VACCINATION - Q&A MODERNA, PFIZER & ASTRAZENECA

  

VACCINE - GENERALLY

As stated in the Communication, COVID-19 vaccination reduces the risk of a person being infected with the SARS-CoV-2 virus that causes COVID-19. Like all medicines, no vaccine is completely effective and it takes a few weeks after the vaccine to create protection from the body.

Therefore, even after vaccination, the person should continue to apply the usual practices of personal cleaning and protection, such as frequent hand washing, maintaining social distance and using a face mask. Some people may be affected by COVID-19 despite having been vaccinated, but vaccination will reduce the severity of any infection.

It is stressed that vaccination with both (2) doses of vaccine is required to reduce the chance of a person being seriously ill or dying. The vaccine may not cause COVID-19 in the vaccinated person.

1. Before leaving the Vaccination Centre after the 1st dose of vaccine, make sure that you have scheduled an appointment for the 2nd dose

2. Better protection is required as you are vaccinated with both (2) doses of the vaccine

3. After administration of the 1st dose you will receive a COVID-19 Vaccination Card which you should present when you come for the 2nd dose of vaccine

Like all medicines, vaccines can cause side effects. Most of them are mild and don't last long and certainly don't happen at all. It is stressed, however, that even if you experience any symptoms after the 1st dose, you should also do the 2nd dose for better protection.

1. What is COVID-19 Vaccine Moderna and what is it used for?

COVID-19 Vaccine Moderna is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older.

COVID-19 Vaccine Moderna contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. COVID-19 Vaccine Moderna does not contain the virus itself and cannot cause COVID-19.

Detailed information about this vaccine is available in the product information, which includes the package leaflet.

 

2. How is COVID-19 Vaccine Moderna used?

COVID-19 Vaccine Moderna is given as two injections, usually into the muscle of the upper arm, 28 days apart.

Arrangements for the supply of the vaccine will be the responsibility of national authorities. For more information about using COVID-19 Vaccine Moderna, see the package leaflet or consult a healthcare professional.

 

3. How does COVID-19 Vaccine Moderna work?

COVID-19 Vaccine Moderna works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.

The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.

 

4. What benefits of COVID-19 Vaccine Moderna have been shown in studies?

A very large clinical trial showed that COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age.

The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection.

The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial.

The trial also showed 90.9% efficacy in participants at risk of severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.

 

5. Can people who have already had COVID-19 be vaccinated with COVID-19 Vaccine Moderna?

There were no additional side effects in the 343 people who received COVID-19 Vaccine Moderna in the trial and had previously had COVID-19.

There were not enough data from the trial to conclude on how well COVID-19 Vaccine Moderna works for people who have already had COVID-19.

 

6. Can COVID-19 Vaccine Moderna reduce transmission of the virus from one person to another?

The impact of vaccination with COVID-19 Vaccine Moderna on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus.

 

7. How long does protection from COVID-19 Vaccine Moderna last?

It is not currently known how long protection given by COVID-19 Vaccine Moderna lasts. The people vaccinated in the clinical trial will continue to be followed for 2 years to gather more information on the duration of protection.

 

8. Can children be vaccinated with COVID-19 Vaccine Moderna?

COVID-19 Vaccine Moderna is not currently recommended for use in children. EMA has agreed with the company on a plan to conduct trials involving children at a later stage.

 

9. Can immunocompromised people be vaccinated with COVID-19 Vaccine Moderna?

There are limited data on immunocompromised people (people with weakened immune systems). Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.

 

10. Can pregnant or breast-feeding women be vaccinated with COVID-19 Vaccine Moderna?

Animal studies do not show any harmful effects in pregnancy, however data on the use of COVID-19 Vaccine Moderna during pregnancy are very limited. Although there are no studies on breast-feeding, no risk from breast-feeding is expected.

The decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

 

11. Can people with allergies be vaccinated with COVID-19 Vaccine Moderna?

People who already know they have an allergy to one of the components  of the vaccine* listed in section 6 of the package leaflet should not receive the vaccine.

Allergic reactions (hypersensitivity) have been seen in people receiving the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) have occurred. Therefore, as for all vaccines, COVID-19 Vaccine Moderna should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions. People who have a severe allergic reaction when they are given the first dose of COVID-19 Vaccine Moderna should not receive the second dose

* The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid
(mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG],
cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine,
tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose (US FDA)

 

12. How well does COVID-19 Vaccine Moderna work for people of different ethnicities and genders?

The clinical trial included people of different ethnicities and genders. The high efficacy was maintained across genders and racial and ethnic groups.

 

13. What are the risks associated with COVID-19 Vaccine Moderna?

The most common side effects with COVID-19 Vaccine Moderna in the trial were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting. They affected more than 1 in 10 people.

