Modern anti-Covid vaccine, here are how it works and Spikevax side effects

Modern anti-Covid vaccine, here’s how it works and what are the side effects of Spikevax.

the Spikevax vaccine (formerly COVID-19 Modern mRNA-1273), as theaifais a vaccine designed to prevent disease Coronavirus 2019 (COVID-19) for people aged 12 and over.

This is the second COVID-19 vaccine approved by the 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 with 93.6% from 14 days after managing the second dose.
  • * Extra dose and dose”Amplifier” – the additional dose is given 28 days after the last dose; the dose “Booster“(Booster vaccination) can be administered after four months (120 days) after the completion of the primary vaccination course, regardless of the previously used vaccine (Circular No. 59207 of December 24, 2021, Note of the Extraordinary Commissioner of December 28, 2021). “Booster” of the Spikevax vaccine is 50 mcg in 0.25 ml, which is half the dose used for the primary vaccination course.

  • * Preservation method
    – in the freezer at a temperature between -25 °C and -15 °C it can be stored unopened between +2 °C and +8 °C for 30 days

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 the protein top of the SARS-CoV-2 virus. So the vaccine it doesn’t deliver the actual virus into the cells, just the genetic information the cell needs to make copies of the protein top. The mRNA used does not remain in the body but is broken down shortly after vaccination.

Here she is Circular 12/06/2021 – Update to the Advanced Vaccine Information Notice

What is a modern COVID-19 vaccine and what is it used for?

The modern COVID-19 vaccine is used to prevent 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 defences) to produce antibodies and blood cells that are active against the virus, thus providing protection against COVID-19. Because the modern COVID-19 vaccine does not contain the virus to induce immunity, it cannot transmit COVID-19.

What you need to know before you get the modern COVID-19 vaccine

Vaccine COVID-19 Moderna should not be given if you are allergic to the active substance or any of the other ingredients of this medicine (listed below).

Warnings and Precautions

Talk to your doctor or healthcare provider at the vaccination center before you get the vaccine if:

  • • * have had a severe allergic reaction or breathing problems in the past after being injected with any other vaccine or after receiving the modern COVID-19 vaccine;
    • * passed out after an injection;
    • * have a serious illness or infection with a high fever. However, if you have a low-grade fever or an upper respiratory infection (e.g. a cold), you can still be given the vaccine;
    • * have bleeding problems, bruise easily or if you are taking medicines to prevent blood clots;
    • * have a weakened immune system due to a disease such as HIV infection or medicines that affect the immune system such as corticosteroids.

Other medicines and modern COVID-19 vaccine

Tell your doctor or healthcare provider at the vaccination center if you are using, have recently used or might use any other medicines, or have recently received any other vaccine.

pregnancy and breast feeding period

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 you are given this vaccine. There are limited data from the use of the modern COVID-19 vaccine in pregnant women. Animal testing indicates no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Administration of the modern COVID-19 vaccine during pregnancy should only be considered if the potential benefits outweigh the potential risks to the mother and fetus.

Duration of protection and limits of vaccine efficacy

The duration of protection of the vaccine is not known; clinical trials are still ongoing to establish it. As with all vaccines, vaccination with the modern COVID-19 vaccine may not protect all who receive it. People may not be fully protected for up to 14 days after the second dose of vaccine. It is therefore imperative to continue to strictly follow public health recommendations (face mask, distance and frequent hand washing).

How the modern COVID-19 vaccine is administered

The COVID-19 Moderna vaccine is given as an intramuscular injection in the upper arm. There is a booster dose and it is recommended that the second dose of the same vaccine is given 4 weeks (and in any case no later than 42 days) after the first dose to complete the vaccination cycle. It is very important that the second administration is done to achieve an optimal immune response. If you forget to return to the scheduled date for the second dose, please contact your doctor or the vaccination center where the first dose was administered. The modern COVID-19 vaccine can be used to complete a mixed course of vaccination in people 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 it 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
    • * A headache
    • * Nausea, vomiting
    • * Muscle, joint pain and stiffness
    • * Pain or swelling at the injection site
    • * Feeling of extreme tiredness
    • * Chills, fever
  • frequent 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 flaccid facial paralysis (Bell’s palsy)
    • * Facial swelling (facial swelling may occur in patients who have previously received facial cosmetic injections)

Not known (frequency cannot be estimated from the available data): severe allergic reaction; hypersensitivity.

If you notice any side effects, even if they are not listed above, talk to your doctor or contact the vaccination center.

It can also Report side effects directly through the national reporting system
(https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse).

What the modern COVID-19 vaccine contains

The active substance 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 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 known risk of myocarditis and pericarditis following vaccination with 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), the other was based on data from the Nordic registry.

Based on the reviewed data, the PRAC has made this determination the overall risk for these two events is “very rare”, meaning up to 1 in 10,000 vaccinated people may be affected. In addition, the data show that the increased risk of myocarditis after vaccination is greater in younger men. The PRAC therefore recommended updating the product information to reflect this data.

Myocarditis and pericarditis can develop within days of vaccination and most cases have occurred within 14 days. They were observed more frequently after the second administration.

The French and Nordic studies provide estimates of the number of excessive cases of myocarditis in younger men after the second dose compared to unexposed subjects of the same age and sex.
Myocarditis and pericarditis are inflammatory heart diseases that present with a range of symptoms, including shortness of breath, a fast heartbeat that can be irregular (palpitations), and chest pain. Available data indicate that the course of post-vaccination myocarditis and pericarditis does not differ from myocarditis or pericarditis in the general population.

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