Vaccines: effective and safe, but everyone must decide for themselves 

11 July 2021

The Solidarity Research Institute found in a comprehensive scientific report that vaccines are an effective and safe way to end the Covid-19 pandemic. The report also supports people’s freedom to decide for themselves. Strong criticism is also levelled at the government's central control of the vaccine program and consequently it was also found that the private sector should become involved on a major scale. 

According to Solidarity Movement Chairperson Flip Buys, large numbers of the Solidarity Movement’s members and other South Africans will have to make a decision regarding vaccinations within the next few weeks. “We want to enable our members and other South Africans to make decisions in a responsible way. Covid-19 is hitting all of us hard and everyone is longing for an end to the pandemic.

With all the opinions, fake news and political agendas doing the rounds, good scientific research is essential. From the findings in the report, we can encourage our members to get the vaccines, but on condition that everyone must make their decision in a responsible way and take their own unique circumstances into account. The data indicate one risk that for most people is much greater than the vaccines, and that is not to get the vaccine.” 

According to the report, in which a proper international study was done, it was found that vaccines are indeed effective. In countries such as Israel, the United Kingdom and Hungary, there is a direct link between the administration of vaccines, a decrease in infections and in particular a decrease in hospitalisation and deaths. Pfizer, Moderna, AstraZeneca and Johnson & Johnson are effective. It is also on the basis of findings in this report that the Solidarity Movement can neither recommend the Chinese vaccine SinoVac nor the Russian Sputnik V vaccine. The availability of existing data is insufficient, with the result that no conclusion can be drawn at present on the efficacy of these two vaccines 

An in-depth investigation was conducted into data on reports of side effects, as stated by Connie Mulder, head of the Solidarity Research Institute. “Proper scientific research has been done and original data have been used so that inferences are watertight. It has been found that the vaccines are indeed safe to a large extent. Like other medications, there are side effects, but for most people the risk posed by Covid-19 is much higher than the risk of getting the vaccine.” 

Mulder also said that none of the vaccines can provide total protection against Covid-19. However, they do provide comprehensive protection against serious symptoms and death. It is probably not necessary for children to be vaccinated but parents can seek good medical advice from doctors.  

Data show that claims that large numbers of people die due to vaccination are simply not true. The risk for blood clots and cardio-related side effects is small. Most of the side effects reported are mild and similar to those of any other vaccine.  

The researchers also found that it is important that individuals who are already experiencing health problems, are currently ill and who have previously experienced side effects from vaccines should first contact their doctor to find out whether it would be safe for them to be vaccinated against Covid-19.  

According to AfriForum Chief Executive Kallie Kriel, those who want to make a choice should be able to do so. “The government’s centralisation of vaccines is causing a bottleneck in the vaccination process. The fact that the process is being monopolised is unacceptable. The private sector must on a large scale be involved at all levels of the value chain. Not only is it important that people should be able to choose whether they want to be vaccinated or not, but they should also be able to choose which vaccine they want to receive.” 

According to Solidarity Chief Executive Dr Dirk Hermann, Solidarity’s members, like so many other South African citizens, are currently being hard hit by the third wave of the Covid-19 pandemic. “Our members are tired of lockdowns and want to get rid of it. Vaccination can definitely play a major role in getting out of the pandemic. Levels of confidence in the government are justifiably so very low. There is a fine line between trust in the government and trust in vaccines. The government abused its power during the lockdown, eroded freedoms and created a breeding ground for scepticism about vaccines. 

“What we now have to do is to consider the facts. We encourage all to assess their circumstances, make their decision (in a responsible way) and to exercise their freedom of choice,” Hermann concluded. 

Text of the report:

VACCINES

HELPING OR HURTING

Report of the Solidarity Movement, compiled by the Solidarity Research Institute led by Connie Mulder

Summary point of view

Members of Solidarity, like many other South African citizens, are being severely affected by the third wave of the Covid-19 pandemic. Many of our members and their relatives are falling sick and are hospitalised or even die because of this disease. The death rate among Solidarity members at present is 40% higher than the comparative figure for 2019, and among non- members the situation is likely to be no different. Many people are heart-broken, their lives have been disrupted and they are living with fear and record-low emotional levels. Covid-19 is a painful reality.

We also continue to be greatly concerned about the economic impact of the pandemic and we know that we have to act on behalf of our members on a daily basis to ensure that they can continue working and earning an income in safe circumstances.

Vaccines and lockdowns

Our members are sick and tired of lockdowns and want to get out. One of the effective routes out of lockdowns in other countries is vaccines. Vaccines, however, come with new questions and uncertainties. Our members are yearning for the right information.

Globally, vaccines against Covid-19 are being administered on a massive scale. More than 2,9 billion doses have been administered in over 140 countries. Successful vaccine countries include Israel, England, Hungary and the US. Numerous countries with small populations already have vaccinated major proportions of their populations.

South Africa’s struggling vaccination programme is slowly gaining momentum. Compared to other countries, our government has failed South African citizens with its poor handling of vaccines.

