Professor Barry Schoub, a world-renowned virologist, details the Covid-19 vaccine process and the innovations being made in the field as well as the involvement of Africa in these trials.



 



Q. Given how each phase within a clinical trial has been expedited to find a Covid-19 vaccine, do you think it will have the same effectiveness or efficacy as other vaccines used to combat infectious diseases similar in nature?



A. I think up to the Pfizer release, scientists, virologists, vaccinologists thought it would be a vaccine with a 60% efficacy. So these results are in the same ballpark as the influenza vaccine because it’s got a similar kind of disease process. It is only an interim analysis of course, but it certainly has very good connotations attached to it. It is also a possibility that the corona vaccines will have a higher protection rate than the influenza vaccine for example. However, it will not have the same efficacy rate as more successful vaccines such as the measles vaccine which has an efficacy of about 95% and therefore we do need to have some reservation.



Q. There are a number of vaccine types currently in trials. Pfizer and BioNTech are developing a genetic vaccine while Johnson &amp; Johnson are trialing a viral vector vaccine model they have used for finding an Ebola vaccine previously. Do you think the type of vaccine influences the efficacy rate?



A. These vaccines are all new, this has never been done on humans, so there is no definitive way to say. We’ve never had an RNA or DNA vaccine going into human beings and we’ve never had a virus vector going into human beings. Previous use of a viral vector for HIV vaccine trials didn’t go well because of pre-existing immunity to the adenovirus being used as the vessel. All of this is new territory and really in a way, unpredictable.



Q. What do you think of the innovations then made with these vaccines?



A. It’s very exciting and just the speed with which these vaccines have come out as well. This disease has only been with us from the beginning of the year, so it’s amazing as vaccines usually take years to develop.&nbsp;



Q. These trials are also being tested throughout the world, and given that South Africa is the only site in Africa with any of these trials happening, do you think there should be more testing sites in Africa?



A. I don’t think all of Africa needs involvement in trials per se… It would just be where there is prevalence of disease, for example, endemic diseases such as HIV and TB in southern Africa and more tropical diseases so these are scenarios that do need to be looked at.



Q. Do you think these trials have accounted for all necessary factors that could play a role in how successful the vaccines could be?



A. In European and American trials, there are still key populations missing in the evaluation of these vaccinations like the elderly or people with co-morbidities, so all of these factors do need to be evaluated. All the vaccines currently in Phase III lack the optimal populations, so they all have a set age parameter and these vaccines still need testing in high-risk populations.



Q. Do you see any potential barriers that could decrease the uptake of the vaccine?



A. Well… there’s always suspicion, and polls here and abroad have shown hesitance and reluctance. First of all, things have been done at such fast speeds so there are concerns about safety and also the novelty of these vaccines and that they haven’t been used on humans before. So these factors can lead to suspicion.&nbsp;



Q. Do you think there any possible solutions to this?



A. They need to be reassured that these do undergo very rigorous safety testing and this will prove to be an educational exercise.



Q. What are your thoughts on the eventual accessibility of the vaccine within Africa?



A. In the beginning, we could possibly get a relatively small proportion of vaccines for the population, so the initial batches will have to go to priority groups. This includes frontline workers as an example, people in elderly homes and other high-risk populations.



Q. Do you think initiatives such as CEPI could also see Africa receiving the vaccine sooner than anticipated?



A. Initiatives such as CEPI and COVAX are pooled procurement mechanisms, so these aim to provide both middle and low income countries with their initial supply of the vaccine when it becomes available. So the vaccination process will need to happen in two steps; first step would be to protect vulnerable groups and then only later try to achieve herd immunity.



