Filenews 24 December 2020
The European Medicines Agency (EMA) has published in all EU languages the evaluation and justification for eu approval of Pfizer-Biontech vaccine, Comirnaty (COVID-19 mRNA vaccine modified nucleotide)
In particular, EMA notes that Comirnaty, a 2019 corovirus prevention vaccine (COVID-19) for people aged 16 years and over, "contains a molecule called messenger RNA (mRNA) which carries instructions for the production of protein from SARS-CoV-2, the virus that causes COVID-19. Comirnaty does not contain the virus itself and cannot cause COVID-19" disease.
The EMA notes that it is administered "with two injections, usually to the muscle of the upper arm, with a time difference of at least 21 days between them" and "the arrangements for the disposal of the vaccine are the responsibility of the national authorities".
The vaccine works by preparing the body to defend itself against COVID-19 disease. "It contains a molecule called messenger RNA (mRNA) which has been instructed to produce the spike protein. This is the protein found on the surface of the SARS-CoV-2 virus that the virus needs to enter the body's cells. His immune system will then recognize this protein as a foreign body, produce antibodies and activate the T cells (the white blood cells) to attack it. If the person then comes into contact with the SARS-CoV-2 virus, his immune system will recognize him and be ready to protect the body from it. The mRNA contained in the vaccine does not remain in the body but breaks down shortly after vaccination," the EMA explains in detail.
It stresses that "a very large clinical trial has shown that Comirnaty was effective in preventing COVID-19 in people aged 16 years and over. A total of about 44,000 people participated in the test. Half of the participants received the vaccine while the other half were given a dummy injection. The individuals did not know if they were receiving the vaccine or the dummy injection."
Efficacy was estimated "in more than 36,000 people aged 16 years and over (including people over 75 years of age) who had no evidence of prior infection" and showed a 95% reduction in the number of symptomatic cases of COVID-19 in vaccinated people (8 cases out of a total of 18,198 people showed COVID-19 symptoms) compared to those who received a dummy injection (162 cases out of 18,325 people showed COVID-19 symptoms). This means that the vaccine demonstrated 95 % efficacy in the trial."
"The trial also showed efficacy in approximately 95% of participants at risk of being seriously ill with COVID-19, including people suffering from asthma, chronic lung disease, diabetes, high blood pressure or having a body mass index of ≥30 kg/m2."
It notes that "no additional adverse reactions were found in the 545 people who received Comirnaty in the trial who had previously been infected with COVID-19", but that there are insufficient data from the trial to draw a conclusion as to how well Comirnaty works in people already infected with COVID-19".
Furthermore, the impact on the spread of SARS-CoV-2 virus in the community is not yet known and it is not yet known how many of the vaccinated people will still be able to transmit and spread the virus.
The duration of the protection is not known either. Individuals vaccinated as part of the clinical trial will continue to be monitored for 2 years in order to gather more information on the duration of protection.
In addition, the vaccine is not currently recommended for children under 16 years of age. Ema agreed with the company to conduct a plan to test the vaccine in children at a later stage.
According to EMA, data on immunocompromised individuals (people with weakened immune systems) are limited. Although immunocompromised individuals may not respond equally well to the vaccine, there are no particular safety concerns. Immunocompromised individuals may be vaccinated as they may be at greater risk from COVID-19.
The EMA notes that "animal studies show no harmful effect on pregnancy, however data on the use of Comirnaty during pregnancy are very limited. Although there are no studies on breastfeeding, there is not expected to be a risk to breastfeeding."
"The decision to administer the vaccine to pregnant women should be taken in close monitoring with a healthcare professional, taking into account the benefits and risks," it says.
"People who already know that they have an allergy to one of the vaccine ingredients listed in section 6 of the package leaflet should not receive the vaccine," he notes.
"Allergic reactions (hypersensitivity) have been observed in people who have been vaccinated. A very small number of cases of anaphylaxis (severe allergic reaction) have been observed since the start of the use of the vaccine in vaccination campaigns. Therefore, as with all vaccines, Comirnaty should be administered under close medical supervision and with appropriate medical treatment available. People who have a severe allergic reaction when administering the first dose of Comirnaty should not take the second dose," the EMA says.
Finally, "the most common side effects of Comirnaty during the trial were usually mild to moderate and improved within a few days after vaccination. They included pain and familiarity at the injection site, fatigue, headache, muscle and joint pain, chills and fever. They appeared in more than 1 in 10 people. Erythema at the injection site and nausea occurred in less than 1 in 10 people. Uncommon side effects (occurred in less than 1 in 100 people) included itching at the injection site, pain in the extremities, swollen lymph nodes, difficulty sleeping and feeling sick. Muscle weakness on one side of the face (acute peripheral facial paralysis or personoplegia) rarely occurred in less than 1 in 1,000 people."
Comirnaty has shown "allergic reactions, 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 medical treatment available."
It is noted that The EMA "will review any new information available and this review will be updated accordingly".
The company that markets Comirnaty "will continue to provide results from the main test which will continue for 2 years. This test and additional studies will provide information on the duration of protection, the extent to which the vaccine prevents severe COVID-19 disease, the degree of protection of immunocompromised individuals, children and pregnant women, and on the prevention of asymptomatic events."
With regard to the measures taken for safe and effective use, "recommendations and information on appropriate precautions to be taken by healthcare professionals and patients for safe and effective use have been included in the summary of product characteristics and the package leaflet".
A "Risk Management Plan (GPA) for Comirnaty containing important information on vaccine safety, how to collect further information and how to minimise potential risks" shall also be implemented.
Source: eyenews/KYPE
