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What is vaccination?
Vaccination is a simple, safe, and effective way to protect people against harmful diseases, before they come into contact with them. It uses your body’s natural defences to build resistance to specific infections and makes your immune system stronger.
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How do vaccines work?
Vaccines train your immune system to create antibodies, just as it does when it is exposed to a disease. When you get a vaccine, your immune system responds. It:
- recognises the invading germ, such as the virus or bacteria
- produces antibodies. Antibodies are proteins produced naturally by the immune system to fight disease
- remembers the disease and how to fight it. If you are then exposed to the germ in the future, your immune system can quickly destroy it before you become unwell.
However, because vaccines contain only killed or weakened forms of germs like viruses or bacteria, they do not cause the disease or put you at risk of its complications.
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How are vaccines given to people?
Most vaccines are given by an injection, but some are given orally (by mouth) or sprayed into the nose.
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Why is vaccination important?
Vaccination is a safe and effective way to prevent disease and save lives. When we get vaccinated, we do not just protecting ourselves, but also those around us. Some people, like those who are seriously ill, are advised not to get certain vaccines – so they depend on the rest of us to get vaccinated and help reduce the spread of disease.
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What is “herd immunity”?
When a person gets vaccinated against a disease, their risk of infection is also reduced – so they are far less likely to spread the disease to others. As more people in a community get vaccinated, fewer people remain vulnerable, and there is less possibility for passing the germ on from person to person. Lowering the possibility for a germ to circulate in the community protects those who cannot be vaccinated due to other serious health conditions from the disease targeted by the vaccine. This is called “herd immunity.”
“Herd immunity” exists when a high percentage of the population is vaccinated, making it difficult for infectious diseases to spread, because there are not many people who can be infected. But herd immunity only works if most people are vaccinated.
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Why should I get vaccinated?
Two key reasons to get vaccinated are to protect ourselves and to protect those around us. Because not everyone can be vaccinated – including very young babies, those who are seriously ill or have certain allergies – they depend on others being vaccinated to ensure they are also safe from vaccine-preventable diseases.
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Is there a vaccine for COVID-19?
Yes. There are COVID-19 vaccines that certain countries’ regulatory authorities have approved for them to use and many more COVID-19 vaccines that are currently being developed.
Once vaccines are demonstrated to be safe and effective, they must be approved by national regulators, manufactured to exacting standards, and distributed. The World Health Organization (WHO) is working with partners around the world to help ensure equal access to safe and effective COVID-19 vaccines for the billions of people who will need them.
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What must happen before COVID-19 vaccines can be delivered to countries around the world?
The first COVID-19 vaccines are beginning to be introduced in countries. Before COVID-19 vaccines can be delivered:
- the vaccines must be proven safe and effective in large clinical trials
- a series of independent reviews of the efficacy and safety evidence must be done, including regulatory review and approval in the country where the vaccine is manufactured, before WHO considers a vaccine product
- in addition to review of the data for regulatory purposes, the evidence must also be reviewed for the purpose of policy recommendations on how the vaccines should be used
- an external panel of experts convened by WHO, called the Strategic Advisory Group of Experts on Immunization (SAGE), analyses the results from clinical trials, along with evidence on the disease, age groups affected, risk factors for disease, and other information. The panel then recommends whether and how the vaccines should be used
- officials in individual countries decide whether to approve the vaccines for use in their country and develop policies for how to use the vaccines based on the WHO recommendations
- the vaccines must be manufactured in large quantities, which is a major and unprecedented challenge – all the while continuing to produce all the other important life-saving vaccines already in use
- as a final step, all approved vaccines will require distribution through a complex logistical process, with rigorous stock management and temperature control
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How quickly could COVID-19 vaccines stop the pandemic?
The impact of COVID-19 vaccines on the pandemic will depend on several factors. These include factors such as the effectiveness of the vaccines; how quickly they are approved, manufactured, and delivered; and how many people get vaccinated.
Most scientists anticipate that, like most other vaccines, COVID-19 vaccines will not be 100 per cent effective. The WHO is working to help ensure that any approved vaccines are as effective as possible, so they can have the greatest impact on the pandemic.
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Will COVID-19 vaccines provide long-term protection?
