Can you give me some information about Covid-19 vaccines?Yes. There are four COVID-19 vaccines which have already been authorised for use in European countries. So far, the European Medicines Agency has authorised : Comirnaty™ (the Pfizer/BioNTech vaccine), Spikevax™(Moderna vaccine), Vaxsevria (the AstraZeneca vaccine) and the Janssen (Johnson & Johnson) vaccine.
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.
This is happening with all the Covid vaccines which have been authorised for use.
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.
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),Spikevax™(COVID-19 vaccine Moderna), Vaxsevria (the COVID-19 vaccine AstraZeneca) and COVID-19 vaccine Janssen (Johnson & Johnson) have all gone through 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 Janssen vaccine recruited over 40,000 people in its trials in three countries. 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 Spikevax™ (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 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 in clinical studies and have been shown to be safe and reasonably well-tolerated.
COVID-19 Vaccines AstraZeneca and Janssen (Johnson and Johnson)are vaccines composed of inactivated 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.The inactivated carrier virus is eliminated from the body within days of the vaccination. The virus in the vaccine cannot replicate as it is genetically modified and inactivated.
How will people know when to attend for vaccination?For priority groups 1 to 4, 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 persons under 60 years will be asked to register online or through sms so that an appointment will be issued for them.
Those who have received an appointment but need to reschedule it for serious reasons 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.
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 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.There are very few specific medical conditions where one vaccine may be preferred over another.These exceptions will be identified by medical specialists.
Because mutated variants are and will be emerging, continuous monitoring of the vaccines’ performance over time is required. Some vaccines against viral diseases remain effective many years after their development and provide long-lasting protection, such as vaccines for measles or rubella. On the other hand, for diseases such as flu, virus strains change so often and to such an extent that the vaccine composition must be updated on a yearly basis for it to be effective.
Do the vaccines work against the Covid-19 variants?Based on published studies, the vaccines authorised in the EU provide protection against variants circulating in the EU, including the alpha(UK.B.1.1.7) and the delta variant(Indian or B.1.617.2) Two doses of Vaxzevria, Comirnaty or Spikevax provide protection against symptomatic disease but more strongly against hospitalisation and severe disease
caused by variants circulating in the EU, including the alpha, beta,delta and the Omicron variant. The same applies for one dose of the Johnson & Johnson vaccine.However, the antibody level has been demonstrated to wane after around 12 weeks and after 8 weeks with the Johnson & Johnson vaccine, so the use of booster doses is of utmost importance following primary vaccination.
If the virus spread is not controlled, it has been reported that at some point there may be mutations against which the current vaccines may no longer work or no longer work sufficiently. So, increasing vaccination and maintaining public health measures remain very important tools to fight the pandemic.
Is there a risk that the virus mutates quicker in a population that has only received one dose of the vaccine?There is a potential risk of the virus mutating in people with an incomplete immune response. This could potentially happen even in persons with a poor immune response who have received 2 doses, but the chances will be lower.
The levels of antibodies produced by the first dose of mRNA vaccines are low, so it is I,portant not to delay the second dose beyond the manufacturer’s specifications as this may trigger the virus to mutate.
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 should be 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 the first positive PCR before taking the vaccine. 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.
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.
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.
Are there any other groups of people who should not take the Covid vaccines?
Age Limitations
As from the 24th November, the European Medicines Agency has authorised the use of Comirnaty™ (the Pfizer/BioNTech) vaccine for children aged 5 – 11 years. This is a specific vaccine preparation which uses one third of the adult dose. Children should still receive 2 doses with a 3-week interval. The Moderna vaccine is still not licenced for use in children under 12 years of age because safety trials on this group are still being carried out. Recent trials involving thousands of children have shown that Pfizer vaccine is safe and effective in children 5 years and over.
In the case of the Vaxservia (AstraZeneca) and Janssen vaccines, the age-limit has been set at 18 years as studies in persons under 18 years are still ongoing.
Note on the use of AstraZeneca vaccine in the elderly: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 is efficacious in older persons as well. The WHO recommends the vaccine for use in all persons over 18 but even in those aged 65 years and older. In Malta the vaccine is used for persons between 18 and 70 years.
Persons with allergies
Persons who have a history of serious allergy (anaphylaxis) following a vaccine or injectable medication should have the vaccine under medical supervision.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 call 21231231 or 21222444 to speak to a doctor 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 Vaxservia (AstraZeneca) and Janssen ones have specific pregnancy-related risks.
