Forum Discussion

Forum Discussion

Questions on General Concerns

Prof Dorfman, Prof Preiser and Prof Whitelaw have compiled a comprehensive document providing answers to the remaining questions submitted to our forum. 

You can find those answers in the link on the right: 

Question:

Please comment on the Pfizer data submitted to the FDA which has a very high mortality as well as why individuals are biased towards to certain position?

Prof Keymanthri Moodley

(MBChB, EMBA)

The Pfizer data submitted to the Food Drug Administration (FDA) could not be released to the public for administrative and legal reasons.

Question:

Why is natural immunity not considered in the vaccine mandate?

Prof Keymanthri Moodley

(MBChB, EMBA)

The problem with natural immunity is that we are unsure how long immunity would last and monitoring antibodies levels requires expensive repeated testing.

Question:

Can COVID-19 really be considered a serious health problem?

Prof Jeff Dorfman

(MBChB, MMed, PhD)

The data is self-evident. The overflowing hospitals around the world is self-evident. When the number of serious cases overwhelmed hospitals here in the Western Cape and South Africa at large, the reality was quite clear. It is a myth that this is not a serious disease.

People have died for lack of a bed, for lack of oxygen in South Africa, even in the United States, where there is greater capacity of health resources per capita.

Developing countries in some ways have been hit much harder, for example in India, during the delta wave, the numbers hit millions. All the data we have seen related to the pandemic in hospitals has demonstrated the severity. 

Question:

Johnson & Johnson, as well as Pfizer, are both listed under the corporate donors of SU.

It seems to me that a clear conflict of interest exist where SU forces all their student and staff members to use the products of these two donors.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

The university does not source the vaccine from these companies, the government does. The university is obliged to use what vaccines are available and currently only vaccines from these 2 companies are. There is thus no conflict of interest.

Question:

Covid deaths are artificially inflated.

Countries around the globe have been defining a “Covid death” as a “death by any cause within 28/30/60 days of a positive test”

Removing any distinction between dying of Covid and dying of something else after testing positive for Covid will naturally lead to over-counting of “Covid deaths”. Some scientists have been warning about this substantial over-estimate for some time.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

If one compares deaths officially reported as being due to COVID-19 – with excess deaths reported by the South African Medical Research Council (Report on weekly deaths), it is clear that deaths due to COVID-19 are under reported rather than over reported.

Question:

Can the vaccines be taking during pregnancy?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Yes, COVID-19 vaccines can be taken in pregnancy. 

Click here for a link to the National Institute for Communicable Diseases’ website.

Question:

Can the vaccines be taking concurrently with other vaccines?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Yes, the National Department of Health has recently issued a circular which states exactly that – NATIONAL COVID-19 VACCINATION PROGRAMME CIRCULAR 3 OF 2022: CO-ADMINISTRATION OF COVID-19 AND OTHER VACCINES.

Question:

Is it okay to donate blood before receiving a vaccine?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Blood donation can be given after vaccination and therefore by implication before donation of blood.

Click here for a useful reference.

Question:

What happens when you’ve received one J&J and one Pfizer as the premises were out of stock of one of them? This has happened. What are the interactions between the 2 vaccines?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Mixing of vaccines has been researched in a number of studies and shown to be safe.

The National Department of Health has recently issued a circular permitting the mixing of vaccine doses (at different times) also referred to as heterologous boosting. NATIONAL VACCINATION PROGRAMME CIRCULAR 2 OF 2022. CHANGES TO DOSING INTERVALS AND INTRODUCTION OF HETEROLOGOUS BOOSTER DOSES.

Question:

What are the intervals that you should receive your booster in? There is no clear communication about that.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

The J&J booster can be given 2 months after the last dose and the Pfizer booster, 3 months after the second dose.

See national circular: NATIONAL VACCINATION PROGRAMME CIRCULAR 2 OF 2022. CHANGES TO DOSING INTERVALS AND INTRODUCTION OF HETEROLOGOUS BOOSTER DOSES.

