A common insecticide that is a major hazard for honeybees is now effectively detected in honey thanks to a simple new method.

In the long dark tunnel that has been 2020, November stands out as the month that light appeared. Some might see it as a bright light, others as a faint light – but it is unmistakably a light.

On November 9, Pfizer announced the interim results of its candidate vaccine, showing it to be “more than 90% effective” in preventing symptomatic Covid-19 in late-stage human trials. The news was greeted with joy.

A couple of days later, the Russian Direct Investment Fund announced that the candidate vaccine they are funding – dubbed Sputnik V – showed 92% efficacy in late-stage trials. Not to be outdone, Moderna then announced that its candidate vaccine showed 94.5% efficacy.

The latest Covid-19 vaccine announcement comes from Oxford University. And, as with all of the above announcements, it came via press release. Its vaccine candidate, developed in partnership with AstraZeneca, showed an overall effectiveness of 70.4%.

In case that sounds disappointing, bear in mind that these are interim results and the figures might change. Also, the Oxford vaccine was given to one group of volunteers as two standard doses, which showed 62% effectiveness, and another group of volunteers as a smaller dose followed by a standard second dose. This raised effectiveness to 90%.

It’s not immediately clear why this is the case. Professor Andrew Pollard, one of the lead researchers on the project, described the results as “intriguing”. He also highlighted that the use of lower doses means that there would be more vaccine doses available.

There were no cases of severe Covid-19 in those who received the vaccine. And it seems to generate a protective immune response in older people. Although we’ll have to wait for the final breakdown of results to get clarification on that.

Effectiveness is not the only measure

Despite the Oxford vaccine having lower overall effectiveness than the Pfizer or Moderna vaccines – at least at this interim stage – there are other success factors to consider. Safety is one, and the Oxford vaccine is so far reported to have a good safety record with no serious side-effects.

Another crucial factor is storage. The Oxford vaccine can be stored in a domestic fridge. The need for sustained freezing across the whole vaccine journey from factory to clinic at ultra-low temperatures – as seen with the Pfizer vaccine – may be a problem for many countries, but especially poorer countries.

The Oxford vaccine, based on a viral vector, is also cheaper (around US$4) than Pfizer and Moderna’s mRNA vaccines – around US$20 and $33, respectively. AstraZeneca has made a “no profit pledge”.

Equitable distribution

As I have previously discussed, equitable distribution of new vaccines is vital, especially for low- and middle-income countries who don’t have the profile or purchasing power of wealthier countries. GAVI – a global health partnership that aims to increase access to immunisation in poor countries – has worked for years to address this very point.

It set up the COVAX initiative in 2020, which has access to 700 million doses of Covid vaccine if clinical trials are successful.

Oxford and AstraZeneca have previously made their own commitments to provide a billion doses of their vaccine for low- and middle-income countries, with a commitment to provide 400 million doses before the end of 2020.

Certainly, AstraZeneca has committed to provide more doses to countries outside of Europe and the US than any of its nearest competitors.

An excellent start

These commitments will clearly not be enough for immediate global coverage, but it is an excellent start. Around 9% of the world’s population live in extreme poverty, and the health systems around them are fragile.

With promises for equitable vaccine distribution, there is hope that the poorer populations around the world will not be forgotten. The global health community must keep its focus on this area.

What does this announcement mean for the world? Potentially a huge amount. But remember that the trials are not yet complete and, at the time of writing, the regulators have yet to approve any of the new vaccine candidates.

Even when those hurdles are cleared, we still need to vaccinate the world, which requires successfully navigating the complex obstacles of distance, terrain, politics, cold-chain logistics and human behaviour.

The global pandemic is not over and won’t be for a long time yet – but the light is getting brighter.

Michael Head, Senior Research Fellow in Global Health, University of Southampton

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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• Growth measured in height and weight recognised as a measure of health
• Imbalance between investment in improving nutrition in pre-schoolers, and in school-aged children and adolescents
• In SA, polices needed to to support an enabling environment

“Tall as trees” sounds very clichéd but it may not apply to children in many sub-Saharan African countries, according to a Lancet article reporting on children’s height and weight changes over the past thirty years. 

The Lancet article pooled data from over two thousand studies from two hundred countries with a study population of 65 million participants and reported on the projected changes of height and body-mass index (BMI) of school-aged children and adolescents from 1985 to 2019. 

The data showed that the unhealthiest changes – gaining too little height and/or too much weight for their height occurred in many countries in sub-Saharan Africa, including South Africa, New Zealand, and the USA for boys and girls; in Malaysia and some Pacific island nations for boys; and in Mexico for girls.

Growth measured in height and weight has long been recognised as a measure of the health of individuals, hence part of the reasoning for the promotion of routine growth monitoring for children under five years of age. In South Africa, every child is presented with a Road to Health Booklet to record and monitor their weight and height measures from birth.

Mothers and caregivers are encouraged to visit their health facility for monthly growth monitoring to track their child’s growth and development as a proxy for health. 

A major public health concern

Malnutrition identified in the failure to grow in height and weight is a major public health concern worldwide. In South Africa, 27% of children younger than five years are too short for their age and in the same age group, 15% are too fat. These indicators serve as proxies for the state of overall health.

As reflected in the Lancet article, young South African children are too short and too fat.Our adolescent nutrition profile does not paint a much better picture, with 6.1% males and 16.7% females in the age group 15-19 years overweight and their average height below the global average of 1.62m. 

The Lancet reported that 19-year-old boys in 11 countries throughout Asia, Latin America, and sub-Saharan Africa had the same mean height as that of Dutch boys aged 13 years. In many countries in sub-Saharan Africa, with emerging economies, the height of children and adolescents, especially boys, has on average stagnated or become shorter since 1985.