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[IN NUMBERS] 



<h2 class="has-text-align-center wp-block-heading" id="h-12-billion">$12 BILLION</h2>



In an African Union (AU) meeting in November to discuss Africa’s strategy for financing Covid-19 vaccines, AU Chairperson and South African President Cyril Ramaphosa noted that about $12 billion was required, and this was expected to come from three sources: the COVAX Donor Initiative, The World Bank, direct donors, and the African Import-Export Bank, which has committed to raising up to $5 billion.
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<h4 class="wp-block-heading" 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?&nbsp;(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>



<a href="https://www.forbesafrica.com/focus/2020/12/10/qa-endemic-diseases-like-hiv-are-still-an-emergency/">Q&amp;A: ‘ENDEMIC DISEASES LIKE HIV ARE STILL AN EMERGENCY’ (Forbes Africa)</a>

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‘ALL OF THIS IS NEW TERRITORY AND REALLY IN A WAY, UNPREDICTABLE’

TOPLINE With optimism rising that an end to the coronavirus pandemic is in sight as shipments of Pfizer’s vaccine began Sunday, Bill Gates warned in a television interview that the U.S. was far from out of the woods yet and is facing what is likely to be the deadliest period over the winter.&nbsp;



<h4 class="wp-block-heading" id="h-key-facts">KEY FACTS</h4>



“Sadly the next four to six months could be the worst of the pandemic,” Gates, the co-chair of the Bill and Melinda Gates Foundation, which has committed significant resources to the quest for a vaccine, told CNN on Sunday.&nbsp;



Trucks pulled out of Pfizer’s factory in Michigan on Sunday laden with the first shipments in an initial distribution round of around 3 million doses, and Food And Drug Administration Dr. Stephen Hahn&nbsp;<a href="https://twitter.com/CNNSotu/status/1338132165515730946?s=20" target="_blank" rel="noreferrer noopener">said</a>&nbsp;during a television interview Sunday he expects the first shots to be administered on Monday.&nbsp;



Healthcare workers and nursing home residents&nbsp;<a href="https://www.forbes.com/sites/joewalsh/2020/12/01/cdc-panel-health-workers-and-nursing-homes-should-get-first-covid-vaccine-doses/">will get the vaccine first</a>, and it won’t be until the spring or summer before shots are widely available.&nbsp;&nbsp;



For that reason, health officials&nbsp;<a href="https://www.cnbc.com/2020/12/08/covid-vaccines-fauci-says-virus-could-be-under-control-in-back-half-of-2021.html" target="_blank" rel="noreferrer noopener">say</a>&nbsp;the virus is not likely to be under control in the U.S. until the “back half of 2021”—as Dr. Anthony Fauci recently said—when most of the population, around 75%, is vaccinated, generating an “umbrella of herd immunity.”



“In the near term, it’s bad news,” Gates went on, citing an Institute for Health Metrics and Evaluation&nbsp;<a href="https://covid19.healthdata.org/global?view=resource-use&amp;tab=trend&amp;resource=all_resources" target="_blank" rel="noreferrer noopener">model</a>&nbsp;that shows the U.S. could suffer more than 200,000 additional deaths by April 1, 2021 from the virus.



<h4 class="wp-block-heading" id="h-what-to-watch-for">WHAT TO WATCH FOR</h4>



Pfizer’s vaccine will arrive at 145 distribution locations on Monday throughout all 50 states, with 425 more receiving shipments on Tuesday, and 66 on Wednesday,&nbsp;<a href="https://apnews.com/article/coronavirus-pandemic-united-states-d4525c56fd2606f1c0dae46ac3c96405" target="_blank" rel="noreferrer noopener">according to the Associated Press</a>. It will take up to three weeks for the first round of doses to be shipped out to all government-identified vaccine sites. The vaccine is being apportioned by state population.&nbsp;



<h4 class="wp-block-heading" id="h-surprising-fact">SURPRISING FACT</h4>



The Pfizer vaccine must be stored at 94 degrees below zero, which has posed&nbsp;<a href="https://www.forbes.com/sites/danielreed/2020/12/09/operation-warp-speed-now-comes-the-really-hard-part-delivering-10-billion-doxes-of-liquid-gold-quickly/?sh=5e2fcabe7e58">logistical issues</a>.&nbsp;



<h4 class="wp-block-heading" id="h-crucial-quote">CRUCIAL QUOTE</h4>



Hahn said Sunday he doesn&#8217;t think allergic reactions to the Pfizer Covid-19 vaccine will be a &#8220;highly frequent issue&#8221;: “We do not think that this is a highly frequent issue that will arise, but we do want to be careful because vaccine safety, medical product safety is top of mind for us,” the FDA chief said.