Question:

How can science be denied? How can RCTs be denied? How can asking questions be wrong?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

All scientific data including data from RCTs must be critically analysed to ensure that satisfactory methods of data collection and analysis have been performed – this is part of the scientific method. It will always be important to asks questions – this is never wrong.

Questions on Side Effects

Question:

Why is there apparently no product insert to document the possible side effects (as listed by the FDA in Oct 2020)?

Dr Veshni Pillay-Fuentes Lorente

(MBChB, MMed)

Adverse events from the respective clinical trials are stated in the package insert.

You can find the package inserts/label on the various vaccines in the links below.

Link one.

Link two.

Link three.

Question:

Is it true that 1 in 2700 boys will develop myocarditis and 50% will die within 11 years?

Are you aware of the study that shows EVIDENCE OF A BIOLOGICAL MECHANISM OF HOW mRNA VACCINES MAY BE CONTRIBUTING TO INCREASED CARDIAC EVENTS, published in the highest impact cardiology journal: Dramatically increase inflammation on the endothelium and T cell infiltration of the cardiac muscle and may account for the observation of increased thrombosis, cardiomyopathy, other vascular events following vaccination.  

Dr Veshni Pillay-Fuentes Lorente

(MBChB, MMed)

Firstly, it is important to note that the article stated in question 2 is an abstract and a full-length article is not available to critically appraise the study especially in the light of the study design and methodology. Subsequent to this publication, a warning and expression of concern was stated and the article was subsequently corrected.

The conclusion of the article now reads: “In conclusion, the mRNA vacs numerically increase (but not statistically tested) the markers IL-16, Fas, and HGF, all markers previously described by others for denoting inflammation on the endothelium and T cell infiltration of cardiac muscle, in a consecutive series of a single clinic patient population receiving mRNA vaccines without a control group.” 

A recent descriptive study of myocarditis reports on the VAERS evaluated 192 405 448 patients over 8 months and found 1991 patient reports of myocarditis. Of the 1991 patients, 1626 met the case definition of myocarditis – 1195 (73%) were younger than 30 years of age, 543 (33%) were younger than 18 years of age, and the median age was 21 years (IQR, 16-31 years). Among persons younger than 30 years of age, there were no confirmed cases of myocarditis in those who died after mRNA-based COVID-19 vaccination without another identifiable cause and there was 1 probable case of myocarditis but there was insufficient information available for a thorough investigation. Of note is this study is a descriptive study and is subject to many limitations. 

Question:

Which vaccine has presented with more adverse effects?

 

Dr Veshni Pillay-Fuentes Lorente

(MBChB, MMed)

In the initial vaccine clinical trials it was found that there were very few serious side effects from the Pfizer vaccine. The adverse events experienced by those in the placebo and the trial groups were similar.

This finding was similar for the J&J vaccine.

A paper published in December 2021: Analysis of COVID-19 Vaccine Type and Adverse Effects Following Vaccination evaluated factors potentially associated with participant-reported adverse effects after COVID-19 vaccination.

This study was conducted to give the public a better understanding of real-world experience of adverse effects.

Final analysis included only participants who reported receiving BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna), or JNJ-78436735 vaccines because of small numbers of receipt of other vaccines in this study and included real-world digital cohort of 19 586 people. 

The most common vaccine adverse effects were fatigue, muscle pain, headache, chills, redness/swelling at the injection site, joint pain, and fever.

Adverse effects and adverse effect severity varied across vaccine brands. Participants receiving JNJ-78436735 had lower odds of adverse effects compared with BNT162b2 (OR, 0.64; 95%CI, 0.52-0.79; P < .001).

Compared with participants receiving BNT162b2 vaccine, participants receiving mRNA-1273 had 1.88 times (95%CI, 1.63-2.17) the odds of reporting severe or very severe adverse effects (P < .001).

There was not a statistically significant difference in odds of severe or very severe adverse effects reported by participants receiving the JNJ-78436735 vaccine compared with the BNT162b2 vaccine (OR, 1.03; 95%CI, 0.67-1.58; P = 0.89).

The overall conclusion: serious adverse effects, such as anaphylaxis or allergy, were rare.

