The health ministry on Thursday issued a Q&A answering frequently asked questions about Comirnaty, the Pfizer-BioNTech vaccine currently administered in Cyprus.
The Q&A was based on questions most often asked to health visitors and healthcare professionals who carry out the vaccinations.
“In view of the beginning of the second phase of vaccinations, these are considered questions that concern people,” the ministry said.
Among other things, the ministry said that it is a myth that the vaccine will change people’s genetic code, while the use of mask and other protective measures will still be necessary for quite some time despite vaccinations.
Comirnaty is given to adults and adolescents from 16 years of age and older. The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against Covid-19. As Comirnaty does not contain the virus to produce immunity, it cannot give people Covid-19.
- To what extent can Comirnaty offer protection against the virus and for how long?
About 95 per cent protection. The duration of the protection provided by Comirnaty is currently unknown as it is still being determined by ongoing clinical trials.
Individuals vaccinated during the clinical trial will continue to be monitored for two years to gather more information about the duration of protection.
- Will I develop the disease after vaccination?
None of the Covid-19 vaccines licensed in the EU use the live virus caused by Covid-19. The goal of vaccination is to teach our immune system how to recognise and fight the virus that causes Covid-19. Sometimes this process can cause symptoms such as fever. These symptoms are normal and are a sign that the body is building immunity.
- Do vaccines protect against the virus or the infection it causes?
Initially, clinical trials were designed to record the percentage of volunteers who show symptoms of the disease. This leaves open the possibility for some vaccinated people to become infected without showing symptoms and thus spread the virus unknowingly, even though they are themselves protected. Until sufficient data is collected for this parameter, the use of the masks should continue.
- What happens if someone gets sick between the two doses?
If they develop symptoms before the day of the second dose, it should be postponed and administered after they recover, in consultation with their doctor.
- What is the security data of Comirnaty?
Like all vaccines, Comirnaty can cause side effects, although not everybody gets them.
Very common side effects that may affect more than 1 in 10 people concern pain and swelling in injection site, tiredness, headache, muscle pain, joint pain, chills, fever.
Common side effects that may affect up to 1 in 10 people: injection site redness, nausea. Uncommon side effects that may affect up to 1 in 100 people: enlarged lymph nodes, feeling unwell, pain in limb, insomnia, injection site itching.
Allergic reactions have occurred with Comirnaty, including a very small number of cases of severe allergic reactions (anaphylaxis) observed when Comirnaty was used in vaccination campaigns.
As with all vaccines, Comirnaty should be administered under close supervision and with appropriate available medical treatment.
- In which population groups is the Comirnaty vaccine contraindicated, based on the European Medicines Agency’s (EMA’s) announcements?
The Comirnaty vaccine is not currently recommended for children under 16 years of age and for people with known allergies to the vaccine ingredients. Relevant studies will follow for children.
- Can the vaccine protect from the mutations in the virus?
The known mutations in the spike protein (which concerns us since it is the ‘tool’ of vaccines) are not going to significantly change the effectiveness of the vaccines. Vaccines develop multiple antibodies to different regions of the whole protein and not to a specific one, whose structure and configuration may have changed due to the mutation. Think of this protein as a 1273-letter word. Its meaning does not change if there are some deletions or letter replacements. The mutation highlights the benefits of new mRNA vaccines that can be adapted quickly. So, in a potentially significant mutation we may have a new vaccine in a few weeks. But it is reassuring that this virus is not very ‘active’ in mutations. However, it is important to limit the transmission of the virus and end the pandemic, because the longer the virus continues to circulate, the greater the chances of a new critical mutation occurring.
- What are the differences between mRNA technology and ‘traditional’ vaccine technology? Is it related to DNA?
In clinical trials there are more than 60 candidate vaccines. They use ten different techniques. The mRNA technique is one of them. It is a technique that is first used in vaccines, since ways have been found to utilise it after 30 years of research.
It is a myth that the vaccine will change our genetic code. Vaccines help to develop the body’s defences against viruses and germs. Some new generation vaccines carry the message (hence the name messengers) so that the body can produce a virus protein. This production takes place far away in another part of the cell from where the genetic material is located. mRNA vaccines do not carry the coronavirus to us and do not affect or interact with our DNA.
Our immune system will recognise the virus protein as a ‘foreign body’ and begin the process of immune response.
The mRNA is rapidly degraded by transmitting information, while our body has mechanisms in place to deal with and destroy the free-foreign mRNA.
Many traditional vaccines use parts of viruses or whole viruses that are either dead or weakened.
- What are the warnings and precautions for using Comirnaty?
Talk to your doctor, pharmacist or nurse before you are given the vaccine if:
- you have ever had a severe allergic reaction or breathing problems after any other vaccine injection or after you were given Comirnaty in the past.
- you have ever fainted following any needle injection.
- you have a severe illness or infection with high fever. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold.
- you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots.
- you have a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your immune system
- Can people with allergies be vaccinated with Comirnaty?
Comirnaty should not be given if you are allergic to the active substance or any of the other ingredients of this medicine:
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159), 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC), Cholesterol, Potassium chloride, Potassium dihydrogen phosphate, Sodium chloride, Disodium phosphate dihydrate, Sucrose, Water for injections.