<figure class="wp-block-embed-twitter wp-block-embed is-type-rich is-provider-twitter"><div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">“We do not think that this is a highly frequent issue that will arise, but we do want to be careful because vaccine safety, medical product safety is top of mind for us.” &#8211; FDA chief Dr. Stephen Hahn on the possibility of allergic reactions to the Pfizer Covid-19 vaccine <a href="https://twitter.com/hashtag/CNNSOTU?src=hash&amp;ref_src=twsrc%5Etfw">#CNNSOTU</a> <a href="https://t.co/SfsaJJYQsw">pic.twitter.com/SfsaJJYQsw</a>&mdash; State of the Union (@CNNSotu) <a href="https://twitter.com/CNNSotu/status/1338132703909191682?ref_src=twsrc%5Etfw">December 13, 2020</a></blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
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<h4 class="wp-block-heading" id="h-chief-critic">CHIEF CRITIC</h4>



Asked to comment on President Trump’s executive order prioritizing Americans for vaccine shipments, Gates said: “Well, the extreme idea that everybody should die until we have the very last American vaccinated, that&#8217;s hardly the appropriate response.



<figure class="wp-block-embed-twitter wp-block-embed is-type-rich is-provider-twitter"><div class="wp-block-embed__wrapper">
<blockquote class="twitter-tweet" data-width="500" data-dnt="true">Bill Gates on Trump signing an executive order prioritizing the distribution of vaccines to Americans first: &quot;Well, the extreme idea that everybody should die until we have the very last American vaccinated, that&#39;s hardly the appropriate response.&quot; <a href="https://t.co/CcLT9uheSu">pic.twitter.com/CcLT9uheSu</a>&mdash; Aaron Rupar (@atrupar) <a href="https://twitter.com/atrupar/status/1338133587066032131?ref_src=twsrc%5Etfw">December 13, 2020</a></blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>
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<h4 class="wp-block-heading" id="h-big-number">BIG NUMBER</h4>



$1.75 billion. That’s how much the Bill and Melinda Gates Foundation has donated to the fight against Covid-19,&nbsp;<a href="https://www.forbes.com/sites/carolinehoward/2020/12/10/bill-and-melinda-gates-foundation-injects-another-250-million-into-the-battle-against-covid-19/?sh=32b5535b12d4">according to Forbes</a>.&nbsp;



<h4 class="wp-block-heading" id="h-further-reading">FURTHER READING</h4>



<a href="https://www.forbes.com/sites/nicholasreimann/2020/12/12/pfizer-covid-vaccine-expected-to-arrive-in-all-50-states-by-monday/?sh=4a0fd1ac467e">Pfizer Covid Vaccine Expected To Arrive In All 50 States By Monday</a>&nbsp;(Forbes)



<a href="https://www.forbes.com/sites/carolinehoward/2020/12/10/bill-and-melinda-gates-foundation-injects-another-250-million-into-the-battle-against-covid-19/?sh=32b5535b12d4">Bill And Melinda Gates’ Foundation Injects Another $250 Million Into The Battle Against Covid-19</a>&nbsp;(Forbes)



by Jack Brewster, Forbes Staff

2019 New York Times Dealbook

Gates Says Next 4-6 Months Could Be ‘Worst Of Pandemic’ As Vaccine Shipments Roll Out

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 class="wp-block-heading" 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’

This story is part of the &#8216;<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</a>&#8216; piece. 



Preclinical Phase



This phase within a study is most intensive and can often require the most amount of time and extensive research into possible cellular reactions between the intervention being investigated and the body’s immune response. This phase is often tested thoroughly with the use of animal test subjects before proceeding to Phase I.



Phase I&nbsp;



This initial phase is conducted on a relatively small number of participants (six-10). It allows scientists to closely study and examine any effects or interactions that the intervention being investigated has in human participants. This phase is used to determine the safety and tolerability elements that an intervention may have in treating human participants. Participants are closely watched for the possible occurrence and severity of any side-effects that may occur.



