Status of vaccines
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What is the difference between “emergency use” vaccines and the “normal” fully registered vaccines available in pharmacies and clinics?
The mandate of the South African Health Products Regulatory Authority (SAHPRA) is to ensure the health and safety of all South Africans. Therefore, it will only allow full market registration of medicines and vaccines once all Phase 3 clinical trials have been completed and all data have been thoroughly reviewed against required standards of safety, quality and efficacy.
Studies for Phase 3 clinical trials are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment for a particular health condition is approved.
In a public health emergency such as the COVID-19 pandemic, approval for the emergency use of vaccines that are not yet registered can be streamlined through a Section 21 emergency-use authorisation, which is normally valid for six months. For COVID-19 vaccines, many regulators around the globe, including the SAHPRA, have issued emergency-use authorisation, based on a thorough review of data from completed Phase 3 clinical trials and others that are ongoing. All role-players have agreed to accept and evaluate data from companies on a rolling basis to enable a full market registration.
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Is the Johnson & Johnson (J&J) vaccine approved or are we still busy with clinical trials? What is still needed?
Clinical trials for the J&J vaccine have been completed and the SAHPRA has registered the vaccine for use in South Africa, subject to certain conditions. These conditions include that the vaccine is supplied and administered in accordance with the National Department of Health's COVID-19 vaccination plan and guidelines. Furthermore, the company has to submit to SAHPRA longer term clinical data from ongoing studies to monitor the safety of the vaccine (pharmacovigilance) with agreed timelines, as outlined in their approved risk management plan.
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Why are the Chinese vaccines being approved so quickly but J&J took so long? Is this an economic convenience because of government’s relationship with China?
As an independent body responsible for ensuring the health and safety of all South Africans, the SAHPRA does not determine the vaccines being bought by government. It only authorises COVID-19 vaccines after they have passed Phase 3 clinical trials and have been thoroughly reviewed against the required standards of safety, quality and efficacy. Phase 3 clinical trials for the J&J vaccine had been completed before it was considered for use in the country. Phase 3 clinical trials for the CoronaVac COVID-19 vaccine from China, which recently received emergency-use authorisation, had already been completed when SAHPRA received the application for authorisation.
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Which of the two vaccines, the J&J vaccine or the Pfizer vaccine, is the best and the safest?
All vaccines being used in South Africa are safe and effective in protecting against severe disease, hospitalisation and death. The vaccines have similar mild side effects which ease off within the first three days after vaccination.
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Vaccine safety
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Why do I need to be vaccinated against COVID-19 if I have previously recovered from COVID-19 more than once? Surely this shows I can fight the virus on my own without being vaccinated.
Scientific evidence shows that the immune response against SARS-CoV-2 is much weaker and more short-lived than the immune response to the COVID-19 vaccines. This weaker, short-lived response is exactly why you have suffered more than one episode of COVID-19. Receiving the COVID-19 vaccine will provide you with a much stronger and more long-lasting immune response. The common mild and transient side effects usually last only a few days.
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Why has the time between the two doses of Pfizer vaccine been extended instead of shortened, given that one dose is not very effective against the Delta variant?
Scientific evidence shows that one dose of the Pfizer vaccine is effective against severe COVID-19 disease and death, including from the Delta variant. The gap was extended because of the evidence that the immune response is much stronger and lasts longer when the second dose is given 42 days after the first dose.
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Can people with chronic conditions such as high blood pressure get the vaccine?
People with chronic conditions such as high blood pressure, heart disease and diabetes are at a higher risk of severe outcomes when contracting COVID-19. The vaccines will help them to prevent severe illness or death from COVID-19. In addition to getting the COVID-19 vaccine, they should also control their medical conditions by taking their prescribed chronic medication and going for regular medical check-ups. If you are unsure about your health condition, consult your medical practitioner.
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I have COVID-19 symptoms – is it safe to get vaccinated?
You should not get vaccinated when you have symptoms of COVID-19 and should rather be tested. If you have COVID-19, you should wait at least 30 days after you have recovered from COVID-19 before you get your vaccine.
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Allergies and vaccination
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How dangerous is an allergic reaction to a COVID-19 vaccine?
Anaphylaxis is the most dangerous allergic reaction to any vaccine BUT it is very rare and can be managed successfully with no long-term effects. It usually occurs within seconds or minutes after vaccination, which is why ALL people undergo a 15-minute observation period after receiving the vaccine to ensure there is no allergic reaction.
