AstraZeneca has resumed its phase three clinical trials in the United Kingdom for the company’s coronavirus vaccine candidate after abruptly&nbsp;<a href="https://www.forbes.com/sites/danielcassady/2020/09/08/astrazeneca-puts-phase-3-vaccine-trial-on-hold-shares-drop-6/#45d5afba43fd">halting</a>&nbsp;the program earlier this week over fears that a study participant living in the U.K. was reportedly experiencing negative side effects from the drug.



<h5 class="wp-block-heading">KEY FACTS</h5>



On Saturday, AstraZeneca announced trials were back on after the pause, which the firm said in a statement was voluntary and allowed for a safety review by independent parties and regulators worldwide.



The U.K. leg of the investigations determined it was safe to continue, according to a release, and the U.K. Medicines Health Regulatory Authority gave their blessing for the trials to resume.



The phase three trials were called off earlier this week after reports that a participant had side effects that could possibly be linked to the trial.



Astrazeneca called the pause a “<a href="https://www.forbes.com/sites/danielcassady/2020/09/08/astrazeneca-puts-phase-3-vaccine-trial-on-hold-shares-drop-6/#45d5afba43fd">routine action</a>” when a clinical trial comes across a potentially unexplained illness in a participant that must be investigated to “maintain the integrity of the trials.”



AstraZeneca is developing the candidate alongside the University of Oxford, and has enjoyed a boost of&nbsp;<a href="https://www.forbes.com/sites/danielcassady/2020/09/08/astrazeneca-puts-phase-3-vaccine-trial-on-hold-shares-drop-6/#45d5afba43fd">$1 billion</a>&nbsp;from the U.S. government in funding along with 400 million doses on pre-order if the vaccine turns out to be safe and effective.



<h5 class="wp-block-heading">CRUCIAL QUOTE</h5>



“AstraZeneca is committed to the safety of trial participants and the highest standards of conduct in clinical trials,” a Saturday statement from the firm read. “The Company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic.”



<h5 class="wp-block-heading">KEY BACKGROUND</h5>



The trial’s pause and the idea of vaccine side effects has made many uneasy. Experts say it will likely take widespread vaccination against the coronavirus to end the pandemic and for life to return to any semblance of normal. But in the U.S., the vaccine has been politicized as the presidential race heats up. U.S. President Donald Trump has promised the possibility of a successful vaccine release well before the end of the year—even before Election Day in November—while health officials, like the nation’s leading infectious disease expert Anthony Fauci say&nbsp;<a href="https://www.forbes.com/sites/sarahhansen/2020/09/11/fauci-says-it-will-be-well-into-2021-before-us-returns-to-normal-from-coronavirus/#7cdbfe962f7c">next year</a>&nbsp;is more likely. Critics have accused Trump and his administration of pressuring health organizations to speed up the vaccine approval process to help Trump’s chances at reelection as&nbsp;<a href="https://www.forbes.com/sites/jackbrewster/2020/09/10/todays-2020-election-polls-biden-keeps-strong-national-lead-but-pennsylvania-florida-tighten/#15a278445f1f">polls</a>&nbsp;show his opponent Democratic nominee Joe Biden with a slight leg up. Trump and health officials like Fauci and Health and Human Services Secretary Alex Azar Thursday have&nbsp;<a href="https://www.forbes.com/sites/andrewsolender/2020/09/08/fauci-worries-operation-warp-speed-fuels-perception-vaccine-is-being-rushed/#1aae5ce621dc">denied</a>&nbsp;the accusations, with Azar insisting last week that “any vaccine that comes out is going to meet FDA’s&nbsp;<a href="https://www.forbes.com/sites/carlieporterfield/2020/09/03/azar-denies-november-goal-for-vaccine-preparedness-is-tied-to-presidential-election/#3f9d28c37f73">gold standards</a>&nbsp;for authorization or licensure. The president’s made that clear, I’ve made that clear, the FDA commissioner has made that clear.”



