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Vaccines

​This document will be regularly updated as the situation evolves and new evidence emerges.
Last updated: 25/01/2021
Can you give me some information about Covid-19 vaccines?Yes. There are three COVID-19 vaccines which have already been authorised for use in some countries. So far, the European Medicines Agency has authorised all three: Comirnaty™ (the Pfizer/BioNTech vaccine) on the 21st December,2020the Moderna vaccine on the 6th January, 2021 and the AstraZeneca vaccine on the 29th January, 2021.

Once vaccines are demonstrated to be safe and effective, they must be approved by national regulators responsible for overseeing medical treatments, manufactured to high standards, and distributed. The World Health Organization is working with partners around the world to help coordinate key steps in this process, including to ensure fair access to safe and effective COVID-19 vaccines for the billions of people who will need them.

What are the stages of vaccine development?​​The general stages of the development cycle of a vaccine are:
  • Exploratory stage
  • Pre-clinical stage
  • Clinical development
  • Regulatory review and approval
  • Manufacturing
  • Quality control

Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and the vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.

Many vaccines undergo Phase IV-formal, ongoing studies after the vaccine is approved and licensed.

How are new vaccines approved in the European Union?The regulation of vaccines forms part of medicines regulation, which includes several activities that aim to protect public health. In the European Union, once enough data is available from research and clinical trials, companies can apply to the European Medicines Agency (EMA) for authorisation to place their vaccine on the EU market.

The EMA then evaluates all the data and carries out a thorough, independent scientific assessment of the vaccine. Based on result of the EMA’s assessment, the European Commission grants a marketing authorisation in the EU. The vaccine can then be used. Each country has its own Medicines Regulatory Authority but countries within the European Community must first wait for direction from the European Medicines Agency before approving a medicine locally.

During a public health emergency, the EMA may grant a conditional marketing authorisation for a vaccine. This may happen when the benefit of immediate availability outweighs the risk of having less complete data than would normally be requested for authorisation. A conditional marketing authorisation allows prompt response to a public health threat such as the COVID-19 pandemic. In these cases, the producer commits to providing further data according to an agreed timeline.

In any case, the European Commission will only grant a marketing authorisation once the European Medicines Agency’s assessment shows that the vaccine is both safe and effective. Once a new vaccine is placed on the market, EU authorities will carry out continuous monitoring and evaluation of new data on the vaccine, including monthly safety reports from vaccine producers and results of further studies. The EU safety monitoring plan for COVID-19 vaccines involves more frequent monitoring than usual as well as monitoring activities specifically tailored to COVID-19 vaccines.                                                                                                                                                                                                                                                                                                                             Pfizer/BioNtech,Moderna and AstraZeneca have submitted applications for conditional marketing authorisation of their COVID-19 vaccines to the EMA, which were which were granted on the 21st December 2020,6th January 2021 and 29th January 2021 respectively. The COVID-19 vaccines developed by Janssen-Cilag is also currently undergoing rolling review by the EMA. Applications from other companies are expected in the near future.

Since the vaccines are being produced at record speed should I worry about safety?The usual time frame for producing a vaccine is usually 10-15 years. COVID vaccines however are being produced in less than 12 months, so the question regarding safety is a relevant question. There are several important factors that explain why the vaccine has been produced in such a short period of time but not at the expense of safety.

These include:
  • high levels of cooperation between stakeholders such as governments, private industry and NGOs to come up with an effective, safe vaccine
  • massive financial commitment of industry and governments to develop the vaccines
  • researchers were able to build on work that had already been done. For example, techniques for using mRNA in vaccines had already been developed for cancer therapy, and a large amount of research had been carried out on other Coronaviruses
  • the regulatory agencies responsible for vaccine approval have been reviewing the data from the trials on an ongoing basis instead of reviewing all the data at the end
  • some companies have taken the risk of producing large amounts of their vaccine before obtaining approval, so the vaccine would be available straight away once approved

These factors have been crucial in shortening the time from the development of COVID-19 vaccines without compromising safety. There are many strict measures in place to help ensure that COVID-19 vaccines will be safe. All COVID-19 vaccines applying for marketing authorization on the EU market need to go through the usual rigorous, independent scientific assessment of the European Medicines Agency (as described in the previous question) before being approved for use.

Comirnaty™ (the Pfizer/BioNTech vaccine),COVID-19 vaccine Moderna and COVID-19 vaccine AstraZeneca have gone through all the usual phases of the vaccine development and evaluation process, including initial laboratory studies and Phase 1, 2 and 3 clinical trials in humans. The phase 3 trial for Comirnaty involved over 40,000 participants across 6 countries, that for COVID-19 vaccine Moderna involves around 30,000 participants and the phase 3 trial for Astra Xeneca vaccine has 23,700 participants in three countries..The trials included people at high risk for COVID-19, and were specifically designed to identify any common side effects or other safety concerns. Further monitoring and studies are ongoing.

More information about development, evaluation, approval and monitoring of COVID-19 vaccines in the EU is available here​ 

What types of Covid-19 vaccines are being developed and how do they work?Scientists around the world are developing many potential vaccines for COVID-19. These vaccines are all designed to teach the body’s immune system to safely recognize and block the virus that causes COVID-19.

