Vaccination Wall of Fame

NO, the exact opposite is true. The AstraZeneca vaccine was approved for emergency use in December 2020 after being deemed safe and with good efficacy by studies conducted in the UK and Brazil. However, a study done by our excellent South African researchers has now revealed important information about the way the vaccine works on the new variant of COVID-19 called variant 501Y.V2, which was first identified in South Africa.

It is important to remember that at the time the study was started, the new variant had not yet been identified. As soon as it became evident that a variant had evolved in South Africa, excellent work was done by South African medical researchers to quickly identify the exact structural differences between the wild type COVID-19 virus (the original virus) and the COVID-19 variant (the mutated COVID-19 virus 501Y.V2). The impact of the new variant on the efficacy of the AstraZeneca vaccine was then added to the objectives of the AstraZeneca vaccine trial that was already ongoing within South Africa.

Until the end of October 2020 the AstraZeneca vaccine was remarkably efficacious in reducing the likelihood of becoming infected with COVID-19. This unfortunately changed when the new variant started spreading in South Africa and the study was used to evaluate how well the vaccine worked against the variant. There was little difference between the number of COVID-19 infections in the vaccine group versus the placebo group, meaning that the vaccine did not do much to prevent people getting infected with the new variant. The vaccine is therefore less effective against the new variant than the original COVID-19 virus. What the study did not show was whether the vaccine decreases the chance of severe disease or death from the new variant. We therefore do not know yet how useful the vaccine will be.

As soon as this information became available, the South African Department of Health immediately decided to halt the planned roll-out of the AstraZeneca vaccine, because of its poor results against the 501Y.V2 variant which is most predominant in South Africa now. The AstraZeneca vaccines are not wasted as they may still prove to be effective in some individuals as more information becomes available, and the possibility of returning the vaccines to be used in other parts of the world is also being investigated.

Minister Zweli Mkhize has further confirmed in statement on the 24th of February 2021 that the one million AstraZeneca vaccine doses procured by SA have been sold to the African Union at cost price.

SARS-CoV-2 virus multiplies all the time, and every time it multiplies it can make a mistake, so that it looks slightly different and has slightly different genetic make-up.  We call these mistakes mutations and these slightly different viruses, different variants.  Some variants might be less strong than the original virus, and some might be stronger.  It is just a matter of luck, which mistakes are made, and how they affect the virus.  In South Africa, our excellent scientists found a variant virus called 501Y.V2. which comes from the B.1.351 lineage.

• What is it called?
  • You might hear the viral variant being referred to as either of these names (501Y.V2 or B.1.351), which can be confusing. Many people are calling it the “South African” variant, however scientists prefer us not to call it that because we do not know for sure that it developed in South Africa, and we do not want other countries to blame us for it, when in fact it could have come from any country.

• How does the new variant differ from the old variant?
  • The new variant is different from the original virus that was circulating in South Africa because it has multiple changes in the spike protein on the outside of the virus – this is a particularly important part of the virus that binds to the cells inside the human body and it is also the main target for many vaccines.
• Does this variant spread faster than the original SARS-CoV-2 virus?
  • Yes, it does seem to be spreading more rapidly, and to more people. This means that it is more easily transmittable, however it is still spread in the same manner as the original SARS-CoV-2 virus, so the same methods of prevention apply (hand washing, mask wearing, avoiding close contact with people, avoiding closed environments with other people, etc.)
• Is this new variant more severe than the old variant?
  • No, it does not seem to cause more severe disease or more death than the original SARS-CoV-2 virus, however, because the virus spreads more easily and infected more people in the second wave, than the original virus infected in the first wave, we found that more people developed severe disease and died as compared to the first wave.
• Does the new variant affect younger people more than the original virus?
  • No, the proportion of young people with severe disease or who died, is the same in the second wave as the first wave.
• Do we need to treat the new variant with different medications?
  • No, we are treating the new variant in the same way as we treated the original virus. We do not have any evidence showing that it requires different medication.
• Do vaccines work the same on the new variant?
  • No, so far it looks like certain vaccines do not work as well on the 501Y.V2 variant as they do on the original SARS-CoV-2 virus. A study done by our excellent South African researchers has recently revealed that the AstraZeneca vaccine had a 75% efficacy rate against the original SARS-CoV-2 virus, but the rate dropped to 22% against mild to moderate disease caused by the new variant, 501Y.V2.  The vaccine is therefore much less efficacious against the new variant than the original COVID-19 virus. What the study did not show, was whether the vaccine decreases the chance of severe disease or death from the new variant.  We therefore do not know yet how useful the vaccine will be and need to wait for more data to become available.  The South African government has therefore decided to not use the AstraZeneca vaccine at this point and will rather start the vaccine rollout with the Johnson and Johnson and Pfizer vaccines which have shown better efficacy against the new variant.

