Modern anti-Covid vaccine, here is how it works and what are the side effects of Spikevax.
The Spikevax vaccine (ex COVID-19 Modern mRNA -1273), as theAifa, is a vaccine intended to prevent disease from coronavirus 2019 (COVID-19) in people from 12 years of age.
This is the second COVID -19 vaccine authorized by AIFA in Italy (January 7, 2021), after the Comirnaty vaccine. It contains a molecule called messenger RNA (mRNA) with instructions for making a protein found on SARS-CoV-2, the virus responsible for COVID-19.
- * The effectiveness was rated at 93.6% starting from 14 days after the administration of the second dose.
- * Additional dose and dose “booster” – the additional dose is given 28 days after the last dose; the dose “booster“(booster) can be administered after four months (120 days) from the completion of the primary vaccination course, regardless of the vaccine previously used (Circular No. 59207 of 24 December 2021, Extraordinary Commissioner Note 28 December 2021). “booster” of the Spikevax vaccine is 50 mcg in 0.25 ml, corresponding to half the dose of that used for the primary course.
* Method of conservation – in the freezer at a temperature between -25 ° C and -15 ° C, it is stable between + 2 ° C and + 8 ° C for 30 days if unopened
How the Spikevax Moderna vaccine works
Similar to the Comirnaty developed by Pfizer / BioNTech, the Spikevax vaccine is based on messenger RNA technology: mRNA encodes protein spike of the SARS-CoV-2 virus. The vaccine, therefore, it does not introduce the actual virus into the cells, but only the genetic information that the cell needs to build copies of the protein spike. The mRNA used does not remain in the body, but degrades shortly after vaccination.
Here she is Circular 12/06/2021 – Modern vaccine information note update
What is Modern COVID-19 Vaccine and what it is used for
The Modern COVID-19 Vaccine is used for the prevention of COVID-19, a disease caused by the SARSCoV-2 virus. The Modern COVID-19 Vaccine is given to adults aged 18 and over. The vaccine causes the immune system (the body’s natural defenses) to produce antibodies and blood cells that are active against the virus, thus providing protection against COVID-19. Since the Modern COVID-19 Vaccine does not contain the virus to induce immunity, it cannot transmit COVID-19.
What you need to know before receiving the Modern COVID-19 Vaccine
Vaccine COVID-19 Moderna must not be given if you are allergic to the active substance or to any of the other ingredients of this medicine (listed below).
Warnings and Precautions
Talk to your doctor or health care provider at the vaccination center before receiving the vaccine if:
- • * have had a severe allergic reaction or breathing problems after injecting another vaccine or after receiving the Modern COVID-19 Vaccine in the past;
• * passed out after an injection;
• * have a severe illness or infection with a high fever. However, if you have a mild fever or an upper respiratory infection (such as a cold) you may still be given the vaccination;
• * have a bleeding problem, a tendency to bruise, or if you use medicines to prevent blood clots;
• * have a weakened immune system, due to a disease such as HIV infection, or from medicines that affect the immune system, such as corticosteroids.
Other medicines and Modern COVID-19 Vaccine
Tell your doctor or health care provider at the vaccination center if you are using, have recently used or might use any other medicines, or if you have recently been given any other vaccines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this vaccine. There are limited data on the use of Modern COVID-19 vaccine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Administration of the Modern COVID-19 vaccine during pregnancy should only be considered when the potential benefits outweigh the potential risks to the mother and fetus.
Duration of protection and limitations of vaccine efficacy
The duration of protection offered by the vaccine is unknown; clinical trials are still underway to establish it. As with all vaccines, vaccination with the Modern COVID-19 Vaccine may not protect everyone who receives it. People may not be fully protected up to 14 days after the second dose of the vaccine. It is therefore essential to continue to strictly follow public health recommendations (face mask, spacing and frequent hand washing).
How the Modern COVID-19 Vaccine is given
The COVID-19 Moderna vaccine is given as an intramuscular injection in the upper arm. There is a booster and it is recommended that the second dose of the same vaccine be administered 4 weeks (and in any case no later than 42 days) after the first dose to complete the vaccination course. It is very important that the second administration is performed to achieve an optimal immune response. If you forget to return to the set date for the second dose, please contact your doctor or the vaccination center where the first dose was given. The Modern COVID-19 Vaccine can be used to complete a mixed vaccination course, in subjects under the age of 60 who have already received a first dose of Vaxzevria vaccine, 8-12 weeks after administration of this vaccine.
Possible side effects
Like all vaccines, the Modern COVID-19 vaccine can cause side effects (the so-called side effects, ed), although not all people manifest them. Very common side effects (may affect more than 1 in 10 people):
- • * swelling in the armpits
• * headache
• * nausea, vomiting
• * muscle, joint pain and stiffness
• * pain or swelling at the injection site
• * feeling of extreme tiredness
• * chills, fever - Common side effects (may affect up to 1 in 10 people):
• * rash
• * redness or hives at the injection site - Uncommon side effects (may affect up to 1 in 100 people):
• * itching at the injection site - Rare side effects (may affect up to 1 in 1,000 people):
• * temporary unilateral facial flaccid paralysis (Bell’s palsy)
• * facial swelling (facial swelling may occur in patients who have previously had facial cosmetic injections)
Not known (frequency cannot be estimated from the available data): severe allergic reaction; hypersensitivity.
If you get any side effects, even if not listed above, talk to your doctor or contact the vaccination center.
It can also report side effects directly via the national reporting system
(https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse).
What does the Modern COVID-19 vaccine contain
The active ingredient is an anti-COVID-19 mRNA vaccine. The other ingredients are: lipid SM-102, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-dimyristoyl-rac-glycer-3-methoxy polyethylene glycol-2000 (PEG2000 DMG), trometamol , trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.
Update on the risk of myocarditis and pericarditis with mRNA vaccines
Published by AIFA on: 03 December 2021
The EMA Safety Committee (PRAC) has assessed the updated data on the known risk of myocarditis and pericarditis following vaccination with the COVID-19 Comirnaty and Spikevax vaccines which included two large European epidemiological studies. One study was conducted using data from the French national health system (Epi-phare) and the other was based on data from the Nordic registry.
Based on the data reviewed, the PRAC determined that the risk for both of these events is overall “very rare”, which means that up to one in 10,000 people who are vaccinated may be affected. Furthermore, the data show that the increased risk of myocarditis after vaccination is greater in younger males. The PRAC therefore recommended updating the product information to reflect these data.
Myocarditis and pericarditis can develop within days of vaccination and most cases have occurred within 14 days. They were observed more often after the second administration.
The French and Nordic studies provide estimates of the number of excess myocarditis cases in younger males after the second dose, compared to unexposed people of the same age and gender.
Myocarditis and pericarditis are inflammatory heart conditions that have a number of symptoms, including shortness of breath, rapid heartbeat that can be irregular (palpitations), and chest pain. Available data suggest that the course of myocarditis and pericarditis after vaccination is no different from myocarditis or pericarditis in the general population.
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