New ÍøÒ×ÌåÓý regulations are the real state of disaster

30 March 2022 - Scientists Collective

The incoherent and illogical new government ÍøÒ×ÌåÓý regulations are the real state of disaster

These draft regulations are seemingly an ill-conceived and misdirected attempt to continue preventing SARS-CoV-2 infections and appear to be oblivious to the new realities of ÍøÒ×ÌåÓý, two years into a pandemic. 

Despite the low coverage of ÍøÒ×ÌåÓý vaccinations in South Africa and failure to vaccinate the targeted 40 million people (or administer 40 million doses of vaccine) by the end of 2021, there has been evolution of widespread population immunity and resultant protection, particularly against severe ÍøÒ×ÌåÓý and death in South Africa.

Even before the Omicron-driven fourth wave that started in late November 2021, up to 70% of the population had been infected at least once, which has since likely increased to >80% after the fourth wave due to Omicron’s high transmissibility.

The high force of SARS-CoV-2 infections in SA, and the 300,000 excess deaths that have been mostly attributed to ÍøÒ×ÌåÓý, is indicative of the failure of the government-enforced regulations to prevent significant numbers of infections in South Africa. 

These regulations, such as lockdown strategies, limits on gatherings, curfews, social distancing and mask mandates, at best drew out the initial period over which roughly the same number of infections would have occurred. 

These regulations may have assisted in relieving the pressure on healthcare facilities when the population was generally not immune. However, large scale immunity from those surviving infection and moderate vaccine coverage will probably continue to contribute to the decoupling of cases from severe disease and death seen during the Omicron wave in future waves. 

Consequently, it is not conducive for economic recovery and inappropriate to continue pursuing policies and imposing regulations aimed at trying to prevent SARS-CoV-2 infections, as opposed to primarily focusing on enhancing population immunity through vaccination to prevent severe disease and death from ÍøÒ×ÌåÓý. 

An update and review of the current regulations are certainly critical at this time, when the landscape has changed in relation to the risk to the integrity of the health service from ÍøÒ×ÌåÓý and given the increasing need to balance public health measures, the new reality of high levels of immunity, and regulations that have limited civil liberties, restricted movement and challenged the economy. 

What was hoped for was a mature, thoughtful set of regulations that considered these new realities. What was published, however, was an inconsistent, incoherent and illogical set of draft regulations firmly rooted in 2020 when knowledge about ÍøÒ×ÌåÓý was more rudimentary. 

The first thing to appreciate is the context of these regulations. 

Until now, the regulations governing the ÍøÒ×ÌåÓý restrictions have stemmed from the Disaster Management Act, the powers for which kicked in when the state of disaster was declared in early 2020. The government has recently announced that it at least intends to end the state of disaster. However, in the government’s view, new regulations are required to be promulgated via other acts (largely, but not exclusively, the National Health Act), so that ÍøÒ×ÌåÓý restrictions can be continued in some form when the state of disaster ends. 

One big challenge with the draft regulations is that they mostly appear to be written in a general way that would apply to all notifiable medical conditions (NMCs) and not just ÍøÒ×ÌåÓý. Perhaps that will be amended, but regardless, it’s worth remembering that the intention behind these draft regulations was to accommodate ÍøÒ×ÌåÓý. This makes many of the details even more baffling.

Four sets of draft regulations were released for public comment on 15 March. A thorough review of these is beyond the scope of an article like this, but we do feel strongly that they contain several large conceptual errors that are worth pointing out. For instance:

The regulations contain numerous mentions of quarantining. But the reason for this is unclear, as quarantine following a contact with a case of ÍøÒ×ÌåÓý is no longer a requirement in South Africa. And rightfully so, as some of us have pointed out previously.

The regulations list criteria for self-isolation that are unrealistic and untenable in the context of most of the South African population. 

Stipulating that persons wishing to self-isolate or self-quarantine, must “have access to the internet and a phone that allows the daily reporting of symptoms” and must “have access to a private physician” is ludicrous and not a reality for most people in South Africa, nor is the requirement that the facility for self-isolation/quarantine “must be a separate well-ventilated bedroom with bathroom and toilet”. 

The writers of these regulations seem to remain out of touch with the realities of the daily lives of the South African population.

The regulations strengthen the ability of the government to mandate “prophylaxis, treatment, isolation and quarantine”. There is less recourse for patients to refuse any of these than previously. Yet, apart from the other problems with isolation and quarantine above, the only current “prophylaxis” for ÍøÒ×ÌåÓý is vaccination. 

This is not currently mandatory in SA, nor is it proven to alter the natural history of a recent contact or acute case of ÍøÒ×ÌåÓý if given directly after a high-risk contact or during the incubation period of the infection.  

The draft guidelines contain an entire section on establishing a national database for contact tracing. The fact that the government continues to believe that contact tracing for ÍøÒ×ÌåÓý is a viable and realistic option, when fewer than 10% of infections are ever diagnosed, shows that their thinking is firmly rooted in 2020. The reasons for this have been outlined elsewhere.