The WHO and Royal College of Obstetrics and Gynaecology (UK) recommend that pregnant women who have passed the first 12 weeks of pregnancy should receive an mRNA vaccine (Pfizer or Moderna). This is because unvaccinated expectant mothers are at greater risk from the Delta variant, with both mother and unborn baby at particular danger of becoming severely ill from COVID-19. There has been a worrying rise in the number of unvaccinated women being admitted to hospital with severe COVID-19, according to new data published by the University of Oxford. About one in 10 pregnant women admitted to hospital with symptoms of COVID-19 requires intensive care and about one in five gives birth prematurely, according to new data.
The choice of an mRNA vaccine reflects the fact that most of the safety data regarding vaccination in pregnancy comes from the USA where pregnant women were usually offered the Pfizer- BioNTech or Moderna vaccines. However, women who had one dose of AstraZeneca vaccine before becoming pregnant should take the second dose of AstraZeneca after the 12th week of pregnancy.
It should also be noted that there is no need to avoid pregnancy once both doses of the COVID-19 vaccine have been received.
All the information also applies to the booster dose of vaccine. This may be taken at any time during pregnancy but ideally after the first trimester.
Regarding breast-feeding, the vaccines are not thought to be a risk to the breast-feeding infant and vaccination with any type of the authorized vaccines should be considered. Women who are breast-feeding may receive the vaccine without having to pause breastfeeding.The booster dose may also be given during breastfeeding.
In summary:
If there is a higher chance of contracting infection, or a woman is at a higher risk of severe illness from COVID-19, the vaccine should be offered at the earliest opportunity, including in the first trimester.
Breastfeeding women can receive a COVID-19 vaccine; there is no need to stop breastfeeding to have the vaccine.
Women planning a pregnancy or fertility treatment can also receive a COVID-19 vaccine and do not need to delay conception.
Women who are pregnant or breastfeeding, or planning a pregnancy and have been called to take the booster dose, should take the dose when invited.
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% in preventing serious disease with or without hospitalisation. This means that the vaccine will prevent serious disease and complications from Covid-19 in most persons who receive the vaccine.
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 protect individual patients from serious disease and complications, a large proportion of the population must be immunised and protected before transmission is substantially reduced. Vaccinating whole populations will take several months.
To establish whether and how the vaccines reduce spread of the virus in the community, real-world studies are being conducted in places where large numbers of people are vaccinated. It is not yet fully known to what extent vaccinated people may still be able to carry and spread the virus, however emerging data are encouraging.
So far we know that the vaccines are highly effective at preventing symptomatic cases of COVID-19. We do not yet have data to indicate whether the vaccine prevents asymptomatic or mild 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 taking the vaccination, 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 still NOT exempt from quarantine e.g if they have close contact with a positive case.
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).
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 used, 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 vaccines are effective for at least a 4-month period with no decrease in protection.. Monitoring will be ongoing to provide further data regarding duration of protection and the need for a booster dose.
How many shots of Covid-19 vaccine will be needed?The Pfizer-BioNTech, Moderna and AstraZeneca vaccines all require 2 doses each with a different interval between the doses. The Johnson & Johnson vaccine only requires one dose for the time being. Each brand has established the dose interval according to studies carried out by the company. It is not recommended to change these intervals as this may affect the efficacy of the vaccine. The dose interval for the different vaccines is as follows:
- Comirnaty(Pfizer/Biontech) 3 weeks
- Spikevax (Moderna) 4 weeks
- Vaxsevria(AstraZeneca) 4 to 12 weeks
How much time should I wait between when I take the Covid vaccine and taking another vaccine?There should be a minimum interval of 14 days between administration of Covid vaccine and any other vaccine against other conditions. This recommendation only applies for the first dose of the covid vaccine so as not to confuse side effects with other vaccines. Subsequent doses may be given with other vaccines or at any interval. For example, the third dose of Covid vaccine may be given on the same day as the influenza vaccine or even within a few days of each other.
Will we need a booster dose?One must distinguish between an additional (third dose) dose of vaccine and a booster dose. In September the third dose of vaccine started being given to persons over 65 years and people who are immunocompromised due to medical treatment or disease. This is because studies indicate that these groups of people may not build an adequate level of immunity after the regular course of vaccination. These people may benefit from an additional dose to ensure adequate protection against COVID-19. This additional dose may be given from 28 days after the second dose (or the single dose of Johnsons & Johnson vaccine)
On the 4th October, the European Medicines Agency approved the use of mRNA vaccines (Pfizer and Moderna) to be given as a booster dose to persons who do not fall in the above categories, that is, people with healthy immune systems. However, unlike in the case of the elderly and immunosuppressed, this is because studies are showing that some waning of the immune response to Covid infection may start to be demonstrable from 3 months from the completion of the course of vaccines. Nevertheless, breakthrough infections in vaccinated people were noted to be mild and not requiring hospitalisation.