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In the case of people with allergies, who should NOT receive a particular COVID-19 vaccine?
If you fall into one of the following categories, then you should NOT get a particular COVID-19 vaccine:
- Anyone with a history of anaphylaxis or a severe hypersensitivity reaction to any component of the vaccine.
- Anyone who experienced anaphylaxis after getting the first dose of a specific vaccine, should not get the second dose of that vaccine.
- Anyone who is allergic to polyethylene glycol should not get the Pfizer vaccine because it is one of the components of the vaccine.
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In the case of people with allergies, who should first consult with their doctor before getting the COVID-19 vaccine?
Anyone with a history of anaphylaxis or a non-severe immediate allergic reaction to other vaccines (not COVID-19 vaccines) should first consult with their doctor to ascertain what component caused the allergic reaction. If it is decided that you can receive the vaccine, and if your previous reaction to other vaccines was severe, you should be vaccinated in a hospital setting and be observed for 30 minutes after vaccination. If your previous reaction was a non-severe immediate allergic reaction, you can be vaccinated in a clinic setting and you must undergo a 30-minute observation period after receiving the vaccine to ensure there is no allergic reaction.
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In the case of people with allergies, who should receive the COVID-19 vaccine?
Anyone with a history of food, insect venom, oral medication, environmental or latex allergies or a family history of anaphylaxis to other vaccines, should receive the COVID-19 vaccines. All people with any allergy that is unrelated to vaccines or injectable medicines must be observed for 30 minutes after vaccination.
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Is it safe to get the COVID-19 vaccine if you have an egg allergy?
None of the COVID-19 vaccines contain any egg proteins. It is therefore safe to get the COVID-19 vaccines. If you have a history of allergies, you will undergo the required 30-minute observation period after receiving the vaccine instead of 15 minutes.
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Illness or death post vaccination
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I have heard of elderly people dying shortly after receiving the COVID-19 vaccine. Is the vaccine safe for the elderly?
Yes, it is very safe. Unfortunately, old age is in itself a major risk factor for death. For example, if we had a very safe vaccine that was totally ineffective, we would expect that the death rate in the vaccinated elderly would be exactly the same as the death rate in the unvaccinated elderly. Since the vaccine is both safe and highly effective in preventing severe COVID-19 disease and death from COVID-19 in the elderly, almost all of the deaths from COVID-19 in the elderly have been occurring in unvaccinated elderly people.
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Why do some people still get COVID-19 within two weeks after being vaccinated?
It takes at least two weeks for the body to develop immunity after being vaccinated. A person is only considered fully vaccinated 30 days after receiving the J&J vaccine or five days after the second dose of the Pfizer vaccine. If you are infected during this time, you are unprotected and may develop COVID-19. Also, if a person develops COVID-19 within a few days after being vaccinated, it means that the person had already been infected before receiving the vaccine and that they were in the incubation period at the time of vaccination.
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Can the COVID-19 vaccine cause COVID-19?
None of the COVID-19 vaccines used in South Africa contains the live virus that causes COVID-19. The COVID-19 vaccine can therefore not make you sick with COVID-19.
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Can the Pfizer vaccine cause heart inflammation (myocarditis and pericarditis)? Is it safe to give the vaccine to elderly people?
It is not yet clear if the slight increase in heart inflammation seen in young men who received the Pfizer vaccine is coincidental or caused by the vaccine. If it is caused by the vaccine, these are very rare side effects, usually seen within two weeks after the second dose of the vaccine. Common symptoms are chest pain, shortness of breath and an abnormal heartbeat (fast, pounding or fluttering). These events are mostly mild and can be treated successfully, followed by a recovery shortly thereafter. People should therefore be aware of the symptoms and seek medical help immediately.
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Reporting adverse effects
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What is an ‘adverse event’ following vaccination?
An ‘adverse event following immunisation’ (AEFI) is any untoward health event which happens after a person receives a vaccine. A ‘health event’ is a symptom (something with a person complains of, for example a ‘headache’ or ‘difficulty seeing’) or a ‘sign’ (something a health practitioner notices about a patient, for example, raised blood pressure). The health event may or may not be caused by the vaccine. For example, the following are adverse events following immunisation: a person who receives a COVID-19 vaccine and then has a stroke, a heart attack or a death in a motor vehicle accident. Any of these events may or may not be associated with vaccination, but all of these events are ‘AEFI’. An AEFI usually occurs within 28 days following vaccination, but there is no time limit to reporting an event.