Question:

US department of defence reported a 300% increase in miscarriages and 1,000% in neurological effects

Prof Hassan Mahomed

(MBChB, MMed, PhD)

I have not come across such reports (as COVID-19 vaccine side effects) from any authorised source such as the CDC (USA), SAHPRA (South Africa) or World Health Organisation. The author of the question should supply the exact source of their data in order for us to respond fully.

Question:

As of 11 February 2022, VAERS (U.S. Government’s Vaccine Adverse Events Reporting System database) recorded 1,103,893 reported cases of injuries and deaths following COVID-19 vaccines. Of this more than 23 000 were deaths. It is well-recognized that most cases will not be reported, thus how can SU continue to claim that these vaccines are ‘safe’? What is your measure of ‘safe’?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

It is very important to distinguish between surveillance systems for vaccine side effects and proof that vaccines are the cause of these side effects.

An adverse event following immunization needs to be investigated before a conclusion can be drawn that the vaccine caused that event. VAERS (Vaccine Adverse Event Reporting System) is an American surveillance system where clinicians and members of the public are encouraged to report any side effects that happen after vaccination.

In other words, it is an attempt to try and detect as many side effects as possible (common or rare) that may be linked to a vaccine.

However, many reported side effects are co-incidental so these reports need to be assessed first to see if they are linked to the vaccine concerned – expert clinicians are usually involved in this. 

VAERS data are often misused to claim that vaccines are causing large numbers of side effects but this is a misrepresentation of the facts.

South Africa has a similar system referred to as AEFI Adverse Event Following Immunisation and we have a national committee of experts who review these reports to see if they are vaccine related.

Question:

Is the statement that the vaccine is safe not inconsistent with the VAERS , Eudovigilance and Yellow card data.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

You will see the response to the question above for the discussion around VAERS.

Again Eudravigilance is a surveillance system and their data is not an indication of confirmed side effects related to vaccination.

Question:

Why was a healthy preventative lifestyle not promoted before the vaccines? Dr McCullough, together with five other researchers, published an article in the International Journal of Innovative Research in Medical Science (IJIRMS) Volume 06, Issue 03, March 2021 titled “Early Ambulatory Multidrug Therapy Reduces Hospitalization and Death in High-Risk Patients with SARS-CoV-2 (COVID-19)”.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

The Department of Health are actively seeking out treatments and I am very confident that any treatment that would claim to be as effective as this would be rigourously tested and undergo trials all of which are publicly available online.

Any effective treatment would go through consideration, and yes, there are some that are moderately successful and have been licensed but they vary in their efficaciousness.

This country saves lives by immunising, by vaccinating against many diseases which are susceptible to antibiotics. Lives are saved by immunisation and without trying to dismiss the importance of treatments, damage may be accumulated prior to treatment and vaccines are considerably cheaper in controlling morbidity and mortality and play an important role in this. 

Question:

Have there been any statistics of death related to individuals dying from the vaccine and those who have not?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

For South Africa on the SAHPRA website, they publish all the adverse events following vaccination which includes deaths and the statistics surrounding this, an international platform such as the CDC publishes all of their data as well.

Questions on Long Term Effects

Question:

Has an adequate number of studies been conducted to proof that there won’t be long term complications?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

With any new treatment, after it is shown to work and registered for use by the public, there are mechanisms for ongoing monitoring for side effects. This is normal practice and this is the case for COVID-19 vaccines as it would be for any new medication. Vaccines were first given to humans more than 18 months ago – there is no evidence of any major adverse events affecting large numbers of people so far – more than 10 billion doses of a range of COVID-19 vaccines have been given to date.

Yes, the future is unknown but we can use our experience with other vaccines and other treatments to say that we do not expect any major side effects that will affect a large number of people in the future.

Questions on Clinical Trials and Production of Vaccines

Question:

Is this possible, as Pfizer has requested a 75years reprieve before sharing their data?

Why is the FDA and Pfizer so desperate to keep the trial data secret including going to court several times to limit the release

Prof Hassan Mahomed

(MBChB, MMed, PhD)

This request did not come from Pfizer nor was it a request to provide data after 75 years– the FDA agreed to release the data immediately but they claimed it only had the resources to process 500 pages per month which would mean it would take 75 years to release all 455 000 pages. A judge recently ordered them to release 55 000 pages per month.