This points directly to the increasing levels of poverty driving the vicious cycle of malnutrition as households and communities struggle to access adequate and sufficiently nutritious food. The Lancet reported that the largest improvements in average height of children over the 35-year period were seen in emerging economies such as China, South Korea and some parts of southeast Asia.

For example, 19-year-old boys in China in 2019 were 8cm taller than in 1985, with their global rank changing from 150th tallest in 1985 to 65th in 2019. Over the same period, the average height of South African girls stagnated, while boys gained only around 2cm.

Nineteen-year-old South African girls had the same average height as 12-year-old Dutch girls, while South African boys of the same age had the average height of 14-year-old Dutch boys. 

South Africa is mentioned in the report as one of the countries where children compared fairly well with international growth references at the age of five years, but by the time they reached 19 years, they fell behind due to insufficient growth in height during school-age years.

While little or no height was gained per year of age, the girls in particular gained weight, so that the average weight of South African girls in each age group was markedly higher after 2010 than in the 1980s and was in the overweight range at age 19 years.

Falling behind

The Lancet report also highlighted that while children in some countries grow healthily to age five years, they fall behind in the school years in terms of growth in length.

This highlights that there is an imbalance between investment in improving nutrition in pre-schoolers, and in school-aged children and adolescents. This issue was especially important during the Covid-19 pandemic when schools were closed throughout the world, and many poor families are unable to provide adequate nutrition for their children.

This recognition that school feeding is an important and integral intervention to promote and sustain child nutrition, prompted civil society in South Africa to approach the courts to force government to reinstate the national school nutrition programme.

While many school-aged children do not have access to adequate nutritious food for linear growth and physical development, they seem to have high enough intakes of sweetened cold drinks and cheap snack foods to gain excessive weight. Some of these cold drinks and snacks are even available in the school environment at low cost.

This is probably an important driver of the weight gain reported in South African school-age girls.

Ensure food security

The Lancet report re-affirms the imperative to sustain adequate food and nutrition support throughout the critical stages of life including during pregnancy, early childhood, adolescent and adult years to consolidate and reap the benefits gained in food and nutrition interventions and investments in infants and children younger than five years.

This is imperative because adolescents and women of child-bearing age are the future parents of the next generation of children. 

Mothers with poor nutritional status will bear children with poor nutritional status and this is a lost and costly opportunity as malnutrition castes a long shadow into the future robbing individuals, communities and countries of health, well-being and development.

If we are to improve child health and nutrition, governments need to ensure food security.

Food security is defined as all people at all times having physical and economic access to adequate amounts of nutritious, safe, and culturally appropriate foods. This will help children grow taller without gaining excessive weight for their height. 

To achieve these goals, South Africa needs policies to support an enabling environment, with restricted access to unhealthy foods and drinks and more access to facilities in the community and in the school environment for safe play and sports.

*Dr Witten is at based the University of the Free State’s Faculty of Health Sciences, Division of Health Science Education. Kruger is a Professor at the North-West University’s Centre of Excellence for Nutrition.

*This article was produced by SPOTLIGHT – health journalism in the public interest. SIGN UP for our newsletter.

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The first drug against HIV brought dying patients back from the brink. But as excited doctors raced to get the miracle drug to new patients, the miracle melted away. In each and every patient, the drug only worked only for a while.

It turned out the drug was very good at killing the virus, but the virus was even better at evolving resistance to the drug. A spontaneous mutation in the virus’ genetic material prevented the drug from doing its work, and so the mutant viruses were able to replicate wildly despite the drug, making the patients sick again. It took another decade before scientists found evolution-proof therapies.

Could the same thing happen to a Covid-19 vaccine? Could a vaccine that is safe and effective in initial trials go on to fail because the virus evolves its way out of trouble? As evolutionary microbiologists who have studied a poultry virus that has evolved resistance to two different vaccines, we know such an outcome is possible. We also think we know what it takes to stop it. Covid-19 vaccines could fail – but if they have certain properties, they won’t.

History of vaccine resistance

For the most part, humanity has been lucky: Most human vaccines have not been undermined by microbial evolution.

For instance, the smallpox virus was eradicated because it never found a way to evolve around the smallpox vaccine, and no strain of the measles virus has ever arisen that can beat the immunity triggered by the measles vaccine.

But there is one exception. A bacterium that causes pneumonia managed to evolve resistance against a vaccine. Developing and replacing that vaccine with another was expensive and time-consuming, with seven years between the initial emergence of resistant strains and the licensing of the new vaccine.

There haven’t been other failures for human vaccines yet, but there are hints that viruses, bacteria and parasites can evolve or are evolving in response to vaccination. Escape mutants that are able to evade vaccine-induced immunity are regularly seen in the microbes that cause hepatitis B and pertussis.

For such human diseases as malaria, trypanosomiasis, influenza and AIDS, vaccines have been hard or impossible to develop because the microbes that cause those diseases evolve so fast. In agricultural settings, animal vaccines are frequently undermined by viral evolution.

What would it look like?

If SARS-CoV-2 evolves in response to a Covid vaccine, there are several directions it could take. The most obvious is what happens with the flu virus. Immunity works when antibodies or immune cells bind to molecules on the surface of the virus. If mutations in those molecules on the surface of the virus change, antibodies can’t grab on to them as tightly and the virus is able to escape.

This process explains why the seasonal flu vaccine needs updating each year. If this happens, a Covid vaccine would need frequent updating.

But evolution might head off in other directions. It would be better for human health, for example, if the virus evolves a stealth mode, perhaps by reproducing slowly or hiding in organs where immunity is less active. Many pathogens that cause barely noticeable chronic infections have taken this tack. They avoid detection because they do not cause acute disease.

