Question 1

1. How does a vaccine work?

COVID-19 vaccines help our bodies develop immunity to the virus that causes COVID-19 without us having to contract the disease. Different types of vaccines work in different ways to offer protection, but with all types of vaccines, the body is left with a supply of "memory" T cells and B cells that will remember how to fight that virus in the future.

It usually takes a few weeks for the body to produce T lymphocytes and B lymphocytes after vaccination. Therefore, it is possible for a person to become infected with the virus that causes COVID-19 just before or just after vaccination and then become ill because the vaccine did not have enough time to provide protection.

Sometimes, after vaccination, the process of developing immunity can cause symptoms, such as fever. These symptoms are normal and are a sign that the body is developing immunity.

Question 2

2. What are the types of vaccines in COVID-19?

Currently, there are three main types of COVID-19 vaccines that are either soon to undergo large-scale clinical trials (Phase 3) in the or have already been approved. Below is a description of how each type of vaccine encourages our body to recognize and protect ourselves from the virus that causes COVID-19. None of these vaccines can give you COVID-19.

mRNA vaccines contain material from the virus that causes COVID-19 that gives our cells instructions on how to make a harmless protein that is unique to the virus. Once our cells make copies of the protein, they destroy the genetic material in the vaccine. Our bodies recognize that the protein shouldn't be there and build T lymphocytes and B lymphocytes that will remember how to fight the virus that causes COVID-19 if we become infected in the future.

Protein subunit vaccines include harmless parts (proteins) of the virus that cause COVID-19 rather than the entire germ. A Once vaccinated, our immune system recognizes that the proteins they do not belong in the body and begin to produce T lymphocytes and antibodies. If we ever get infected in the future, memory cells they will recognize and fight the virus.

Vector vaccines contain a weakened version of a live virus, a virus other than the one that causes COVID-19, that has genetic material from the virus that causes COVID-19 inserted into it (this is called a viral vector). Once the viral vector is inside our cells, the genetic material instructs the cells to make a protein that is unique to the virus that causes COVID-19. Using these instructions, our cells make copies of the protein. This prompts our bodies to build T lymphocytes and B lymphocytes that will remember how to fight that virus if we become infected in the future.

Question 3

3. What are the vaccines authorized and approved worldwide?

NAME: BNT162b2 Vaccine type: mRNA-based vaccine Primary Manufacturers: Pfizer, BioNTech, Fosun, Paharma Country of Origin: Multinational Authorization and approval: UK, USA, EU Bahrain, Canada, Mexico, US, Singapore, Oman, Saudi Arabia, Kuwait, EU 2. NAME: Mrna-1273 Vaccine type: mRNA-based vaccine Primary Manufacturers: Moderna, BARDA, NIAID Country of Origin: USA Authorization and approval: USA, Canada 3. NAME: CoronaVac Vaccine Type: INACTIVATED Vaccine (formalin with alum adjuvant) Primary Manufacturers: Sinovac Country of Origin: China Authorization and approval: China 4. NAME: No name announced Vaccine Type: INACTIVATED Vaccine Primary Manufacturers: Wuhan Institute of Biological Products; China National Pharmaceutical Group (Sinopharm) Country of Origin: China Authorization and approval: China 5. NAME: Sputnik V Vaccine Type: NON-REPLICANT Viral Vector Primary manufacturer: Gamaleya Research Institute, Acellena Contract Drug Research and Development Country of Origin: Russia Authorization and approval: Russia 6. NAME: BBIBP-CorV Vaccine Type: INACTIVATED Vaccine Primary Manufacturers: Beijing Institute of Biological Products;, China National Pharmaceutical Group (Sinopharm) Country of Origin: China Authorization and approval: China and SaudiArabia 7. NAME: EpiVacCorona Vaccine Type: Peptide Vaccine Primary Makers: Federal Budget Research Institution State Budget Research Center virology and biotechnology Country of Origin: Russia Authorization and approval: Russia

Question 4

4. How is the Pfizer - Comirnaty vaccine used?

The vaccine is given as two injections, usually into the muscle of the upper arm, separated by at least 21 days.

Arrangements for the supply of the vaccine will be the responsibility of the national authorities. For more information on the use of the vaccine, see the package leaflet or consult a healthcare professional.

Question 5

5. How does the vaccine work?

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

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

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

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

Question 6

6. What benefits of the vaccine have been shown in the study?

A very large clinical trial showed that the vaccine was effective in preventing COVID-19 in people 16 years of age and older.

The trial involved about 44,000 people in total. Half received the vaccine and the other half received a dummy injection. People did not know if they had received the vaccine or the dummy injection.

Efficacy was calculated in more than 36,000 people 16 years of age and older (including people older than 75 years) who had no signs of prior infection. The study showed a 95% reduction in the number of symptomatic COVID-19 cases in people who received the vaccine (8 cases out of 18,198 had COVID-19 symptoms) compared to people who received a dummy injection (162 cases of 18,325 had COVID-19 Symptoms). This means that the vaccine was 95% effective in the trial.