With a virus strangling us, we have to approach vaccines with an open mind. In these times, many people will have to choose between the options of being vaccinated or not being vaccinated, facing the different consequences of each option. Making a choice on vaccines literally means making a choice between life and death. We have to get answers on how to get out of this pandemic headlock. We cannot carry on like this.

Reliable research

Solidarity instructed its researchers to conduct thorough research on vaccines.A comprehensive investigation was launched into the development, spread, safety, risiks and other factors concerning vaccination.

Our members and their families are being inundated with information on vaccines, resulting in widespread confusion. This report brings clarity. It has been drafted without an agenda and without trying to make a point. It is an objective investigation into the part that vaccines can play in combating Covid-19.

On the one hand, people receive videos, articles, sound bites and other messages on social media all the time, and on the other hand there are global groups and unfortunately also the South African government that do not inspire much confidence. Many of our members are positive about vaccines but negative about the government. People’s distrust is justified, because the government has a dismal track record in virtually all other fields. We ordinary people find it virtually impossible to make sense of all the information.

Solidarity’s instruction to its researchers was simple: do not rely on our government’s data, the World Health Organization or any of the experts on YouTube or Facebook. Consult original sources, raw data, and focus on countries where large numbers have been vaccinated and where there is transparency with regard to side effects. Ironically, South Africa’s miserable vaccination programme makes it possible to look at other countries retrospectively.

Freedom of choice

A core principle that must not be undermined, however, is freedom of choice. Everyone has the right to bodily integrity, and Solidarity will protect this right. No government and no employer may compel an individual to be vaccinated.

No country with a successful vaccination programme has forced people, whether inside or outside the workplace, to receive the vaccine. Coercion creates resistance.

In a country such as Hungary there was initial strong resistance to vaccination. Thanks to that government’s professional presentation of the vaccines, transparent communication and obvious success and little side effects experienced, many people eventually decided themselves to be vaccinated.

Solidarity will take to court any employer who unlawfully forces his employees to receive the vaccine. And Solidarity certainly will neither subtly nor openly force its members to make a choice. We trust our members to make responsible choices, in accordance with their own unique circumstances.

Making a choice requires good information. Solidarity has a research institute with excellent researchers who can conduct original research. This report is the product of comprehensive research by our team.

The effectiveness of vaccines

Following a proper international study, the report found that vaccines are indeed effective. In countries such as Israel, England and Hungary there is a direct relationship between the administration of vaccines and a decrease in infections, hospitalisations and deaths. Pfizer, Moderna, AstraZeneca and Johnson & Johnson are effective. We do not feel at liberty to say the Chinese vaccine SinoVac and the Russian Sputnik V vaccine are effective, pending the availability of further real-world data.

None of the effective vaccines offers total protection against Covid-19 infection, but they do give comprehensive protection against serious symptoms and death, according to clinical studies confirmed by the data of eventual vaccinations. Full information in this regard may be found in the report itself.

The safety of vaccines

The second question is whether vaccines are safe. During this study, data of reported side effects were investigated in depth. Intentionally, no effort was made to simply investigate all the claims on social media. Original data were used, ensuring watertight conclusions. It was found that, to a large extent, the vaccines are indeed safe. As with other medication, there are side effects, but the risk of Covid-19 is much higher than the risk of vaccines for most people.

The data show that claims of large numbers of people dying as a result of vaccines simply are not true. The risk of blood clots and heart-related side effects is small. Most side effects reported are mild and correspond to those of any other vaccine.

Our researchers found that it is important that individuals with existing health problems, who are sick now and who have experienced side effects from vaccines in the past, should speak to their doctor first to get certainty on whether it is safe to be vaccinated.

Vaccines such as the Pfizer vaccine have to be administered in two doses. People still get sick after receiving the first dose, but this is not because of the vaccine but because of Covid-19. It has also been found that the vaccines cannot cause or transmit Covid-19.

Vaccines do not guarantee that you will not get Covid-19, but they allow radically downward management of the risk of contracting Covid-19 and of getting sick or dying. It is all about weighing up of risks.

The report also shows that ivermectin may form part of the Covid-19 treatment protocol and that vaccines and ivermectin should not be seen as opposing each other.

The data show that there is one risk that is much bigger than vaccines, and that is not to use vaccines. If you decide not to be vaccinated, you should seriously consider the concomitant risks. These include your own health and your chances of contracting Covid-19, but also the risk of transmitting Covid-19 to other people.

The government’s poor handling and the availability of vaccines

If people want to decide on vaccines, these should be available. Reality is that vaccines should have been available long ago. The government’s dealing with the vaccine process simply is a disgrace. South Africa still is among the worst vaccination countries in the world. One of the main reasons for this is that our ineffective government has been centralising the process. In the South African circumstances this cannot work. Solidarity and AfriForum are fighting in court against the nationalisation of vaccines.

We have to put an end to government centralisation of vaccines. The government is the bottleneck in the vaccine process. There is little trust in them and they have little capability.

