• 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.

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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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Three households will be allowed to meet indoors over a five-day period between 23-27 December.

People have tendency to soldier on, potentially making colleagues sick, health secretary says.

Nearly 14,000 deaths occurred in the week ending 13 November – with 3,000 linked to Covid.

LATEST SCIENCE AND RESEARCH

READ | Another Covid vaccine candidate reports promising results – what we know

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.

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].”

READ | African countries must not be at back of queue for Covid-19 vaccine

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.”

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. 

READ | WHO says $4.3 bln urgently needed for vaccine sharing scheme

There is a risk that the poor and vulnerable will be trampled on in the stampede for coronavirus vaccines, the head of the World Health Organisation said on Monday, adding that $4.3 billion was needed urgently for a world vaccine-sharing scheme.

Tedros Adhanom Ghebreyesus was speaking at a virtual briefing in Geneva.

Dozens of countries have signed up to the global vaccine plan known as COVAX, which was set up by the WHO and the GAVI vaccine group to provide vaccine doses for countries that could not otherwise afford them.

CORONAVIRUS CASES LATEST

SA cases update: 

The latest number of confirmed cases is 769 759.

According to the latest update, 20 968 deaths have been recorded in the country.

There have been 711 195 recoveries.

So far, more than 5.3 million tests have been conducted, with 14 377 new tests reported.

Global cases update:

For the latest global data, follow this interactive map from Johns Hopkins University & Medicine.

Early on Tuesday morning, positive cases worldwide were just over 58.9 million, while deaths were close to 1.4 million.

The United States had the most cases in the world – close to 12.3 million, as well as the most deaths – more than 256 000.

WHAT’S HAPPENING IN SA

Latest news:

READ | Eastern Cape health MEC to target taverns amid Covid-19 second wave concerns

Eastern Cape Health MEC Sindiswa Gomba said the provincial government was concerned about the surge in Covid-19 infections, which signalled a second wave of infections in the province.

Taverns and other places that draw large crowds will be a focus point when Gomba, Health Minister Zweli Mkhize, Cooperative Governance and Traditional Affairs Minister Dr Nkosazana Dlamini-Zuma, and Social Development Minister Lindiwe Zulu meet this week to intensify the fight against the second wave.

HeraldLive reported that scores of unmasked patrons were sharing drinks in overcrowded taverns and not adhering to social distancing rules.

These were just some of the disturbing discoveries made by the police and Eastern Cape Liquor Board officials during tavern inspections over the weekend, the newspaper reported.

Broadcaster eNCA reported that 80% of people needing ventilators in Nelson Mandela Bay Municipality public hospitals and half of those entering casualty wards, do not make it out alive.

According to the channel, there were no oxygen points left at Uitenhage Provincial Hospital and award meant for eight patients had 20.

The channel also estimated that 10 people die daily of Covid-19 at Eastern Cape public hospitals.

Hospitals are filled to capacity amid a critical shortage of beds, the channel reported.This comes as the Nelson Mandela Bay Municipality and the Sarah Baartman District Municipality are battling a second wave of Covid-19.

The numbers of health workers testing positive was also increasing rapidly in the metro.

Gomba has announced that the provincial health department will this week continue to intensify the fight against Covid-19 by meeting with health workers, organised labour, religious and church leaders, civil society and businesses, especially tavern associations.

WHAT’S HAPPENING IN THE REST OF THE WORLD 

Latest news:

READ | Boris Johnson to relax UK Covid-19 lockdown and allow households to celebrate together over Christmas

UK Prime Minister Boris Johnson is set to announce that strict coronavirus rules will be suspended for several days over Christmas, allowing multiple households across the country to mix both at home and in pubs over the festive period.

Johnson will announce a UK-wide plan for relaxed rules at the end of December after discussions with scientists, government ministers, and the devolved administrations about how to let people see their families this Christmas in a way that minimises transmission of the virus.

The details of the government’s Christmas plan are yet to be confirmed. However, ITV’s Robert Peston reported that up to three households will be allowed to form bubbles for five days between December 23 and 27.

Johnson is expected to announce the plan this week, possibly as soon as Tuesday, once it has been signed off by the devolved administrations in Scotland, Northern Ireland, and Wales as part of a UK-wide approach.

The prime minister will on Monday afternoon also set out to Members of Parliament details of a new regional tier system for England that will replace the current national lockdown when it expires on Wednesday, December 2.

The new system of local restrictions is expected to be harsher than its predecessor, with households in tier 2 and 3 areas unable to mix in any other indoor setting, possibly for several months.

The toughened tiers are set to be particularly restrictive for England’s hospitality industry.

Unlike the previous tier system, households will not be allowed to mix in pubs, restaurants, and other hospitality settings, according to multiple reports. Pubs and restaurants in tier 2 will only be allowed to serve alcohol to people in the same household as part of “substantial meals,” and in tier 3 they will have to be takeaway-only, reports suggest.

READ | Bodies of Covid-19 victims are still in New York City freezer trucks 8 months after they died

More than 600 bodies of New Yorkers who died in the Covid-19 pandemic’s first wave are still being stored in freezer trucks, according to a Wall Street Journal report.

The cost of burial and the difficulty in contacting relatives led to a backlog, the paper reported, even as the country experiences a sustained resurgence of the virus.

The temporary cold storage was set up on a Brooklyn pier to handle the overflow of deaths from the virus in late March, when New York City was the US epicentre of the surging pandemic.

At that time, hospital morgues were running out of room, as Insider’s Dave Mosher reported. The city’s chief medical examiner’s office became overwhelmed, according to the Journal.

The paper said that Chief Medical Examiner Dina Maniotis and her team were faced with 200 deaths to process per day, instead of the 20 or so they were used to.

To cope with the influx of calls, more than 100 staff were redirected from the city’s health department, the Journal reported.

But it was not enough to solve the backlog. The office is still trying to track down the next of kin of about 230 people from that period, per the Journal’s report on Sunday November 22.

Medical staff found that in some cases, the relatives they were trying to reach had themselves died, Aden Naka, the deputy director of forensic investigations told the Journal.

Most of the remaining deceased are still in storage due to the costs of holding a funeral, according to the WSJ. While the city increased burial assistance from $900 to $1,700 under an emergency directive, the funeral costs still remain out of many families’ reach. 

HEALTH TIPS (as recommended by the NICD and WHO)

• Maintain physical distancing – stay at least one metre away from somebody who is coughing or sneezing

• Practise frequent hand-washing, especially after direct contact with ill people or their environment

• Avoid touching your eyes, nose and mouth, as your hands touch many surfaces and could potentially transfer the virus

• Practise respiratory hygiene – cover your mouth with your bent elbow or tissue when you cough or sneeze. Remember to dispose the tissue immediately after use.

^{Image credit: Getty Images}