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Time to substitute evidence for emotion about vaccine delays

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OP-EDS

This week, a balloon of hope that thousands of healthcare workers would be well on their way to long-awaited immunity against COVID-19 was deflated as the government announced it wouldn’t dispense the one million doses of the Oxford/AstraZeneca vaccine as planned. The vaccine’s efficacy against the 501Y.V2 South Africa variant was unveiled at just 22%.

As this development was announced, my Facebook feed became increasingly flooded with frustrated community members calling out the “inept” government for buying one million vaccines that now need to be thrown away. “Typical South Africa!”; “Trust our country to get it wrong!” These were the comments attracting the most attention.

My mind went to a mere six weeks ago, when I followed a webinar in which Professor Barry Schoub, the chairperson of the COVID-19 Ministerial Advisory Committee on coronavirus vaccines, said that the government would be taking its time to evaluate the most appropriate choice of vaccines and rollout approach in view of the complexities of the population and variants here. This would be in contrast to countries like Israel that had already dived into a mass rollout. Interestingly at the time, I also came across similar “typical inept South Africa!” comments.

Aside from the apparent cynicism that has grown in our society – perhaps from inconsistency in public policy in so many facets of public life, COVID-19 being no exception – I believe a real understanding of levels of evidence of medical research is needed here. Sound medical decisions are informed by evidence. Evidence is graded into seven levels: randomised control trials occupying levels 1 and 2, control trials without randomisation level 3, case controls level 4, large reviews level 5, single studies level 6, and expert opinions level 7. So, without getting too technical, when you visit your doctor and (s)he tells you (s)he strongly believes in a new supplement, it may be a level 7 at most.

The risky and expensive process of rolling out millions of vaccines across South Africa ought to be informed by the highest level of evidence – randomised control trials (RCTs). An RCT involves recruiting thousands of volunteers and randomising them to two groups: one that receives the vaccine and one that doesn’t. However, the volunteers ought not to know who is in which group lest their preconceived beliefs and subsequent behaviour play a role in the outcome of their results.

In the context of a COVID-19 vaccine, to test whether an Oxford/AstraZeneca vaccine would work on our population, thousands of people needed to be recruited and randomly assigned to either a placebo or a real intervention group, and then followed for months to see whether there would be a difference in incidence of COVID-19 infections between the groups.

South African mainstream medical scientists have, thankfully, always been focused on these principles with a deep commitment to recommending interventions that do no harm and work scientifically. COVID-19 has been no exception to this. So, the above process was followed.

The Wits Vaccines and Infectious Diseases Analytics (VIDA) Research Unit has run the Oxford COVID-19 vaccine trial in South Africa for months, and has raced ahead to produce results as quickly as possible. It so happens that because of the immune pressure on the SARS-CoV-2 virus to survive amongst a relatively already exposed population, the virus mutated in November 2020.

It was only due to the rigorous efforts of units like VIDA that South Africa identified the variant so quickly and soon began to evaluate whether the Oxford/AstraZeneca vaccine would work here. It also soon became apparent that 95% of all cases in the second surge of the pandemic were, indeed, this new variant.

Stuck between a rock and a hard place of procuring stock while still awaiting results, the government secured its first shipment and cautiously forged ahead. Telling results have now followed, just before implementation.

We are all deeply disappointed by the failure in the efficacy of the Oxford/AstraZeneca vaccine against our local strain of COVID-19. But we should be equally encouraged by our scientists’ and the country’s commitment to balancing swift action against evidence-based results, which unfortunately takes time to unravel.

With this mindset, let’s take a moment to reflect on what we now know about COVID-19 in February 2021 that we didn’t know six or eight months ago through this evidence-based lens:

1.    The 501Y.V2 variant of SARS-CoV-2, causing COVID-19, was detected in the Eastern Cape in November 2020. It accounts for 95% of infections in South Africa today. It’s more transmissible than its predecessor, the original SARS-CoV-2 virus. (High-level evidence.)

2.    The Oxford/AstraZeneca vaccine showed 70% efficacy against the original strain. A high standard trial showed only 22% effectiveness against the variant. This was for mild and moderate illness only though. (Level 1 – RCT on young, healthy people). (High-level evidence.)

3.    The Oxford/AstraZeneca vaccine’s efficacy against severe disease in South Africa is still unknown and being determined. (High-level evidence.)

4.    The Johnson & Johnson vaccine, which is a single-dose vaccine, showed a 82% efficacy against the original strain. This dropped against the variant to 57%, but the number remains high against preventing serious disease, hospitalisation, and death, even against the variant – 83%. This is very important. (High-level evidence.)