During the lockdown, the government abused its power, eroded freedoms and created a breeding ground for scepticism regarding vaccines. It is not, as the Minister said, fake news that has created mistrust concerning vaccines, but the government’s abuse of power that has created mistrust of the government. There is a fine line between mistrust of the government and mistrust of vaccines.

Solidarity’s research is an input in your process of making a decision. It remains everyone’s right to decide according to his or her own unique circumstances. You have the right to bodily integrity. Solidarity will help you to protect it.

Conclusion

Our conclusion, therefore, is that vaccines are safe and effective for those who decide to receive them. However, everyone should make a responsible decision according to his or her own unique circumstances. Vaccines do not eliminate the use of important medication, including ivermectin, for the treatment of Covid-19. Neither does vaccination eliminate continued sound principles with regard to hygiene, physical distancing and maintaining good eating habits as well as other ways of keeping one's health in good condition. Together we must and will conquer this pandemic. Too many of our people have fallen ill already. Too many have died. Too many have lost their income, assets and hope. We have to fight the pandemic together and overcome it.

***

Introduction

For the past 18 months, the world has been in the iron grip of the Covid-19 pandemic. Globally, every state has put in place a set of measures in an attempt to combat the pandemic. Over the past year several vaccines have been developed that may help fighting the pandemic. All medication has some side effects, and the vaccines currently available are no exception. The question to be answered is what is the difference between the advantages and the risks of the vaccines.

To make a sound judgment, one has to look at the effectiveness and the safety of the vaccines. This report endeavours to find answers to these and other relevant questions.

Context

For background it is important to understand the context giving rise to this point of view.

COVID-19

SARS-COV-2 or COVID-19 is a coronavirus that originated in Wuhan, China, in 2019 and subsequently spread to the rest of the world. Covid-19 has a case fatality rate of 2,2% (Johns Hopkins University, 2021), meaning that approximately 22 people from every 1 000 who are diagnosed with Covid-19 will eventually die because of it. By way of comparison, the common flu has a case fatality rate of 0,1% (Taubenberger, 2006), which means that 1 of every 1 000 people diagnosed with flu will die of it.

One of the major challenges posed by the Covid-19 pandemic is that hospitalisations occur at a relatively high rate. By comparison, in the year 2018/2019 in the US there were 490 000 hospitalisations owing to flu (Center for Disease Control and Prevention, 2020), whereas in 2020 there were a total hospitalisation of more than 800 000 because of Covid-19 in only 36 states of the US (The Atlantic Monthly Group, 2021). Big states such as California, New York and Texas do not report total hospitalisation, which suggests that the actual figure for 2020 may be closer to 1,5 million hospitalisations. Covid-19 places enormous pressure incredibly fast on healthcare systems, which increases the risk of healthcare being overwhelmed.

Owing to the combination of these factors, countries view Covid-19 as a substantial threat and virtually every state worldwide has been implementing measures to curb the impact of the pandemic on healthcare specifically.

Vaccines

In response to the Covid-19 pandemic, several pharmaceutical companies started developing vaccines against Covid-19 in 2020. At least 23 companies started developing a Covid-19 vaccine in May 2020 (Lee, 2020), and eventually only three of these vaccines were approved for use in the US – Pfizer, Moderna and Johnson & Johnson (Center for Disease Control and Prevention, 2021).

Worldwide, 18 different vaccines are being used, and only seven manufacturers have published their phase 3 clinical test results (Shrotri, 2021).

It is important to note that the vaccines are not identical – diverse technologies are used in vaccine development, and there are substantial differences in reported effectiveness. The vaccines currently being used, however, all show substantial protection (>50%) against symptomatic Covid-19 according to their phase 3 studies (Voysey, 2020) (Polack, 2020) (Baden, 2021) (Logunov, 2021) (Kaabi, 2021) (Shinde, 2021) (Sadoff, 2021).

*Interim results

Effectiveness

The first question with regard to Covid-19 vaccines is simple – do they work? To respond to this question in real conditions rather than test conditions, we looked at outcomes at grassroots level in several countries.

Four different criteria were used to evaluate vaccine effectiveness:

- Percentage of population vaccinated

- Hospitalisations owing to Covid-19 (where available)

- New deaths owing to Covid-19

- Positive test percentage

These criteria were used because none of the vaccines offers total protection against Covid-19 infection, but they do give comprehensive protection against serious symptoms and death, according to clinical studies (Polack, 2020) (Logunov, 2021) (Baden, 2021) (Kaabi, 2021) (Shinde,

2021) (Sadoff, 2021).

All data were obtained from www.ourworldindata.org/coronavirus and were processed by us in Excel to draw the necessary comparative graphs.

Top countries

FIGURE1

Israel uses the Pfizer vaccine – as may be seen, an incredible number of the population were vaccinated against Covid-19 in a very short time.

It is notable that the vaccinations started at the peak of a third wave; this implies that effectiveness could be tested properly. In addition, Israel has been reporting extremely comprehensively.