All health events after vaccination are important to investigate, because vaccines are given to healthy people. Therefore, whilst some mild and short-lasting symptoms are acceptable, moderately severe and severe side effects are not acceptable, and should be fully investigated to understand if the vaccination was responsible. If the public understands that all ‘adverse effects following immunisation’ are taken seriously, and appropriate action is taken, people will have more trust that vaccines are safe.
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What adverse effects can be expected after COVID-19 vaccines?
All vaccines (and medicines) have side effects. COVID-19 vaccines have mild side effects, which differ slightly among the vaccines that are available. Most COVID-19 vaccines cause mild fever or pain or redness at the injection site. Other side effects include high fever, fatigue, headache, muscle pain, rash at the injection site, chills, and mild diarrhoea. Most reactions to vaccines are mild and go away within a few days on their own. Allergic reactions (medically known as ‘hypersensitivity reactions’ are not uncommon after any kind of vaccine. Allergic reactions can be mild (such as a rash or itchiness around the injection site), or very uncommonly, severe. A severe allergic reaction known as anaphylaxis leads to low blood pressure, collapse, difficulty breathing with/without skin rash. This reaction needs emergency treatment including fluid, oxygen and adrenaline.
More serious or long-lasting side effects to vaccines have been reported but extremely rare. The most well publicised adverse reaction is a condition known as vaccine-induced thrombosis and thrombocytopenia (VITT). Symptoms appear 10-14 days after vaccination and may include symptoms of a stroke, or bleeding, and depend on which blood vessels and organs are affected. The exact mechanism of this is not clearly understood, but is likely to occur because of antibody responses to parts of the vaccine.
When adverse events are investigated, they are classified as:
- Minor local reactions – these include swelling, redness or rash at the injection site
- Minor systemic reactions – these include mild headache, body aches and pains, fainting or fever less than 38oC
- Severe local reactions – these include longer duration of symptoms at the injection site, but also includes swollen glands or abscess at the injection
- Severe systemic reactions – any condition that results in hospitalisation, severe allergic reactions, high and prolonged fevers or collapse
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Which adverse effects that happen after a COVID-19 vaccine should be reported?
Theoretically, all adverse events after vaccination should be reported, even those that have improved clinically or resolved spontaneously. However, adverse events that occur commonly, such as mild fever, tiredness or headache are often not reported. Uncommon and serious side effects should always be reported. Serious adverse effects are those that need medical attention or admission to hospitalisation. In general, health authorities watch out for adverse effects that have proven associations with immunization, but also for adverse effects that may theoretically occur but which have not yet been observed.
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If an adverse effect happens after a COVID-19 vaccine, who should report it?
Any health practitioner or member of the public may report that an adverse event following immunisation has occurred. When the vaccine is given at a vaccination station, the vaccinator or person responsible for the vaccination ‘station’ or the facility manager should report the adverse event.
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How should an adverse event after immunisation be reported?
The adverse event may be reported using the Med Safety App (see below) or by completing a paper ‘Case report form’ which may be found at https://www.nicd.ac.za/diseases-a-z-index/adverse-event-following- immunization-aefi/. The form should be returned by email to AEFI@health.gov.za.
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How can a member of the public report an adverse event after a COVID-19 vaccine?
The best way for a member of the public to report an adverse effect is by using the ‘MedSafety App’ as described below.
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What is the ‘MedSafety App’ and how can it be used to report adverse effects that happen after a COVID-19 vaccine?
The ‘Med Safety App’ may be found on Google Play Store (Android) or the App store (iOS). Instructions and a video explaining how to use it may be found at https://medsafety.sahpra.org.za/. Health practitioners and members of the public may report the adverse event using the app. After the app has been downloaded, a person can report immediately, or register on the app by providing medical registration and contact details. The app will ask for details of the person reporting the event, so that the public health authorities can investigate the event. However, the patient details (the person who experienced the event) are not mandatory fields on the app. In this way the patient details will remain confidential and known only to the health authorities. If persons experience problems with the app, they may contact the helpline (012-501 0311 on weekdays during office hours) or send an email to adr@sahpra.org.za.
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Who is responsible for investigating the adverse events that are reported?