Phase II&nbsp;



The size of the participant pool could vary greatly here as the size is dependent on the type of illness being investigated (typically between 20-300 participants). In this phase, the dosage is often experimented with. This is done to successfully determine the dosage required for the intervention to be most effective and safe to administer. Different dosages of the intervention could produce different results. As such, multiple simulations of Phase II may occur for a single intervention, being tested within numerous populations of interest.



Phase III&nbsp;



As with Phase II, the sample increases substantially (300-3,000 participants). These large numbers are used to confirm the level of safety and efficacy of the medical intervention. This phase also allows for a significant comparison between the drug being tested and other similar interventions on the market. It can also be used to test the efficacy of the intervention when used as part of a treatment plan and it tests the interactions it has with other medical interventions within the treatment plan. Finally, this phase allows for the prescribed dosage to be finalized.



Phase IV



The last and final phase occurs after regulatory approval has been granted. This phase looks at the long-term administration of the medical intervention and possible side-effects that could occur as a result of prolonged use of the intervention. This phase tests the overall efficacy and safety of the intervention within larger groups and sub-groups within a population. By this phase, the occurrence of any serious medical events has been resolved and the intervention becomes available as a viable treatment option within the sub-area of the medical market. Regulatory bodies keep a close eye on the intervention as it continues to monitor the administration of the intervention to the general public. Doing this ensures that any medical intervention currently in the public domain or in the clinical trial phase is entirely safe for human use.



<h4 class="wp-block-heading" id="h-further-reading">Further Reading </h4>



PLEASE NOTE: 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 <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/all-you-need-to-know-about-the-vaccine/">All You Need To Know About The Vaccine</a> (Forbes Africa)



<a href="https://www.forbesafrica.com/focus/2020/12/10/qa-endemic-diseases-like-hiv-are-still-an-emergency/">Q&amp;A: ‘ENDEMIC DISEASES LIKE HIV ARE STILL AN EMERGENCY (Forbes Africa)</a>

Florida Volunteers Take Part In COVID-19 Vaccine Trials

What Goes Into A Clinical Trial?

<p id="h-toplineas-a-dangerous-resurgence-of-the-coronavirus-spreads-across-the-country-state-leaders-are-reimposing-restrictions-on-daily-life-but-one-measure-curfews-are-coming-under-increasing-scrutiny-from-some-public-health-experts-who-say-they-won-t-be-effective-in-actually-combating-covid-19">TOPLINE: As a dangerous resurgence of the coronavirus spreads across the country, state leaders are reimposing restrictions on daily life, but one measure, curfews, are coming under increasing scrutiny from some public health experts who say they won’t be effective in actually combating Covid-19.



<h3 class="wp-block-heading" id="h-key-facts">KEY FACTS</h3>



A number of cities and states—including&nbsp;<a href="https://www.forbes.com/sites/rachelsandler/2020/11/19/california-issues-covid-19-curfew-for-most-counties/?sh=76e7f0b3474e">California</a>,&nbsp;<a href="https://www.usatoday.com/story/news/health/2020/11/06/massachusetts-covid-curfew-may-not-have-big-case-impact-experts-say/6183084002/" target="_blank" rel="noreferrer noopener">Massachusetts</a>,&nbsp;<a href="https://www.forbes.com/sites/jemimamcevoy/2020/11/11/new-york-imposes-curfew-new-restrictions-to-slow-covid-spike/">New York</a>,&nbsp;<a href="http://v/" target="_blank" rel="noreferrer noopener">Ohio</a>,&nbsp;<a href="https://apnews.com/article/business-newark-ras-baraka-coronavirus-pandemic-new-jersey-e920f70ebda5a7007c8fa4f135dec539" target="_blank" rel="noreferrer noopener">Newark</a>&nbsp;and&nbsp;<a href="https://www.miamidade.gov/global/news-item.page?Mduid_news=news1590901593044688" target="_blank" rel="noreferrer noopener">Miami-Dade</a>—have adopted curfews in recent days in an effort to stop late-night activity, especially at restaurants and bars.