Question:

Is it true that during the Pfizer trial the end point was changed from all cause mortality because no benefit could be shown.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

This is not correct, the trial showed the efficacy against infection and prevention of severe COVID-19 disease but too few COVID-19 related deaths occurred in the trial to show its benefits for preventing COVID-19 deaths. The end point was not changed at any point in time.

Click here.

Question:

Is it true that the unblinded participants were included in the results negating the findings ( as reported in the BMJ ).

Prof Hassan Mahomed

(MBChB, MMed, PhD)

The claim of possible unblinding is made in a report by an employee of a trial monitoring company which was monitoring certain sites in Texas.

The trial was conducted at 153 sites. This investigative report indicates a number of deficiencies in the conduct of the trial at these sites.

No evidence of unblinding across all or the majority of trial sites is reported so one cannot say what happened at these trial sites invalidated the trial findings.

Subsequent independent analyses of the efficacy of the Pfizer vaccine have confirmed its efficacy.  Clinical trials are closely monitored and regulated and trial sites are audited on a regular basis.

Thacker PD. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021)

World Health Organisation COVID-19 Weekly Epidemiological Update no 50.

Question:

Were phase 2 (animal) completed?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Phase 2 trials are conducted in humans and are focused mainly on safety. Yes, phase 2 trials were conducted – see below.

 

Pfizer phase 2-3 trial. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

Janssens (J&J) phase 1-2a trial. Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine. Sadoff J, Le Gars M, Shukarev G, Heerwegh D, Truyers C, de Groot AM, Stoop J, Tete S, Van Damme W, Leroux-Roels I, Berghmans PJ, Kimmel M, Van Damme P, de Hoon J, Smith W, Stephenson KE, De Rosa SC, Cohen KW, McElrath MJ, Cormier E, Scheper G, Barouch DH, Hendriks J, Struyf F, Douoguih M, Van Hoof J, Schuitemaker H. N Engl J Med. 2021 May 13;384(19):1824-1835. doi: 10.1056/NEJMoa2034201. Epub 2021 Jan 13.

Question:

Were the phase 3 trials completed?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Yes, phase 3 trials (for efficacy) have been conducted and the results published in peer review journals.

Pfizer phase 2-3 trial. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

 

Janssens (J&J) phase 3 trial. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guiñazú J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

Question:

Were the phase 3 trials completed?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Yes, phase 3 trials (for efficacy) have been conducted and the results published in peer review journals.

Pfizer phase 2-3 trial. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

 

Janssens (J&J) phase 3 trial. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guiñazú J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

Question:

What was the testing process – was it cut short, as reported, and have pharma companies been transparent about their testing methods; to date, what is the effectiveness of vaccines, in percentages, and have vaccines been helpful; why should they be mandatory; how will this technology be used in the future.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

What was the testing process: The vaccines were tested in clinical trials

Was it cut short, as reported: No, for some trials, follow up is continuing. For many trials, an interim analysis is built in. If promising results are seen, then the trial may be stopped and the findings presented to regulatory authorities for public use especially if new treatments are urgently needed.

have pharma companies been transparent about their testing methods: all the details of the trials are required to be reported to regulatory authorities such as the FDA and SAHPRA so that they can make informed decisions about approving the product

what is the effectiveness of vaccines: Pfizer was shown to be 95% efficacious in its first efficacy trial and the Janssens J&J vaccine 66% against infection and 77-85% against severe disease. See trial publications under 7 above

have vaccines been helpful: yes, multiple studies have shown vaccines to be effective in preventing infection, severe disease and deaths – see World Health Organisation COVID-19 Weekly Epidemiological Update no 50.

why should they be mandatory: if having COVID-19 can pose a threat to others particularly those who are vulnerable, then a reasonable argument can be made for mandatory vaccination

how will this technology be used in the future: The experience and knowledge gained through the use of this technology will be used to design better vaccines in the future

Question:

The new mRNA injections are not made on the same basis as other vaccines with an attenuated virus. As far as I understand all injections for Covid 19 are still in trial phase, with Pfizer only aiming to release the data n 75 years. Full disclosure of contents, ALL possible side effects and long term studies on safety and fertility cannot be given so why am I expected to take part in a trial because I want to study at the only university that I am close to?