A more dangerous avenue would be if the virus evolved a way to replicate more quickly than the immunity generated by the vaccine. Another strategy would be for the virus to target the immune system and dampen vaccine-induced immunity.

Many microbes can survive inside the human body because of their exquisite ability to interfere with our immune systems. If SARS-CoV-2 has ways of even partially disabling human immunity, a Covid vaccine could favor mutants that do it even better.

Evolution-proof vaccines

Before Covid came along, the two of us compared vaccines that keep working with vaccines that have been undermined by pathogen evolution.

It turns out that truly evolution-proof vaccines have three features. First, they are highly effective at suppressing viral replication. This stops further transmission. No replication, no transmission, no evolution.

Second, evolution-proof vaccines induce immune responses that attack several different parts of the microbe at the same time. It is easy for a single part of the virus to mutate and escape being targeted. But if many sites are attacked at once, immune escape requires many separate escape mutations to occur simultaneously, which is almost impossible.

This has already been shown in the laboratory for SARS-CoV-2. There the virus rapidly evolved resistance to antibodies targeting a single site, but struggled to evolve resistance to a cocktail of antibodies each targeting multiple different sites.

Third, evolution-proof vaccines protect against all circulating strains, so that no others can fill the vacuum when competitors are removed.

Will a Covid vaccine be evolution-proof?

Around 200 Covid vaccine candidates are at various stages of development. It is too soon to know how many of them have those evolution-proofing features.

Fortunately we don’t need to wait until a licensed vaccine fails to find out. A bit of extra effort during vaccine trials can go a long way to working out whether a vaccine will be evolution-proof. By swabbing people who have received the experimental vaccine, scientists can tell how far virus levels are suppressed.

By analysing the genome of any virus in vaccinated people, it might be possible to see evolutionary escape in action. And by taking blood from vaccinees, we can work out in the lab how many sites on the virus are being attacked by vaccine-induced immunity.

Clearly, the world needs Covid vaccines. We believe it is important to pursue those that will keep working. Likely, many candidates in the current portfolio will. Let’s work out which those are in clinical trials and go with them. Vaccines that provide only temporary relief leave people vulnerable and take time and money to swap out. They may also negate other vaccines should viruses evolve that are resistant to several vaccines at once.

Today, the world has insecticide-resistant mosquitoes and crop pests, herbicide-resistant weeds, and an antibiotic resistance crisis. No need for history to repeat itself.

Andrew Read, Evan Pugh University Professor of Biology and Entomology, Eberly Professor of Biotechnology, Director, Huck Institutes of the Life Sciences, Penn State and David Kennedy, Assistant Professor of Biology, Penn State

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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• Two Covid-19 vaccine trials have shown promising results during recent weeks
• Vaccines could start reaching people before the end of the year, experts say
• However, the threat of vaccine nationalism has increasingly become a concern

Two vaccine candidates from pharmaceutical and biotech companies Pfizer and Moderna have shown promising results, but African countries need to ensure they aren’t left behind when vaccine rollouts start happening.

These were the words of the Regional Director of the World Health Organization (WHO) Regional Office for Africa, Dr Matshidiso Moeti, during a virtual discussion hosted by Doha Debates on Wednesday.

“It’s true we need to wait for full efficacy and safety data to be available, but we are all gearing up to make sure there is equitable distribution in Africa,” Moeti said. “Coming from Africa, I have to say our experience in the past has been that when a new technology comes out, African countries are at the back of the queue to get it.

“We’ve seen sometimes it takes a decade for a new technology to be available in Africa, in a scaled-up fashion in our health systems.”

‘Vaccine nationalism’

In comments made earlier this year, Professor Helen Rees, executive director of the Wits Reproductive Health and HIV Unit (RHI), stressed that the opportunity to participate in trials must ensure that Africa is not left behind like it was in the past.

If trials are limited to the North, Rees cautioned that it will result in “vaccine nationalism”, which typically occurs when a country’s government manages to secure vaccine doses for its own citizens before it’s made available to other countries – something that has already been seen in the US and UK. 

According to The Telegraph, the UK has already put in an order for five million doses of the Moderna vaccine, while CNBC reported in July that the US struck an agreement with Pfizer to get 100 million doses of their vaccine, and acquire 500 million additional doses if needed.

Rees commented then on the crisis with the pandemic flu vaccine and HIV antiretrovirals in the past, where Africa got left behind and ultimately received very little vaccine and months too late. “We cannot allow that to happen again,” she said. 

COVAX Facility

Moeti also drew attention to the COVAX Facility – led by Gavi, the Vaccine Alliance, along with the WHO and the Coalition for Epidemic Preparedness Innovation – an alliance that finances vaccine development in order to guard against inequity in the distribution of the vaccine to developing countries.

By September, the Gavi COVAX Advance Market Commitment (AMC) had raised around US$ 700 million from sovereign donors as well as philanthropy and the private sector, against an initial target of US$ 2 billion in seed funding needed by the end of 2020, the WHO stated.

Funding the Gavi COVAX AMC is critical to ensuring that the ability to pay is not a barrier to accessing Covid-19 vaccines, “a situation which would leave the majority of the world unprotected, with the pandemic and its impact continuing unabated”, the organisation noted.

However, Moeti cautioned that wealthier countries, mainly the Western countries, are already entering into advanced purchase agreements with vaccine manufacturers to reserve doses. 

“From the African perspective, we are very concerned but also hoping that we hold to this principle of equity and that we don’t have deals being entered into with countries that then sweep up the supplies,” Moeti said.

Moeti said that they are hoping for at least 20% of populations to be covered in Africa, initially, starting with the most vulnerable. “We hope we do not have inequality based on geography, income level of countries and also racial inequality,” she commented.

Covid-19 vaccine for distribution in Africa: Where do we stand?