EMA has allowed for the use of the booster dose to be left at the discretion of each Member State, depending on supply and individual Government policies. The Maltese Health Authorities have decided to offer the booster dose to all persons over 18 years. The booster dose should be given after 3 months have passed from the second dose of any Covid-19 vaccine (or from the single dose of Johnson & Johnson vaccine). Invitations to receive the booster dose of vaccine will be published starting from older persons at 64 years and moving downwards.
I had received the AstraZeneca vaccine. Should I get the same brand as a booster dose?Studies have shown that the mRNA vaccines (Pfizer and Moderna) are the best choice of vaccine to obtain a better immune response. This also applies to persons who have already had 2 doses of a different vaccine earlier on.
How long before a coronavirus vaccine takes effect?Studies carried out during vaccine trials as well as post-marketing surveillance show that the vaccines reach their maximum protection against Covid disease 10 to 14 days after the second dose. It is now known that even after the first dose, at least 85% protection from serious disease is reached after 10 days but this starts to wane and the second dose is necessary to boost immunity.
What are the side effects of the vaccines?Most side effects of the COVID-19 vaccine are mild and should not last longer than a week, these are:
- a sore arm where the needle went in
- feeling tired
- a headache
- muscle pains
- nausea and loss of appetite
You may also get a fever or feel hot or shivery 1 or 2 days after having your vaccination. You can take pain killers, such as paracetamol, if you have a fever or are in pain.
If your symptoms get worse or you are worried, speak to your doctor or call 21231231/ 21222444.
What are the blood clots that have been reported lately?Several scientific agencies are carrying out a detailed review of reports of an extremely rare blood clotting problem affecting a small number of people who have had the Vaxsevria (Oxford/AstraZeneca) and the Johnson & Johnson vaccines. It is not yet clear why it affects a very small number of people out of the millions who received the vaccine.
The COVID-19 vaccine can help stop you getting seriously ill or dying from coronavirus and the benefits of being vaccinated outweigh any risk of clotting problems.
You should Call your doctor immediately if you get any of these symptoms starting from 3 days after the vaccine:
- a severe headache that is not relieved with painkillers or is getting worse
- a headache that's unusual for you and occurs with blurred vision, feeling or being sick, problems speaking, weakness, drowsiness or seizures (fits)
- a rash that looks like small bruises or bleeding under the skin
- shortness of breath, chest pain, leg swelling or persistent abdominal pain
Can I get facial palsy (drooping of one side of the face) from taking the covid 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.
Can mRNA vaccines cause myocarditis?EMA’s safety committee (PRAC) is continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with Pfizer/BioNTech and Moderna vaccines. . Most of these cases were mild and resolved within a few days. They mainly affected males under 30 years of age, with symptoms mostly starting within several days of vaccination with the second dose.
Can the vaccine affect my menstrual cycle? Menstrual changes after receiving a COVID-19 vaccine were not noted during the clinical trials of the four authorised COVID-19 vaccines. Data recorded to date in EudraVigilance from vaccination campaigns have not raised a safety concern regarding menstrual changes. Thus, menstrual changes are not included in the product information of COVID-19 vaccines as adverse drug reaction.
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?
Now that all the priority groups and the general public have been invited to get vaccinated, those who have not taken the vaccine as yet may attend for vaccination without appointment. In Malta, the University Gateway Building is open Monday to Saturday between 8am and 3pm.
Is the vaccine available in private practice?The vaccine is given free of charge and is available through government entities. The vaccine is not 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.
Advice and precautions for persons with bleeding disorders and those taking anticoagulants (blood-thinning medication). This advice applies to all Covid-19 vaccines.
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 any 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 any 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 the covid-19 vaccine. In most cases it will be possible for you to receive any 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 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.
COVID VACCINE IN CHILDREN – WHAT PARENTS SHOULD KNOW
Can my child get a COVID-19 vaccine?The European Medicines Agency has approved the use of the Pfizer Covid vaccine Comirnaty™ for children ages 5 and older. This was done after trials involving around 3000 children in that age group showed that the vaccine is safe and effective in children too. The dose of the vaccine has been greatly reduced to a third of the adult dose and was found to be just as safe and effective in children as the larger dose is for adults. Currently, Pfizer’s vaccine is the only approved COVID-19 vaccine for children.
Are COVID vaccine side effects the same in children?No vaccine in existence has had any side effects more than two months from the point of vaccination. This includes the effects which have been reported after billions of vaccines have been administered so far.
Some parents are worried about their child getting myocarditis from the COVID vaccines, but the chances of that happening are much higher if the child gets sick with COVID. Myocarditis remains a very rare side effect and one that can be treated with rest or medication.
The general side effects are the same in children as in adults. Your child might notice pain at the injection site in the upper arm and could feel more tired than usual. Headache, muscle pain or pain in the joints as well as fever and chills are also possible. These side effects are usually temporary and generally clear up within 48 hours.