Redness, hives and rash at the injection site and rash occurred in less than 1 in 10 people. Itching at the injection site occurred in less than 1 in 100 people. Swelling of the face, which may affect people who had facial cosmetic injections in the past, and weakness in muscles on one side of face (acute peripheral facial paralysis or palsy) occurred rarely, in less than 1 in 1000 people.

Allergic reactions have occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis). As for all vaccines, COVID-19 Vaccine Moderna should be given under close supervision with appropriate medical treatment available.

 

14. Why has EMA recommended the authorisation of COVID-19 Vaccine Moderna?

COVID-19 Vaccine Moderna offers a high level of protection against COVID-19 which is a critical need in the current pandemic. The main trial showed that the vaccine has a 94.1% efficacy. Most side effects are mild to moderate in severity and are gone within a few days.

The European Medicines Agency therefore decided that COVID-19 Vaccine Moderna’s benefits are greater than its risks and it can be recommended for authorisation in the EU.

COVID-19 Vaccine Moderna has been recommended for ‘conditional marketing authorisation’. This means that there is more evidence to come about the vaccine (see below), which the company is required to provide. The Agency will review any new information that becomes available and this overview will be updated as necessary.

 

15. What information is still awaited for COVID-19 Vaccine Moderna?

Since COVID-19 Vaccine Moderna has been recommended for conditional marketing authorisation, the company that markets COVID-19 Vaccine Moderna will continue to provide results from the clinical trial, which is ongoing, for 2 years. This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.

In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population.

The company will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine as the manufacturing continues to be scaled up.

 

16. What measures are being taken to ensure the safe and effective use of COVID-19 Vaccine Moderna?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of COVID-19 Vaccine Moderna have been included in the summary of product characteristics and the package leaflet.

A risk management plan for COVID-19 Vaccine Moderna is also in place and contains important information about the vaccine’s safety, how to collect further information and how to minimise any potential risks. A summary of the RMP is available.

Safety measures will be implemented for COVID-19 Vaccine Moderna in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets COVID-19 Vaccine Moderna will provide monthly safety reports.

As for all medicines, data on the use of COVID-19 Vaccine Moderna are continuously monitored. Suspected side effects reported with COVID-19 Vaccine Moderna are carefully evaluated and any necessary action taken to protect patients. 

17. Other information about COVID-19 Vaccine Moderna

COVID-19 Vaccine Moderna was recommended by EMA’s human medicines committee (CHMP) on 6 January 2021 for a conditional marketing authorisation valid throughout the EU. The European Commission will issue a decision shortly.

Detailed recommendations for the use of this product are described in the product information, which will be available in all official European Union languages after a decision on the marketing authorisation has been issued by the European Commission.

Common side effects of the COVID-19 mRNA Moderna vaccine include:

• local sensitivity/swelling/redness at the vaccination site

• shivering

• feeling tired

• headache

• nausea, vomiting

• muscle pain (myalgia) or joint pain (arthralgia)

• feeling of fever

• swelling of the glands (lymphadenopathy)

Symptoms usually last less than a week. However, if your symptoms appear to be worsening or if you are concerned contact your Personal Physician.

It is recalled that any suspected or suspected adverse reactions presented to those receiving the COVID-19 vaccine should be reported through the National Adverse Reaction Reporting System to Pharmaceutical Services, Ministry of Health, by submitting the Yellow Card in the following ways:

- Electronic submission: http://www.kitrinikarta.gov.cy

- Printed shipment of the Yellow Card available from the Website of Pharmaceutical Services:

https://www.moh.gov.cy/phs

• By post (free of charge): Pharmacovigilance Unit, Pharmaceutical Services, Ministry of Health

CY-1475, Nicosia, phone 22608607

• Submission by fax to +357 2260866

Source: eyenews

COMIRNATY - PFIZER-BioNTech VACCINE

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.

 

1. 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.

 

2. 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.

 

3. 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.

 

4. 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.

 

5. 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.

 

6. 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.

 

7. 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.

8. 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.

9. 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

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. Can a person with beta thalassemia who is taking iron deficiency drugs be vaccinated?

There is no contraindication.

17. 
    Can a person with heart disease get the vaccine?

Yes, but always with the advice of their doctor, as in any other case.

18. 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.

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.

20. Can people with G6PD deficiency get the vaccine?

There is no relevant contraindication.

21. 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.

22. I’m allergic to penicillin, can I get vaccinated?

Yes. The vaccine does not contain penicillin.

23. 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.

24. 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.

25. 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.

26. 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.

27. 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.

28. 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.

ASTRAZENECA

Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine and half were given another control injection, either a dummy injection or another vaccine. People did not know if they had been given the vaccine or the control injection.

The safety of the vaccine has been demonstrated across the four studies. However, the Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given 4 to 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen.