It is too early to know if COVID-19 vaccines will provide long-term protection. Additional research is needed to answer this question. However, it is encouraging that available data suggest that most people who recover from COVID-19 develop an immune response that provides at least some period of protection against reinfection – although we are still learning how strong this protection is, and how long it lasts.
Most COVID-19 vaccines being tested or reviewed now will need two doses.
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How can we know if all countries will receive COVID-19 vaccines in a fair way?
A global alliance known as COVAX (which South Africa is part of) is working to speed up the development and manufacturing of COVID-19 vaccines and ensure that there is fair and equal access to these vaccines for all countries. COVAX will allocate vaccines across countries according to a framework developed by a group that includes ethicists, scientists, and other health experts and vetted by WHO’s Member States.
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What is COVAX?
COVAX is a global alliance bringing together governments, global health organisations, manufacturers, scientists, the private sector, civil society and philanthropy, with the aim of providing innovative and equitable access to COVID-19 vaccines. This will ensure that people in all corners of the world will get access to COVID- 19 vaccines once they are available, regardless of their wealth.
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How will the vaccines be allocated to different countries?
Once any of the COVAX vaccines have successfully undergone clinical trials and are proved to be both safe and effective, and have received regulatory approval, available doses will be allocated to all participating countries at the same rate, proportional to their total population size.
No country will receive enough doses to vaccinate more than 20 per cent of its population until all countries in the COVAX group have been offered this amount.
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Will South Africa receive some of the COVAX vaccines?
Yes. In his address to the nation on Monday, 14 December 2020, President Cyril Ramaphosa announced that South Africa is set to receive initial vaccines from the COVAX facility to cover 10 per cent of our population in the early part of 2021.
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What financing options were available to South Africa for the COVAX Facility?
The COVAX Facility offered self-financing countries two different options to participate in. In the “committed purchase” option, participating countries make a lower upfront payment, but need to make firm guarantees to procure doses from the facility without the option to opt-out of specific candidates. In the “optional purchase” option, participating countries make a larger upfront payment, but can opt-out of vaccine allocations while they still reserve the option for later vaccines.
In order to gain access to vaccines rapidly, South Africa agreed to participate in the “committed purchase” option of the COVAX Facility to vaccinate at least 10 per cent of South Africa’s population.
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What else is South Africa doing to get vaccines?
In addition to the COVAX vaccine, South Africa is also part of the African Vaccine Acquisition Task Team that is looking at alternative financing mechanisms to secure additional vaccines for African countries beyond COVAX.
Health Minister, Dr Zweli Mkhize, is part of this task team and is also looking at innovative partnerships with the private sector to ensure that South Africans have access to an effective vaccine that is suitable to local conditions.
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How much vaccine is South Africa purchasing initially and why?
The Ministerial Advisory Committee on Vaccines (MAC) recommended that the commitment made by South Africa should be to purchase sufficient vaccines for 10 per cent of its population through the COVAX Facility. It also recommended continuing with the current ongoing bilateral discussions with vaccine manufacturers.
Vaccination, even with the limited initial allocation, could be used to immunise front-line healthcare workers who are of critical importance to both manage COVID-19 patients and to sustain all aspects of health service delivery.
Partial coverage of the population with a vaccine combined with non-pharmaceutical interventions, would significantly contribute to achieving a herd immunity threshold, thus protecting the population against forthcoming future waves of COVID.
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Why did South Africa not procure vaccines directly from manufacturers?
South Africa was approached directly by vaccine manufacturers to consider bilateral purchasing agreements. However, the risk with these arrangements was that price negotiations were confidential; up-front payments could have been lost should the vaccine not have proved safe and efficacious; and South Africa would have been limited to only a few vaccines through this mechanism and could have run the risk of not having a vaccine if these candidates were not successfully licensed.
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How will South Africa make sure that the vaccines we use are safe?
The Department of Health will work with the South African Health Products Regulatory Authority (SAHPRA) to ensure that whichever vaccine being recommended or made available through the COVAX Facility has met all the regulatory requires of safety, efficacy, and quality.
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When will South Africa get the first vaccines?
According to production estimates, we should expect to receive the first batch of stock in quarter two of 2021.