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Not all vaccines are made with viruses – some are made of protein, some with killed whole cells and others still with polysaccharide. mRNA occurs naturally in the body and was first synthesised in 1990s and the first mRNA vaccines were already in clinical trials prior to 2020. See references below

“This type of vaccine uses genetically engineered mRNA to give your cells instructions for how to make the S protein found on the surface of the COVID-19 virus. After vaccination, your immune cells begin making the S protein pieces and displaying them on cell surfaces. This causes your body to create antibodies.”

This quote can be found on the Mayoclinic website

 

“The first report of the successful use of in vitro transcribed (IVT) mRNA in animals was published in 1990, …”, quoted from: mRNA vaccines — a new era in vaccinology. Norbert Pardi, Michael J. Hogan, Frederick W. Porter & Drew Weissman. Nature Reviews Drug Discovery volume 17, pages261–279 (2018) Published: 12 January 2018

Question:

According to Pfizer themselves, they say their “vaccine”is a medicinal product ,ONLY registered for emergency use.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Their vaccine was originally registered for emergency use but is now fully registered with the FDA.  

 

Question:

Limited experience in pregnancy/fertility.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

“On one hand, despite the low risk of infection in the male reproductive system or fetus, COVID-19 could pose an enormous threat to human reproductive health. On the other hand, our review indicates that both men and women, especially pregnant women, have no fertility problems or increased adverse pregnancy outcomes after vaccination, and, in particular, the benefits of maternal antibodies transferred through the placenta outweigh any known or potential risks.”

Click here.

There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems (problems trying to get pregnant) in women or men. 

World J Mens Health. 2020 Oct;38(4):506-520. doi: 10.5534/wjmh.200134. Epub 2020 Aug 14. Male Fertility and the COVID-19 Pandemic: Systematic Review of the Literature. Mohammad Ali Khalili 1, Kristian Leisegang 2, Ahmad Majzoub 3 4 5, Renata Finelli 5, Manesh Kumar Panner Selvam 5, Ralf Henkel 6 7, Moshrefi Mojgan 1 8, Ashok Agarwal 9 

Lancet. 2021 Nov 6;398(10312):1683-1684. doi: 10.1016/S0140-6736(21)02282-0. Epub 2021 Oct 21. Fertility rates and birth outcomes after ChAdOx1 nCoV-19 (AZD1222) vaccination Kushalinii Hillson 1, Sue Costa Clemens 2, Shabir A Madhi 3, Merryn Voysey 1, Andrew J Pollard 1, Angela M Minassian 4, Oxford COVID Vaccine Trial Group

 

Effectiveness of the BNT162b2 mRNA COVID-19 vaccine in pregnancy. Dagan N, Barda N, Biron-Shental T, Makov-Assif M, Key C, Kohane IS, Hernán MA, Lipsitch M, Hernandez-Diaz S, Reis BY, Balicer RD. Nat Med. 2021 Oct;27(10):1693-1695. doi: 10.1038/s41591-021-01490-8. Epub 2021 Sep 7.

Question:

No studies done on immune compromised patients or patients on immune suppressant meds.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

See references below:

Administration of COVID-19 vaccines in immunocompromised patients. Negahdaripour M, et al. Int Immunopharmacol. 2021.

Immunogenicity of COVID-19 mRNA vaccines in immunocompromised patients: a systematic review and meta-analysis. Mehrabi Nejad MM, et al. Eur J Med Res. 2022.

Short-term effectiveness of COVID-19 vaccines in immunocompromised patients: A systematic literature review and meta-analysis. Marra AR, et al. J Infect. 2022. PMID: 34982962.

Question:

No genotoxitity nor carsinogenicity studies done!