These showed a 59.6% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (68 of 5,494 got COVID-19 with symptoms) compared with people given control injections (164 of 5,438 got COVID-19 with symptoms). This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.

Most of the participants in these studies were between 18 and 55 years old. There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine could be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.

COVID-19 Vaccine AstraZeneca is given as two injections into the arm, 4 to 12 weeks apart. The most common side effects with COVID-19 Vaccine AstraZeneca were usually mild or moderate and got better within a few days after vaccination. The most common side effects are pain and tenderness at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and by European authorities.

Where to find more information

The product information approved by the CHMP for COVID-19 Vaccine AstraZeneca contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation.

An assessment report with details of EMA’s evaluation of COVID-19 Vaccine AstraZeneca, and the full risk management plan, will be published within days. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency’s clinical data website in due course.

More information is available in an overview of the vaccine in lay language, including a description of the vaccine’s benefits and risks and why EMA recommended its authorisation in the EU.

How COVID-19 Vaccine AstraZeneca works

COVID-19 Vaccine AstraZeneca is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2. This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause disease.

COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. The adenovirus itself cannot reproduce and does not cause disease. Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defences − antibodies and T cells − against this protein. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be prepared to attack it: antibodies and T cells can work together to kill the virus, prevent its entry into the body’s cells and destroy infected cells, thus helping to protect against COVID-19.

Conditional marketing authorisation

The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for COVID-19 Vaccine AstraZeneca, allowing vaccination programmes to be rolled out across the EU.

EU legislation foresees that conditional marketing authorisation (CMA) is used as the fast-track authorisation procedure to speed up approval of treatments and vaccines during public health emergencies.

A CMA guarantees that the vaccine meets rigorous EU standards for safety, efficacy and quality and is manufactured and controlled in approved, certified facilities in line with high pharmaceutical standards that are compatible with large-scale commercialisation. CMAs allow for the authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available. However, the data must show that the benefits of the medicine or vaccine outweigh any risks.

Once a CMA has been granted, AstraZeneca must provide further data from ongoing studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks. The company will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine following the scaling-up of the manufacturing.

Monitoring the safety of COVID-19 Vaccine AstraZeneca

In line with the EU’s safety monitoring plan for COVID-19 vaccines, COVID-19 Vaccine AstraZeneca will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines. Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated.

Companies are required to provide monthly safety reports in addition to the regular updates required by the legislation and conduct studies to monitor the safety and effectiveness of the vaccines as they are used by the public. In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed

Assessment of COVID-19 Vaccine AstraZeneca

During the assessment COVID-19 Vaccine AstraZeneca, the CHMP had the support of EMA’s safety committee, PRAC, who assessed the risk management plan of COVID-19 Vaccine AstraZeneca, and the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

Answer to frequently-asked questions on COVID-19 Vaccine AstraZeneca COVID-19 Vaccine (ChAdOx1-S [recombinant])

1. What is COVID-19 Vaccine AstraZeneca and what is it used for? 

COVID-19 Vaccine AstraZeneca is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus. COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2. COVID-19 Vaccine AstraZeneca does not contain the virus itself and cannot cause COVID-19. Detailed information about this vaccine is available in the product information, which includes the package leaflet. 

2. How is COVID-19 Vaccine AstraZeneca used?

COVID-19 Vaccine AstraZeneca is given as two injections, usually into the muscle of the upper arm, 4 to 12 weeks apart. Arrangements for the supply of the vaccine will be the responsibility of national authorities. For more information about using COVID-19 Vaccine AstraZeneca, see the package leaflet or consult a healthcare professional. 

3. How does COVID-19 Vaccine AstraZeneca work? 

COVID-19 Vaccine AstraZeneca works by preparing the body to defend itself against COVID-19. It is made up of another virus (adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells. Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it. If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it. The adenovirus in the vaccine cannot reproduce and does not cause disease. 

4. What benefits of COVID-19 Vaccine AstraZeneca have been shown in studies? 

Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine and half were given another control injection, either a dummy injection or another vaccine. People did not know if they had been given the vaccine or the control injection. 

The Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases occurring in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given 4 to 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen. These showed a 59.6% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (68 of 5,494 got COVID-19 with symptoms) compared with people given control injections (164 of 5,438 got COVID-19 with symptoms). This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.

Most of the participants in these studies were between 18 and 55 years old. There were not enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine could be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.

 5. Can people who have already had COVID-19 be vaccinated with COVID-19 Vaccine AstraZeneca? 

There were no additional side effects in the 185 people who received COVID-19 Vaccine AstraZeneca in the trial and had previously had COVID-19. There were not enough data from the trial to conclude on how well COVID-19 Vaccine AstraZeneca works for people who have already had COVID-19. 

6. Can COVID-19 Vaccine AstraZeneca reduce transmission of the virus from one person to another? 

The impact of vaccination with COVID-19 Vaccine AstraZeneca on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus. 