Data on whether curfews actually work is scarce, and public health experts are mixed on whether they will actually have any impact.&nbsp;



John Swartzberg, a clinical professor emeritus of infectious diseases at UC Berkeley, told&nbsp;Forbes&nbsp;they send a powerful message to the public and impact “people eating/drinking after 10:00 p.m.,” who, as a group, are “less likely to be taking precautions against becoming infected and infecting others.”



But Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, is skeptical people will actually comply, and will instead meet in private gatherings inside homes if restaurants and bars are closed, an activity he suspects is spreading the virus even more than gathering in public areas.



Adalja said there isn’t contact tracing data showing that people behave differently depending on the time of night, and noted the virus doesn’t spread any more or less after 10 p.m. either.



William Hanage, an epidemiologist at the Harvard T. H. Chan School of Public Health,&nbsp;<a href="https://www.usatoday.com/story/news/health/2020/11/06/massachusetts-covid-curfew-may-not-have-big-case-impact-experts-say/6183084002/" target="_blank" rel="noreferrer noopener">told</a>&nbsp;USA Today&nbsp;that “curtailing the evening for dining by an hour or so isn&#8217;t likely to make a very large impact,” and Lee Riley, an infectious disease specialist at UC Berkeley’s School of Public Health,&nbsp;<a href="https://www.capradio.org/articles/2020/11/20/can-californias-curfew-slow-the-spread-of-covid-19-we-asked-an-infectious-disease-specialist/" target="_blank" rel="noreferrer noopener">told</a>&nbsp;CapRadio curfews will likely “have more of a cosmetic effect than a real impact.”



<h3 class="wp-block-heading" id="h-crucial-quote">CRUCIAL QUOTE</h3>



“I’m not even sure what this was designed to do and I don’t suspect they’re going to see any major benefit from it,” Adalja told&nbsp;Forbes. “And then they’re going to say that it failed and we have to do something more strong rather than understanding from contact tracing data how people are getting infected and what they can do to make that less likely. . . . If it’s people getting infected at private gatherings you need a totally different strategy because public health can’t really reach into people’s homes.”



<h4 class="wp-block-heading" id="h-key-background">KEY BACKGROUND</h4>



A dangerous third resurgence of the coronavirus is&nbsp;<a href="https://www.forbes.com/sites/siladityaray/2020/11/20/more-than-2000-people-died-of-covid-19-in-the-us-on-thursday-with-around-80000-now-hospitalized/?sh=1e365375123d">spreading</a>&nbsp;across the country, overwhelming healthcare systems in&nbsp;<a href="https://www.miamidade.gov/global/news-item.page?Mduid_news=news1590901593044688" target="_blank" rel="noreferrer noopener">several</a>&nbsp;states. Curfews are just one restriction state and local leaders are imposing in an effort to stem the spread of the virus. Los Angeles has&nbsp;<a href="https://www.cbsnews.com/news/covid-restrictions-los-angeles-county-indoor-dining/" target="_blank" rel="noreferrer noopener">banned</a>&nbsp;in-person dining altogether. New York&nbsp;<a href="https://www.forbes.com/sites/jemimamcevoy/2020/11/18/new-york-city-to-close-public-schools-again/?sh=862878a214ad">closed</a>&nbsp;schools. Others are putting&nbsp;<a href="https://www.forbes.com/sites/alisondurkee/2020/09/17/state-by-state-reopening-guidelines-coronavirus/?sh=72d03e9d533b">limits</a>&nbsp;on social gatherings. Some Republicans are taking the opposite approach, however, and&nbsp;<a href="https://www.theverge.com/2020/11/23/21591366/foxconn-wisconsin-google-server-component-assembly-contract-report" target="_blank" rel="noreferrer noopener">promising</a>&nbsp;not to shut down parts of the economy.



-by Rachel Sandler, Forbes Staff

Tag: coronavirus curfew

FORBES AFRICA SOCIAL MEDIA

‘ALL OF THIS IS NEW TERRITORY AND REALLY IN A WAY, UNPREDICTABLE’

Gates Says Next 4-6 Months Could Be ‘Worst Of Pandemic’ As Vaccine Shipments Roll Out

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

What Goes Into A Clinical Trial?

Will Covid-19 Curfews Work? Public Health Experts Unsure Of Potential Impact