Many of the general measures to contain the spread of NMCs that can be transmitted through droplets or aerosols, detailed in section 16 of the above regulations, lack logic or ability to enforce. 

“No person may be allowed to use any form of public transport… if they do not wear a mask.” A fair objective, but it lacks enforcement, particularly on trains and taxis. Furthermore, experience with the highly transmissible and infectious Omicron variant indicates that the type of cloth mask most worn by the public (which rarely provides a good seal around the nose and mouth) provides little-to-no protection against being infected and does not meaningfully reduce transmission. 

Physical distancing at work and in queues is also detailed in the regulations. But this ignores the fact of aerosol spread of infectious virus particles, which can comfortably exceed distances of the recommended one metre. The notion of physical distancing to reduce risk of infecting others is firmly rooted in an era prior to realising that spread of SARS-CoV-2 is mainly via the airborne route, and most efficient in poorly ventilated indoor spaces irrespective of distancing between people. 

Besides which, as pointed out, prevention of infections by SARS-CoV-2 is no longer an attainable objective as it may have seemed two years ago.  Adequate ventilation is key to prevent transmission and requires emphasis.

For travellers exiting South Africa, screening is continuously referenced. We know that temperature screening is useless, missing >50% of symptomatic persons and all those who are asymptomatic, and superficial thermal screening is scientifically flawed in detecting fever. 

No one is going to volunteer symptoms at the border if the consequence is forced isolation or being forcibly restricted from leaving.

The proposed regulations for people entering South Africa are even worse. Travellers would need proof of full vaccination, or else a recent negative PCR test. There is great value in ensuring that visitors to our country are vaccinated before entry and considerations to achieve this will be welcome – as they would for other communicable diseases such as influenza that are also not currently mandatory. Several other potential restrictions are then listed. 

But consider: If a thousand, ten thousand, a hundred thousand or a million people have ÍøÒ×ÌåÓý at any point in time in South Africa, what impact will a handful or even hundreds of cases of ÍøÒ×ÌåÓý coming into the country make on the epidemic in that country? None, particularly as so many people already here who have ÍøÒ×ÌåÓý are transmitting whilst asymptomatic. 

Furthermore, PCR tests aren’t sensitive enough to ensure that travellers who test negative 72 hours before travel won’t be carrying the virus and able to transmit. 

If vaccinated passengers do not have to perform a PCR test, but may still be infected, these transmitters will not be stopped at the border. In addition, PCR tests tend to stay positive for weeks or even months after the infectivity is over, leaving travellers trapped trying to enter South Africa. 

These half-arsed, pointless and bureaucratic testing rules for travellers entering South Africa are of no benefit, harm tourism, confer huge and unplanned costs on travellers with no health benefits and hurt the economy.

The proposed regulations advise that mandatory quarantine may be required for inbound travellers (even though South Africans in-country who are contacts no longer require quarantine). They further suggest that “a person who wishes to be placed under self-quarantine must submit a written application, 72 hours prior to intended date of entry into the Republic, to the Director-General: Health to obtain approval”. When has this, or would this, ever happen? As well as a spectacular waste of a senior official’s time, by the time they got a reply, the person applying would probably officially have long-Covid!

Most perplexing of all is the proposal that “All unvaccinated travellers will be offered vaccinations”, an intervention that will serve no value in influencing the trajectory of the pandemic in South Africa. As people who think vaccines are important, we love the idea, but why are we forcing all this testing and everything else on people, and THEN vaccinate them at the end? Why not just offer them vaccines before they travel?

The list of inconsistencies and confusing logic goes on throughout the four sets of draft regulations. From emphasis on cleaning and disinfection of public spaces – knowledge has moved on, i.e. the contribution of fomites from surfaces is negligible – to again regulating for mandatory prophylaxis (relevant to some other NMCs), which, apart from vaccination, does not currently exist.

There is another issue worth considering too, and that is whether ÍøÒ×ÌåÓý should be a notifiable medical condition at all, as it currently is. According to the National Institute for Communicable Diseases, an NMC is a condition – most of them communicable – of public health importance. 

“Surveillance of NMCs involves the systematic collection, analysis and use of epidemiologic data to provide scientifically proven and accurate information to detect and act against public health threats rapidly.” In other words, it allows timeous detection and response to public health threats in order to prevent disease outbreaks, estimates burden of said NMC and identifies populations at risk, monitors trends and helps direct public health interventions and informs policy decisions. 

Most NMCs relate to communicable diseases with epidemic capability or those that are nearing elimination and thus critical to survey and control new cases, such as acute flaccid paralysis caused by poliomyelitis. 

On the list of NMCs under the National Health Act, 2003 (Act No. 61 of 2003) and published under Government Notice No. 1434 of 15 December 2017, is “respiratory disease caused by a novel respiratory pathogen”, with the example of Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV), which, like SARS-CoV-2, has epidemic potential. SARS-CoV-2 clearly fell into this category at the time of its recognition in 2020, and adding it to the list of NMCs was undoubtedly the right thing to do at that time. 