7. How long does protection from COVID-19 Vaccine AstraZeneca last? 

It is not currently known how long protection given by COVID-19 Vaccine AstraZeneca lasts. The people vaccinated in the clinical trials will continue to be followed for 1 year to gather more information on the duration of protection. 

8. Can children be vaccinated with COVID-19 Vaccine AstraZeneca? 

COVID-19 Vaccine AstraZeneca is not currently recommended for use in children.  EMA has agreed with the company on a plan to conduct trials involving children at a later stage.

9. Can immunocompromised people be vaccinated with COVID-19 Vaccine AstraZeneca? 

There are limited data on immunocompromised people (people with weakened immune systems). Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19. 

10.Can pregnant or breast-feeding women be vaccinated with COVID-19 Vaccine AstraZeneca? 

Preliminary animal studies do not show any harmful effects in pregnancy, however data on the use of COVID-19 Vaccine AstraZeneca during pregnancy are very limited. Although there are no studies on breast-feeding, no risk from breast-feeding is expected. The decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks. 

11.Can people with allergies be vaccinated with COVID-19 Vaccine AstraZeneca? 

People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine. Allergic reactions (hypersensitivity) have been seen in people receiving the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) have occurred. Therefore, as for all vaccines, COVID-19 Vaccine AstraZeneca should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions. People who have a severe allergic reaction when they are given the first dose of COVID-19 Vaccine AstraZeneca should not receive the second dose. 

12.How well does COVID-19 Vaccine AstraZeneca work for people of different ethnicities and genders? 

The clinical trial included people of different ethnicities and genders. The efficacy was maintained across genders and ethnic groups. 

13.What are the risks associated with COVID-19 Vaccine AstraZeneca?

The most common side effects with COVID-19 Vaccine AstraZeneca in the trials were usually mild or moderate and got better within a few days after vaccination. The most common side effects are pain and tenderness at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea. They affected more than 1 in 10 people. Vomiting and diarrhoea occurred in less than 1 in 10 people. Decreased appetite, dizziness, sweating, abdominal pain and rash occurred in less than 1 in 100 people. Allergic reactions have occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis). As for all vaccines, COVID-19 Vaccine AstraZeneca should be given under close supervision with appropriate medical treatment available. 

14.Why has EMA recommended the authorisation of COVID-19 Vaccine AstraZeneca? 

COVID-19 Vaccine AstraZeneca offers a good level of protection against COVID-19 which is a critical need in the current pandemic. The main trials showed that the vaccine has around 60% efficacy. Most side effects are mild to moderate in severity and are gone within a few days. 

The European Medicines Agency therefore decided that COVID-19 Vaccine AstraZeneca’s benefits are greater than its risks and it can be recommended for authorisation in the EU. COVID-19 Vaccine AstraZeneca has been recommended for ‘conditional marketing authorisation’. This means that there is more evidence to come about the vaccine (see below), which the company is required to provide. The Agency will review any new information that becomes available and this overview will be updated as necessary. 

15.What information is still awaited for COVID-19 Vaccine AstraZeneca? 

Since COVID-19 Vaccine AstraZeneca has been recommended for conditional marketing authorisation, the company that markets COVID-19 Vaccine AstraZeneca will continue to provide results from the clinical trials, which are ongoing. These trials and additional studies will provide information on how long protection lasts, including against new variants of the virus, how well the vaccine prevents severe COVID-19, how well it protects older people, immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases. 

In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population. The company will also carry out studies to provide additional assurance on the pharmaceutical quality and testing of the vaccine as the manufacturing continues to be scaled up. 

16.What measures are being taken to ensure the safe and effective use of COVID-19 Vaccine AstraZeneca? 

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of COVID-19 Vaccine AstraZeneca have been included in the summary of product characteristics and the package leaflet. A risk management plan for COVID-19 Vaccine AstraZeneca is also in place and contains important information about the vaccine’s safety, how to collect further information and how to minimise any potential risks. 

A summary of the RMP is available. Safety measures will be implemented for COVID-19 Vaccine AstraZeneca in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets COVID-19 Vaccine AstraZeneca will provide monthly safety reports. As for all medicines, data on the use of COVID-19 Vaccine AstraZeneca are continuously monitored. Suspected side effects reported with COVID-19 Vaccine AstraZeneca are carefully evaluated and any necessary action taken to protect patients. 

17.Other information about COVID-19 Vaccine AstraZeneca COVID-19 Vaccine

 AstraZeneca was recommended by EMA’s human medicines committee (CHMP) on 29 January 2021 for a conditional marketing authorisation valid throughout the EU. The European Commission will issue a decision shortly. Detailed recommendations for the use of this product are described in the product information, which will be available in all official European Union languages after a decision on the marketing authorisation has been issued by the European Commission.