Prof Hassan Mahomed

(MBChB, MMed, PhD)

There is ongoing monitoring of the safety of all medical products and there is thus no need for such studies. Such studies are warranted only if there is a reasonable expectation that genotoxicity or carcinogenicity will occur.

Question:

How have the vaccine trials addressed the issue of possible long term complications for those who receive these relatively novel vaccines?  The large scale trials provide an indication of short to medium term side effects, but I have not seen any evidence that these vaccines are safe in the long term, maybe 20 or 30 years down the line.  I do not think it prudent to simply assume the same good long term safety record of inactivated virus vaccines.

Prof Hassan Mahomed

(MBChB, MMed, PhD)

Is it realistic to wait 20-30 years before any new treatment can be used? We can definitely use our experience with other products where we know that any long term effects will be extremely rare.

Questions on Ethics

Question:

I wanted to ask with regards to the Siracusa principle which mandates in a public health emergency is this still viable?

Prof Keymanthri Moodley

(MBChB, EMBA)

Rights remain restricted in Southern Africa. As we sit here your rights are restricted by you having to wear a mask. The nature of restriction in the pandemic is fluid and subject to continual change and amendments.

Question:

Novak Djokovic and his strong belief in bodily autonomy. It now becomes a conversation of Autonomy vs Beneficence i.e. Paternalism, not for Djokovic, but for the collective individuals since those who we are protecting. In other words Djokovic does not want to take the vaccine because he has the right to put what goes into his body, but him taking the vaccine will benefit the greater good. It probably won’t benefit him, it could actually be detrimental to him if he is unlucky. What do you think of this? I am someone who has been vaccinated and boosted, but I am a strong believer of bodily autonomy, but I do believe there are times when you have to be Paternalistic. What are the ethics? It’s individualism until a pandemic starts, then we all become collective. It’s interesting. If collectivism did not exist, I probably wouldn’t be typing this because I wouldn’t be alive as my ancestors would have died from smallpox… This healthy tennis player who is healthier than the doctor who smokes is getting criticism for not taking a vaccine because he does not understand what it will potentially do to his body outside of protecting him from severe Covid symptoms.

Prof Sharon Kling

(MBChB, MMed, MPhil)

You raise some interesting points, but the essence of the argument is that in a pandemic (which essentially is a public health emergency) the public good outweighs individual autonomy. Novak Djokovic has the right to refuse to be vaccinated, but then he must accept that there are consequences arising from that decision.

Question:

With regards to the ethics and the suppression of our rights, will there be ensuing discrimination concerning the vaccinated and the unvaccinated as the vaccinated places a burden on the population as well?

 

Prof Keymanthri Moodley

(MBChB, EMBA)

There is no guarantee that you will not get the disease, but the vaccine remains highly efficacious. When talking about public health, as many people as possible need to be vaccinated to protect public health systems and the economy. When we talk about restrictions and mandates we talk about the impact of vaccination versus the impact of the unvaccinated. Vaccinated individuals are not at the same level of risk as those who are unvaccinated. There are rules in place at every work environment for the safety of all staff and students where applicable. This is not about discrimination but rather public health and workplace safety

Question:

Will SU be held liable for adverse effects due to vaccination in individuals who got vaccinated in order to comply with the institution’s vaccine mandate?

Prof Sharon Kling

(MBChB, MMed, MPhil)

Firstly, the University has put the vaccine mandate regulation on hold. However, should there be a vaccine mandate, SU will not be liable for any adverse effects.

Question:

In the interest of freedom of speech why can’t we have open debates where individuals from various other disciplines like statisticians can argue both sides of this, as it makes the system more reliable and students may have a better buy-in?

Prof Keymanthri Moodley

(MBChB, EMBA)

The perspective we represent is from a clinical background and practical experience, whereas other experienced individuals who synthesize data do not have any medical background. They have not worked in hospitals during COVID-19 or seen patients dying of COVID-19. We find the anti-vax position difficult to explain, and we present this information from our understanding. We are here to respond to some of the questions raised and were not invited to a debate to actively engage on the topic.