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Will these vaccines have to be approved before it can be used in South Africa?
Yes. Before a vaccine can be rolled out the South African Health Products Regulatory Authority (SAHPRA) must assess the safety, efficacy and quality of the vaccine. SAHPRA has committed to ensuring the expeditious evaluation of these vaccines once they have been received, through various mechanisms that will shorten the timeframe it usually takes to approve a product.
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Does South Africa have a strategy to distribute the vaccines once we receive them?
Yes. The Ministerial Advisory Committee on COVID-19 Vaccines has been developing a strategy for the implementation of a COVID-19 vaccination rollout. This strategy will include a review of available resources, services delivery platforms, and the required investment to ensure a successful administration to the selected priority groups. Collaboration between the private and public health sectors will be key to the successful implementation of this life-saving intervention.
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What does the phased approach to vaccine rollouts mean?
A phased approach is recommended when limited supplies of vaccines become available. These are the various groupings of those who will receive vaccine tranches:
- Health professionals and general health workers at high risk of infection, care home workers and traditional healers.
- Persons with co-morbidities who are at risk for morbidity and mortality: These include persons 60 years and older, persons living with HIV, tuberculosis, diabetics, chronic lung disease, cardiovascular disease, renal disease, or obesity.
- Persons in congregate or overcrowded settings: This includes persons in prison, detention centres, shelters and care homes. In addition, people working in the hospitality and tourism industry, and educational institutions.
- Essential workers: This group includes police officers, miners and workers in the security, retail food, funeral, banking and essential municipal and home affairs, border control and port health services.
Note that the safety and efficacy of vaccines in children and pregnant women are not known and will probably be the subject of future trials and thus the framework will be revised if necessary.
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How many people in South Africa can be vaccinated with the first batch of vaccines?
The first vaccines that South Africa will receive can vaccinate 10 per cent (roughly six million people) of the population. The country’s membership in the COVAX facility ensures that South Africa receives its equitable share of the vaccines as it becomes available.
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Who in South Africa will be vaccinated first?
The WHO’s Strategic Advisory Group of Experts (SAGE) has provided recommendations about which populations within a country should be prioritised first. These include frontline healthcare workers at high risk of infection, older adults, and those people at high risk of death because of underlying conditions like heart disease and diabetes. In the second phase of the roll-out, as more doses are produced, vaccines should go to groups less at risk of being infected of suffering badly.
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Vaccine safety is a priority
Our rollout strategy includes testing each vaccine. We thank the efforts of our scientists in working with government to ensure the safety of all vaccines.
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Which vaccines are effective against the 501.V2 mutation?
The AstraZeneca vaccine is safe and effective, and is being used all over the world. For South Africa, however it was shown that it is less effective against the 501Y.V2 variant for people who are mildly ill. The 501Y.V2 variant is currently the dominant variant in the country. However, the AstraZeneca vaccine is still effective in protecting people against severe Covid-19 symptoms, hospitalisation and death caused by the 501Y.V2
The Johnson & Johnson trial has shown that its vaccine has proved effective against the 501.V2 Variant. Early results from Moderna also suggest its vaccine is effective against this variant. The Pfizer-BioNTech vaccine is being tested to confirm that it protects against the new variants and early results from the trials are positive.
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Can the AstraZeneca vaccine still be used?
Developers of this vaccine have said that they are likely to introduce a modified version against the variant known as 501.V2 or B.1.351, later this year. Scientists will now discuss amongst themselves and they will advise us how the vaccine will be used.
It is important to note that the virus has mutated numerous times, and will continue to do so, as many other viruses do. Vaccine developers have the ability to redesign and tweak existing vaccines to better combat new variants in a matter of weeks or months if necessary, as they learn more about how the virus mutates.
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Was the President, Minister and the country misled?
All countries in the world are urgently awaiting lifesaving vaccines.
All vaccines were developed on the basis of the original SARS-COV-2 variant that was prevalent throughout the world. The vaccine, developed by AstraZeneca and Oxford University showed promise, and in clinical trials conducted in South Africa, people who received the vaccine were 75 per cent less likely to develop mild to moderate cases of COVID-19 than were people who received a placebo.