The decrease in hospitalisations, deaths and positive test percentage for Covid-19 strongly correlates with the number of adults vaccinated. This suggests that vaccination starts bringing clinical advantages even at low numbers, easing pressure on healthcare.

Israel as case study (Dagan, 2021) shows that the effectiveness of the Moderna vaccine is about 94% during vaccination of an entire population (N = 1 193 236). It is noteworthy that vaccination of an entire population closely correlates with the clinical studies that found 94,1% effectiveness for the Moderna vaccine.

At present there are media reports of a new wave of Covid-19 in Israel1, yet it is noteworthy that the number of new cases is considerably smaller than previously and that there is no increase in hospitalisations.

Israel did not make vaccination mandatory but introduced a green pass for people who have been vaccinated. This pass enables people to attend concerts and other mass gatherings.

FIGURE2

An important aspect of the United Kingdom’s data is that in spite of another increase in Covid-19 cases in June 2021, interim studies (Stowe, 2021) show that there is no significant increase in hospitalisations or deaths owing to Covid-19. The United Kingdom last had more than 12 000 new cases per day at the beginning of a Covid-19 wave on 6 October 2020, with 3 642 hospitalisations and 76 deaths. On 24 June 2021 there again were 12 009 cases, with 1 505 hospitalisations and 21 deaths.

Seeing that the new infections in the United Kingdom mostly are the Delta variant2, which spreads more rapidly, the sharp decline in hospitalisations and deaths has to be linked to the success of the vaccination programme.

The United Kingdom uses AstraZeneca, Johnson & Johnson, Pfizer and Moderna vaccines.

Vaccination was not made mandatory in the United Kingdom, except for medical workers working in homes for the aged.3

FIGURE3

The US affords a fascinating view on the impact of vaccines because of the huge population and the federal approach to vaccines. Some states are way ahead of others as far as vaccination is concerned. The US also reports particularly comprehensively on all aspects of the Covid-19 pandemic, presenting very rich data to work with.

It is clear that at present the smallest number of people are being hospitalised because of Covid- 19 since the pandemic started in the US. This correlates well with the increase in the adult population vaccinated and appears to be further decreasing.

An analysis by the Associated Press shows that 99% of hospitalisations and deaths due to covid- 19 in May 2021 in the USA were unvaccinated people. 4

On a more practical level, several states (Texas, Oklahoma, South Carolina, etc.) have totally done away with most of the regulations (USA Today, 2021).

The US uses Pfizer, Moderna and Johnson & Johnson vaccines.

The US did not make vaccination mandatory, but private companies have launched several incentives for people who have been vaccinated, so as to encourage people to be vaccinated.

FIGURE 4

Hungary also started a vaccination programme in the midst of a third wave, with dramatic results in a very short time. Here, too, there was a decline in hospitalisations and deaths owing to Covid- 19, and good correlation with the number of people vaccinated.

Hungary uses several vaccines, mainly Pfizer, Sputnik, AstraZeneca, Sinopharm, Moderna and Johnson & Johnson.

Hungary did not make vaccination mandatory but instead launched an education campaign. Empowering people to make informed decisions about their own health and safety is an approach that Solidarity supports.

FIGURE 5

Chile is unique in that it is one of the countries where most of the population have been vaccinated but without any dramatic improvement in some of the criteria that would indicate that the vaccination programme is working.

Chile does not collect data on hospitalisations, but deaths and cases have not decreased notably in spite of almost 45% of the population being fully vaccinated. On the contrary, deaths appear to be increasing again as the latest wave of Covid-19 sweeps across the country.

Chile primarily uses the Sinovac vaccine, with Pfizer and AstraZeneca as supplementary vaccines. Based on the case of Chile there is doubt about the effectiveness of the Sinovac vaccine.A similar pattern can be seen in other countries where Sinovac is also used as primaty vaccine (e.g. Uruguay, Colombia and the Seychelles).

The Chilean parliament has enabled the government to make vaccination mandatory, but this has been rendered unnecessary by the high rate of voluntary vaccination.

FIGURE 6

Italy serves as a useful comparison with South Africa because the total population is roughly the same (60,3 million against 59,8 million). Although Italy reported considerably more official cases of Covid-19, testing was considerably better. Consequently, Italy was able to get a much better understanding of the spread and consequences of Covid-19 thanks to better data. Italy’s official death rate of 127 3525 is closer to South Africa’s excess death rate of 173 1326 and shows what an efficient vaccination programme in South Africa could achieve. Italy’s demographics differ from South Africa, specifically regarding median age, thus a complete direct comparison is not possible.

Italy started implementing its vaccination programme in the midst of a continuing second wave. Once again there was a decline in hospitalisations, positive test percentages and deaths, showing good correlation with the number of vaccinations.

Italy uses Pfizer, AstraZeneca, Johnson & Johnson and Moderna vaccines.

Italy made vaccination mandatory for frontline health workers, but the general population may be vaccinated voluntarily.