How can I be sure that the vaccine is safe in young children?International Regulatory Bodies including the American FDA and the European Medicines Agency reviewed vaccine studies of more than 4,600 children in this age range. Of this group, about 3,100 were given the Pfizer-BioNTech COVID-19 vaccine. The other children were given an inactive (placebo) shot. Children who were given the vaccine were monitored for side effects for at least 2 months after the second dose. Side effects were generally mild to moderate and lasted an average of 48 hours.
The studies also took an early look at cases of COVID-19 that occurred one week after children were given a second dose of the vaccine. Among 1,305 children given the vaccine, there were 3 cases of COVID-19. Among 663 children given the placebo, there were 16 cases of COVID-19. The results suggest that the vaccine is about 91% effective in preventing COVID-19 in this age group.
Is there any research on the long-term effects of the Pfizer-BioNTech COVID-19 vaccine?Research on mRNA vaccines had been going on for years before the Covid-19 mRNA vaccine was developed. There was no concern with long-term side effects throughout the research period and with real-world data involving billions of doses of mRNA vaccines administered so far.
A portion of the children in each age group were monitored for safety for at least two months after being given the second dose of the COVID-19 vaccine.
As part of its first request for emergency use authorisation of its COVID-19 vaccine in 2020, Pfizer created a safety monitoring plan. The plan now includes the monitoring of children and adolescents given the COVID-19 vaccine. No safety issues have been reported so far.
Is there any difference in the ingredients or dosing of the Pfizer vaccine for younger children?The Pfizer-BioNTech COVID-19 vaccine for children ages 5 through 11 contains a lower dose (10 micrograms) than the vaccine used for older children and adults (30 micrograms).
The vaccine for children ages 5 through 11 also contains a different buffer than the vaccine used for older children and adults. This different buffer, which is used in other vaccines given to children, will help keep the vaccine stable in refrigerated temperatures for longer.
Are there any children who shouldn't get the Pfizer COVID-19 vaccine?This vaccine is not yet available to children younger than age 5. Clinical trials involving younger children are in progress.
The vaccine also should not be given to a child with a known history of a severe allergic reaction to any of its ingredients. If this is the case, your child might be able to get another COVID-19 vaccine in the future.
Can my child get Covid-19 from the vaccine?No. All the Covid-19 vaccines including the children’s vaccine approved in the EU do not use the live virus that causes COVID-19.
How soon can a child get the COVID-19 vaccine before or after getting another vaccine?The COVID-19 vaccine and other vaccines can be given on the same day.
Previously, due to the newness of COVID-19 vaccines, it was recommended that an interval of two weeks should be kept between taking other vaccines and a COVID-19 vaccine. These recommendation were changed based on safety data gathered in recent months.
Why should I get my child vaccinated if Covid-19 in children is usually very mild?Although COVID-19 in children is usually milder than in adults, some children infected with the coronavirus can get severe lung infections, become very sick and require hospital care. This is especially important to remember in light of the delta and omicron variants, which are now known to be more contagious than other coronavirus variants. Children can also have complications such as multisystem inflammatory syndrome that may require intensive care or long-lasting symptoms that affect their health and well-being. The virus can cause death in children, although this is rarer than for adults.
The vaccine helps prevent or reduce the spread of COVID-19: Like adults, children can also transmit the coronavirus to others if they’re infected, even when they have no symptoms. Latest studies show that as more adults get vaccinated, there is higher transmission in the unvaccinated child population and subsequent breakthrough or re-infection in their adult contacts. Getting the COVID-19 vaccine can protect the child and others, reducing the chances of transmission to others, including family members and friends who may be more susceptible to severe consequences of the infection.
Getting vaccinated for COVID-19 can help stop other variants from emerging: Cases of COVID-19 are increasing among children. Reducing viral transmission by getting vaccinated also reduces the virus’ chance to mutate into new variants that may be even more dangerous. However, the virus can transmit easily between unvaccinated children and adults, giving new variants a chance to emerge.
Having your child vaccinated for COVID can help restore a more normal life: Children exposed to the coronavirus who are vaccinated are less likely to get infected, and so would be able to continue attending school regularly and participate in other activities.
COVID-19 vaccines help protect the community: Another reason to strongly consider vaccinating your child against Covid-19 is to protect the health of your family and those living and working in your community. Each child or adult infected with the coronavirus can transmit the virus to others in the community causing disruption to daily life.
Can I get COVID-19 from my child?Yes, it is possible for a child infected with the coronavirus to transmit COVID-19 to another person. Data from some studies suggest that young children are becoming more likely than adults to spread the coronavirus to others.
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