South Africa had not yet managed to secure any doses of vaccines from Pfizer, whose vaccine was shown to be over 95% efficacious this week, or any other manufacturer, Spotlight recently reported, adding that the country also missed the first deadline to commit to COVAX.

However, spokesman for the Department of Health, Popo Maja, confirmed to Spotlight that although SA had not concluded any vaccine deal, negotiations with manufacturers and COVAX were underway.

“My staff and I, with partners, are doing all our best to persuade the African countries to go for it, to go looking for the money. Let’s have a pooled approach so that we constitute a market that’s going to be competing,” said Moeti.

“We’re working with the African countries to get ready now. In fact, we are doing an assessment of their readiness and preparing to roll out the vaccine in terms of all the logistics, the technical work that needs to be done. 

“I do think one of the best experiences from the HIV era was the solidarity among people. Covid-19 has become very political, much more than HIV did,” she said.

READ | Pfizer ends Covid-19 vaccine trial with 95% efficacy, to seek emergency-use authorisation in US

READ | Covid-19: Two of the vaccine front runners have already reported promising evidence – so what now?

READ | Why vaccines need to be tried and tested in different populations across the world

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• Researchers have developed a simple system that can help the body clear alcohol at a quicker rate 
• A similar device was approved by the FDA in 2019 to treat carbon monoxide poisoning
• It was then modified to also address alcohol poisoning 

Scientists from the Toronto General Hospital Research Institute in Canada, have developed a device that essentially reverses the effects of binge drinking – and may soon be used in clinical settings. The greatest potential of the device is that it could reduce road fatalities.

According to the World Health Organization (WHO), worldwide, three million deaths are caused by the harmful use of alcohol every year.

The device is a compact, simple, proof-of-concept system that can help the body clear alcohol at a faster-than-normal rate. To do this, it employs the lungs to join the liver in driving out the alcohol.

A basic, low-tech device

The liver normally removes 90% of alcohol from the blood, but until now, there was no way for this process to be sped up. However, if the lungs can help to expel the alcohol, it can be cleared from the blood and the rest of the body up to three times faster, the team found.

This means that the harder the breathing, the more alcohol is eliminated.

“It’s a very basic, low-tech device that could be made anywhere in the world: no electronics, no computers or filters are required,” anaesthesiologist Joseph Fisher, from the Toronto General Hospital Research Institute in Canada said in a news release.

For Fisher, it’s almost “inexplicable” that this wasn’t tried many years ago.

The equipment is the size of a small briefcase. It uses a valve system, connecting tubes, a mask, and a small tank with compressed carbon dioxide. 

The findings were published in Scientific Reports.

Five volunteers

For this study, the scientists adapted the breathing apparatus, called ClearMate, to aid the process and to pump oxygen and carbon dioxide back into the body.

The pilot study included five male volunteers in a laboratory setting, with and without alcohol in their blood (a single vodka-based drink was used to supply the alcohol).

The system is also quite impressive in its ability to return exactly the right amount of carbon dioxide back to the blood, while the alcohol is hyperventilated away.

“You can’t just hyperventilate, because in a minute or two you would become light-headed and pass out,” explained Fisher.

The US Food and Drug Administration (FDA) had already allowed ClearMate to be marketed as a way to treat carbon monoxide poisoning in emergency rooms in 2019. With its latest modifications, the team is hoping it can become a helpful method of also dealing with alcohol poisoning.

Next steps

The scientists are now aiming to test the process more widely, and, more importantly, to ensure it can work with people with serious amounts of alcohol in their system (as participants in this study only had mildly elevated blood ethanol concentrations of approximately  0.1%), and who are at serious risk of health conditions.

“At lower blood ethanol concentrations, impaired judgment and coordination make people a risk to themselves and to those around them, but high levels put them at risk for organ damage and death from pulmonary aspiration, respiratory depression, and malignant arrhythmias,” the researchers wrote.

The team recommends following up with further validation studies to understand how this system could be applied in a clinical setting.

READ | Brain scans reveal binge drinkers have to work harder to feel empathy for others

READ | Your smartphone may be able to tell if you’re drunk by analysing your walk

READ | ‘0% alcohol’ beverages may be the latest sipping trend, but for recovering alcoholics, it could be a dangerous trigger

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• Results from the Oxford University Covid-19 vaccine trial shows promising results, with up to 90% efficacy reported
• The vaccine will now await regulatory approval from independent regulator, the MHRA 
• The UK government has pre-ordered 100 million doses, and AstraZeneca stated that it will seek an Emergency Use Listing from WHO for vaccine availability in low-income countries

Positive data from an interim analysis of the University of Oxford’s Covid-19 vaccine trial in the UK and Brazil shows that it protects 70% of people from developing Covid symptoms, Oxford’s manufacturing partner, AstraZeneca announced on Monday.

The data is from the COV002 Phase 2/3 trial in the UK and COV003 Phase 3 trial in Brazil, which involves more than 23 000 participants. No hospitalisations or severe cases of the disease were reported in volunteers who received the vaccine, named AZD1222.

A total of 30 cases of Covid-19 were found in participants who received two jabs of the vaccine, and 101 cases in people who received a saline injection. According to the researchers, it translates to 70% protection.

Additional data from the large-scale trial also suggests that perfecting the dose could increase protection up to 90%. This was seen for one course of dosing, where volunteers received a half dose of the vaccine, followed by a full dose at least one month after.

When participants were given two “high” doses, it resulted in 62% protection. However, this increased to 90% when participants received a “low” dose followed by a high one. 

Chief investigator pleased with results

Professor Andrew Pollard, the trial’s lead investigator said: “Excitingly, we’ve found that one of our dosing regimens may be around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply.”