FIGURE 7

South Africa’s current Covid-19 situation is desperate. While deaths, positive test percentages and hospitalisations are increasing dramatically, there is no effective vaccination programme, with less than 1% of the population being fully vaccinated by June 2021.7

At present, South Africa uses Pfizer and Johnson & Johnson vaccines for its vaccination programme, and the country has received applications for registration of Sputnik and Sinopharm to augment its vaccination programme.

In South Africa, vaccination is voluntary and Solidarity will oppose any attempt to make vaccination mandatory.

Conclusion

At this stage (28 June 2021), more than 2,9 billion doses of vaccine have been administered worldwide, with more than 800 million people fully vaccinated against Covid-19.8

Data from the clinical studies of the most prominent vaccine manufacturers are confirmed by real-world data from countries where these vaccines are administered.

The effectiveness of Pfizer, Moderna, Johnson & Johnson, Sputnik and AstraZeneca vaccines used in countries appear to be closely correlated with their clinical tests.

SinoVac shows reasonable discrepancies between studies and countries, but with the enormous increase in China’s population being vaccinated, the effectiveness of this vaccine in real-world terms should be known shortly. Information regarding Covid-19 from China is notoriously difficult to verify, thus increasing the difficulty of proper analysis.

From all these data the logical conclusion is that vaccines are effective in preventing infection, hospitalisation, serious illness and death owing to Covid-19.

Safety

An important question regarding vaccines is about their safety for use in humans.A vaccine that is extremely effective but is more dangerous to health than the illness it tries to prevent, is practically useless.

Owing to the rapid development of vaccines, harmful incidents following the administration of the vaccine are accurately reported in a couple of countries with a view to rapidly identifying and mitigating additional side effects where necessary.

Because of the richness of data in the US, the large number of people who have been vaccinated and the use of vaccines that form part of South Africa’s envisaged vaccination programme, use is made specifically of the US’s Vaccine Adverse Events Reporting System (VAERS) to determine the impact on safety.

Data were obtained from the VAERS database9 and were processed by us in Excel for further analysis.

For additional confirmation, data from Eudravigilance, the European medicine monitoring database, were obtained and processed. The European area also uses vaccines that will form part of South Africa’s envisaged vaccination programme.

Critically important is to note that all reporting on adverse effects is by definition short term, since most vaccinations only started in 2021. Data on possible long term side-effects just does not exist yet.

VAERS summary

VAERS as a system is open to anyone to report a side effect of a vaccine, no matter how mild it was. Because reporting is so incredibly open, one has to assume that most reported side effect entries do not necessarily have a causal connection with the administration of the vaccine.

For example, several suicides (More than 12) have been listed on the system as possible side effects of the vaccine (United States Department of Health and Human Services, 2021).

A short analysis of the reported side effects according to the VAERS system is as follows:

The VAERS system contains 331 630 cases reported as side effects from among 160 million people vaccinated.

Most of these side effects are exactly as could be expected, given the clinical tests.

FIGURE 8

Owing to the mild nature of most of these side effects it is highly possible that there is underreporting of mild side effects. However, underreporting is exceedingly difficult in the case of deaths.

FIGURE 9

Of these 331 630 side effects, 3 523 were deaths; looking at deaths within seven days of vaccine administration, there were 1 972 cases. This gives a figure of 0,0013%, or 13 deaths from every 1 million people. Please note – so far, no causal connection has been drawn between these deaths and the vaccine, and these deaths include vehicle accidents, injuries and other terminal conditions.

For context: the present death rate for vehicle accidents in the US is about 119 people from every 1 million (National Safety Council, 2021).

EudraVigilance: Summary

The EudraVigilance system is the European Economic Area’s database for monitoring side effects of all medicines. As with VAERS, the system allows anyone to list just about any side effect.

In this way a plethora of data is collected quickly, so patterns can be discerned and stopped very quickly if necessary.

FIGURE 10

The data show a close correlation with the relationships as described by VAERS. Measured against total number of people vaccinated, only about 0,29% of cases reported a side effect. As expected, there was overreporting of serious side effects and underreporting of less serious side effects. This corresponds to VAERS data.

FIGURE 11

EudraVigilance does not have the same level of symptom descriptions as VAERS and instead uses predetermined categories. It is clear that the vast majority of side effects are general issues, which is in accordance with the clinical tests of the various vaccines.

Conclusion

From the data as reported in the US and the EU area, it is clear that the vaccines are safe for human use in the short term.

The side effects correlate with those identified in the clinical studies, and furthermore, reporting on serious side effects is particularly wide and comprehensive.

There is nothing in the data that suggests that the vaccines used in the US and the EU and that South Africa intends using have substantial disadvantages.

***

Specific concerns

Because of the rapid development of Covid-19 vaccines, and also the new technology being used, there are concerns about the safety of these vaccines, which is understandable.

While the data overwhelmingly show that the vaccines are safe, it is nevertheless important also to look at specific concerns being raised.

The vaccines have been developed too rapidly and therefore are unsafe.