Several different types of potential vaccines for COVID-19 are in development, including:
  • Inactivated or weakened virus vaccines, which use a form of the virus that has been inactivated or weakened so it does not cause disease, but still leads to an immune response.
  • Protein-based vaccines, which use harmless fragments of proteins or protein shells that mimic the COVID-19 virus to safely generate an immune response.
  • Viral vector vaccines, which use a virus that has had its genes modified so that it cannot cause disease, but produces coronavirus proteins to safely generate an immune response.
  • RNA and DNA vaccines, a cutting-edge approach that uses genetically engineered RNA or DNA to generate a protein that itself safely prompts an immune response.

Can you explain in more detail how mRNA vaccines work? Are they safe?The COVID-19 vaccines developed by Pfizer/BioNTech and Moderna are mRNA vaccines.

mRNA stands for ‘messenger ribonucleic acid’. Our body's cells use mRNA as a genetic 'recipe' to make proteins, which are the building blocks of the cell.

The mRNA in this vaccine codes for a protein found on the surface of the SARS-CoV-2 virus that causes COVID-19. This is known as a spike protein as it forms part of the spikes on the outside of the virus. While harmless on its own, it is very good at causing a reaction from the body’s natural defenses, the immune system. This reaction trains the body to recognise the SARS-CoV-2 virus and fight it quickly if it comes across it in the future, preventing symptomatic COVID-19 infection.

Comirnaty (the Pfizer/BioNTech vaccine) and COVID-19 vaccine Moderna are given as an injection in the arm muscle. The mRNA enters the body cells and instructs them to make the virus’ spike protein. The spike protein is recognised by the immune system as foreign material and triggers a reaction from the immune system. The mRNA from the vaccine is broken down by the body within a few days.

The marketing authorisation for the Pfizer/BioNTech COVID-19 vaccine, closely followed by that for COVID-19 vaccine Moderna, represent the first time an mRNA vaccine has been placed on the market. However, the use of mRNA technology in vaccines, despite being a recent development, is not completely new. They have been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). Also, mRNA technology is being used in cancer therapy to trigger the immune system to target specific cancer cells. Human trials of such cancer therapies have been carried out as early as 2011. Several different mRNA vaccines have now been tested from phase I to IIb clinical studies and have been shown to be safe and reasonably well-tolerated.

COVID-19 Vaccine AstraZeneca is a vaccine composed of a type of virus called an adenovirus which is able to code the S glycoprotein of SARS-CoV-2. Following administration, the S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralising antibody and cellular immune responses, which will contribute to protection against COVID-19.

Who will get the vaccine?Now that the European Medicines Agency has granted marketing approval for three vaccines, the manufacturing companies will distribute their vaccines to the different countries in the EU. Distribution of the Pfizer vaccine started on 26th December 2020, that of the Moderna vaccine started on the 10th January 2021, while the AstraZeneca vaccine started its distribution on the 30th January 2021. Once other vaccines are approved, their distribution will follow. Each country will have a priority list of who should get the vaccine first. In Malta the priority list will include:

First Group

  • healthcare workers and long-term care facility workers (public and private sector)
  • persons living in long-term care facilities – elderly and mental health
  • persons aged 85 and over.

Second Group
  • All other frontliners;
  • persons 80-85 years of age.

Third Group
  • persons with chronic illness whose state of health makes them particularly at risk- elevated risk of severe disease or death;
  • persons 70-80 years of age;
  • staff at schools and child-care centers

Fourth Group
  • persons over 55 years of age
  • rest of population
The timing of the roll out will depend on the speed of production of the vaccine.

Will there be different vaccines which are more suited for different medical conditions?All the Covid-19 vaccines which are being developed have the aim of preventing serious disease caused by Covid-19 infection. The vaccine brands may have different mechanisms for producing antibodies against Covid-19 but they can all be given to persons suffering from various types of medical conditions. For this reason there will be no choice as to the type of vaccine a person will receive.

Should people who tested positive for Covid-19 in the past receive the vaccine?There is no evidence of any safety concerns from vaccinating individuals who have had COVID-19 infection in the past, or who have detectable levels of COVID-19 antibodies. Based on the current evidence, we do not know exactly how long the immunity from natural infection lasts. Phase 3 trials involving 2 doses of Covid-19 vaccine have shown that immunity from the vaccine tends to last longer than that from natural infection. Therefore all those who have recovered from COVID-19 infection are advised to take the vaccine.

There is no need to wait for a period of time before taking the vaccine after Covid-19 infection. However it is prudent to wait 4 weeks from the start of symptoms or a positive PCR before taking the vaccine. This is to avoid confusion between Covid-19 symptoms and vaccine side effects which may be similar. The same applies if Covid infection occurs after taking the first vaccine dose. The second dose should be taken from 4 weeks after start of symptoms of positive PCR.

Inadvertently vaccinating individuals who are potentially infected/ asymptomatic/ incubating COVID-19 infection is unlikely to have a detrimental effect on their illness.

If you are suffering from prolonged COVID-19 symptoms (long COVID) you can receive the COVID-19 vaccine unless you are still feeling very unwell or still undergoing investigations.

Can persons with Covid-19 infection take the vaccine?If you are positive for COVID-19, then you should postpone receiving the vaccine until you have recovered, the quarantine period is over and at least 4 weeks have passed from when your symptoms started or from when you had the first positive PCR test. If your COVID-19 vaccination appointment happens to be scheduled during your quarantine period, make sure to inform the COVID-19 vaccine helpline on 145. This is so that you will be given another appointment and your slot will not be wasted.