5.    Pfizer, Moderna, and Sputnik vaccines may achieve similar results against the variant. No trials have been released on them yet.

6.    All these vaccines are safe. The question remains which are effective in the South African context. (High-level evidence.)

7.    The second wave in South Africa is almost over. The R value is 0.43 at the moment. This means we are in a recovery phase. This is the lowest the R value has been since the pandemic began. (Middle-level evidence.)

8.    A third wave is probable – soon. As early as April – June. This is probably inevitable. (Low-level evidence – expert opinion.)

9.    The extent of the third wave is determinable by preventative, non-pharmacological behaviour. (High-level evidence.) Masks and social distancing are definitely here to stay for the next year at least. (Expert opinion – low-level evidence.)

10.  COVID-19 can be contracted twice – particularly with different variants being present. (High-level evidence.)

11.  COVID-19 is likely to last for the rest of our lives and become endemic. However, with the correct vaccination, its clinical effects can be attenuated and it will hopefully tend towards a more common cold. (Low-level evidence. Expert opinion.)

Let’s take a feather out of our South African scientists’ hat, salute our government for its transparency and its approach to following the science, and put up with the unexpected hurdles along the way.

  • Dr Daniel Israel is a family practitioner in Johannesburg.

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1 Comment

1 Comment

  1. Ray

    Feb 21, 2021 at 4:40 pm

    Lets be clear, the government is not following “the” science they are following “their” science

    The W.H.O. arrivied at a different conclusion using their science.

    While the dosing has to be figured out on the AZ vaccine, its undisputed that the vaccine promotes a very healthy immune response and is highly likely to prevent severe illness or death. Meanwhile boosters will be adjusted for new variants in the next few months.

    The vaccines should have been given out amd not wasted (my parents would have been grateful to get one), and this could cost thousands of lives in the next wave to a millon people who could have had protection from severe illnes

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OP-EDS

Every doctor’s COVID-19 jab is one step closer to your vaccination

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The myalgia I awoke to this morning isn’t unfamiliar to me. It’s the common achy feeling we all experience at the onset of a touch of flu. The mild malaise I’m also feeling, after a shorter night’s sleep, is a physiological effect I try to avoid, but it’s the result of a habit that seems to creep into most of our busy lives.

Perhaps more particular, last night was the close constant attention I paid to my glucose levels as a Type 1 diabetic. Thankfully, all remained normal. Barring my mild symptoms, I’m feeling fantastic this morning, 24 hours after receiving the Johnson & Johnson COVID-19 vaccine.

My mind drifts back to almost a year ago, when I contracted a simple rhinovirus (the common cold). In spite of experiencing similar symptoms, I would certainly not have described myself as feeling “fantastic” at the time. These same symptoms used to conjure up uneasiness that my family had to bear as part of the role in life I have chosen. That’s what happens when you live with some comorbidities and work in a busy practice that had started to screen its patients vigilantly for the new “Wuhan flu”.

I welcome the vaccine’s side effects as do my colleagues as we enrol this week as the guinea pigs of the Johnson & Johnson trial. This is the only vaccine to date that has shown significant efficacy in preventing severe COVID-19 or death as a result of the 501.V2 variant, the most common strain of COVID-19 in South Africa today.

It’s a single-dose vaccine, with 500 000 doses secured to inoculate healthcare workers over the next four weeks. This is a trial still at stage 3b, which means that it’s not yet registered anywhere in the world for commercial use, in spite of its rolling application in the United States, the United Kingdom, and South Africa.

The vaccine is being rolled out as an emergency measure while it awaits FDA (Food and Drug Administration) approval potentially at the end of this month. Should the vaccine prove to be effective amongst South Africa’s healthcare workers, it will give SAHPRA (the South African Health Products Regulatory Authority) the green light for commercial rollout to our citizens.

My social media feed has been preoccupied with posts by colleagues receiving their vaccines. I, too, have added my own story to this noise. In reality, it’s far from noise. The supportive response we have all received from the public has been overwhelming.

A dear pulmonology colleague and I engaged in conversation yesterday as to whether doctors should be “flaunting their receipt of a vaccine” on social media or rather just quietly receiving the jab under the radar.

After some meaningful thought, we both agreed on the former. The palpable excitement by the public to doctors’ Facebook posts is fuelled by some valuable perspectives which I would like to share with you. These are the reasons that our community members should feel joy that our healthcare workers are finally being vaccinated this week.