The trial also showed an efficacy of around 95% in participants at risk for COVID-19, including those with asthma, chronic lung disease, diabetes, severe high blood pressure, or a body mass index ≥ 30 kg / m2

Question 7

7. Can people who have already had Covid-19 get vaccinated?

There were no additional side effects in the 545 people who received the vaccine in the trial and who had previously had COVID-19.

There was not enough data from the trial to conclude how well the vaccine works for people who have already had COVID-19.

Question 8

8. Can the vaccine reduce the transmission of the virus from one person to another?

The impact of vaccination with the vaccine on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how many vaccinated people can carry and spread the virus.

Question 9

9. How long does Community protection last?

Currently it is not known how long the protection provided by the vaccine lasts. Vaccinated people in the clinical trial will continue to be followed for 2 years to gather more information on the duration of protection.

People (with a weak immune system) Although immunosuppressed people will not react in the same way to the vaccine, there is no need to worry about particular safety. Immunocompromised people cannot yet be vaccinated as they have a very high risk of contracting COVID-19

Question 10

10. Can children be vaccinated with the Pfizer vaccine (Comirnaty)?

The vaccine is not currently recommended for children under 16 years of age. There is an agreement with the company on a plan to test the vaccine in children at a later stage.

Question 11

11. Can immunosuppressed people get vaccinated?

There is limited data on immunosuppressed people (people with weakened immune systems). Although immunosuppressed people may not respond as well to the vaccine, there are no particular safety concerns. Immunosuppressed people can still get vaccinated, as they may be at increased risk for COVID-19.

Question 12

12. Can pregnant or lactating women be vaccinated?

Animal studies do not show any harmful effects during pregnancy, however, data on the use of the vaccine during pregnancy are very limited. Although there are no studies on breastfeeding, no risk for breastfeeding is expected.

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

Question 13

13. Can allergy sufferers be vaccinated with this vaccine?

People who already know that 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 (hypersensitivity) reactions have been seen in people who received the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) have occurred since the vaccine was first used in vaccination campaigns. Therefore, as with all vaccines, the Pfizer (Comirnaty) vaccine should be administered under medical supervision with appropriate medical treatment available. People who have a severe allergic reaction when given the first close dose of the vaccine should not receive the second dose.

Question 14

14. How well does the vaccine work with people of different ethnicities and genders?

The main trial included people of different ethnicities and genders. An efficacy of about 95% was maintained across all genders, racial and ethnic groups.

Question 15

15. What are the risks associated with the vaccine?

The most common side effects of the vaccine in the trial were generally mild or moderate and improved within days after vaccination. These included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills, and fever. They affected more than 1 in 10 people.

Redness at the injection site and nausea occurred in fewer than 1 in 10 people. Itching at the injection site, pain in the limb, enlarged lymph nodes, trouble sleeping, and malaise are rare side effects (affecting less than 1 in 100 people). Weakness of the muscles on one side of the face (acute peripheral facial paralysis or paralysis) occurred rarely in fewer than 1 in 1000 people.

Allergic reactions have occurred, including a very small number of cases of severe allergic reactions (anaphylaxis) that have occurred when the vaccine has been used in vaccination campaigns. As with all vaccines, the Pfizer vaccine should be administered under close supervision with appropriate medical treatment available.

Question 16

16. Why is the Pfizer Vaccine licensed in the European Union and what does this mean for Aruba?

The Pfizer Vaccine offers a high level of protection against COVID-19, which is a critical need in the current pandemic. The main trial showed the vaccine to be 95% effective. Most of the side effects are mild to moderate in severity and disappear within a few days.

Therefore, the Agency decided that the benefits of the vaccine outweigh its risks and that it can authorize its use in the EU.

Pfizer's vaccine has been granted conditional marketing authorization. This means there is more evidence to come on the vaccine (see below), which the company must provide. The Agency will review any new information that becomes available and this summary will be updated as necessary.

Aruba is part of the Kingdom of the Netherlands and Aruba will receive the vaccine from the Netherlands.

Question 17

17. What information is still expected from the vaccine?

Update: August 23, 2021 the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty. Read more: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

Commentary (FV 1) The approval of a drug that addresses the unmet medical needs of patients based on less complete data than is normally required. The data available should indicate that the benefits of the drug outweigh its risks and the applicant should be able to provide complete clinical data in the future.

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

The company will also conduct studies to provide additional assurance on the pharmaceutical quality of the vaccine as manufacturing continues to expand.

Question 18

18. What measures have been taken to ensure the safe and effective use of the vaccine?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of the vaccine have been included in the Summary of Product Characteristics and the Package Leaflet.

There is also a risk management plan (RMP) for the vaccine that contains important information about vaccine safety, how to collect more information, and how to minimize potential risks.

Community safety measures will be implemented in accordance with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is quickly collected and analyzed. The company that markets the vaccine will provide monthly safety reports.

As for all medicines, data on the use of the vaccine are continuously monitored. Suspicious side effects reported with the vaccine are carefully evaluated and steps are taken to protect patients.