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Another way to look at SA’s COVID-19 vaccine roll-out

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OP-EDS

Going into our second year of the COVID-19 pandemic, we have been fed an ample diet of despair, blame, and negativity, especially when it comes to the vaccine plan – or perceived lack thereof. From what I gather from colleagues overseas, we’re no different to many other countries with a free press. In South Africa, fashioning a negative narrative isn’t too difficult.

To start with, the country last year failed to secure vaccines while so many Western countries were on a buying frenzy to pre-order the as-yet unproven COVID-19 vaccines for their citizens. Then, when South Africa eventually did manage to secure one million doses of the AstraZeneca vaccine in February this year, no sooner had the vaccine landed on our shores than its distribution was stopped in its tracks and the consignment was “dumped” onto some other “hapless” African countries. There was still no vaccine.

Vaccination sort of started up at a snail’s pace via a phase 3b implementation study, using the Johnson & Johnson (J&J) vaccine to vaccinate with urgency our hard-pressed healthcare workers, only for it to be stopped again. Why? This time because of some vanishingly small risk of blood clots which were reported in the United States!

So, now in mid-April, a quarter of a percent of the country’s adult population have been vaccinated, compared to Rwanda, Ghana, and Senegal each having already reached 2.8%, 2.5%, and 2.3% of their respective populations with the first dose of vaccine.

Now, let’s look at another narrative on the same series of events.

Undoubtedly the COVID-19 pandemic has been a seriously damaging event. It has disrupted lives, cost livelihoods, hammered economies and, of course, not to mention, taken more than three million lives globally and at least 50 000 in South Africa. Infection-prevention restrictions have been uncomfortable, tedious, and mentally challenging. However, consider for a moment how challenging COVID-19 would have been had it occurred but 15 years ago, when it could have taken several years rather than 10 months to develop a vaccine.

Let’s consider if the government had listened to the howls from the media and also the handful of howlers from the medical profession, and it had bought up a population’s supply of vaccine, say AstraZeneca. We may then have been stuck with 80 million doses of a vaccine which science has shown may well be ineffective against the dominant variant of coronavirus in this country – B.1.351. Fortunately, it bought only one million doses, which was sold to other countries on the continent where B.1.351 is either non-existent or a minor component, and where it could well have been a lifesaver.

Universally, it’s agreed that first in line for COVID-19 vaccination are the country’s healthcare workers. Fortunately for South Africa, a well-planned clinical trial in this country included elderly participants who would be vulnerable to severe disease, ultimately what we would want to establish in a candidate vaccine. It showed that the J&J vaccine effectively prevented severe disease from B.1.351 coronavirus.

On the coat tails of that trial, J&J donated vaccine for our healthcare workers in a phase 3b implementation study, the so-called Sisonke programme, which commenced in February. The programme, like any other trial, comes with certain regulatory requirements. Among these is the appointment of independent monitoring boards including an ethical monitoring board. The latter is tasked with looking out for any safety signals among participants anywhere in the world where the study is being carried out, no matter how rare. Like any trial, once a safety signal is reported, no matter how rare, safety monitoring requirements oblige the ethical body to hit the pause button while the assessment is carried out. This pause isn’t a suspension of the trial, and is usually only for a few days. In the case of the recent clotting safety signal with J&J in South Africa, the pause lasted about four days. Clearly, a four-day pause out of a 90-day vaccination programme couldn’t have had a serious effect on the vaccination benefit, especially in a time of low virus activity.

The COVID-19 vaccine roll-out programme itself is planned to begin in May. It’s undoubtedly delayed compared to most Western countries and even a significant number of middle-income countries. Starting in May, it will be about four months later than Western countries. And yet, the number of COVID-19 deaths per million population in South Africa is less than half that of the United Kingdom (UK), the first country in the world to kick-off a national vaccination programme. The UK has reached 49% of its population with the first dose of the vaccine, and is only now coming out of the longest and most stringent lockdown in the world.