The researchers stated that it’s not clear why there is a difference, although Pollard told the BBC that the team is “really pleased with these results”.

There were also lower levels of asymptomatic infection in the low followed by high dose group which “means we might be able to halt the virus in its tracks,” Pollard said.

Vaccine’s architect Professor Sarah Gilbert also commented: “The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by [the virus].”

The vaccine uses an adenovirus, which causes the common cold in chimpanzees, that has been genetically engineered so that it’s unable to replicate and cause disease in humans. 

How does the Oxford vaccine fare, compared to Pfizer and Moderna’s vaccines?

This news follows shortly after the positive results announced by Pfizer/BioNTech and Moderna, whose vaccines showed 95% and 94.5% protection respectively. Both companies have applied to regulatory authorities for approval.

While 70% may seem like a disappointing result in comparison to these two vaccines, the Food and Drug Administration (FDA) requires a Covid-19 vaccine to prevent disease in 50% of volunteers in order to gain approval.

Logistics less complex

Logistics of storing and transporting the Oxford vaccine will be far less complex than the Pfizer and Moderna vaccines, as it can be stored at fridge temperature, making it more favourable to distribute worldwide.

The Pfizer/BioNTech vaccine needs to be stored below freezing temperatures (minus 70 degrees Celsius), while Moderna’s vaccine needs to be shipped and transported at minus 20 degrees Celsius.

Reporting by Bhekisisa earlier this month notes that despite its promise, cold chain requirements mean these jabs wouldn’t be the first choice for countries like South Africa.

In addition to the above, the Oxford vaccine is also much cheaper than the Pfizer and Moderna vaccines.

This means that it will play a significant role in fighting the spread of the virus, if it is approved by regulators, which is due to take place in the next couple of weeks.

“I’m really very pleased, I really welcome these figures – this data – that show that the vaccine in the right dosage can be up to 90% effective,” Health Secretary Matt Hancock told Sky News.

“Of course, it’s vital that the independent regulator – the MHRA (Medicines and Healthcare products Regulatory Agency) – will need to look at the data, will need to check to make sure that it’s effective and safe.” 

Comments on results by lead investigator of SA’s trial

Clinical trials are also being carried out in the US, Japan, Russia, South Africa, Kenya and Latin America. Planned trials are due to take place in other European and Asian countries. A total of 60 000 participants are expected to be enrolled globally.

This vaccine candidate was also the first of Covid-19 vaccines to be trialled in South Africa. Named the Ox1Cov-19 Vaccine VIDA trial, it is done in collaboration with Oxford University. The SA trial is being led by Shabir Madhi, Professor in Vaccinology at Wits University.

Commenting on the results, Madhi said in a press release by the university:

“The results from this study add further hope that accessing vaccines to fight the Covid-19 pandemic are fast becoming a reality.

“The results from this study are intriguing, in that a dose-sparing regimen may inadvertently end up being more protective. This has implications not only for the cost of the vaccine, but also how many more people could possibly be vaccinated in the near future when vaccine supply is likely to be constrained.

“Also, the ability to scale up production of this vaccine, and it only needing to be stored at 2-8 degrees Celcius, would greatly assist in the deployment of the vaccine in low- and middle-income countries. The cost of this vaccine is also anticipated to be much cheaper than other Covid-19 vaccines that have recently been shown to be efficacious.”

Madhi emphasised the importance of testing the vaccine in diverse populations, such as South Africa:

“The results of the study from South Africa remain of global interest, and to inform recommendations on Covid-19 vaccine in Africa, as the Covid-19 experience in South Africa has been very different to the UK.

“As for many other vaccines, genetic factors and local conditions could also affect the performance of the vaccine in different populations. The results of the pooled analysis from UK and Brazil creates optimism that we will also show protection against Covid-19 in the South African study, where participants are still being followed-up.”

Who’s first in line to receive the vaccine?

According to the BBC, AstraZeneca is preparing to produce three billion doses for the world next year.

The UK government has already pre-ordered 100 million doses, enough to immunise 50 million people. If approved, four million is expected to roll out by the end of the year.

Earlier this year, Madhi explained that AstraZeneca, however, doesn’t have any direct involvement with SA’s vaccine trial as the agreement to do the trial here preceded Oxford’s agreement with AstraZeneca for further clinical development and manufacturing of the vaccine.

But spokesman for the Department of Health, Popo Maja, confirmed to Spotlight this month that although SA had not concluded any vaccine deal, negotiations with manufacturers and COVAX (an initiative co-lead by the World Health Organization that aims to ensure developing countries get access to Covid-19 vaccines) are underway.

AstraZeneca’s press release notes that “it will now immediately prepare regulatory submission of the data to authorities around the world that have a framework in place for conditional or early approval.

“The Company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries. In parallel, the full analysis of the interim results is being submitted for publication in a peer-reviewed journal,” they stated.

READ | Covid-19: Two of the vaccine front runners have already reported promising evidence – so what now?

READ | Cold truth: South Africa won’t be able to store these Covid vaccines. Here’s why.

READ | The latest news on a leading Covid vaccine candidate is promising, but how optimistic should we be?

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• One of the oldest vaccines to exist, BCG, may offer protection against the world’s newest infectious disease, Covid-19
• In addition to this vaccine, the MMR vaccine is also currently being trialled globally to see if it offers the same benefit
• According to two independent studies recently published, MMR reduced Covid-19 severity in participants, while BCG reduced the chances of contracting Covid-19

Scientists have been looking at existing vaccines to see whether they could also induce protection against Covid-19, the disease caused by SARS-CoV-2. Among them are the measles-mumps-rubella (MMR) vaccine, as well as the decades-old tuberculosis vaccine, Bacillus Calmette-Guérin (BCG).