Can persons who are in preventive quarantine (travel quarantine, contact with a known positive case) take the vaccine?One should not receive the COVID-19 vaccination during the quarantine period, but if your swab tests remain negative, then there should be no delay in taking the vaccine once the quarantine period is over. If your COVID-19 vaccination appointment happens to be scheduled during your quarantine period, make sure to inform the COVID-19 vaccine helpline on 145. This is so that you will be given another appointment and your slot will not be wasted.

Are there any other groups of people who should not take the Covid vaccines?
Age Limitations


For the time being, Comirnaty™ (the Pfizer/BioNTech) vaccine will not be licenced for use in children under 16 years of age because safety trials on this group are still being carried out. Currently we know that children (<16 years) account for a small proportion of the total persons who fall ill with COVID-19 (<5%). They are also more likely to have mild symptoms and recover without complications. As a result, vaccination of children and young persons is currently not routinely recommended . The vaccination of children suffering from medical conditions that put them at greater risk of COVID-19 complications will be considered after initial roll-out of the vaccine when more evidence on risk and benefit will be available.

In the case of the Moderna and AstraZeneca vaccines, the age-limit has been set at 18 years as no studies have been carried out in persons under 18 years for both vaccines as yet.

Note on the use of AstraZeneca vaccine in the elderly: Because a relatively small number of participants aged 65 years or over were recruited into the clinical trials, there is still no hard evidence of the vaccine’s efficacy in people older than 65 years. However, immune responses induced by the vaccine in older persons are well documented and similar to those in other age groups. This suggests it is likely that the vaccine will be found to be efficacious in older persons as well. The WHO recommends the vaccine for use in persons aged 65 years and older. In Malta the vaccine is used for persons between 18 and 65 years.

Persons with allergies

The Pfizer BioNTech and Moderna COVID-19 mRNA Vaccines contain polyethylene glycol (PEG), a known potential allergen commonly found in medicines and also in household goods and cosmetics. Known allergy to PEG is extremely rare but persons with this type of allergy should avoid these vaccines. Patients with undiagnosed PEG allergy may have a history of unexplained anaphylaxis or of anaphylaxis to multiple classes of drugs.
A history of mild allergic reaction to a vaccine or injectable therapy, such as urticaria alone without signs or symptoms of anaphylaxis, is not a contraindication or precaution to these vaccines.

People receiving the vaccine will be monitored for around 15 minutes after being vaccinated in case of a rare anaphylactic event following the administration of the vaccine. Appropriate medical treatment for anaphylaxis will be available at all vaccination centres.

Individuals who have queries regarding the safety of vaccine regarding their medical condition should discuss with their GP or call 145 or send an email to covid-vaccine@gov.mt

Pregnant and breastfeeding women

As is usual in initial trials for new vaccinations/medicines, none of the COVID-19 vaccine has been specifically tested in pregnant and breast-feeding women.

Evidence from non-clinical studies of all the authorised vaccines has been evaluated by the World Health Organization and other regulatory agencies and has not raised concerns about safety in pregnancy. Note that the vaccines do not contain live virus and so cannot multiply in the body and infect the unborn baby in utero. Based on how they work, experts do not think it likely that mRNA vaccines such as Comirnaty™ and Moderna or vaccines with another type of mechanism such as the AstraZeneca one have specific pregnancy-related risks. Although the available data do not indicate any safety concern or harm to the baby, there is currently not enough evidence to recommend that all pregnant women routinely receive this vaccine since studies to investigate effects of the vaccine on pregnancy in animals are still underway. That being said, the potential benefits of vaccination may be especially important for certain pregnant women, such as those who have a high risk of severe complications from COVID-19 or those who have a high risk of catching COVID-19. These women are advised to discuss with their doctor and may decide to receive the vaccine.

The WHO and Royal College of Obstetrics and Gynaecology (UK) recommend that pregnant women who are not at high risk of catching COVID-19/experiencing serious complications from COVID-19 are advised to postpone vaccination until their pregnancy is over. Women who become pregnant after receiving the first dose of any Covid vaccine are advised to delay receiving the 2nd dose until after their pregnancy is over, unless they are at high risk of catching COVID-19/experiencing serious complications from COVID-19. There is no need to avoid pregnancy once both doses of the COVID-19 vaccine have been received.

Key points that pregnant women deciding whether to take the Covid-19 vaccine should discuss with their doctor include:

-That pregnant women have an increased risk of severe illness from COVID-19. While the risk of severe complications from COVID-19 is still low, it is higher than that of women of child-bearing age who are not pregnant. Pregnant women with COVID-19 also have a greater risk of pregnancy complications/adverse outcomes including preterm birth. -Data about the safety of COVID-19 vaccines for people who are pregnant is limited. Studies in pregnant people are planned and researchers are monitoring participants who became pregnant during the clinical trial.

-Their personal risk of exposure to COVID-19 (e.g. due to their occupation) and their risk of experiencing severe illness if infected with COVID-19 (e.g. due to medical conditions).

Regarding breast-feeding, as stated above there are no safety data available regarding any of the authorised Covid vaccines during breastfeeding or in breastfed infants. In spite of this, the vaccines are not thought to be a risk to the breast-feeding infant and vaccination with any type of the authorized vaccines is not considered a contraindication. Women who are breast-feeding may decide to receive the vaccine.