<h2 class="wp-block-heading">FURTHER READING</h2>



<a href="https://www.forbes.com/sites/danielcassady/2020/09/08/astrazeneca-puts-phase-3-vaccine-trial-on-hold-shares-drop-6/#45d5afba43fd">AstraZeneca Puts Phase 3 Vaccine Trial On Hold, Shares Drop 6%</a>&nbsp;(Forbes)



<a href="https://www.forbes.com/sites/karenrobinsonjacobs/2020/09/09/fauci-says-astrazeneca-pause-unfortunate-who-stresses-safety-over-speed-in-race-for-covid-19-vaccine/#905b43346544">Fauci Says AstraZeneca Pause ‘Unfortunate’, WHO Stresses Safety Over Speed In Race For Covid-19 Vaccine</a>&nbsp;(Forbes)



<a href="https://www.forbes.com/sites/sarahhansen/2020/09/11/fauci-says-it-will-be-well-into-2021-before-us-returns-to-normal-from-coronavirus/#7cdbfe962f7c">Fauci Says It Will Be ‘Well Into 2021’ Before U.S. Returns To Normal From Coronavirus</a>&nbsp;(Forbes)



-By Carlie Porterfield,Forbes Staff

Florida Volunteers Take Part In COVID-19 Vaccine Trials

AstraZeneca Coronavirus Vaccine Trials Back On In U.K. After Abrupt Halt

A few days before Yusuf Randera-Rees left for Oxford University, he lay alongside a pool at a game reserve, basking in the African sun. It was another rare opportunity for the Harvard graduate. He cast his eye on the people walking by.
“I know there are people here who are more talented than me, smarter than me and more talented than the people I was with at Harvard, or at least they could compete. I see these people every day and yet I’m about to go off to Oxford and these people are never going to get that chance,” says Randera-Rees.
Randera-Rees took these thoughts with him to Oxford where he met a fellow student who shared his vision. Together they conceptualized the idea for a business that would later become the Awethu Project. The company is dedicated to turning poor people into successful entrepreneurs.
In their first year at university, the two men entered the 21st Century Challenge – a business competition at Oxford University that recognizes solutions to worldwide problems. After being shortlisted for the $40,000 cash prize, they dreamed of spending it.
“We didn’t win, we were told the idea was aspirational, which really pissed me off,” says Randera-Rees.
The winning team came up with a business that used wheelbarrows to purify water for women in the villages.
Randera-Rees was unimpressed.
“You want the idea of an African women walking to the village; you don’t want the idea of Africans who can compete with you.”
He completed two Master’s degrees, in Financial Economics and African Studies, and moved back to Johannesburg where he worked on bringing the Awethu Project to life.
Randera-Rees saw a market in the many people who were excluded from becoming entrepreneurs because government funding and investors require a business plan, a certain amount of turnover and qualifications.
At 26, Randera-Rees moved back in with his parents and started the business with the $5,600 he had saved. He headed for the township of Alexandra where he promoted the company with flyers, posters and radio adverts. Within weeks, he garnered interest from more than 1,000 people. From the large pool of applicants, three were chosen.
“On a test of pure cognitive ability, compared to an American norm group, so basically compared to a world standard, these guys scored in the top three percent in the world. So they’re in the top three percent of intelligence compared to anybody else in the world and they’re sitting, not contributing nearly as much as they could.”
After a bumpy start, the Awethu Project received a $280,000 investment from financial services group Discovery Holdings and later $6.5 million from other investors. This made it possible for a taxi driver, airport baggage handler and cleaner to start businesses.
Each entrepreneur receives between $90,000 and $470,000 in co-investment from the Awethu Project. Over the years, they are guided by one of the company’s 25 mentors. After six years, the entrepreneurs need to pay the money back and also have the option to gain ownership of the company.
“First the entrepreneur earns it and then we empower… The big problem with the South African empowerment model is empowerment first and earning is later,” says Randera-Rees.
Empowerment and equality are principles Randera-Rees values. He grew up in a mixed-race family during apartheid. His dad, an Indian doctor, left the country at the age of 17, and went to England where he met his wife, a white doctor. The two moved to South Africa in 1984 where they were subject to constant discrimination. Randera-Rees’ dad worked in Soweto and his mom worked in Alexandra.
“To see their example was important to me. They did what they needed to do because they believed in it and for no other reason.”
With offices seated at the heart of Constitutional Hill overlooking the hustle and bustle of downtown Johannesburg, Randera-Rees looks down and smiles. Where some see dust; he only sees gold.

Tag: Oxford University

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AstraZeneca Coronavirus Vaccine Trials Back On In U.K. After Abrupt Halt

High Fives High Hopes