Vaccine against Sars-Cov-2

Vaccination involves 2 doses, given at an interval of at least 21 days (Pfizer-BioNTech) or 28 days (Moderna, AstraZeneca), or 1 single dose (Johnson&Johnson). At least 1 booster dose is planned, 4 months after the previous dose. More frail individuals can also have a fourth dose, also 4 months later. Vaccination of children aged 5 to 11 years is planned, only with the Pfizer-BioNTech vaccine, following the same schedule used for others. The dose is one-third of that for adults.

mRNA vaccine (Pfizer-BioNTech, Moderna), or viral vector (AstraZeneca, Johnson&Johnson). Administration is by the intramuscular route.

Comirnaty is the trade name of the first Covid19 vaccine produced by Pfizer and BioNTech licensed by the European Commission in December 2020.

The vaccine, modified at the nucleoside level, is based on mRNA technology, or messenger RNA that transmits to the cells of the vaccinated subject how the antigen is produced.

Features

Comirnaty is presented as a multidose vial (0.45 ml) for dilution, once diluted it contains a total of 6 doses of 0.3 ml each.

Each dose contains 30 micrograms of vaccine in the form of lipid nanoparticles.

Comirnaty can be stored at several degrees below 0, so its external appearance is that of a frozen white or whitish dispersion (pH: 6.9-7.9).

Once thawed, it may have opaque amorphous particles that are white to whitish in color.

Vaccine storage.

Storage is at a temperature of -90 °C to -60 °C and should not exceed 6 months.

Once thawed, the vial cannot be refrozen.

There is an option to store the vaccine at a higher temperature once taken out of the freezer, for a period of 5 days between 2 °C and 8 °C, and up to 2 hours at a temperature not exceeding 30 °C.

Once removed from the freezer (<-60 °C), trays of closed-top vials containing 195 vials can remain at room temperature (<25 °C) for up to 5 min to allow transfer between ultra-low temperature environments. After being transferred back to the freezer following exposure to room temperature, trays of vials must remain in the freezer for at least 2 hours before they can be taken out again.

Thawing before dilution

To allow for dilution, each vial should be thawed by transferring it to a room temperature between 2 °C and 8 °C.

A 195-pack that is to be used immediately thaws in about 30 minutes at a temperature not exceeding 30 °C.

Following the approval of the Comirnaty vaccine, manufactured by Pfizer-BioNTech, Moderna's is the second vaccine to receive a recommendation for conditional marketing authorization from EMA on 06/06/2021.

COVID-19 VACCINE MODERNA is indicated for active immunization in the prevention of COVID-19, a disease caused by SARS-CoV-2 virus, in individuals aged 18 years and older. COVID-19 VACCINE MODERNA contains mRNA inserted into lipid nanoparticles. The mRNA encodes for the entire spike protein of SARS-CoV-2, modified via 2 proline substitutions within the seven-peptide repeat (S-2P) domain to stabilize it in pre-fusion conformation. Following intramuscular injection, cells at the injection site and draining lymph nodes absorb the lipid nanoparticles, managing to release within them the mRNA sequence for translation into viral protein. The delivered mRNA does not enter the human cell nucleus or interact with the genome; it is non-replicating and its expression is transient, mainly by dendritic cells and subcapsular sinus macrophages. The spike protein of SARS-CoV-2, expressed and membrane-bound, is then recognized by immune cells as a foreign antigen. This̀ induces a response of both T cells and B cells that generate neutralizing antibodies, which can contribute to protection against COVID-19.

The vaccine should be administered intramuscularly. The preferred site is the deltoid region of the arm. The vaccine course includes two doses (0.5 ml each) 28 days apart. Vaccinated individuals may not be fully protected until 14 days after receiving the second dose.
The vaccine is contraindicated in cases of hypersensitivitỳ to the active ingredient or any of the excipients.

COVID-19 MODERN VACCINE.

• is available in multi-dose vials.
• One vial contains 10 doses of 0.5 ml.
• Unopened vials should be stored frozen in a freezer at a temperature between -25 °C and -15 °C and in the original box to protect the medicine from light.
• must be thawed before use (2 hours and 30 minutes in a refrigerator between 2 °C and 8 °C, or 1 hour at room temperature between 15 °C and 25 °C).
• Once thawed, the vaccine should not be refrozen. The vaccine, in closed (unperforated) vials, caǹ be stored in a refrigerator at 2 °C to 8 °C, protected from light, for up to 30 days and caǹ be stored at 8 °C to 25 °C for up to 12 hours after it is removed from the freezer.
• Once thawed, the vaccine is ready for use. The vial should not be diluted.
• The vial should not be shaken. After thawing and before each withdrawal gently swirl the vial. Ten (10) doses (of 0.5 ml each) may be drawn from each vial.
• The syringe dose should be used immediately.
  After withdrawal of the first dose (perforated vial), the vial remains chemically and physically stable for 6 hours at a temperature between 2 °C and 25 °C.
• For each vial, it is recommended to note the date and time of the first use of the first use on the vial label and to discard the punctured vial 6 hours after the first puncture.

Astrazeneca vaccine and calssified as a viral vector vaccine.