Immunocompromised individuals and immunosuppressant therapy

Immunocompromised persons are at higher risk of severe COVID-19. It is possible that the immune response to the vaccine may be reduced, which may lower its clinical effectiveness. But, given that all the authorised vaccines are nonreplicating, immunocompromised persons who are part of a group recommended for vaccination may be vaccinated.

No data are available about concomitant use of immunosuppressants and individuals with stable HIV infection on treatment. Again, given that the vaccines are non-replicating, persons with HIV or on immunosuppressant therapy may be given the vaccine.

Persons with chronic disease

Certain chronic diseases have been identified as increasing the risk of severe COVID-19 disease and death. The clinical trials demonstrated that the vaccines have similar safety and efficacy profiles in persons with various underlying medical conditions, including those that place them at increased risk for severe COVID-19. Vaccination is recommended for persons with chronic diseases that have been identified as increasing the risk of severe COVID-19.

How Much Does a Vaccine Reduce the Risk of COVID-19 and Its Complications?Clinical trials have shown that some vaccines are registering a vaccine efficacy of 90% to 95% and prevention of serious disease with or without hospitalisation in almost 100% This means that the vaccine will prevent serious disease and complications from Covid-19 in all persons who receive the vaccine and in at least 90- 95% of them it will prevent Covid-19 infection altogether The clinical efficacy of the AstraZeneca vaccine has been calculated as 100% in preventing serious disease and complications from Covid-19 and 64% in preventing Covid-19 infection.
Note that (as for all vaccines) since efficacy is not 100%, vaccination cannot provide a guarantee that an individual is fully protected from COVID-19.

Will the vaccine stop the pandemic? Can vaccinated people still transmit COVID-19?While a vaccine will help protect individual patients and those around them, a large proportion of the population must be immunised and protected before transmission is substantially reduced. Vaccinating whole populations will take several months.

So far we know that the vaccine is highly effective at preventing symptomatic cases of COVID-19. We do not yet have data to indicate whether the vaccine prevents asymptomatic COVID-19. It may be the case that vaccinated people can still get asymptomatic COVID-19 and pass it to others.

Because of this, it is crucial that the public health measures currently in place to reduce COVID-19 transmission continue to be followed even after the vaccine becomes available, as COVID-19 will remain a continuing concern. Effective public health measures, such as social distancing, limiting the size of gatherings, and wearing masks, will still be needed for at least several more months, and potentially longer before these measures can start to be eased gradually. Also, in view of the fact that we do not yet know whether vaccinated persons can get asymptomatic infection and spread the virus to others, vaccinated persons are NOT exempt from quarantine e.g if they have close contact with a positive case.

How many shots of Covid-19 vaccine will be needed?Most of the vaccines that have been authorised or are currently being developed require that they be given in 2 doses.

How much time should I wait between when I take the Covid vaccine and taking another vaccine?Co-administration with other vaccines.                                                                                                                          There should be a minimum interval of 14 days between administration of Covid vaccine and any other vaccine against other conditions. This recommendation may be amended as data on co-administration with other vaccines become available.

Does immunity from getting Covid-19 last longer than from getting the vaccine?The protection someone gains from having an infection (called natural immunity) varies depending on the disease, and it varies from person to person. Since this virus is new, we do not know how long natural immunity might last. Some cases of re-infection with COVID-19 have already been documented. The vaccines being developed, however, are showing a very strong immune response which may provide better and longer protection than natural immunity. More studies and more time are required before these questions may be answered. Thus far the follow-up data available has confirmed that the vaccine is effective for at least a 2-month period with no decrease in protection for Comirnaty™ (the Pfizer/BioNTech vaccine). In the case of COVID-19 vaccine Moderna, so far we know that levels of the antibodies relevant for vaccine effectiveness remained elevated four months after the second dose. Monitoring will be ongoing to provide further data regarding duration of protection down the line.

What percentage of the population needs to get vaccinated to achieve herd immunity?Herd immunity is a term used to describe when enough people have protection—either from previous infection or vaccination—to make it unlikely for the disease to continue to spread among the population. As a result, a community is protected even if a small proportion of people do not have any protection themselves (for example those who cannot take the vaccine for medical reasons). The percentage of people needed to be immune to obtain herd immunity for covid-19 is estimated to be 70 to 75%.

Will a coronavirus vaccine need to be given annually?When a vaccine is licensed, we will only have information about the length of immunity for that particular period of time included in the trial. For example, if the first people in the study were vaccinated in July 2020 and the vaccine is licensed in December 2020, we will only have information about the immune response up to 5 months after vaccination. The vaccine manufacturer will continue to monitor vaccine recipients for several months or more, so that over time, we will continue to get a better picture of the duration of immunity. With this information, we will be better able to understand whether vaccines against COVID-19 will require annual dosing like influenza.

How long before a coronavirus vaccine takes effect?It usually takes a week or two for immunity to develop following vaccination, but the specific timeline for any coronavirus vaccine will depend to some extent on which type of vaccine is licensed.