The South African government has sought to acquire vaccines from a number of sources, including the global COVAX initiative. However, the government’s process of procuring vaccines was already underway before the 501Y.V2 variant and other variants were discovered. Before the efficacy results, South Africa could not delay receipt of the vaccine batches to await the results of the efficacy studies by our scientists, as this would have relegated the country to the back of the line for vaccines due to global shortage of supplies.
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Was South Africa aware that the vaccines ordered would expire in April?
It is important to note that the vaccines we acquired have not yet expired. In addition, the Department of Health, in the original vaccination plan, had planned the first phase of the AstraZeneca vaccine roll-out, to have been completed before the expiry date.
The April expiry date was confirmed through the implementation of our quality assurance and control protocols.
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What is SA’s recourse on the matter, are we sending the batch back?
Although it has been found that the AstraZeneca vaccine does not work against mild and moderate illness, it could still offer protection against serious illness, hospitalisation or death. We will therefore be exploring all possible avenues before deciding on the appropriate course of action.
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Why did South Africa take delivery of the AstraZeneca vaccine without knowing its efficacy against the variant that is most prevalent in the country?
All countries pre-ordered vaccines as there is a global shortage of doses. Therefore, when doses were available for South Africa, we needed to proceed. However, our scientists started checking the efficacy of available vaccines immediately when they discovered the prevalence of the 501.V2 variant. This process is a laborious and detailed, and unfortunately was only completed when the country had already taken delivery of the first batch.
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Will this be considered fruitless and wasteful expenditure?
South Africa, along with the rest of the world finds itself in unchartered waters. Every moment is precious if we are to save lives and preserve our way of life. We will continue to explore all avenues to access lifesaving vaccines that are both safe and effective.
Our scientists will continue with further deliberations on the AstraZeneca vaccine use in South Africa, and depending on their advice, the vaccine will be swapped before the expiry date. By exchanging unused vaccines before the expiry date, the Department of Heath will ensure that the acquired AstraZeneca vaccines do not become wasteful and fruitless expenditure.
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How safe are these vaccines?
Vaccines undergo rigorous testing for safety and efficacy, based on trial data from thousands of participants across the globe. Several national and international regulatory agencies have closely examined the COVID-19 vaccines for safety and effectiveness.
In South Africa we have an additional layer of safety. The SA Health Products Regulatory Authority (SAHPRA) looks at all the scientific data to ensure the vaccine is safe, effective, and a quality product.
Additionally because COVID-19 vaccines were developed speedily, all regulators globally have put extra mechanisms in place to monitor them.
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What is the difference between registered vaccines and “emergency use” vaccines?
In normal times, you can only use a vaccine if it is registered with the South African Health Products Regulatory Authority (SAHPRA). SAHPRA will only register a vaccine if:
- all the clinical trials are done, and
- they have studied all the information from the trials to see if it is safe, good quality and effective
In an emergency like the COVID-19 pandemic, SAHPRA can approve an unregistered vaccine to be used for a certain time (emergency use authorisation). This happens when there is enough information that SAHPRA can be confident that the vaccine is safe and effective, but the information is not yet enough to meet all the requirements for full registration.
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Is the J&J vaccine still a clinical trial?
No. The clinical trials for the J&J vaccine are done and it is now registered with SAHPRA. J&J will continue to do studies and submit the information to SAHPRA to monitor the safety of the vaccine.
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Why were the Chinese vaccines approved so quickly but J&J took so long? Is this because of government’s relationship with China?
CoronaVac (the Chinese vaccine) had completed their clinical trials when they applied to SAHPRA for approval. J&J still had to complete their phase 3 clinical trial before it could be approved. SAHPRA is independent from government. Only vaccines that are approved by SAHPRA can be used, but government is responsible for deciding which vaccine/s will be provided as part of vaccination programmes.
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Which vaccine (J&J or Pfizer) is the best?
Both vaccines are safe and will protect you from getting very sick, going to the hospital or dying from COVID-19. The side effects from J&J and Pfizer are similar. They are mild and will go away within three days. Therefore, the best vaccine is the vaccine that is available and offered to you first.
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Do I need to be vaccinated if I have previously recovered from COVID-19? Can my body not fight the disease on its own, without suffering the side effects of the vaccine?
