Filenews 22 December 2020
Answers to questions about the Pfizer Comirnaty vaccine COVID-19 mRNA(nucleoside modified ), was given by the Ministry of Health.
What is Pfizer and what is it used for?
It is a vaccine for the prevention of coronavirus disease 2019 (COVID-19) in people aged 16 years and over.
The vaccine contains a molecule called messenger RNA (mRNA) with instructions for the production of a protein from SARS-CoV-2, the virus that causes COVID-19. The vaccine does not contain the virus itself and cannot cause COVID-19.
Detailed information about this vaccine is available in the product information contained in the package leaflet.
How is the vaccine used?
The vaccine is given in two doses (two injections), usually in the upper arm muscle, in an interval of at least 21 days.
The supply of the vaccine will be the responsibility of the national authorities. For more information about using the vaccine, see the package leaflet or consult a healthcare professional.
How does this vaccine work?
The vaccine works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA and has instructions for producing a specific protein. This protein is found on the surface of the SARS-CoV-2 virus, by which the virus enters the cells of the body.
When a person receives the vaccine, some of his cells will read the mRNA instructions and temporarily produce this protein. The person's immune system will then recognize this protein as foreign and produce antibodies and activate the T cells (white blood cells) to attack it.
If, later, the person comes into contact with the SARS-CoV-2 virus, his immune system will recognize it and be ready to defend the body against it.
MRNA from the vaccine does not remain in the body, but breaks down shortly after vaccination.
What benefits has this vaccine shown in studies?
A very large clinical trial showed that the vaccine was effective in preventing COVID-19 in people over 16 years of age.
About 44,000 people participated in the clinical trial in total. Half received the vaccine and the other half received a dummy injection. All participants in this clinical trial did not know whether they received the vaccine or the dummy injection.
The efficacy of the vaccine was estimated in more than 36,000 people over 16 years of age (including people over 75 years of age) who had no evidence of a previous infection. The study showed a 95% decrease in the number of symptomatic cases of COVID-19 in people receiving the vaccine (8 out of 18,198 cases showed COVID-19 symptoms) compared to those receiving a dummy injection (162 cases out of 18,325 showed symptoms of COVID-19). This means that the vaccine showed 95% efficacy in the clinical trial.
The clinical trial also showed approximately 95% efficacy in participants with a severe COVID-19 event, including those with asthma, chronic lung disease, diabetes, high blood pressure or body mass index ≥ 30 kg/m2.
Can people who already have COVID-19 be vaccinated with the vaccine?
No additional adverse reactions occurred in the 545 people who had previously been treated with COVID-19 and who received the vaccine in the clinical trial.
There was not enough data from the clinical trial to determine how well the vaccine works in people already infected with COVID-19.
Can the vaccine reduce the transmission of the virus from one person to another?
The effect of vaccination with the vaccine on the spread of SARS-CoV-2 virus in the community is not yet known. It is not yet known whether vaccinated individuals can carry and spread the virus.
How long does protection take?
It is not currently known how long the protection provided by the vaccine lasts. Individuals vaccinated in the clinical trial will continue to be monitored for 2 years to collect more information about the duration of protection.
Can children be vaccinated with this vaccine?
This vaccine is not currently recommended for children under 16 years of age. The European Medicines Agency (EMA) has agreed with the company on a new clinical trial of the vaccine in children at a later stage.
Can immunosuppressed people be vaccinated?
There are limited data on immunosuppressed individuals (people with weakened immune systems). Although immunosuppressed individuals may not respond to the vaccine, there are no particular safety concerns. Immunosuppressed individuals may still be vaccinated as they may be at greater risk than COVID-19.
Can pregnant or lactating women be vaccinated?
Animal studies do not show harmful effects on pregnancy, however data on the use of the vaccine during pregnancy are very limited. Although there are no studies on breastfeeding, no risk is expected during breastfeeding.
The decision on whether to use the vaccine in pregnant women should be taken in close consultation with the health professional taking into account the benefits and risks.
Can people with allergies get vaccinated?
People who already know that they are allergic to one of the vaccine ingredients listed in section 6 of the leaflet should not receive the vaccine.
Allergic reactions (hypersensitivity) have been observed in people receiving the vaccine. A very small number of cases of anaphylaxis (severe allergic reaction) were observed when the vaccine started to be used in vaccination campaigns. Therefore, as with all vaccines, the vaccine should be administered under close medical supervision and with appropriate medical care. People who have a severe allergic reaction when given the first dose of vaccine should not receive the second dose.
How well does the vaccine work for people of different nationalities and genders?
The main clinical trial involved people of different nationalities and genders. Efficacy of approximately 95% was observed in both sexes, racial and other ethnic groups.
What are the risks associated with the vaccine?
The most common side effects with the vaccine in the clinical trial were usually mild or moderate and improved within a few days after vaccination. These include pain and swelling at the injection site, fatigue, headache, muscle and joint pain, chills and fever. These side effects affect more than 1 in 10 people.
Redness at the injection site and nausea occurred in less than 1 in 10 people. Itching at the injection site, pain in the extremities, enlarged lymph nodes, difficulty sleeping and feeling sick were unusual side effects (affecting less than 1 in 100 people). Muscle weakness on one side of the face (acute peripheral facial paralysis or paralysis) rarely occurred in less than 1 in 1,000 people.
Allergic reactions with the accine 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 vaccine should be administered under close supervision with appropriate medical care.
Why did THE EMA recommend the approval of the vaccine?
The vaccine offers a high level of protection against COVID-19, which is a critical need for the current pandemic. The main clinical trial showed that the vaccine shows 95% efficacy. Most side effects are mild to moderate in severity and disappear within a few days.
Therefore, the Agency has decided that the benefits of the vaccine outweigh the risks associated with it and that it can be recommended for authorisation in the EU.
The EMA recommended the issue of a conditional marketing authorisation for the vaccine. This means that there is more data on the vaccine (see Below) that are required by the company. The Agency shall review any new information made available and this review shall be carried out whenever necessary.
What information is still outstanding for the vaccine?
As the vaccine is recommended for conditional marketing authorisation, the company marketing the vaccine will continue to provide results from the clinical trial, which has been in progress for 2 years. This clinical trial and additional studies will provide information on how long the protection lasts, how well the vaccine prevents severe cases of COVID-19, how well it protects immunosuppressed people, children and pregnant women and whether it prevents asymptomatic cases.
In addition, independent studies on COVID-19 vaccines by EU authorities will also provide more information on the long-term safety and benefit of the vaccine to the general population.
The company will also conduct studies to provide additional assurance about the pharmaceutical quality of the vaccine, as manufacturing continues to grow.
What measures are being 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 package leaflet.
There is also a Risk Management Plan (RMP) for the vaccine and it contains important information about vaccine safety, how to collect further information and how to minimize any potential risks. A summary of RMP is available.
Safety measures will be implemented for the vaccine in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is collected and analysed quickly. The company that markets the vaccine will provide monthly safety reports.
For all medicines, data on the use of the vaccine are continuously monitored. Suspicious adverse reactions reported with the vaccine are carefully evaluated and the necessary measures are taken to protect patients.
Other information on the vaccine
The Pfizer vaccine was proposed by the EMA 's Committee of Medicinal Products of Human Use (CHMP) on 21 December 2020 for a conditional marketing authorisation valid across the EU. The European Commission will issue a decision soon.
Detailed recommendations for the use of this product are described in the product information, which will be available in all the official languages of the European Union following the adoption of a marketing authorisation decision by the European Commission.
Source: eyenews