In the case of Comirnaty™ (the Pfizer/BioNTech vaccine), while there is evidence of some protective effect some days after the first dose, the vaccine reaches 95% effectiveness at preventing symptomatic COVID-19 from 7 days after the 2nd dose. In the case of COVID-19 vaccine Moderna, while there is evidence of up to 80.2% efficacy some days after the first dose, the vaccine achieves 94.5% efficacy at preventing symptomatic COVID-19 from 14 days after the second dose.

Who is eligible for the COVID-19 vaccine?All Maltese citizens and all residents of Malta with a valid residency card are eligible for the vaccine.

How will people know when to attend for vaccination?A letter with an appointment for the vaccine will be sent to groups of people at a time so that they can take the vaccine. It is important to wait for this letter, as the vaccine will not be given to anyone without an appointment. This is done to make sure that those people who are most at risk are protected from the complications of COVID-19 infection.

Those who have received an appointment but need to reschedule it for any reason are kindly requested to inform the covid19 vaccine helpline on Tel. 145. Any healthcare professional who counsels a patient to defer or refrain from vaccination is kindly asked to remind patients to inform the 145 Covid-19 vaccine helpline that they will not be attending for their vaccination. This will help to avoid wastage of vaccines. This is particularly relevant for the Pfzer/BioNTech vaccines in view of the complex logistics related to thawing and preparation of this vaccine.

Will the vaccine be available in private practice?The vaccine will be given free of charge and will be available from government entities only. The vaccine will not be available on the private market. Beware of any individuals or websites selling the vaccine. Vaccines being sold online or by unauthorised persons may be fraudulent and there is no way of knowing if they were kept under the required standards.

Information specific to Comirnaty (the Pfizer / BioNTech vaccine)

What does getting Comirnaty (the Pfizer/BioNTech vaccine) involve? How many doses will I need?The vaccine is given as an injection in the muscle of the arm or thigh. For the vaccine to work effectively and provide protection against the virus, two doses will need to be given to each person at least 21 days apart. This will help the body produce a full immune response and fight the infection in case there is contact with the COVID-19 virus.

Enough doses of the vaccine will be set aside to make sure that the second dose given to a person is of the same company as the first dose received.

What does Comirnaty (the Pfizer/BioNTech vaccine) contain?
Vaccine ingredient Functions
BNT162b2 RNA This is the mRNA (genetic recipe) that codes for the COVID-19 virus spike protein. This is the active ingredient.
ALC-0315 These are lipids (the same group of molecules that fats, oils and waxes form part of). They surround the mRNA in the form of very tiny fatty bubbles called lipid nanoparticles. This protects the delicate mRNA and helps it enter cells.
ALC-0159
1,2-Distearoyl-sn-glycero-3-phosphocholine
Cholesterol
potassium chloride These are salts, including one we’re all familiar with - table salt (sodium chloride). They work together to keep the pH (acidity level) of the vaccine close to that of the human body, so the vaccine does not injure the body’s cells.
potassium dihydrogen phosphate
sodium chloride
disodium hydrogen phosphate dihydrate
sucrose Another familiar ingredient – table sugar. Here it acts to protect the lipid bubbles mentioned above and stop them from sticking together when frozen.
water for injection Before being injected, the vaccine is mixed with water containing sodium chloride. This is so that the concentration of this salt in the vaccine is similar to that in the blood.

The vaccine is egg-free so may be used by those with an egg allergy.

There are no animal products or preservatives in the vaccine.

The vaccine is administered from vial with a synthetic rubber (bromobutyl) stopper that does not contain latex so is safe in those with latex allergies.

Can people who suffer from allergies take Comirnaty™ (the Pfizer/BioNTech vaccine)?It depends what kind of allergy. Any person who has had a severe allergic reaction (anaphylaxis) to any ingredient/ component of the Pfizer-BioNTech COVID-19 vaccine in the past should NOT receive the Pfizer/BioNTech vaccine. This vaccine contains polyethylene glycol (PEG), a known allergen commonly found in medicines and also in household goods and cosmetics. Known allergy to PEG is extremely rare but those who suffer from this allergy should NOT receive this vaccine.

While reports of allergic reactions following vaccination outside the clinical trials are further investigated, persons who have had a severe allergic reaction (anaphylaxis) to any other vaccine or injectable therapy (e.g., intramuscular, intravenous, or subcutaneous), specific food or medicine should speak to their doctor so a risk assessment to determine the risk benefit ratio of taking the vaccine.

A history of mild allergic reaction to a vaccine or injectable therapy, such as urticaria (itchy/stinging red bumps on the skin) alone without signs or symptoms of anaphylaxis, does not mean one should not receive the Pfizer-BioNTech COVID-19 vaccine.

When receiving the vaccine you will be monitored for 15 minutes afterwards in case of a rare serious allergic reaction. All vaccination centres are equipped to treat such reactions. Individuals who have queries regarding whether they should take the vaccine in view of their medical condition should discuss with their GP, call the COVID-19 vaccine helpline on 145 or send an email to covid-vaccine@gov.mt.