It’s also worth bearing in mind that many of those middle-income countries against which we are compared and which are well ahead of us in their vaccine roll-out programmes, are probably driving their programmes with vaccines which haven’t been approved by any stringent regulatory authority or the World Health Organization, and wouldn’t currently receive approval from our regulatory authority, SAHPRA (the South African Health Products Regulatory Authority).

Meanwhile, after much tough talks with vaccine manufacturers involving complex and difficult negotiations on procurement contracts and liability, sufficient amounts of the two premier vaccines, J&J and Pfizer, both effective against the B.1.351 variant, have been secured to vaccinate the entire adult population over 2021.

Maybe, just maybe, there’s another way to look at the half-filled vaccine vial.

  • Barry Schoub is the chairperson of the Ministerial Advisory Committee on COVID-19 vaccines. He is the founding director of the National Institute for Communicable Diseases, and professor emeritus of virology at the University of the Witwatersrand. He isn’t employed by the department of health, receives no remuneration from the department, and isn’t a spokesperson for the department.

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1 Comment

  1. Franca Falanga

    Apr 22, 2021 at 2:42 pm

    Well balanced information that needs to be made more public

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OP-EDS

No evidence that COVID-19 vaccines cause infertility

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Fighting misinformation and a pandemic is taxing. However, it doesn’t help for Reform UK leader Richard Tice to make misleading claims about COVID-19 vaccines and fertility.

In a widely shared and now-deleted tweet posted on 19 July, Tice claimed that “forcing” young women to have the COVID-19 vaccine is “almost certain” to lead to “increased stillbirths, miscarriages, disabled children, and infertility”. There’s no evidence to support his claim.

There’s no evidence that new vaccines against COVID-19 cause infertility, yet that’s a worry that’s been cited by some healthcare workers as a reason why they’re reluctant to be first in line to get the shots.

Unfortunately, there was already a bunch of people out there saying there’s no such thing as COVID-19. “It’s no worse than the flu,” said some. Many of these people gained substantial followings for themselves on social media. When the vaccines came along, they used these platforms to stir up conspiracy theories.

Claims that the vaccine can affect a woman’s fertility due to the generation of the spike protein have been circulating since the start of the rollout of the vaccine.

In early December 2020, a German doctor and epidemiologist named Wolfgang Wodarg, who has been sceptical about the need for vaccines during other pandemics, teamed up with a former Pfizer employee to ask the European Medicines Agency (the European Union counterpart to the United States Food and Drug Administration) to delay the study and approval of the Pfizer/BioNTech vaccine.

One of their concerns was a protein called syncytin-1, which shares similar genetic instructions to part of the spike of the new coronavirus. That same protein is an important component of the placenta in mammals.

If the vaccine causes the body to make antibodies against syncytin-1, they argued, it might also cause the body to attack and reject the protein in the human placenta, making women infertile.

Their petition was picked up by anti-vaccination blogs and websites, and posted on social media. Facebook eventually removed posts about the petition from its site for spreading misinformation.

The idea that vaccines could be deployed for population control was also woven into the plot of a recent, fictional mini-series on Amazon Prime Video called Utopia. In that show, a drug maker obsessed with population control creates the illusion of a flu pandemic to convince people to take its vaccine, which doesn’t prevent infection but acts against human reproduction.

A spokesperson for Amazon Studios says the series is pure fiction.

The coronavirus’s spike protein and syncytin-1 share small stretches of the same genetic code, but not enough to make them a match. This is like two people having phone numbers that both contain the number 7. You couldn’t dial one number to reach the other person even though their phone numbers share a digit.

Looking at the two largest systems currently monitoring adverse reactions to COVID-19 vaccines, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and the Vaccine Adverse Event Reporting System in the United States rely on voluntary reporting from medics and members of the public, and are intended to provide early warning of any previously unknown risks.

There is no evidence that COVID-19 vaccines affect fertility. The Pfizer/BioNTech and Moderna vaccines have been widely used during pregnancy in other countries and no safety concerns have been identified. Evidence reviewed by the MHRA has raised no specific concerns about safety in pregnancy.