Each province and district has allocated persons who are responsible for investigating adverse events following vaccination. Usually these persons will belong to the ‘EPI team’ and/or the communicable disease surveillance team. The EPI team is responsible for co-ordinating the ‘Expanded Programme of Immunisation’ and is supporting the rollout of COVID-19 vaccines.
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What investigations are done after an adverse event following COVID-19 vaccination is reported?
The person responsible for investigating the event will complete a ‘case investigation form’. This form asks a set of comprehensive questions that will provide all the information that is necessary to work out the relationship between the vaccine and the adverse events. Questions on the form include vaccination details and procedures, immunisation practices at the place where the vaccine was administered, cold chain and vaccine transport, community investigations (to identify clusters of cases), patient medical history, clinical examination and results of investigations. The investigator will obtain the medical records of the person who experienced the adverse event. The investigator will not make a judgement themselves on the cause of the adverse event, but will submit these data to the provincial or the national immunisation safety expert committee (NISEC).
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How are adverse effects following COVID-19 vaccination investigated?
The provincial committee responsible for reviewing the adverse event or NISEC uses the WHO algorithm to examine what is reported about the event, including the case investigation form, the patient’s clinical details, standard case definitions from the Brighton collaboration (https://brightoncollaboration.us/), currently available literature regarding vaccine adverse events, and product-related data from the manufacturers. When all the data is put together, the committee categorises the event as being
- ‘consistent with a causal association to immunisation’. This includes ‘vaccine product-related reactions, vaccine quality defect-related reactions’, ‘Immunisation error-related reactions’ or ‘Immunization anxiety-related reactions’.
- a co-incidental event
- temporally associated with vaccination but without definitive evidence for vaccine causing the event
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What is the National Immunisation Safety Expert Committee (NISEC)?
This committee is appointed by the Minister of Health. It includes experts from all clinical disciplines whose expertise may contribute to determining the role of vaccines causing adverse events. Presently, experts on the committee include pharmacists, pharmacovigilance experts, infectious disease specialists, paediatricians, EPI programme experts, immunologists, microbiologists, pathologists, public health specialists. The committee may ask advice from specialists who do not sit on the committee. Meetings are held quarterly or adhoc depending on volume of cases that are reported.
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What happens with the results of the investigations that are done by NISEC?
The NISEC committee reports findings to the Minister of Health, the National Department of Health and the Provincial Departments of Health and to the South African Health Products Regulatory Authority (SAHPRA). NISEC adverse event data and final assessments are reported into the WHO so that pooled data from countries can contribute to global monitoring of safety signals. These data are reported via SAHPRA through the global ‘Vigibase’ and ‘Vigiflow’ database systems that are used to track adverse effects related to pharmaceutical and therapeutic treatments.
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What is ‘no fault compensation’ and how is this process administered?
All COVID-19 vaccines that are currently administered are novel vaccines which are made available to people through the WHOs Emergency Use assessment and Listing procedures (EUALs). These are a set of procedures to evaluate health products for acceptable performance, quality and safety so as to accelerate the use of these tools during the epidemic. However, because products that are used under EUAL criteria are new products, there may be risks associated with the administration of these. Therefore, the WHO advised countries to ensure fair compensation through creation of ‘no fault compensation schemes’. A ‘no-fault’ compensation allows for a payout without the need to go to court to establish who was responsible (hence ‘no-fault’). Therefore it makes the compensation process faster and cheaper.
WHO has provided funds for countries that are beneficiaries of COVID-19 vaccines through the advance market commitment scheme. However, South Africa does is not eligible for this funding, and is obliged to provide our own legislative framework for compensation. The South African government has issued draft legislation under the Disaster Management regulations for public comment regarding a ‘vaccine injury no fault compensation scheme’. This scheme allows individuals who have suffered an adverse event to receive monetary compensation following review and investigation of the case by NISEC. The exact details of how the South African ‘no fault compensation process’ will work are being finalised.
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Where can I find out more information?
For more information: Detailed information on COVID-19 vaccine adverse effects may be found at https://www.who.int/news-room/q-a-detail/coronavirus-disease-(covid-19)-vaccines-safety. Email addresses of provincial persons who are responsible for investigation of adverse events following immunisation are listed below.
For assistance with the Med Safety App, please contact the helpline (012-501 0311 on weekdays during office hours) or send an email to adr@sahpra.org.za.
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