In a new study published in mBio, an open-access journal of the American Society for Microbiology, researchers provide evidence that in the MMR vaccine, mumps IgG titers (also known as levels of IgG antibody) are inversely correlated with severity in recovered Covid-19 patients previously vaccinated with the MMR II vaccine produced by Merck.

And, according to a new study by Cedars-Sinai, Bacillus Calmette-Guérin (BCG) is associated with reduced likelihood of contracting Covid-19. The study was published in the Journal of Clinical Investigation.

Why the MMR vaccine?

The MMR vaccine has been looked at as a possibility to work against Covid-19 since the early months of the pandemic, as it is known to protect against viruses that are similar to the coronavirus.

The World Health Organization (WHO) states that the vaccine is widely used for the immunisation of children in certain regions of the world due to its advantages over individual vaccines.

The vaccine, which was developed almost 50 years ago, has since been received by hundreds of millions of people worldwide.

Countries involved in a study launched earlier this year include Canada, Ghana, Ireland, South Africa, Uganda, the UK, the US, Zambia and Zimbabwe, Health24 reported.

“… This type of vaccine, which contains small amounts of very weakened measles, mumps and rubella viruses, appears to strengthen the body’s immune response to infections in general, not just to the viruses in that particular vaccine,” said Sinead Delany-Moretlwe, one of the SA trial’s national principal investigators, and a research professor at the Wits Reproductive Health and HIV Institute (Wits RHI).

Another reason it may be effective is that there are similarities between the weakened viruses in the vaccine and the Covid-19 virus, Delany-Moretlwe explained.

The researchers commented that all of these viruses have similar proteins on their surfaces that are involved in infecting cells in the body, and they therefore hypothesise that antibodies made in response to the MMR vaccine may also recognise and fight SARS-CoV-2.

About the more recent study, lead study author Jeffrey Gold, president of World Organization in Watkinsville, Georgia, said: “We found a statistically significant inverse correlation between mumps titer levels and Covid-19 severity in people under age 42 who have had MMR II vaccinations.

“This adds to other associations demonstrating that the MMR vaccine may be protective against Covid-19. It also may explain why children have a much lower Covid-19 case rate than adults, as well as a much lower death rate.”

The majority of children get their first MMR vaccination around 12 to 15 months of age and a second one from 4 to 6 years of age, commented Gold.

Co-author David Hurley, professor and molecular microbiologist at the University of Georgia, also commented: “The MMR II vaccine is considered a safe vaccine with very few side effects. If it has the ultimate benefit of preventing infection from Covid-19, preventing the spread of Covid-19, reducing the severity of it, or a combination of any or all of those, it is a very high reward low risk ratio intervention.

“Maximum seropositivity is achieved through two vaccinations at least 28 days apart. Based upon our study, it would be prudent to vaccinate those over 40 regardless of whether or not they already have high serum MMR titers.”

TB vaccine linked to lower risk of contracting Covid

The BCG vaccine was developed between 1908 and 1921 and is given to more than 100 million children around the globe every year.

Researchers have been studying BCG’s potential to curb illnesses other than TB for several years, in part because of a concept scientists call “trained immunity”, explains this article by Bhekisisa.

Researchers think that immunisations such as BCG and measles, the article explains, help reprogramme our immune cells to better respond to infections later.

A 2014 research review published in the Journal of Clinical Infectious Disease, for instance, found that BCG worked effectively to protect children against TB in northern countries, which typically have lower burdens of TB.

Researchers of the Cedars-Sinai study tested the blood of more than 6 000 healthcare workers in the Cedars-Sinai Health System for evidence of antibodies to SARS-CoV-2. Participants were also asked about their medical and vaccination histories.

The findings reveal that those who had received BCG vaccinations in the past (nearly 30% of participants) were significantly less likely to test positive for SARS-CoV-2 antibodies in their blood or to report having had infections with coronavirus or coronavirus-associated symptoms over the previous six months, compared to those who had not received BCG.

These effects were not related to whether workers had received meningococcal, pneumococcal or influenza vaccinations.

However, the reasons for the lower SARS-CoV-2 antibody levels in the BCG group were not clear, according to Moshe Arditi, MD, director of the Paediatric and Infectious Diseases and Immunology Division at Cedars-Sinai and co-senior author of the study.

“It appears that BCG-vaccinated individuals either may have been less sick and therefore produced fewer anti-SARS-CoV-2 antibodies, or they may have mounted a more efficient cellular immune response against the virus,” said Arditi.

“We were interested in studying the BCG vaccine because it has long been known to have a general protective effect against a range of bacterial and viral diseases other than TB, including neonatal sepsis and respiratory infections.”

Based on their study results, co-author Susan Cheng, associate professor of Cardiology and director of Public Health Research at the Smidt Heart Institute at Cedars-Sinai, believes that large, randomised clinical trials are urgently needed to confirm whether BCG vaccination can induce a protective effect against SARS-CoV2 infection.

“It would be wonderful if one of the oldest vaccines that we have could help defeat the world’s newest pandemic,” commented Arditi.

READ | Covid-19: An MMR vaccine trial just started in SA – and latest research appears to be promising

READ | What the latest science says about a TB vaccine and Covid-19

WATCH | Why are scientists testing a TB vaccine to see if it protects against Covid-19?

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• There is a risk of atrial fibrillation in adulthood for babies who were born with a higher body weight 
• Maintaining a healthy weight and a healthy lifestyle early on can, however, prevent the onset of AF later in life
• Pregnant mothers should also pay more attention to diet control and have regular check-ups

Research presented at the 31st Great Wall International Congress of Cardiology (GW-ICC) indicates that elevated birth weight can be associated with atrial fibrillation (irregular heart rate) in adulthood. 