The Royal College of Obstetricians and Gynaecologists states on its website: “COVID-19 vaccines don’t contain ingredients that are known to be harmful to pregnant women or to a developing baby.” It goes on to say that studies of the vaccines in animals to look at effects on pregnancy have shown no evidence that the vaccine causes harm to the pregnancy or to fertility.

It’s clear that getting the COVID-19 vaccine won’t affect your fertility. Women actively trying to conceive may be vaccinated with current COVID-19 vaccines. There’s no reason to delay pregnancy after completing the vaccine series.

Importantly, COVID-19 can be severe in pregnant women. The Centre for Disease Control includes pregnant women as a high-risk group for severe COVID-19 illness, therefore we need to see pregnancy as a comorbidity for COVID-19.

Therefore, getting vaccinated against coronavirus is an important consideration for pregnant women. Recent data report an increased risk of intensive-care admission, the need for mechanical ventilation and ventilator support, and both intra-uterine foetal death and death in pregnant women with symptomatic COVID-19.

We can gain perspective by looking at the available statistics. By January 2021, consider that more than 22 million people in the United States had been infected by SARS-CoV-2. In fact, experts believe that number is much higher because 22 million is just the number tested and found positive.

Most think the real number is at least three times that. Therefore, consider that 70 million Americans have been infected, or about 20% of the population. If the infertility theory was true, we would expect that the body making antibodies against natural infection would show up in the fertility statistics. It hasn’t.

The incidence of infertility in any population is one in seven couples. There is no evidence that this pandemic has changed fertility patterns, so if the raw viral illness doesn’t appear to affect fertility, why should vaccination do so?

Although there’s no reason to believe that the vaccine poses a risk to women who are pregnant or are trying to conceive, there is evidence about the danger of COVID-19 infection for pregnant women, which is a reason we should embrace rather than avoid vaccination.

Pregnant women get sicker when they get COVID-19 compared with other people their age, and pregnant women with COVID-19 are more likely to experience pre-term delivery. The effect of COVID-19 disease on pregnancy is real, and it’s important to prevent it.

A recently published peer-reviewed journal article discusses the potential negative impact of the COVID-19 disease on testicular function, sperm production, and male fertility.

Some studies have shown that the SARS-COV-2 virus has been found in the sperm of men with COVID-19 infection, and it may have an impact on the male hormones necessary for normal sperm production. Also, there are numerous reports of men with testicular or scrotal pain after getting COVID-19.

Men who are worried about their fertility should probably get the COVID-19 vaccine as there are some concerns about the potential effect of COVID-19 disease – but not the vaccine – on male fertility.

In all the data thus far, we don’t see any increased risk of developing infertility, either in the near or distant future, with getting these vaccines.

We need to get everyone vaccinated as soon as possible, otherwise we’re going to completely muddle through an ongoing pandemic.

This article doesn’t replace the option of discussing COVID-19 and vaccination with your primary healthcare provider.

  • Dr Lawrence Gobetz is a reproductive medicine specialist and the medical director of Vitalab, a centre for assisted conception.

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OP-EDS

Vaccination is the mitzvah of the moment

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On Sunday, amidst all the challenges and trauma of this pandemic, I had a most inspiring experience. I decided to visit the pop-up vaccination site at Rabbi Aharon Zulberg’s shul, The Base, just to see what was happening. I witnessed a truly heart-warming spectacle: scores of passionate volunteers from our community helping people of all backgrounds register on the Electronic Vaccination Data System and get vaccinated.

The pop-up site was part of a wider initiative called GiVV (Gauteng Vax Volunteers). Set up and run by Dr Menachem Hockman, Josh Falkson, and Raphi Segal, in partnership with the Gauteng health department, it involves high school and university students volunteering at vaccination sites and government hospitals across the province to speed up the data-capturing process and improve efficiency at these sites.