A very small number of severe allergic reactions (hypersensitivity) have been observed in vaccinated individuals.
In the United States, the CDC reports that the incidence of these events is 11.1 per million vaccine doses, and that 71 per cent of cases occur within the first 15 minutes of the vaccine administration.
People who have a severe allergic reaction to the first dose of Comirnaty should not take the second dose.
- Based on the quantities of vaccines that Cyprus will receive from various companies, will it be possible for someone to choose which vaccine to use?
This probably cannot be done based on availability. All vaccines are approved on the basis of safety and efficacy, so there is no criterion of superiority. Only when there is a specific contraindication for a vaccine what is indicated should be made. But at the moment we only have one vaccine.
- Can the second dose be with the vaccine of another company?
Individuals receiving one dose of Comirnaty should receive a second dose of Comirnaty to complete the vaccination cycle. No data are available on the interchangeability of Comirnaty with other Covid-19 vaccines to complete the vaccination cycle.
- Can I get vaccinated with Comirnaty if I am taking other medicines?
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, or have recently taken any other vaccines. Especially in case of using another vaccine such as flu, the vaccination should be done with a window of 14 days.
- Does the vaccine affect the ability to drive and use machines?
Some of the effects of the vaccine (possible side effects, such as pain, myalgia, headache, etc.) may temporarily affect your ability to drive or use machines. Wait until these effects subside before driving or operating machinery.
- I plan on getting pregnant. Can I be vaccinated?
There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development.
Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Although there are no studies on breastfeeding, no risk is expected.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
- Can a person with beta thalassemia who is taking iron deficiency drugs be vaccinated?
There is no contraindication.
Can a person with heart disease get the vaccine?
Yes, but always with the advice of their doctor, as in any other case.
- Can immunocompromised individuals be vaccinated with Comirnaty?
Data on immunocompromised individuals (individuals with a weakened immune system) are limited. Although immunocompromised individuals may not respond equally well to the vaccine, there are no particular safety concerns. Immunocompromised individuals can be vaccinated, as they may be at higher risk for Covid-19.
- Can an oncology patient receiving chemotherapy be vaccinated?
Yes, but it is a decision they need to make with their doctor depending on their condition.
- Can people with G6PD deficiency get the vaccine?
There is no relevant contraindication.
- Does the appearance of the vaccine mean a return to ‘normality’?
No. Until the community acquires immunity, the measures of personal protection and hygiene will accompany us, in a different degree of course.
- I’m allergic to penicillin, can I get vaccinated?
Yes. The vaccine does not contain penicillin.
- I have coagulation disorders, can I get vaccinated?
As with other intramuscular injections, the vaccine should be used with caution in people receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as hemophilia) because bleeding or bruising may occur after intramuscular administration to these individuals.
- I got coronavirus a month ago but I was completely asymptomatic. Do you advise me to get the vaccine?
Yes, studies show that asymptomatic people do not have high levels of protection against physical illness.
No additional adverse reactions were observed in the 545 subjects who received Comirnaty in the trial and had previously had Covid-19.
There is insufficient data from the study to suggest how well Comirnaty works in people already infected with Covid-19.
- I already have coronavirus, does it make sense to get vaccinated at this stage? Would it be better to test my antibodies with antibody tests first?
Because of the serious health risks associated with Covid-19 and the fact that a new Covid-19 infection is possible, you should be vaccinated, regardless of whether you have already been infected with the virus.
At present, experts do not know how long one is protected from getting sick again after recovering from Covid-19. The degree of immunity that one acquires from an infection, called natural immunity, varies from person to person. Some early evidence suggests that natural immunity may not last long.
Vaccination is recommended regardless of the history of Covid disease.
- Before I get the vaccine would it be wise to take a rapid test so that we can be sure that I am not positive for the coronavirus and any disease not attributed to the vaccine?
No pre-vaccination test is required.
The vaccine cannot develop the disease, as it does not contain live virus.
If someone is found positive either by PCR or a rapid test, then the vaccination should be postponed, as it should also be postponed in people with acute severe febrile illness or acute infection.
The presence of a mild infection and/or a low-grade fever should not delay vaccination. If someone is positive then they should postpone the vaccination until they recover. Once the test is negative, the vaccine can be given.
- How will the Vaccination Certificates work?
A common approach to pharmacovigilance and the issuance of reliable and verifiable Vaccination Certificates across the EU could enhance the success of vaccination schemes in the member states, as well as public confidence.
Recording vaccination data is important at both the individual and population levels. At the individual level, it is a means for people to know and prove their vaccination status.
From the moment of vaccination people will be provided with the Vaccination Card, while a relevant certificate will be issued by the vaccination platform. Vaccination certificates could, for example, be useful in travel, as they would prove that a person has been vaccinated and therefore may not need to be tested and quarantined when arriving in another country.
- When will the vaccine be able to control the pandemic?
For some known communicable diseases, it is estimated that in order to achieve herd immunity that can control a pandemic and eventually eradicate the disease, approximately 70 per cent of the population must be protected from the disease either by vaccination or by prior infection. Depending on the rate of vaccination and natural infections, the pandemic could be brought under control in Europe by the end of 2021.
More information on Cominarty may be found here.