The Covid-19 vaccines have been developed in record time, but this should not come as a surprise. Although Covid-19 is new, coronaviruses is not a new phenomenon and scientists have been studying them for more than 50 years.10 With the outbreak of Covid-19 specifically there were mountains of knowledge on coronaviruses that was used to develop a vaccine as quickly as possible. This background knowledge enabled scientists in China to fully unravel the RNA of the Covid-19 virus as early as January 2020, so vaccine development could start almost immediately.11 12

Vaccine development usually is an extremely costly process, but in this case there was no shortage of resources thanks to the huge demand. The American government of President Trump launched Operation Warp Speed, which made adequate funding available for vaccine development.13

This is not the first time a vaccine for a pandemic was developed within a year. With the 2009 swine fever pandemic, a vaccine was also developed within a year. Following a meeting in May 2009 to develop a vaccine, the first tests on a vaccine started as early as July 2009.14

Given this level of resources and demand, as well as the existing knowledge on coronaviruses and the specific knowledge on Covid-19, it is not unusual for a vaccine to be manufactured within a couple of months. This has enabled pharmaceutical companies to begin with clinical tests as early as May 2020, which eventually meant that the phase 3 testing of most vaccine candidates were completed by December 2020 and the successful candidates for human use could be approved. (Shrotri, 2021)

It is too difficult to transport the vaccine and there is no guarantee that it will still be effective by the time it reaches me.

This fear is specifically applicable to South Africa, where the government insists on centralising the purchasing and distribution of vaccines. It is a valid fear, but one has to take into account that there are various types of vaccines requiring different ways of transportation.

The Pfizer vaccine is most difficult to transport because it has to be stored at -70 °C in the long term. What is important, is that the Pfizer vaccine can be stored at normal refrigerator temperatures for up to a month, according to the FDA (United States Food and Drug Administration).15 This allays most of the fears about possible interruption of the cold chain.

Refrigerator temperature cold chains are common in South Africa and are effective.

The other vaccines (Moderna, Johnson & Johnson) may be transported with normal cold chain technology and should not pose any particular logistical challenges.16 17

The long-term effects of the vaccine are serious.

The present reality is that the long-term effects of Covid-19 vaccines simply are not known yet, because not enough time has passed to determine such effects. This is one area where there is uncertainty, simply because of the fact that no clinical test can move forward in time.

Fortunately, vaccines are not something new and there are lessons to be learned from the long- term effects of other vaccines. The history of vaccines shows that most side effects occur within two months after a person has received the vaccine.18 This history shows that long-term effects are a particularly rare occurrence for vaccines in general, simply because of the way vaccines work. Most of the material used to stimulate an immune reaction is excreted by the body within a couple of days.

The technology used in vaccine manufacturing has been used for many years, with minimal long-term effects.mRNA has been used and studied since 1989, and the first experiments on mRNA technology in vaccines were conducted way back in 1994. (Verbeke, 2019)

Other technologies such as the viral vector of the Johnson & Johnson vaccine have been used since 1974. The adenovirus version is used specifically because of its safety in clinical studies of other vaccines. (Ura, 2014)

You get Covid-19 when you have received the vaccine.

There is no viral Covid-19 protein in the vaccine (Corbett, 2020). This implies that there is no way the vaccine can give you Covid-19, because the virus itself is not in the vaccine. The vaccine creates only a modified spike protein.

It is important to first explain exactly what the spike protein is. The Covid-19 cell contains several small proteins surrounding it that help the viral cell to attach to your cells. These proteins give the Covid-19 cell the characteristic form that in a way creates a “corona” around it. Because of its unique nature, the spike proteins have been identified as the ideal target for a vaccine to be based on, because all mutations of Covid-19 have to contain a spike protein. (Salvatori, 2020)

For the virus to spread, it is necessary for the viral cells to multiply – viral cells therefore must use the spike proteins to attach to your cells and then the viral cell itself has to multiply. The spike protein is not a virus on its own and cannot multiply on its own. Therefore, it is not possible to get Covid-19 from the vaccine, because there are no Covid-19 cells in the vaccine.

The spike protein of Covid-19 on its own is dangerous.

There is no viral Covid-19 spike protein in the vaccine (Corbett, 2020).

Although the viral spike protein on its own can cause damage, it is important to note that vaccines produce a modified, harmless spike protein that is aimed at launching an immune reaction so your immune system then react better when the actual virus makes its appearance.

The spike protein of the vaccine spreads through your entire body, causing damage.

There is no viral Covid-19 spike protein in the vaccine (Corbett, 2020).

Although studies on rats show that the spike protein does not stay specifically at the injection area, the same studies also show that most of the vaccine stays near the injection area and then moves to the liver – as expected (Pharmaceuticals and Medical Devices Agency, 2021). The largest amount found outside these areas is 1,03% of the total vaccine dose that is found in the spleen. The table from the study concerned appears below.

FIGURE 12

The quantity of spike protein that a vaccine produces is 100 000 times less than what is required to cause damage.19 Consequently, the spread outside the vaccination area of at most 1,03% is not a substantial threat.20 21

The vaccine has a harmful effect on breast feeding.