The kindness and selfless concern for others; the ingenuity to come up with innovative solutions to tough challenges; and the determination to see them through – this initiative represents the best of our community, exemplifying everything we stand for. And all in service of that most sacred of Torah principles – pikuach nefesh – the mitzvah to protect and preserve life.

In one day, the team at The Base vaccinated 3 000 people, which is truly remarkable. That’s 3 000 people now protected from the worst effects of COVID-19, with all the positive knock-on effects that it entails for our society.

It also serves as a reminder of the urgency to get vaccinated. Vaccination is the mitzvah of this moment. It falls squarely within the parameters of pikuach nefesh, and we need to seize it with both hands. Every day we delay can potentially cost life.

We have a mitzvah to preserve our own life and take care of our health, and to save the lives of others. By getting vaccinated, we fulfil this vital mitzvah. We take steps to prevent ourselves from becoming seriously ill, and we protect those around us from a potentially deadly disease which, in its current Delta variant, is particularly contagious.

And, it goes well beyond the people we come into direct contact with. As a country, as a society, the sooner we reach societal immunity, the sooner we rid ourselves of the suffering and death of COVID-19. Every immunisation is a step towards freeing ourselves of this pandemic. Vaccination is the only way out. Like polio and numerous other diseases humanity has overcome, the only way we will get past coronavirus is to vaccinate the disease into oblivion.

By getting vaccinated, we also fulfil our role as Hashem’s partners in creation. The Talmud teaches that G-d gave doctors permission – and in fact, a mandate – to heal. The commentators explain that G-d wants our partnership in healing the world. Doctors, nurses, virologists, immunologists, all of those involved in the holy work of healthcare are, in fact, Hashem’s partners in creation.

Having faith in G-d doesn’t mean that we can sit back and do nothing and expect Him to take care of us. Of course, we recognise that no doctor can heal and no vaccine can protect from disease without Hashem’s blessing. But our sages teach us explicitly that G-d wants us to work as His partners in creating a better world by using the laws of nature that He, Himself created. And we daven to Hashem and acknowledge that even our best efforts cannot succeed without His will and partnership. There is no contradiction. Both are essential.

And so, at this pivotal time, we need to act with speed and urgency. We need to fulfil our obligations to Hashem, our community, our fellow countrymen, and to ourselves. We need to embrace this mitzvah and get vaccinated if we are eligible. This isn’t a mitzvah that can be delayed even for a moment. Pikuach nefesh, the opportunity to preserve life, isn’t something we stand around debating.

The virus won’t burn itself out, no amount of wishful thinking will make it magically disappear. SARS-CoV-2 will constantly reinvent itself, mutating into new variants, wreaking fresh havoc on our lives, our livelihoods, and our health. The only way to stop it is the vaccine. The data is conclusive. Countries around the world with advanced vaccination programmes have shown us that even when infections start to rise again, hospital admissions are lower by orders of magnitude relative to previous waves. In effect, through vaccination, we transform coronavirus into a manageable form of flu.

I’d like to take this opportunity to call on everyone who is eligible in our community to vaccinate themselves and to assist and encourage those who haven’t. The options are plentiful, the process is easy. Our own Hatzolah and The Chev have just launched a programme: you make a booking; you arrive; you are in and out of the door in minutes, with very little paperwork and at no cost.

The vaccine is our ticket back to the life we knew. We must take it.

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OP-EDS

Mental health – the pandemic behind the pandemic

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In addition to the health pandemic we are, unsurprisingly, in the midst of a global mental-health pandemic. Instead of hiding behind whispers and closed doors, mental health has, unfortunately and out of necessity, become a pervasive hot topic. The stigma has, in part, been eroded, as we have a sense that the uncertainty and huge challenge of our times effects all of us, albeit in different ways.

Mental health isn’t just the absence of mental illness, it also refers to functionality, resilience, and ability to cope and self-regulate at least most of the time. Of course, there are bad days, but generally, if functioning at work, at home, or in regard to other relationships isn’t impaired, we experience “normal” reactions to an unprecedented, abnormal global situation.