South African front line healthcare workers are currently receiving the Johnson & Johnson (Janssen) COVID-19 Vaccine as part of the SISONKE vaccine study and although this means that the Janssen COVID-19 vaccine has not been registered for commercial use yet, it has shown to be both safe and efficacious against the 501Y.V2 variant in the ENSEMBLE study that was conducted in South Africa, the USA and Brazil.

The SISONKE vaccine study is an open label, single-arm Phase 3b vaccine implementation study of the investigational single-dose Janssen COVID-19 vaccine candidate and it aims to monitor the effectiveness of the single-dose Janssen vaccine candidate at preventing severe COVID-19, hospitalizations and deaths among healthcare workers as compared to the general unvaccinated population in South Africa.

Manufacturers apply for vaccines to be licensed after trials show them to be safe and effective. The Janssen COVID-19 vaccine trial results were released in early February and applications for licensing are underway in the US, Europe, and South Africa.

The Sisonke Programme allows the government to make this safe and efficacious vaccine immediately available to healthcare workers using a research programme. Sisonke is not the same as a clinical trial – rather it is a way that research can help to make it available while the licensing process takes place. The South African government has chosen to move ahead with this programme because it would be unethical to withhold a vaccine known to be safe and effective. The South African Health Products Regulatory Authority (SAHPRA) has approved the use of the Janssen COVID-19 vaccine for the Sisonke Programme while it processes the full licensing.

It is important to understand that the fact that it is not yet licenced does not mean that it is not safe or efficacious and as a third wave of COVID-19 is predicted to begin in South Africa this winter, protecting healthcare workers is a priority before the third wave arrives.

The first step to accessing a vaccine is to register on the country’s Electronic Vaccination Data System (EVDS). You can access the system by visiting this website: https://vaccine.enroll.health.gov.za In general, patient-facing health workers will receive priority access to vaccines. Non-clinical staff and traditional healers are also eligible to register on the EVDS system. You will receive a SMS alert with a vaccination voucher and details on what vaccination centre to attend and when. You will also be asked to read an information sheet and provide advanced consent for vaccination before your visit. On the day of your vaccination, you will need to arrive with your voucher and an identity document.

The Janssen COVID-19 vaccine is given as a single dose into the upper arm. Protection starts around 10-14 days after vaccination, and even as early as 7 days for severe disease. Protection rises to good levels around a month after vaccination. The Janssen COVID-19 vaccine is the only COVID-19 vaccine currently available that only uses a single dose.

Pain, tenderness and redness at the injection site, headache, chills, joint pain, muscle pain, tiredness, generally not feeling well, nausea and fever have been seen with this vaccine. These reactions usually start within 1 to 2 days after the injection and most of the reactions get better within 1 to 3 days.

It is rare for anyone to have a serious allergic reaction to a vaccine. If this does happen, it usually happens within minutes. The person who vaccinates you will be trained to deal with allergic reactions and treat them immediately. With fast treatment you will make a good recovery.

Yes. Healthcare workers are not obliged to take part in the SISONKE study – participation is completely voluntary.

COVID-19 vaccine efficacy refers to the ability of the vaccine to reduce the number of people who get infected with COVID-19 in a clinical trial. It is calculated by comparing the number of vaccinated participants who develop COVID-19 with the number of unvaccinated participants who develop COVID-19.  It does not give any information on the severity of COVID-19 infection.

A vaccine is a tool that teaches your immune system to respond to a virus by deactivating it. Unfortunately, the SARS-CoV-2 virus is continually mutating (changing), just like many other viruses. New versions of the SARS-CoV-2 virus may not be deactivated by current vaccines. This is what happens with the influenza virus and because of this, we need to have a new, updated vaccine to influenza every year. So yes, you may be infected by a new variant of COVID-19 even though you have received a vaccine before. Vaccine boosters will be created continuously to ensure that you are still protected against the new variants of the virus in your country.

No, vaccines work by stimulating the body the same way the virus would if someone were infected. That means when you receive the vaccine the body then recognized that it looks like the coronavirus and then it releases certain chemicals that start a chain reaction to make immune cells that can fight the real virus.

The vaccine does not mix with the DNA of the body. Some people think that because some of the vaccines are made using RNA technology that means the RNA will interact with the DNA. That is not how it works. The technology is simply the way the vaccine is made – not what it will do to the body.

