unemployment and urbanization, contributed to radicalization.

IN NUMBERS

46% 18-24-year-olds say religion plays negative role in politics.

58% 18-24-year-olds would support home football side against France.

Other researchers say those who traveled to Syria came overwhelmingly from poor urban areas, where they faced discrimination in the job market, housing and police checks.

“Some young people feel they are viewed as sub-citizens, while media rhetoric gives credence to the idea that Muslims are ‘banding apart’,” said Elyamine Settoul, a lecturer at the National Conservatory of Arts and Crafts in Paris.

“This otherness between ‘them’ and ‘us’ represents a breeding ground for radicalization. Radical groups will not only sell them full citizenship but also compensate for all their deficiencies, whether they are identity based, affective or narcissistic.”

It is perhaps surprising, then, that just 47 percent of the 18-24 cohort surveyed by Arab News en Francais and YouGov believe their religion is perceived negatively in France — significantly lower than the overall average of 59 percent among all age groups.

Few topics better reflect a community’s sense of national pride than an international football tournament. Dual identities often lead to the question: Should I support the national side from my place of origin or cheer for my adopted nation?

Once again, a generational split emerges. The survey found 58 percent of men aged 18-24 would support their country of origin against the French side compared with an average of 47 percent among all respondents.

If the French World Cup victory in 1998 is considered the peak of the country’s “black-blanc-beur” multiculturalism, then the 2001 friendly between France and Algeria must be considered its nadir, when Algerian fans invaded the pitch.

The Arab News en Francais/YouGov study found that support for the French national team tended to increase with age. About 58 percent of 35-44-year-olds and 50 percent of over-55s said they would support the French national side over their country of origin.

“Young people under 25 are still building their identity and tend to get closer to their country of origin at this age. They fully claim their belonging to the country of origin, but this remains like folklore, as they often do not know much about it,” Settoul said.

“Over time, the identity asserts itself: We integrate professionally, get married, buy property and no longer take the same positions.”