Previous studies have indicated that a high BMI during pregnancy is linked to atrial fibrillation in offspring, and advised that preventing maternal obesity can lessen the likelihood of the condition.

Now a study authored by Dr Songzan Chen of Zhejiang University suggests  that there is a risk of atrial fibrillation in adulthood for babies who were born with a higher body weight (over 4 000 grams). Researchers conducted a trial using data from 321 223 individuals “to identify 132 genetic variants associated with birth weight”.

The relationship between birth weight and atrial fibrillation

Dr Chen found that there is a causal relationship between birth weight and atrial fibrillation. Also, birth weight presents an indication of adult height, and the risk of atrial fibrillation is higher in tall people.

However, maintaining a healthy weight and a healthy lifestyle early on can prevent the onset of AF later in life.

Elevated birth weight preventable

According to Professor Guosheng Fu of Sir Run Run Shaw Hospital, ”reducing the number of newborns with elevated birth weight is probably considered as a feasible prevention to ease the burden of atrial fibrillation. Therefore, pregnant women should pay more attention to diet control and regular check-ups, especially for those with obesity or diabetes.”

People who were born with higher weight should also try to avoid other triggers of AF, such as drinking alcohol, obesity, smoking and drinking caffeinated drinks, as these increase the risk. Dr Chen emphasised that these individuals should adopt a healthy lifestyle to lower their chances of developing AF.

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• SA’s health products regulator will need to approve any potential vaccine
• The registration process can often be slow
• But the regulator must balance the need for products to be rapidly available, with proper evaluation

Over a hundred vaccine candidates are under development for Covid-19 globally. Twelve of these are undergoing large-scale phase III clinical trials to assess their safety and efficacy.

Vaccines being developed by BioNtech/Pfizer,Moderna and Oxford University/AstraZeneca all appear to be highly effective based on preliminary findings – although not all effective vaccines will necessarily be appropriate for use in South Africa.

As more evidence for competing vaccine candidates becomes available, South Africa’s National Essential Medicines List Committee will need to review available evidence and identify which products are appropriate for use in our public health sector.

As it is anticipated that initial vaccine supply will be limited and prices may be prohibitive, South Africa will need to identify priority populations for initial vaccination. The Ministerial Advisory Committee is developing recommendations for the Minister of Health, Dr Zweli Mkhize, on who should be prioritised for initial vaccination and how vaccines should be delivered to priority populations. 

But before any vaccines can be delivered to priority populations – or marketed through the private sector- their use must be authorised by the South African Health Products Regulatory Authority (SAHPRA). 

The role of the regulator

Director of Affordable Medicines at the National Department of Health, Khadija Jamaloodien, explains that “South Africa has a well-respected Regulatory Authority (SAHPRA) and that in terms of Section 14 of the Medicines and Related Substances Act, no medicine may be sold in the country unless it is registered by SAHPRA”. 

“This would apply to vaccines as well.” 

SAHPRA, which replaced South Africa’s former medicines regulator (the Medicines Control Council [MCC]) in 2018, ensures that all medicines (including vaccines) that are distributed and marketed in the country are safe, effective and of good quality. Before medicines can be provided in the public sector, or sold through private sector facilities, they must be registered by SAHPRA.

This process is, however, often very slow and – when delayed or inefficient – can limit access to new medicines in South Africa. Under the former medicines regulator, the MCC, the registration of new medicines took on average around four years. 

As Covid-19 requires urgent access to safe, effective and quality health technologies – and particularly vaccines – SAHPRA must ensure that regulatory delays do not impede access to vaccines once required evidence for registration is available and dossiers (applications) are submitted.

Pharmaceutical companies must also ensure that dossiers for registration of Covid-19 vaccines are timeously submitted in South Africa and other low- and middle-income countries (LMICs) –a s sometimes tardiness on the side of pharmaceutical companies is to blame for registration delays.

How the WHO is supporting rapid regulatory review in LMICs 

Recognising the harmful impact of weak regulatory systems and delayed regulatory processes on medicine access and public health, the World Health Organisation (WHO) has created systems and processes to support the strengthening of regulatory bodies in LMICs, as well as the rapid registration of essential medicines and critical health technologies.

These processes can support rapid and trustworthy regulatory decision-making for Covid-19 vaccines by SAHPRA and other LMIC regulatory authorities.

Over the past two decades, the WHO has established and grown its prequalification procedures, building on earlier efforts to evaluate vaccines and in vitro diagnostics dating back to the 1980s.

Through its prequalification processes, the WHO evaluates the safety, efficacy and quality of essential and critical medicines, vaccines, diagnostics, and other health technologies. Products that are ‘WHO Prequalified’ are essentially certified as meeting WHO standards. 

National medicine regulatory authorities can then leverage and use the work already done by the WHO when making domestic regulatory assessments.

South Africa is a ‘participating country’ in the WHO’s ‘Collaborative Procedures for Finished Pharmaceutical Products’ and, as of this year, began registering products domestically using these collaborative procedures. 

Covid-19 collaboration

In addition to its prequalification and collaborative procedures, the WHO recently committed to work with the International Coalition of Medicines Regulatory Authorities (ICMRA) to promote greater transparency and sharing of data between regulatory agencies in response to Covid-19.

In announcing their collaboration, the WHO and ICMRA stated, “as in other areas of the pandemic response, multilateral cooperation between regulatory authorities will be critical in ensuring there is a level playing field, that Covid-19 vaccines and medicines are safe, effective and quality-assured, and that all countries may benefit from such products equitably and at the same time”. 

The United States’ medicines regulatory authority, the Food and Drug Administration (FDA), further committed (on 17 November) to “publicly post their reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs [Emergency Use Authorisations] for all drug and biological products, including vaccines, as part of [its] Covid-19 response”.