The problem now, as highlighted above, is that South Africa, like almost every country in the world, has proven itself incapable – through little fault of its own – of undertaking the sort of surveillance, contact tracing, quarantine and isolation of cases that is required for containment of a respiratory spread NMC, to meaningfully alter the course of a pandemic. 

Hence, the regulations now out for review will not meaningfully alter the course of the epidemic of ÍøÒ×ÌåÓý in South Africa.

If we accept that current surveillance misses 90% of infections, how is continuing that surveillance going to change public health interventions? 

All laboratory confirmed tests for SARS-CoV-2 – be they PCR or rapid antigen test (in future) – can simply be reported to a central database and nationally (as they are now) without being an NMC. It’s simple laboratory reporting. Similarly, wastewater surveillance for SARS-CoV-2, which is a very useful predictor of community transmission levels, does not necessitate ÍøÒ×ÌåÓý being an NMC. 

Genomic surveillance continues to be critical in understanding the evolution of the virus and requires ongoing investment and support. Such strategies would continue to allow surveillance of the epidemic in South Africa and optimise efficiencies. 

Alternatively, as for influenza, we could move to incorporating SARS-CoV-2 into a sentinel surveillance programme such as is undertaken both in the community (influenza-like illness – ILI) and in hospital (severe acute respiratory illness – SARI) surveillance. 

Influenza is not an NMC, and like the “swine flu” (H1N1pdm09) pandemic influenza virus of 2009, the way forward for ÍøÒ×ÌåÓý is to be considered in the same light now that extensive population immunity has evolved against severe illness and development of herd immunity or elimination of SARS-CoV-2 are no longer realistic goals.  

In conclusion, the current proposed regulations are confusing, inconsistent and illogical in the face of advancing science of ÍøÒ×ÌåÓý and vaccine roll-out. 

Part of the reason for this is that by lumping ÍøÒ×ÌåÓý in with standard NMCs, a mockery is being made of advancing understanding of the pandemic. 

Surveillance and reporting of the small percentage of ÍøÒ×ÌåÓý cases that we confirm can easily continue, and should, but ÍøÒ×ÌåÓý should be removed as an NMC, and these regulations should be rewritten to consider the knowledge gained through science over the past 26 months.

We recommend that SARS-CoV-2 be removed from the list of notifiable medical conditions and that the following regulations be put in place:

1. Existing wastewater surveillance and laboratory confirmed cases of ÍøÒ×ÌåÓý should continue to be reported monthly.
2. SARS-CoV-2 monitoring should be added to the current influenza community and hospital surveillance programmes.
3. Continued genomic based sentinel surveillance to track viral evolution.
4. Public health interventions – optimising ventilation of indoor spaces and avoiding whenever possible and masking should be recommended for during a ÍøÒ×ÌåÓý and/or any other respiratory virus (including influenza should the winter influenza seasons return) waves and particularly for high-risk individuals.
5. Mandatory performance of hand hygiene should be stopped at points of entry to public spaces, BUT for reasons of general risk reduction of transmission of contact-related infections that are not ÍøÒ×ÌåÓý, alcohol-based hand rub should remain available for personal choice.
6. All border restrictions entering and leaving the country regarding SARS-CoV-2 should be removed with immediate effect.

And that the focus of South Africa’s efforts in this third year of the ÍøÒ×ÌåÓý pandemic should be on repairing:

1. The damage done to children’s education.
2. The damage done to non-ÍøÒ×ÌåÓý health priorities, including childhood vaccination, HIV, TB, antimicrobial resistance and chronic care programmes.
3. The public health of vulnerable populations such as the elderly and those with comorbidities and who lack social protections. A clear plan is required for protection for future SARS-CoV-2 waves, that ensures mitigation measures have substance.
4. The collapse of hospital services such as in the Eastern Cape, which occurred during each wave with depressing regularity. Services in prior waves in many provinces were characterised by late managerial reaction, something that is in sharp relief currently in Gauteng as hospitals fail to meet their most basic service standards. The poor accountability of health service senior managerial services across the country requires focused attention in 2022.

We are frustrated at the seeming unwillingness to break with two years of behind-the-doors decision-making and are now presented with a poorly written policy document for comment, with the deadline for these comments timed for the exact moment the State of Disaster will simply be renewed.

It is incompetence and South Africa deserves better.

Marc Mendelson is Professor of Infectious Diseases at Groote Schuur Hospital and the University of Cape Town. Shabir A Madhi is the Dean, Faculty of Health Sciences and Professor of Vaccinology at University of the Witwatersrand. Jeremy Nel is an infectious diseases expert, University the Witwatersrand. Glenda Gray is the President & CEO of the South African Medical Research Council). Regina Osih is an Infectious Diseases Specialist. Francois Venter is Professor of Medicine, University of the Witwatersrand. This article was first published in the Daily Maverick.