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Vaccines

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 have authorised Cominarty™ (the Pfizer/BioNTech vaccine) on the 21st December and the Moderna vaccine on the 6th January 2021. On the 31st December the World Health Organization also approved Cominarty™ for emergency use.

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
  • Post marketing surveillance

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 and Moderna have submitted applications for conditional marketing authorisation of their COVID-19 vaccines to the EMA, which were approved on the 21st December 2020 and the 6th January 2021 respectively. Applications from other companies are expected in the near future. COVID-19 vaccines developed by AstraZeneca and Janssen-Cilag are currently undergoing rolling review by the EMA.

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.

Cominarty™ (the Pfizer/BioNTech vaccine) has 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 involved over 40,000 participants across 6 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.

Cominarty (the Pfizer/BioNTech vaccine) is 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 represents 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.

When will Covid-19 vaccines be ready for distribution?Within the EU all vaccines must be approved by the European Medicines Agency before they can be distributed. The European Medicines Agency meeting to evaluate Cominarty (the Pfizer/BioNTech vaccine) marketing authorisation application was brought forward to the 21st December, when the EMA recommended that a marketing authorisation be granted. The first doses of the vaccine were administered across the EU on the 27th, 28th and 29th of December. Approval was granted to the Moderna vaccine by the EMA on the 6th January and distribution to Member States is under way.The vaccines are being made available to EU countries at the same time and under the same conditions. The EU has secured 2 billion doses of Covid-19 vaccine for its citizens, with each country receiving a supply of vaccines according to its population.

Distribution will be staggered according to the ability of the manufacturing companies to produce the vaccines as fast as possible.

Who will get the vaccine?Now that the European Medicines Agency has granted marketing approval for two 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 while distribution of the Moderna vaccine started on the 10th 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?No. All the Covid-19 vaccines which are being developed have the aim of preventing serious disease caused by Covid-19 infection. The vaccine brands in development 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. So the public will not be given a choice as to the type of vaccine they will receive.

What does getting Cominarty (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 Cominarty (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 Cominarty™ (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) 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. Also, persons who have allergic reactions (including severe allergic reactions) that are not related to vaccines or injectable therapies (e.g., allergies to food, pets, venom, environmental allergies, or latex allergies; allergies to medications taken by mouth such as tablets, capsules and syrups [including the oral equivalents of injectable medications]) are not excluded from taking the 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 other groups of people who should not take Cominarty (the Pfizer/BioNTech vaccine)?
  • Children aged under 16 years
    Initially Cominarty™ (the Pfizer/BioNTech) vaccine will not be licenced for use in children under 16 years of age because safety trials on this group have not yet been 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 is currently not routinely recommended for children and young persons below aged 16. 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.

  • Pregnant and breastfeeding women
    As is usual in initial trials for new vaccinations/medicines, the Pfizer/BioNTech COVID-19 vaccine (Cominarty™) has not been specifically tested in pregnant and breast-feeding women.

    Evidence from non-clinical studies of Cominarty™ has been evaluated by the World Health Organization and other regulatory agencies and has not raised concerns about safety in pregnancy. Note that the vaccine does 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 Cominarty™ 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.

    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 Cominarty™ 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 Pfizer/BioNTech COVID-19 vaccine have been received.

    Key points that pregnant women deciding whether to take Cominarty™ should discuss with their doctor include:
    • That pregnant people 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 people 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 the Pfizer/BioNTech vaccine during breastfeeding or in breastfed infants. In spite of this, the vaccine is not thought to be a risk to the breast-feeding infant. Women who are breast-feeding may decide to receive the vaccine, or may choose to postpone vaccination until they have finished breastfeeding their child.

Are there any situations where you should postpone taking Cominarty™ (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 pased from your first positive PCR swab test).

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 Cominarty™ (the Pfizer/BioNTech vaccine)?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 Cominarty™ (the Pfizer/BioNTech vaccine)? 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.

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 the 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.

Can I get facial palsy (drooping of one side of the face) from taking Cominarty (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.

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.

Current evidence suggests it is uncommon to get infected with COVID-19 again in the 90 days after you are first infected, so persons who have had confirmed COVID-19 infection may decide to postpone getting vaccinated until 90 days have passed if they wish.

If you are suffered 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, if you are asymptomatic, until 4 weeks past from your first positive PCR swab 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.

How Much Does a Vaccine Reduce the Risk of COVID-19 and Its Complications?The WHO had originally set as an expectation that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated. However, clinical trials have shown that some vaccines are registering a vaccine efficacy of 90% to 95%. This means that the vaccine will prevent serious disease and complications from Covid-19 in at least 90- 95% of cases.

Effectiveness of Pfizer/BioNTech vaccine:
Part of the Phase 3 trial of this vaccine involved 36,621 individuals at high risk of being infected with COVID-19. They were randomly split into two equal groups to receive either the vaccine or a placebo (non-active substance).

Of all the participants who were still negative for COVID-19 7 days after the second dose (time taken for full immune response to the vaccine to develop), 162 individuals from the placebo group got COVID-19, while only 8 individuals from the vaccine group got COVID-19. This makes the vaccine 95% effective at preventing symptomatic COVID-19 from 7 days after the 2nd dose. The vaccine was similarly effective across different age groups, genders, racial/ethnic groups and in people with medical conditions that put them at greater risk of severe COVID-19.

Note that (as for all vaccines) since efficacy is not 100%, vaccination cannot provide a guarantee that an individual is 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.

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.

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 Cominarty™ (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.

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.

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:

European Commission page on COVID-19 vaccines:                                                                                                      https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans_en​

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, Cominarty (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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