The healthcare worker’s safety perspective: during surges of COVID-19 infection, patients have described the thought of not being able to see their doctors, nurses, and paramedics with ease as a terrifying dynamic. Statistics have shown that healthcare workers are three to four times more likely to develop COVID-19 than the general public. As many as 54 685 healthcare workers in the public sector alone have been infected with COVID-19 over the past year, with 779 losing their lives.

Unfortunately, every community doctor knows another doctor who has either contracted a serious COVID-19 infection or even lost their life to this plague. The vaccine offers you the promise that your doctors will be protected and able to help you when you may need them whether for COVID-19 or another reason.

The experimental perspective: the AstraZeneca vaccine taught us that in the dynamic, evolving space of COVID-19, variants affect efficacy tremendously. This phenomenon is so significant, that an already procured vaccine at one million units had to be returned. It’s still unknown whether the Johnson & Johnson vaccine will indeed be effective in large numbers on the ground, beyond the limited sample size of the original study in South Africa.

It’s best to run a live trial on largely healthy healthcare workers. I have my predictions that even with the Johnson & Johnson vaccine, modifications will need to be made to the product in the near future. Dr Glenda Gray advised me that a two-dose regimen is also being explored. Other expert vaccinologists have reported that it’s relatively simple to modify vaccines. As a member of the public, you will hopefully have access to the next round of vaccines – the improved version two.

The snowball perspective: this is the mindset that has excited me most since the rollout of vaccines a week ago. Every country with a functional vaccine campaign started off by vaccinating its healthcare workers. They constitute less than 5% of the population. Once healthcare workers start being vaccinated, the rollout soon spreads to essential workers and the elderly and vulnerable. Thereafter, vaccines are offered to younger healthy adults.

There is nothing more my wife and I would like to see than our own parents being vaccinated. I can say the same for my elderly patients. Understanding the procurement plan in South Africa, I’m confident that once the initial snowball of vaccinated healthcare workers has been formed, it’s inevitable that it will grow quickly and our deserving, beloved, vulnerable citizens will be vaccinated soon. Every doctor you see vaccinated means you are one step closer to being vaccinated yourself.

COVID-19 has changed our lives. It continues to place tremendous strain on our community socially, emotionally, financially, and physically. It has been proven that our second-nature, non-pharmacological measures of mask wearing, sanitising, and social distancing are powerful weapons in our armament. These measures dropped COVID-19 cases from a peak of 21 980 a day on 8 January 2021 to 998 today. However, we are finally exploring options of real pharmacological immunity. I’m utterly grateful to be contributing towards the body of knowledge of this development, and I have confidence that as the lightning development of vaccines continues to play out in South Africa, we will slowly get back to normal life.

Dr Daniel Israel is a family practitioner in Johannesburg.

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OP-EDS

Tel Aviv rolls out COVID-19 vaccines for illegal foreign nationals

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Although South Africa is only starting to vaccinate its healthcare workers, Israel has already vaccinated nearly half the population.

It’s not only Israel’s citizens who have been vaccinated, but also migrant workers living there from the Philippines, Moldova, and Nigeria, as well as Sudanese and Eritrean asylum seekers. They are receiving the Pfizer-BioNTech coronavirus vaccine at the Tel Aviv COVID-19 Vaccination Centre in the southern part of the city, home to a large migrant community.

As part of an initiative to inoculate the city’s foreign nationals, Tel Aviv City Hall and the Sourasky Medical Center started administering vaccines free of charge to the city’s foreign nationals, many of whom are undocumented asylum seekers.

This was evident on Tuesday, 9 February, the first day of the operation, as dozens of asylum seekers and foreign workers in Tel Aviv lined up outside the building to receive their first dose of the COVID-19 vaccine. Posters provided information in English, Tigrinya, Russian, and Arabic.

“I’m very happy,” Indian national Garipelly Srinivas Goud told Associated Press. Lamenting that foreign workers in Israel don’t have money or insurance to afford to pay for the vaccine, Goud, who has been working in Israel for eight years, welcomed the vaccine drive as a “very good decision”.

Although it’s the government’s responsibility to vaccinate everybody within the nation’s borders, Eytan Schwartz, spokesperson for Tel Aviv municipality, said the city would take the next step and start “to vaccinate illegal or undocumented asylum seekers as well”.

