Dr. Sinead Delany-Moretlwe, Director of Research at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa:



Q. Currently, clinical trials can take years to reach Phase IV. The Covid-19 pandemic has shown us how much quicker it can go. Do you think there are lessons that can be taken from this?



A: We have learned a lot during the Covid-19 pandemic about how we can potentially expedite processes and get products to the people that need them rapidly and I think it’s important to remember that in our region, endemic diseases like HIV are still an emergency. While we don’t want to cut corners and while we want to ensure that we have safe and effective products for people, something that Covid-19 vaccine trials may need to grapple with is no longer using placebo-control trials as it is harder to justify from an ethical perspective, especially as more vaccines begin to hit the market.



Q. What does this then mean from a design perspective for trials going forward?



A. Trial design is going to be very interesting to see going forward. In terms of just the processes, there have been discussions about how to diminish the transition time from Phase II to Phase III and these large gaps that affect when results are being received.&nbsp;



Q. What lessons are there for clinical trials running during a pandemic such as the current one?&nbsp;



A. Future trials are going to have to Covid-proof themselves. We learned during conducting our trial, sibling trials during a pandemic are challenging and we’re going to have to think about how we do these studies so that we are managing staff and participant safety. 



<h4 id="h-further-reading">Further Reading</h4>



PLEASE NOTE:&nbsp;More stories regarding the Covid-19 vaccine will be published. However, if you would like to read the full Focus piece by Simone Sribrath, click&nbsp;<a href="https://www.forbesafrica.com/product/single-digital-issue-dec-jan-2020/">here to download the digital copy of FORBES AFRICA.</a>



<a href="https://www.forbesafrica.com/focus/2020/12/07/what-goes-into-a-clinical-trial/">What Goes Into A Clinical Trial? (Forbes Africa)</a>



<a href="https://www.forbesafrica.com/focus/2020/12/07/all-you-need-to-know-about-the-vaccine/">All You Need To Know About The Vaccine (Forbes Africa)</a>

Medical technician preparing a human sample for HIV testing

Q&A: ‘ENDEMIC DISEASES LIKE HIV ARE STILL AN EMERGENCY’

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>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>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>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>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

South Africa is very much in the early phase of the pandemic, says expert.



South Africa’s University of the Witwatersrand (Wits) announced on Tuesday during a virtual press conference that it will begin the continent’s first clinical trial for a Covid-19 vaccine. Leading the South African Ox1Cov-19 Vaccine VIDA-Trial is Shabir Madhi, Professor of Vaccinology at Wits University and Director of the South Africa Medical Research Council (SAMRC) Vaccines and Infectious Diseases Analytics Research Unit (VIDA).



“This is a landmark moment for South Africa and Africa at this stage of the Covid-19 pandemic. As we enter winter in South Africa and pressure increases on public hospitals, now more than ever, we need a vaccine to prevent infection by Covid-19,” said Madhi at the launch.



“We began screening participants for the South African Oxford 1 Covid-19 vaccine trial last week and the first participants will be vaccinated this week,” he added.



Speaking to FORBES AFRICA, Martin Veller, Dean of the Faculty of Health Sciences at Wits, believes South Africa is very much in the early phase of the pandemic.



“We will be seeing a lot more cases. And that is already reflected in the significant increase of the numbers that we’ve seen in the country.”



South Africa’s total number of cases has surpassed 100,000 with the death toll reaching 1,991.



The South African Ox1Cov-19 Vaccine VIDA-Trial will start tomorrow, June 24.



“2,000 people will be entered into the trial. It’s important to note that the trial is largely going to be a placebo-controlled trial. One needs to see firstly what the safety of the vaccine is but much more importantly whether it’s effective,” says Veller.



He further stated that the participants will be followed for a whole year and the results will be analysed intermittently.



The institution is also collaborating with other institutions on the vaccine trial.



“Because of the expertise that Professor Madhi, his colleagues at Oxford University very early on contacted him to take part in the development and the trials of this vaccine,” says Veller.



Wits will also be collaborating with the Jenner Institute at Oxford University on the trial.

Tag: Wits University

FORBES AFRICA SOCIAL MEDIA

Q&A: ‘ENDEMIC DISEASES LIKE HIV ARE STILL AN EMERGENCY’

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

2,000 Participants To Be Entered Into South Africa’s First Covid-19 Vaccine Trial