Evidence shows that your body’s response when you are sick from COVID-19 is much weaker and shorter than the response to the vaccine. Getting the vaccine will give you a much stronger and longer-lasting immune response. The side effects of the vaccine are mild and do not last more than a day or two, while getting sick from COVID-19 can cause hospitalisation or death.
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Why was the time between the two doses of Pfizer extended?
The time between the Pfizer doses was extended because there is now evidence that if you get the second dose 42 days after the first dose, your body’s response is much stronger and lasts longer than when the time is shorter.
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Can people with chronic diseases, such as high blood pressure, get the vaccine?
People with chronic diseases such as high blood pressure, heart disease and diabetes are at higher risk of getting severe COVID-19. Therefore, they will benefit the most from getting the vaccine. They should also make sure that their condition is controlled, go for regular check-ups with their healthcare practitioner and take their chronic medication. If you are unsure about your condition, consult with your healthcare practitioner.
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I have COVID-19 symptoms – is it safe to get vaccinated?
You should not get the vaccine if 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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How dangerous is an allergic reaction to the vaccine?
Severe allergic reactions to the vaccine are very rare. An allergic reaction usually happens within seconds or minutes after getting the vaccine. This is why ALL people must wait in the observation area for 15 minutes after getting the vaccine to make sure they do not have a major allergic reaction.
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For people with allergies, who should NOT get the vaccine?
- Anyone with a history of severe allergic reaction to any ingredient in the vaccine.
- Anyone who is allergic to polyethene glycol (PEG) should not get the Pfizer vaccine, as it is one of the components.
- Anyone who had a severe allergic reaction after the first dose should not get the second dose of that vaccine.
If you previously had an allergic reaction to a medication or vaccine, but are unsure what specific ingredient caused it, please speak to your healthcare practitioner before getting the vaccine.
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For people with allergies, who should speak to their health practitioner before getting the vaccine?
Anyone with a history of allergic reactions to other vaccines or medicines should first speak to their health practitioner to find out which ingredient caused the allergic reaction. The healthcare practitioner will tell you whether it is safe to get the vaccine. If your healthcare practitioner says you can get the vaccine, but your previous reaction to a vaccine or medication was severe, you should be vaccinated in a hospital and be observed for 30 minutes after vaccination. If your previous reaction was not severe, you can get the vaccine at a normal vaccination site, but you must wait in the observation area for 30 minutes after getting the vaccine to make sure there is no allergic reaction.
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Is it safe to get the vaccine if you are allergic to eggs?
Yes. None of the COVID-19 vaccines have any egg proteins. However, you will have to stay in the observation area for 30 minutes after getting the vaccine, instead of the standard 15 minutes, because you have a history of allergies.
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I have heard of elderly people dying shortly after getting the vaccine. Is the vaccine safe for the elderly?
The vaccine is both safe and highly effective to prevent severe COVID-19 disease and death. Through the use of the vaccine we are seeing a huge drop in deaths from COVID-19 in the elderly in several countries.
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Why do some people still get COVID-19 within two weeks after getting the vaccine?
It takes at least two weeks for the body to develop immunity after getting the vaccine. You are only 'fully vaccinated' 30 days after getting the J&J vaccine or two weeks after the second dose of the Pfizer vaccine. If you are exposed to the virus before you are 'fully vaccinated', you may get the disease.
Also, if you get COVID-19 within a few days after being vaccinated, it means you were already infected before getting the vaccine.
The vaccine also does not completely prevent COVID-19 infection, even after you are 'fully vaccinated' but reduces the risk of severe COVID-19 infection, hospitalisation or death from COVID-19.
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Can the vaccine cause COVID-19 disease?
None of the vaccines used in South Africa contains the live virus that causes COVID-19. The vaccine can therefore not make you sick with COVID-19.
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Can the Pfizer vaccine cause heart inflammation? Is it safe to give the vaccine to elderly people?
In a very few cases, doctors found heart inflammation in young men who got the Pfizer vaccine. This is a very rare side effect, 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 symptoms are mostly mild and can be treated, followed by recovery shortly thereafter. People should therefore be aware of the symptoms and immediately seek medical help.
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