Having said this, the pandemic has served as an incubator, with high levels of depression and anxiety launched by loss and uncertainty.

Initially, I resented the term “new normal” and would talk only about “now normal”, which encompassed the belief that we wouldn’t be forced to settle for this, and that our world mostly as we knew it was awaiting us on the horizon.

What has transpired, however, is that the horizon is being extended and in addition to the anxiety, sadness, and fear that spills out everywhere, there’s also an identifiable unnamed feeling precipitated by the extent and duration of unfamiliar and scary ways of being.

The losses and feelings are expected and obvious. Fear of contracting the virus, fear of isolation, uncertainty about the future, and loss of control. The losses are unprecedented. Unquestionably, most of all is the loss of life without the capacity or necessary rituals associated with severe illness, death, and mourning. Beloved family members are on their own at a time when they need us most.

Often, there is the lack of closure and the inability to pay our respects according to our culturally comforting way. Then there is the overwhelming sadness and anger because “it’s just not fair!”

There are also job losses, which generate a lack of purpose and money, fuelling fear of survival. All of this is in an environment of loss of predictability, certainty, routine, physical contact, and some degree of emotional connectedness.

Boundaries have become blurred. We don’t work “from home”, we work “with home”, parents becoming teachers, children online, limited socialisation, adults having no transitional time, teenagers skipping milestones and rituals concerned with the development of their identity. All of this has required courageous conversation, task negotiation, and often an unsuccessful attempt at establishing any kind of personal boundaries or appropriate self-compassion.

Often, our clients are embarrassed to step forward as what they’re feeling may be unnamed. “It’s just a lack of motivation and energy” they say, a lethargy, a tiredness, and an inability to flourish, a sense of resignation.

In this way, so many of us feel dissociated and de-personalised, not connected enough with “my life as I knew it” and with the outside world. “Who am I?” is a regular question.

These feelings are usually associated with diagnosable mental illness but at these times, appear societally contagious. All you need to do is state your case with openness, vulnerability, and authenticity, and you will open a floodgate, if not an echo chamber, of people who tell you they know exactly what you are talking about because they’re feeling the same thing.

So what do we do?

First, to tame it you have to name it. It’s counterproductive to try to dismiss or deny your personal reality. If you don’t own the story, the story will own you, and will manifest through disassociation withdrawal, or prolonged sadness that can become depression, irritation, low frustration tolerance, and the inability to self-regulate. There may also be physical symptoms like headaches, lower back pain, and appetite and sleep disturbances.

Now, more than ever, we need to experience the immeasurable power of empathic support. This means to develop trust in the people who “have your back”, who will listen to understand, who will really “get it”, and won’t pre-empt you with their own story, at least not initially.

Your tribe, and it can be a tribe of one, will check in, show genuine interest, and understand that love and care are verbs – doing things, not just talking about things. And, usually the “doing thing” is being there and listening. You feel recognised, validated, understood, and not crazy!

Taking care of yourself isn’t selfish, it’s essential. You cannot be available for anyone else unless you feel worthy of your own compassion and self-care. This starts with the basics. Good nutrition, enough sleep, and understanding the importance of exercise – which should never be underestimated in relation to mental health. Take care of your children’s parent, of your parents’ child, and of your boss’s employee.

Conflict often manifests when you have time and space in your head, and unresolved issues and relationships emerge and become toxic. It’s difficult to remember that it’s always more important to be happy than to win.

The pandemic has made us realise that life can change in a heartbeat, and what we thought was under our control might not be. It also has resulted in a priority shift. Mostly, a new priority of relationships and gratitude for connection that we now realise is more important than anything. So take a risk, and make the first move, even without a guarantee. People can’t hear what you don’t say.

And please, cut yourself some slack. Recognise the resilience that you have displayed, the obstacles that you have overcome, and the value that is uniquely you.

We move on by remembering the past, using our experiences and memories, and reimagining and creating a better future – the horizon is getting closer!

We will navigate the journey together.

  • Dorianne Weil (Dr D) is a clinical psychologist.

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