In the VAERS system in the US there are only 271 incidents applicable to people doing breastfeeding. Most of these incidents are where a breast-feeding mother develops one of the normal side effects, such as headache or muscle pain. In only 23 incidents specific reference to breast milk is made. These incidents describe symptoms such as a baby that eats more or has a running nose (Centre for Disease Control and Prevention, 2021).

Shouldn’t one use ivermectin instead of the vaccine?

Recent research has shown that ivermectin probably is effective in the treatment of Covid-19 (Bryant, 2021). Given the possible role that ivermectin can play in the treatment of Covid-19, together with the safety of ivermectin in approved doses, it is astonishing that it was not include long ago already as possible treatment for Covid-19 in South Africa.

Ivermectin has now been approved for human use in South Africa22 and may be prescribed by any doctor. As with all medicine, it is very important to stick to the safe dose in order to avoid undesirable side effects.

Ivermectin and a Covid-19 vaccine are not working against each other and focus on different sides of the treatment spectrum.A Covid-19 vaccine by definition is of a preventive nature, while ivermectin probably is an effective treatment for Covid-19, especially in the early stages of the disease.

Consequently, there is no tension between ivermectin and Covid-19 vaccines and the two may be used together against Covid-19.

More people are dying of the vaccine than of Covid-19.

Vaccines and possible side effects are reported on in great detail, and no exceptional deaths have been noted. On the contrary, the side effects of vaccines are well aligned with those of other vaccines.23

So far, more than 2,9 billion doses of a Covid-19 vaccine have been administered without a significant number of deaths having been reported in the US or in Europe. The few serious side effects reported (blood clots and heart diseases) are exceedingly rare and are manageable if taken care of.

On average, about 2 500 people out of 1 million receiving a Covid-19 vaccine should develop a side effect, most of which will be mild. If 1 million people get Covid-19, about 140 000 should end up in hospital with serious symptoms and about 23 000 should die (CITATION Zunyou 2020).

South Africa’s vaccination programme

All indications are that South Africa’s Covid-19 vaccination programme is a complete failure, with only 0,8% of the population vaccinated by June 2021.24 25 26 This puts the government’s vaccination programme at number 210 in the world, behind most African countries.

FIGURE 13

The government’s short-sightedness concerning vaccine planning is clear from the fact that there were almost no meetings in 2020 to obtain vaccines, whereas the governments of the United Kingdom and the United States ensured sufficient vaccines for their entire populations as early as August 2020.27

In contrast, the South African government hastily tried to make plans in January 2021 to get a vaccine programme off the ground. Initial targets were to receive the first vaccines by the end of January 202128 and then to supply vaccines at a rate in terms of which 67% of the population would be vaccinated by the end of 2021. Part of this target was to have 5 million people older than 60 vaccinated by the end of June 2021.29

This target was missed completely and the chances of reaching the target of 67% of the population appear to be a pipe dream.30

Yet the government still insists on being in sole control of the vaccine programme. In opposing court documents, the Department of Health replied that they did not have a monopoly on vaccines and that the private sector could obtain vaccines if they can do so. Then SAHPRA registered the Johnson & Johnson vaccine for use, on condition that only the government may purchase this vaccine.31

This insistence on centralising the vaccine programme is directly resulting in South Africa’s vaccine programme being way behind the rest of the world and even behind the average for Africa.

During the lockdown the South African government abused its power by imposing irrational regulations that eroded freedoms and by arbitrarily enforcing these regulations. In addition to the authoritarian attitude followed by the government with a command council that enforces decisions “with immediate effect”, several ANC officials have looted relief funds.

The inevitable and understandable impact of the South African government’s actions is that people distrust the government, specifically as far as dealing with Covid-19 is concerned. This distrust, together with the extreme incompetence of ministers and the arrogance of the command council, has created a rich breeding ground for vaccine scepticism. Reluctance regarding vaccines is understandable, given the nature of the South African government’s untransparent actions during the lockdown.

Recommendations

1. Privatise vaccines

The South African government’s vaccine programme is a total failure. If we are going to wait for the government to make vaccines available to the broader South African public, a fourth and fifth wave of Covid-19 are going to hit South Africa before any significant number of people will be vaccinated.

It therefore is clear that the private sector, because of a failing government, will have to do something to obtain and administer vaccines. It is regrettable that the South African government insists on working against the private sector instead of trying to obtain vaccines as quickly as possible through any and all role-players.

Solidarity should do everything in its power to enable the private sector to obtain and distribute vaccines itself, specifically to ensure that the government does not maintain a monopoly on vaccines.

2. Mandatory vaccination

Judging by the countries with successful vaccination programmes it is clear that making vaccination mandatory is not required for success. On the contrary, chances are that compulsion will increase resistance. If South Africa wants to succeed with its vaccination programme, it is more important to instil trust among the public in order to get voluntary participation.

The principle that a government should not force an individual to undergo a medical procedure is one that should be defended.

Solidarity will oppose mandatory vaccination, especially in the workplace, to ensure that freedom of choice and bodily integrity are not violated.