Are there any situations where you should postpone taking Comirnaty™ (the Pfizer/BioNTech vaccine)?
  • If you are very unwell then you should postpone receiving the vaccine till you have recovered. Make sure to inform the COVID-19 vaccine helpline on 145 if you cannot attend for your vaccination appointment. This is so that you will be given another appointment and your slot will not be wasted. If you are only mildly unwell, and are not suffering from fever or other generalised symptoms such as chills, nausea, vomiting or diarrhoea then you do not need to postpone receiving the vaccine. However, if you are experiencing any symptoms that are associated with COVID-19 (fever, cough, shortness of breath, tiredness, sore throat, runny / blocked nose, headache, muscle pain, loss of smell, loss of taste, diarrhoea or vomiting) you are advised to call 111 to arrange a swab test and get further advice. Please do not attend for vaccination if you have potential COVID-19 symptoms or if your swab test result is still pending.
  • If you are positive for COVID-19, then you should postpone receiving the vaccine until you have recovered and at least 4 weeks have passed from when your symptoms started (or, if you are asymptomatic, until 4 weeks have passed from your first positive PCR swab test).

I am immunocompromised/taking medication that suppresses my immune system. Can I take Cominarty (the Pfizer/BioNTech vaccine)?Immunocompromised persons, including persons with HIV and persons taking medications that suppress the immune system, are encouraged to take the vaccine (unless one of the exclusions or precautions discussed above applies). You should be aware that you may have a weaker response to the vaccine due to your weakened immune system. We do not yet have evidence on what is the best timing for receiving the vaccination when taking immunosuppressive therapy. You are advised to discuss with your specialist who will guide you on the ideal timing for you to receive the vaccine. Until further information becomes available, you should continue to follow advice to minimise possible exposure to COVID-19 even after you are vaccinated.

What are the side-effects of Comirnaty™ (the Pfizer/BioNTech vaccine)?Trials involving tens of thousands of individuals have shown that the side effects are short-term and resolve without complication or injury very similar to most vaccines.

The most common side-effects are some pain and redness at the site of the injection, headache, chills, tiredness, muscle pain or fever lasting for a day or two. These side effects indicate that your immune system is responding to the vaccine. They are common side-effects of most vaccinations. You can take medications such as paracetamol to help control these symptoms if you experience them.

Hypersensitivity-related adverse events (allergic reactions) after receiving the vaccine were rare, occurring in 0.63% of those who received the vaccine compared to 0.51% of those who received the placebo (non-active substance). Note that persons who receive the vaccine will be monitored for around 15 minutes after being vaccinated in case of a rare serious allergic reaction following vaccination. Vaccination centres are equipped to give the necessary treatment in case of these rare events.

An uncommon side-effect of the vaccine (occurring in less than 1 in a hundred but more than 1 in a thousand persons who received the vaccine) is lymphadenopathy (swelling of the lymph glands). During the Phase 3 trial, there was also a single case of shoulder injury that was thought to be caused either by the vaccine itself or the way the vaccine was given.

Information specific to COVID-19 Vaccine Moderna

Are there any situations where you should postpone taking COVID-19 Vaccine Moderna?
  • If you are very unwell then you should postpone receiving the vaccine till you have recovered. Make sure to inform the COVID-19 vaccine helpline on 145 if you cannot attend for your vaccination appointment. This is so that you will be given another appointment and your slot will not be wasted. If you are only mildly unwell, and are not suffering from fever or other generalised symptoms such as chills, nausea, vomiting or diarrhoea then you do not need to postpone receiving the vaccine. However, if you are experiencing any symptoms that are associated with COVID-19 (fever, cough, shortness of breath, tiredness, sore throat, runny / blocked nose, headache, muscle pain, loss of smell, loss of taste, diarrhoea or vomiting) you are advised to call 111 to arrange a swab test and get further advice. Please do not attend for vaccination if you have potential COVID-19 symptoms or if your swab test result is still pending.
  • If you are positive for COVID-19, then you should postpone receiving the vaccine until you have recovered and at least 4 weeks have passed from when your symptoms started (or, if you are asymptomatic, until 4 weeks have pased from your first positive PCR swab test).

I am immunocompromised/taking medication that suppresses my immune system. Can I take COVID-19 vaccine Moderna?Immunocompromised persons, including persons with HIV and persons taking medications that suppress the immune system, are encouraged to take the vaccine (unless one of the exclusions or precautions discussed above applies). You should be aware that you may have a weaker response to the vaccine due to your weakened immune system. We do not yet have evidence on what is the best timing for receiving the vaccination when taking immunosuppressive therapy. You are advised to discuss with your specialist who will guide you on the ideal timing for you to receive the vaccine. Until further information becomes available, you should continue to follow advice to minimise possible exposure to COVID-19 even after you are vaccinated.

What are the side-effects of COVID-19 Vaccine Moderna?A clinical trial involving more than 30,000 individuals have shown that the side effects are short-term and resolve without complication or injury very similar to most vaccines.

The most common side-effects are some pain and redness at the site of the injection, headache, chills, tiredness, muscle pain, fever, nausea or vomiting and swelling in the lymph gland of the arm where the injection is given. These side effects indicate that your immune system is responding to the vaccine and generally resolve in a day or two. They are common side-effects of most vaccinations. You can take medications such as paracetamol to help control these symptoms if you experience them. Such side-effects were more commonly reported after the second dose of the vaccine.

Hypersensitivity-related adverse events (allergic reactions) after receiving the vaccine were rare, and were reported in 1.5% of those who received the vaccine compared to 1.1% of those who received the placebo (non-active substance). Note that persons who receive the vaccine will be monitored for around 15 minutes after being vaccinated in case of a rare serious allergic reaction following vaccination. Vaccination centres are equipped to give the necessary treatment in case of these rare events.