And although far from completing the vaccinating of its own population, having thus far delivered more than 4.4 million first doses of the Pfizer vaccine and at least three million second doses, Israel has started providing the Palestinian Authority (PA) with thousands of vaccines for its healthcare workers. This is in spite of the fact that the ultimate responsibility for health services and vaccine acquisition falls upon the PA, elected by Palestinians to govern the West Bank.

After receiving thousands of doses from Israel, the Palestinian Health Ministry administered its first known coronavirus vaccinations at the beginning of February. It announced the start of the campaign by saying that Health Minister Mai al-Kaila had received a first dose along with several frontline medical workers. While acknowledging receipt of 2 000 doses on Monday, 8 February, the first batch of vaccines sent by Israel, the PA didn’t say where they came from.

Back in May 2020, COVID-19 relief aid from the United Arab Emirates was rejected by the Palestinian leadership because it arrived by freight plane to Israel’s international airport without prior co-ordination with the PA. This resulted in 14 tons of urgently needed COVID-19-relief medical supplies languishing at Ben Gurion Airport. The reason for the PA refusing to accept delivery was because it didn’t want to be seen as condoning the normalising of ties between Israel and the Arab world.

Disregarding the health of his people, Osama al-Najjar, the medical services director of the PA health ministry, explained that Ramallah couldn’t “accept shipments that are a gateway to normalisation between Arab countries and Israel”.

Asked what he thought would happen to the medical supplies, al-Najjar responded, “I don’t know where they will go, but we won’t accept them. They’re free to do with them what they please, but we will neither accept them nor welcome them.”

However, Al-Najjar did acknowledge that the PA was “in need of ventilators”.

What we are “all in need of” is better understanding and co-operation as there are no borders when it comes to the health of the planet and its vulnerable citizens. Israeli epidemiologists agree that it’s in Israel’s interest to ensure Palestinians are vaccinated as quickly as possible, as the populations are too intertwined to have one gain herd immunity without the other.

As recently departed Health Ministry Director-General Moshe Bar Siman-Tov told The Times of Israel in January, “The message is very simple: we are one epidemiological unit. As much as we can, we have to help them address this matter.”

  • David E Kaplan is the editor of ‘Lay of the Land’, and executive director of the Global Investigative Journalism Network. This piece was used courtesy of ‘Lay of the Land’.

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OP-EDS

Call to wake up and listen

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The great Rabbi Yehuda says, “The human soul should turn g-dly … Perceive the world, enjoy the sublime, that sublime light and the hearing of the divine speech.” (Zohar)

How far has humanity travelled away from this truth here in South Africa? The dreaded load shedding, darkness upon the face of the earth … hmmm!

It’s time to take a good look at yourself – no television, no devices – could Hashem be asking you to now look inwards?

Then the virus, resulting in the wearing of masks. How many different masks do we wear for our spouse, children, friends, and co-workers, so full of masks covering up our true self, not hearing the divine voice of Hashem. We are now wearing our mask outside of ourselves. Why? No more space inside, full up, the pretence is overflowing.

Then comes a cry of compassion for humanity – a new rule, masks, social distancing, sanitising, or could we say this, could we look at it like this, expose the truth, give each other space, cleanse soul and mind?

Yet, humanity couldn’t obey this simple law of protection, then came lockdown.

Imprisonment not only of your mind – your body, your whole being, locked up.

And now death, what’s more final on this earth than death? Death, giving up or giving in, surrendering. How to die, why, where do we go, what do we do … well this is for another discussion.

If each of us does our best by being still, listening to the voice of Hashem, doing it through prayer is one way to hear his voice.

We have, as some people call it, collective karma, the law of cause and effect, we also have our own individual karma (attaining good merit or drawing negative energy through our deeds and actions). In collective karma, we are all in the same energy, this is where we see how the innocent and guilty suffer together as a result of a situation.

We can open the door to a new energy, a new way of living, we all have the key in our hand, all you need to do is turn the lock and enter.

Let your fancy dress and mask for your Purim celebration be the last mask you wear.

Pesach is nearly upon us. Think of the slaughtered lamb in place of the first born, allow the angel of death to pass you by, the angel will know death has been, she will see the sign written on the door although it’s the blood of the lamb.

What an auspicious time to play your part to turn your life around! A time in which there are no more masks, the truth can be revealed, the doors open wide, children can laugh and play in the park once more, the light of Shekinah shines brightly in your soul once more.

Let’s pray that through the blessing power of Hashem, the truth will set us free and heal us. It’s time to turn to prayer.

Wishing you a spiritual and enlightening Purim and Pesach!

  • Melanie Moritz is a spiritual teacher and healer.

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