3. Covid-19 vaccines

Overwhelming data show that Covid-19 vaccines are safe and effective. The side effects compare well to those of other vaccines for other diseases. The vaccines do not guarantee that you will not get Covid-19 or even die of it, but they dramatically lower your chances of contracting the virus and reduce deaths even more.

Their effectiveness is shown by various countries’ vaccination programmes where substantial success has been achieved measured against real outcomes such as hospitalisations and deaths.

Their safety is shown by a small number of adverse events, specifically in the US. Once again, these are only a small number from among almost 330 million doses of vaccine already administered in the US. Furthermore, the absence of substantial numbers of adverse events worldwide is noteworthy, given the scale of vaccine administration (3 billion), and even particularly rare side effects would by now have shown symptoms.

Based on available data, Solidarity views the Pfizer, Moderna, Johnson & Johnson and AstraZeneca vaccines as safe and effective for members and the broader public who decide to be vaccinated against Covid-19. Every person should consider his or her own personal medical history before taking any medication.

Download the report here.

Footnotes:

1 https://www.nytimes.com/2021/06/24/world/middleeast/israel-covid-delta-variant.html

2 https://www.cnbc.com/2021/06/28/how-the-uk-with-the-delta-variant-is-a-blueprint-for-the-us.html

3 https://www.pinsentmasons.com/out-law/news/compulsory-vaccination-for-care-home-workers-in-england

4 https://apnews.com/article/coronavirus-pandemic-health-941fcf43d9731c76c16e7354f5d5e187

5 https://www.worldometers.info/coronavirus/country/italy/

6 https://www.samrc.ac.za/reports/report-weekly-deaths-south-africa

7 https://ourworldindata.org/explorers/coronavirus-data-explorer?zoomToSelection=true&time=2020-03- 01..latest&pickerSort=asc&pickerMetric=location&Metric=People+fully+vaccinated&Interval=7- day+rolling+average&Relative+to+Population=true&Align+outbreaks=false&country=~ZAF

8 https://ourworldindata.org/explorers/coronavirus-data-explorer?zoomToSelection=true&time=2020-03- 01..latest&pickerSort=asc&pickerMetric=location&Metric=People+fully+vaccinated&Interval=7- day+rolling+average&Relative+to+Population=false&Align+outbreaks=false&country=ZAF~OWID_WRL

9 Available at https://wonder.cdc.gov/vaers.html.

10 https://www.medicalnewstoday.com/articles/how-did-we-develop-a-covid-19-vaccine-so-quickly#Other- coronaviruses

11 https://www.sciencemag.org/news/2020/01/chinese-researchers-reveal-draft-genome-virus-implicated-wuhan- pneumonia-outbreak

12 https://virological.org/t/novel-2019-coronavirus-genome/319

13 https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/

14 https://www.clinicaltrials.gov/ct2/show/NCT00943358

15 https://www.fda.gov/news-events/press-announcements/fda-brief-fda-authorizes-longer-time-refrigerator-storage- thawed-pfizer-biontech-covid-19-vaccine

16 https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/downloads/storage-summary.pdf

17 https://www.cdc.gov/vaccines/covid-19/info-by-product/janssen/downloads/janssen-storage-handling- summary.pdf

18 https://www.chop.edu/news/long-term-side-effects-covid-19-vaccine

19 https://www.deplatformdisease.com/blog/spike-protein-circulating-in-the-vaccinated-what-does-it-mean

20 https://www.salk.edu/news-release/the-novel-coronavirus-spike-protein-plays-additional-key-role-in-illness/

21 https://twitter.com/manorlaboratory/status/1388717008544419843

22 https://www.news24.com/news24/southafrica/news/court-order-allows-use-of-ivermectin-for-covid-19-20210406

23 https://www.medicalnewstoday.com/articles/how-do-covid-19-vaccines-compare-with-other-existing- vaccines#COVID-19-vaccine-and-allergic-reactions

24 https://www.biznews.com/undictated/2021/03/26/sas-failed-covid-19-vaccination

25 https://www.dailymaverick.co.za/article/2021-03-18-south-africas-vaccine-response-a-failure-mobilise-civil-society- for-real-change/

26 https://www.bbc.com/news/world-africa-56944400

27 https://www.nature.com/articles/d41586-020-02450-x

28 https://www.news24.com/news24/southafrica/news/we-are-still-on-course-to-receive-first-batch-of-vaccines-by- end-of-january-mkhize-20210125

29 https://www.iol.co.za/news/politics/sas-vaccine-targets-and-the-consistent-series-of-missteps-c600560a-fc97-4170- 9145-ea4235071e64

30 https://www.news24.com/news24/southafrica/news/most-south-africans-will-have-to-wait-until-november-to-get- covid-19-vaccine-20210325

31 https://www.sahpra.org.za/news-and-updates/sahpra-registers-covid-19-vaccine-janssen-ad26-cov2-s-recombinant- with-conditions/

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 ENDS

Issued by Connie Mulder, Head: Solidarity Research Institute, 11 July 2021