A rare side-effect of COVID-19 vaccine Moderna is facial swelling in individuals with dermal fillers. This is discussed in greater detail in a separate question below.

Can you provide more information about the side effects that occurred in clinical trial participants with dermal fillers? Should I avoid COVID-19 Vaccine Moderna if I have dermal fillers?During the Phase 3 trial of the Moderna vaccine, 3 participants with dermal fillers that received the vaccine experienced localised swelling – two reported facial swelling while another reported swelling of the lips. All cases resolved with steroid and/or antihistamine treatment. These events were rare and effects were mild – none of the affected individuals required adrenaline or hospitalisation. These side-effects were not considered life-threatening and resolved with no long-term complications. Monitoring for similar reactions is ongoing.

Having dermal fillers does not exclude you from receiving a COVID-19 vaccine. The risks of getting COVID-19 are considered to be far greater than the risk of having a reaction to a COVID-19 vaccine, as noted also by The Aesthetic Society (professional organization of plastic surgeons in the U.S.) in a recent statement.

What does COVID-19 Vaccine Moderna contain?
Vaccine ingredient Functions
Messenger RNA (mRNA) that codes for the spike protein of the SARS-CoV-2 virus that causes COVID-19 This is the active ingredient.
Lipid SM-102 These are lipids (the same group of molecules that fats, oils and waxes form part of). They surround the mRNA in the form of very tiny fatty bubbles called lipid nanoparticles. This protects the delicate mRNA and helps it enter cells.
Cholesterol
DSPC (1,2-distearoyl-sn-glycero-3-phosphocholine)
PEG2000 DMG (1,2-Dimyristoyl-rac-glycero-3 methoxypolyethylene glycol-2000)
Tromethamol/TRIS These are commonly used chemicals including one we’re all familiar with (acetic acid is the acid found in vinegar). They work together to keep the pH (acidity level) of the vaccine close to that of the human body, so the vaccine does not injure the body’s cells.
Tromethamol hydrochloride
Acetic acid
Sodium acetate trihydrate
sucrose Another familiar ingredient – table sugar. Here it acts to protect the lipid bubbles mentioned above.

Advice and precautions for persons with bleeding disorders and those taking anticoagulants (blood-thinning medication). This advice applies to both Comirnaty™ (the Pfizer/BioNTech) vaccine and COVID-19 vaccine Moderna.

I am taking warfarin/rivaroxaban (e.g. Xarelto)/ dabigatran (e.g. Pradaxa)/edoxaban (e.g. Lixiana, Savaysa, Roteas) /apixaban (e.g. Elquis). Can I take Comirnaty™ (the Pfizer/BioNTech vaccine) or COVID-19 Vaccine Moderna?Individuals who are stabilised on anticoagulation therapy (blood-thinning medication) , including those mentioned above, can receive intramuscular vaccines in most cases. You should discuss with your doctor who will advise you regarding any additional precautions that might be required (such as scheduling an INR blood test close to the day of vaccination or adjusting the time you take your medication).

When you attend for vaccination, advise the person vaccinating you that you are on anticoagulants so that a fine needle is used. After vaccination, you need to apply firm pressure to the site where you received the injection for at least 5 minutes (do not rub). This will help to minimise bruising at the site of the injection. In the rare case that you develop a large bruise, speak to your doctor.

I have a bleeding disorder/ have a low platelet count. Can I take Comirnaty™ (the Pfizer/BioNTech vaccine) or COVID-19 Vaccine Moderna?If you suffer from a bleeding disorder or low or poorly-funtioning platelets you are advised to discuss with your doctor so he/she can evaluate if you can safely receive an intramuscular injection. In most cases it will be possible for you to receive the vaccine, but additional precautions may be needed to minimise the risk of bruising and/or bleeding. If you receive medication/ treatment to reduce bleeding, for example treatment for haemophilia, vaccination can be scheduled shortly after you receive such medication/ treatment.

When you attend for vaccination, advise the person vaccinating you that you have a bleeding disorder so that a fine needle is used. After vaccination, you need to apply firm pressure to the site where you received the injection for at least 5 minutes (do not rub). This will help to minimise bruising at the site of the injection. You should also carefully observe and feel the site of injection 2-4 hours later to check for delayed bruising. In the rare case that you develop a large bruise, speak to your doctor. It is normal to feel some discomfort in the arm for 1-2 days after vaccination but if this is worsening or you note swelling in your arm then you should seek medical advice.

Can I get facial palsy (drooping of one side of the face) from taking Comirnaty (the Pfizer/BioNTech vaccine) or the Moderna vaccine?The evidence we have so far does NOT support the idea that there is any link between these vaccines and increased risk of temporary facial palsy.

When Phase 3 clinical trials are carried out, the large number of participants involved are monitored for any serious medical events for several months/years. The frequency with which these events occur in the group of participants that receive the vaccine and in the group that receives the placebo (inactive substance) is compared with the frequency of these events in the general population. This is because since the trials involve many thousands of people followed over a long period of time, it is expected that some of them will experience medical events completely unrelated to the vaccine (e.g. heart attacks, strokes etc) just like people in the general population do. When analysing the data from the trial, scientists compare how often any serious medical events occur to see whether they are occurring more frequently in the vaccinated group than they do in the general population and hence might be linked to the vaccine. Every serious medical event that occurs is also thoroughly investigated to see if there are any possible links to the vaccine.