Question:

I would like to know how US intends to deal with the discrimination and apartheid it is intending to create in a court of law, given that our Bill of Rights, in several places, protects all groups from unfair discrimination on any basis, also given that covid is a mild and treatable disease and is barely threat.

Prof Sharon Kling

(MBChB, MMed, MPhil)

COVID-19 is not a mild and treatable disease – it has resulted in millions of deaths globally and in excess of 100 000 known deaths in South Africa. All rights in the Constitution have limitations, and considerations of the greater public good outweigh individual rights when it comes to vaccination. Even people who have had the so-called ‘milder’ Omicron variant have been quite ill, and may suffer from ‘Long COVID’.

Question:

This vaccine is still in an experimental phase. Humans are actively participating in the study. I completely understand what we are trying to achieve, but what I don’t understand is why you would want to force people to participate? You need to give consent if you want to be a part of an experimental trial. You also need to know all the risks involved, to make an informed decision. On top of this, I feel like it will be overkill to enforce vaccination at this stage, as the virus is getting weaker and weaker, and most people survive the latest omicron variant (which is causing almost 100% of covid infections in SA right now).

Prof Sharon Kling

(MBChB, MMed, MPhil)

The vaccines being administered in South Africa are not experimental but have been approved by SAHPRA. The only study under which the vaccine was administered, was to health workers prior to approval by the regulatory body, and this was done as a clinical trial with informed consent (the Sisonke Trial). This vaccine, the J&J vaccine, has since been registered by SAHPRA.

No-one knows how the virus will behave going forward.

Question:

WHY ARE YOU PUTTING STUDENTS AND STAFF UNDER SUCH EMOTIONAL AND PSYCHOLOGICAL STRESS?? If you cared about our health you would be focussing on reducing our stress levels. The proposed policy is irrational and unscientific. The current status of the virus renders the Risk assessment undertaken in 2021 unusable. The risk assessment will need to be redone. The whole policy is a joke and SU should be embarrassed to be following this route given the data coming out of Israel and other highly vaccinated countries.

Prof Sharon Kling

(MBChB, MMed, MPhil)

The vaccine mandate regulation is currently on hold, but it was proposed so that the institution could return to a semblance of normality while safeguarding all those at risk.

Question:

You cannot deny children access to education by taking away their free choice & forcing them to vaccinate with an experimental jab that is against the Nuremburg Code.

Prof Sharon Kling

(MBChB, MMed, MPhil)

This is a nonsensical statement and does not bear answering.

Question:

Does Stellenbosch University deem it unnecessary to adhere to the stipulations and protections set out in the Nuremberg and Helsinki codes? If Stellenbosch University forces mandates on vaccines, will you also stand in for any damages?

Prof Sharon Kling

(MBChB, MMed, MPhil)

The Nuremberg and Helsinki Codes refer to research ethics and are applicable to clinical studies. The vaccines have been approved by the SAHPRA and are not administered as part of a study.

Question:

Why this approach of mandated vaccination?

Prof Sharon Kling

(MBChB, MMed, MPhil)

To protect as many people as possible from the severe effects of COVID-19, and to prevent our healthcare system from being overwhelmed.

Question:

Will SU be held liable for adverse effects due to vaccination in individuals who got vaccinated in order to comply with the institution’s vaccine mandate? Since the vaccines were created for an earlier variant of the virus and not the current variant, are they still effective enough to be made mandatory? Since many vaccinated individuals have now contracted and spread Covid-19.

Prof Sharon Kling

(MBChB, MMed, MPhil)

SU will not be liable. Mandatory vaccination at the university is not required at present. As I understand it though, there is protection from severe disease and death from the current vaccines even with the variants. However, new vaccines may be required in future, analogous to the influenza vaccine, which is updated annually.

Question:

Have you seen the reported adverse side effects in this WHO site below? Please note that most side effects reported are within the 18 year old group. How do you explain your ethical code as to do no harm? http://vigiaccess.org/

Prof Sharon Kling

(MBChB, MMed, MPhil)

As I read it, the adverse effects are greatest in the two groups older than 18 years. Most of the adverse effects are mild and can be justified by the benefits outweighing the risks.