There is overwhelming scientific evidence that vaccination is the best defense against serious infections. Vaccines do not give you the virus, rather it teaches your immune system to recognize and fight the infection.

The COVID-19 vaccine presents the body with instructions to build immunity and does not alter human cells. Vaccine have reduced the morbidity and mortality of infectious diseases such as smallpox, poliomyelitis, hepatitis B, measles, tetanus, whooping cough and pneumococcal pneumonia across the world. Vaccinating an adequate amount of people will help create herd immunity and stamp out the disease. Herd immunity is when a high enough percentage of the population is immune against the disease, thereby protecting the members of the community who cannot be vaccinated.

The South African government has secured 11 million doses of the Janssen COVID-19 vaccine. The first batch of 80,000 doses arrived on the 16^th of February and the second batch of 80,000 doses followed on 27^th of February and further deliveries will follow every two weeks. Vaccines will be available at 49 sites, 32 will be at public hospitals and 17 sites in private hospitals. This includes sites in rural areas to improve access to rural healthcare workers. Research staff will be responsible for ensuring the cold chain and drawing up the correct amount of vaccine. Vaccinators will complete assessment checks, administer the vaccine, and monitor you for 15 minutes.

Once the vaccination of healthcare workers has been completed, phase two of the vaccine roll-out will begin in late April or early May. Phase two will include the elderly, essential workers, persons living or working in institutional settings and those with co-morbidities. For this phase, more sites for vaccination in the public and private healthcare sector will be activated, so that we can reach as many people as possible in the shortest possible time.

Unfortunately, there is no data on the safety of the COVID-19 vaccines in pregnancy yet, and pregnant women are excluded from the SISONKE vaccine study. This is common practice when vaccines are not yet fully licensed as there is very little information on the safety of the Janssen COVID-19 vaccine in pregnancy. It is highly expected that the Janssen COVID-19 vaccine will be found to be safe in this population and that pregnant women will become eligible for vaccination in the coming months. But from what is known from other similar vaccines it is unlikely to pose a significant risk to pregnancy.

PLEASE discuss your specific risk factors for severe COVID-19 with your healthcare provider at your next ante-natal visit.

Yes, the Janssen COVID-19 vaccine can be safely used in breastfeeding women.

Yes. Vaccines are especially important for people with HIV. That is because people with HIV have a higher chance of severe infections and getting complications than other people, and vaccines help prevent infections. People living with HIV were further included in the Janssen COVID-19 ENSEMBLE trial and there was no difference in the vaccine safety and efficacy as compared to HIV-negative participants.

No, you should continue to use general COVID-19 protection measures (such as wearing a mask, practising social distancing, sanitising hands, and frequently touched objects regularly) after being vaccinated.

Vaccine studies have only produced enough data to show that being vaccinated is safe and can protect people from getting sick, particularly severe COVID, and dying from COVID-19. We still need evidence to show that vaccinated people do not spread the virus to others. It remains possible that a vaccinated person could spread the virus to others, even if they are not showing any symptoms.

Yes, individuals with a history of SARS-CoV-2 infection should be vaccinated. Vaccination can be given as soon as the individual has recovered from acute infection (if symptomatic) and met criteria for discontinuation of isolation precautions.

No, there is no evidence to support those claims. It would not be possible to have an unidentifiable chip inside the vaccine. Receiving a vaccine will not allow you to be tracked and your personal information will not be entered into a database. The only information that will be released, is the date on which you received the vaccine.

No, vaccines have no connection with any religious organizations and cannot be infused with spirits, demons, or abstract ingredients. There is no conspiracy to possess, bewitch or control any person.

The current recommendation is that if you are in quarantine following close contact with someone with COVID-19 you should finish your ten-day quarantine period before receiving the vaccine. There is no data available to show that vaccination immediately post-exposure will prevent disease as it is unlikely that the vaccine would get an immune response quickly enough to protect you from developing COVID-19.

If you currently have COVID, you should wait until you have recovered from the initial illness and have completed your isolation before getting vaccinated. This also applies if you have symptoms of COVID before vaccination or develop symptoms between the first and second dose of the vaccine (so you might need to wait to receive your second dose), where a two-dose vaccine is given.

If you receive the vaccine while having asymptomatic infection it may decrease the severity of disease but should not cause additional harm.

People who received monoclonal antibodies or convalescent plasma for severe COVID are advised to delay vaccination for 90 days as these treatments may reduce the effectiveness of the vaccine.