Andy Gray, senior pharmacy lecturer at the University of KwaZulu-Natal, explains that “the major national and regional medicines regulators, including the US FDA and EMA, and the International Coalition of Medicines Regulatory Authorities (ICMRA) have committed to maximising transparency surrounding the approval of Covid-19 vaccines”.

“They will work with one another, and with [the] WHO, to ensure that the data supporting their decisions are in the public domain. Not only will this be critical to public trust in the decisions, but it will also make it easier for regulators like SAHPRA, which will rely on the global efforts,” says Gray.

How SAHPRA is preparing to review dossiers for Covid-19 vaccines

SAHPRA will be under massive public pressure to green light vaccines in the country once regulatory applications have been received. In the face of this pressure, SAHPRA will need to balance the need to ensure products are rapidly available with the need to ensure that products are properly evaluated and regulated – to prevent the entry of potentially harmful and unsafe products into the market.

Spokesperson for SAHPRA, Yuven Gounden, explains that “SAHPRA has in preparation or anticipation of Covid-19 vaccines undertaken a readiness programme that included establishing a specialised working group called the Covid-19 Vaccine registration Working Group (CVr WG) consisting of both external and internal experts specialising in areas of  vaccinology, manufacturing, clinical trials, epidemiology, vigilance and other specialisations informing quality, safety and efficacy of the products”.  

“The working group is mandated to formalise scientific approaches and processes to be followed, as well as look into innovative review mechanisms to ensure prioritisation and expeditious review without compromising on any of SAHPRA’s pillars of quality, safety and efficacy of medicines,” says Gounden.

Pathways for domestic registration of vaccines

Depending on the availability and strength of quality, safety and efficacy data, as well as the type of applications submitted and technology used in the vaccine, there are different processes and pathways that SAHPRA may use to authorise the use of Covid-19 vaccines in the country.

The type of authorisations used by SAHPRA will impact who can access Covid-19 vaccines – besides other factors, such as cost, delivery mechanisms, and global supply.

The most common way that new products are introduced into the market is through domestic registration. Although, as noted above, domestic registration is often a slow process. 

To reduce decision-making times for domestic registration, SAHPRA adopted guidelines in 2019 enabling the regulator to ‘rely’ on the work and decisions of other ‘recognised’ regulatory authorities and the WHO in making domestic registration decisions. Recognised regulatory authorities include, among others, the FDA and the European Medicines Agency (EMA).

The guidelines outline different reliance models that may be used by SAHPRA to register new products, with each model requiring a different level of domestic review.

While it is anticipated that SAHPRA will use reliance approaches in evaluating regulatory applications for Covid-19 vaccines – the precise type of approach that will be used by SAHPRA to evaluate dossiers for Covid-19 remains to be seen.

In response to questions from Spotlight, Gounden clarifies that SAHPRA’s registration approach “will be informed by the type of applications submitted, the technology used in vaccine development and the available data including reviews from other regulators and organisations such as WHO, to inform its decision-making process”.

“Therefore, consideration will be given to reliance processes.”

Another remaining question is whether SAHPRA will require additional clinical evidence for the registration of vaccines that have not been trialled in South Africa or other similar populations.

Regulatory agencies sometimes require that companies undertake a type of study called a ‘bridging study’ to assess the safety and efficacy of new products in domestic populations, when clinical trials were not undertaken in similar populations or contexts. 

In response to queries from Spotlight on whether SAHPRA anticipated that bridging studies or additional clinical evidence would be required for products not trialled in populations similar to South Africa’s, Gounden notes that “this would depend mostly on the information submitted in support of registration and whether the necessary populations have been adequately accounted for in the trials and if they are proposed to be included/excluded from the indications”.

“This would also depend on the risk benefit evaluation where the proven benefits might outweigh any theoretical risks in the emergency situation.”

Mechanisms to enable vaccine access in the absence of domestic registration

In the absence of domestic registration, SAHPRA can use Section 21 authorisations to permit the use of unregistered medical products in the country. Section 21 refers to a section of the Medicines and Related Substances Act that empowers SAHPRA to authorise the importation and use of unregistered medicines into South Africa. 

Gounden explains that “Section 21 authorised unregistered medicines are not intended for marketing purposes”. “They are only intended to satisfy unmet medical needs for a specific individual/patient, or a defined group of individuals/patients, where there are no alternative registered medicines,” he says. 

“It is anticipated that as safety, efficacy, and quality data mature in the vaccine development process, applicants, in conjunction with the National Department of Health Sector Wide Procurement Directorate, will apply for Section 21 authorisations to satisfy an unmet emergency public health need for defined target populations.

Target population restrictions will be informed by the study populations on which evidence of safety and efficacy was obtained during vaccine development,” notes Gounden. 

He adds that “restrictions on types of facilities that would handle the vaccines will be informed by the National Department of Health determinations on the ability of their facilities to maintain cold-chain specifications and other relevant operational considerations”.

SAHPRA is also exploring options to provide conditional registration for marketing purposes, as an additional mechanism to enable access to products without domestic registration. 

“The possibility also exists for an applicant to apply for a conditional registration (marketing authorisation) for emergency use in a pandemic situation, such as in Covid-19, based on the available safety and efficacy data,” Gounden explains. “The submitted available data still has to meet minimum regulatory standards of safety and efficacy before a conditional registration can be granted.

The conditions of registration in such cases invariably include a Risk Management Plan (RMP) to manage and monitor emerging risks of a medicine approved on the basis of limited data.” 

Gray notes that “while there is no specific provision for conditional registration for emergency use in South Africa’s law, there is broad enablement for this implied in the Act”.

*This article was produced by SPOTLIGHT – health journalism in the public interest. SIGN UP for our newsletter.

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