These concerns regarding facial palsy came about because during phase 3 clinical trials there were three individuals who took the Moderna vaccine and four who took Cominarty who developed a temporary facial palsy. There was also an individual who took the placebo (inactive substance) in the Moderna trial who developed facial palsy. While at first glance this might seem alarming, when you compare how often facial palsy occurred in vaccine recipients to how often it occurs in the general population, the rates are very similar. In the general population, this type of facial palsy occurs in 15-30 people per 100,000, while when you consider both these phase 3 trials, the rate was 17.7 per 100,000. Since this means that the number of cases of facial palsy that occurred was not more than occurs in the general population, there is so far no reason to link the vaccine with facial palsy. In fact the American Academy of Otolaryngology - Head and Neck Surgery issued a statement on this issue, advising that the public should not let it put them off from receiving the vaccine.
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COVID-19 vaccine myths and misinformation

The volume of misinformation and disinformation that has accompanied the COVID-19 pandemic has been unprecedented, thanks in part to the new technologies and social media platforms that are available. This includes a large amount of false information being circulated by members of the anti-vaccine community in response to the development of COVID-19 vaccines. We are including below some of the myths that have been circulating about the vaccine below along with the information that debunks them. For more information about COVID-19 vaccines, visit:


World Health Organization page on COVID-19 vaccines:
https://www.who.int/teams/risk-communication​

Vaccine myth: The m-RNA Covid-19 vaccine will alter the body’s genetic make-up
No. The vaccine is made up of lipid mRNA nanoparticles. These do not enter the host’s cell nucleus (where our DNA is stored) and so will not change the host’s genetic makeup. These nanoparticles are broken down by the body after a few days.

Vaccine myth: Covid-19 vaccines are made from foetal cells
The vaccines that have reached Phase 3 trials  were not created with and do not require the use of foetal cell cultures in the production process.

Vaccine myth: More people will die as a result of a negative side effect to the COVID-19 vaccine than would die from the virus.
Fact: A claim circulating on social media is that the COVID-19 mortality rate is 1%–2% and that people should not be vaccinated against a virus with a high survival rate. However, a 1% mortality rate is 10 times more lethal than the seasonal flu. In addition, the mortality rate can vary widely based on age, sex and underlying health conditions.

In contrast, clinical trials of COVID-19 vaccines have shown only short-term mild or moderate vaccine reactions that resolve without complication or injury.

While some people who receive the vaccine may develop symptoms as their immune system responds, this is common when receiving any vaccine, and these symptoms are not considered serious or life-threatening. And you cannot become infected with COVID-19 from COVID-19 vaccines. These are inactivated vaccines, not live-virus vaccines.

Vaccine Myth: COVID-19 vaccines were developed to control the population through microchip tracking or "nanotransducers" in the human brain.
There is no vaccine microchip, and the vaccine will not track people or gather personal information into a database.

This myth started after comments made by Bill Gates from the Bill & Melinda Gates Foundation about a digital certificate of vaccine records. The technology he was referencing is not a microchip, has not been implemented in any manner and is not tied to the development, testing or distribution of COVID-19 vaccines.

Vaccine Myth: COVID-19 vaccines cause infertility or miscarriage.
No, COVID-19 vaccines have not been linked to infertility or miscarriage.

A sophisticated disinformation campaign has been circulating online, claiming that antibodies to the spike protein of COVID-19 produced from these vaccines will bind to placental proteins and prevent pregnancy. This disinformation is thought to originate from internet postings by a former scientist known to hold anti-vaccine views.

These postings are not scientifically plausible, as COVID-19 infection has not been linked to infertility. Also, no other viral infection or vaccination-inducing immunity by similar mechanisms has been shown to cause infertility. Antibodies to the spike protein have not been linked to infertility after COVID-19 infection. There is no scientific reason to believe this will change after vaccination for COVID-19. While there are no formal studies, the best evidence comes from women who got sick with COVID-19 while pregnant. While data clearly indicate pregnant women are at higher risk of hospitalization due to COVID-19 infection, there is no evidence of increased miscarriage rates.

During natural infection, the immune system generates the same antibodies to the spike protein that COVID-19 vaccines would. Thus, if COVID-19 affected fertility, there already would be an increase in miscarriage rates in women infected with COVID-19. This has not happened.

Vaccine Myth: COVID-19 vaccines must be stored at extremely low temperatures because of preservatives in the vaccines.
Pfizer/BioNTech and Moderna have reported that their vaccines contain no preservatives.

Different vaccines have different storage requirements. For instance, Comirnaty (the Pfizer/BioNTech vaccine) must be stored at minus 94 degrees Fahrenheit (minus 70 degrees Celsius), while Moderna has said that its vaccine needs to be stored at minus 4 degrees Fahrenheit (minus 20 degrees Celsius). Both of these vaccines are mRNA vaccines. mRNA is fragile and can break down easily. Storing mRNA vaccines, like these COVID-19 vaccines, in an ultracold environment keeps them stable and safe. The vaccines are thawed before injection following a standard procedure.

For further information or queries:
A Covid 19 vaccine helpline 145 has been set up as well as an email address covid-vaccine@gov.mt                  

Acknowledgement
The input from members of the Advisory Committee on Immunization Policy and Public Health Response Team is gratefully acknowledged 

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