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Vaccine Day is upon us. And so, from Aifa, the Italian drug agency, comes more and more details about the storage, thawing, dilution, administration and disposal of the precious vials of Pfizer-BionTech, the first serum to receive marketing authorization. The first 9,750 doses have already arrived in Italy from Belgium and are now kept in Spallanzani; from there they will depart for the rest of the regions, with the exception of the 955 destined for Lazio. The first small contingent to which new supplies will be added in the coming days for the start of the January vaccination campaign.
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Aifa reminds first of all that the vaccine is intended for citizens aged 16 or over. The vaccine is administered in a cycle of two doses: the first on the so-called “day 0” with an intramuscular injection of 0.3 milliliters (containing 30 micrograms of mRna vaccine against Covid-19, encapsulated in lipid nanoparticles); the second after at least 21 days. Obviously, the preparation will be carried out only by authorized health workers who will use aseptic techniques, to guarantee the sterility of the prepared dispersion.
The preferred injection site is the deltoid muscle in the upper arm.
Currently, there are no data on the interchangeability of Pfizer vaccine with other vaccines, so after the first dose, patients will need to receive a second dose of the same type to complete the vaccination cycle. Each vaccinated person will be provided a reminder card for traceability with the date they will have to return for the second administration.
Covid vaccines, here is everything you need to know about vials
edited by Viola Giannoli
storage
The vaccine should be stored in the freezer between -90 ° C and -60 ° C in the original package to protect from light. During storage, exposure to ambient light should be minimized and exposure to direct sunlight and ultraviolet light should be avoided. Thawed vials can be handled in ambient light conditions.
Once removed from the freezer, open-top vial trays or vial trays containing less than 195 vials can remain at room temperature (<25 ° C) for up to 3 minutes to allow vial removal or transfer between Environments. ultra-low temperature. When a vial is removed from the tray, it must be thawed for use. After being returned to the freezer after being exposed to room temperature, the vial trays must remain in the freezer for at least 2 hours before they can be removed again.
Defrosting
The multidose vial is stored frozen and must be thawed prior to dilution. The frozen vials should be transferred to 2-8 ° C to thaw; Thawing a pack of 195 vials can take 3 hours. Alternatively, the frozen vials can be thawed for 30 minutes at a temperature not to exceed 30 ° C for immediate use. The thawed vial should be allowed to come to room temperature and then gently inverted 10 times before diluting without shaking. Before dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
Dilution
The thawed vaccine should be diluted in its original vial with 1.8 ml of sodium chloride 9 mg / ml (0.9%) solution for injection, using a 21 gauge needle or finer and aseptic techniques. The pressure in the vial should stabilize before removing the needle from the vial stopper by aspirating 1.8 ml of air into the empty solvent syringe.
The diluted dispersion is then gently inverted 10 times without shaking. The diluted vaccine should appear as a whitish dispersion with no visible particles. In the presence of particles or in case of discoloration, the diluted vaccine must be discarded. After dilution, the expiration date should be noted on the vials.
The diluted dispersion must not be frozen or shaken. If refrigerated, the diluted dispersion should be allowed to reach room temperature before use.
Single-dose preparation
After dilution, the vial contains 2.25 ml, corresponding to 5 doses of 0.3 ml. The required dose of 0.3 ml of diluted vaccine must be drawn with a sterile needle. Any unused vaccine should be discarded within 6 hours of dilution.
Precautions
After vaccination, close monitoring is recommended for at least 15 minutes. Do not give the second dose of the vaccine to people who have experienced anaphylaxis with the first dose of the Pfizer vaccine. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress-related reactions, as a psychogenic response to needle injection, can occur in association with vaccination. It is important that precautions are taken to avoid injury from fainting. Vaccination should be postponed in people with severe acute fever or acute infection. The presence of a mild infection and / or mild fever should not lead to postponement of vaccination.
As with all intramuscular injections, the vaccine should be administered with caution to people undergoing anticoagulation therapy or who have thrombocytopenia or any bleeding disorder (eg, Hemophilia), as these people may experience bleeding or bruising after administration. intramuscular. The efficacy, safety, and immunogenicity of the vaccine have not been evaluated in immunosuppressed subjects, including those receiving immunosuppressive therapy. Efficacy may be lower in immunosuppressed individuals. The vaccine is not expected to affect the ability to drive and use machines, although some side effects may temporarily affect the ability to drive or use machines.
Effectiveness and duration
The duration of protection offered by the vaccine is unknown; clinical trials are still underway to establish it. As with all vaccines, vaccination may not protect everyone who receives it. People may not be fully protected for up to 7 days after the second dose of the vaccine. Interaction studies with other drugs have not been performed. Co-administration with other vaccines has not been studied.
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Fertility, pregnancy and lactation
Data on pregnant women are limited. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. In any case, administration during pregnancy should only be considered if the potential benefits outweigh the potential risks to the mother and fetus. It is not known if the vaccine passes through breast milk. Studies in animals do not indicate direct or indirect harmful effects on fertility and reproductive capacity.
Side effects
The safety of the vaccine was evaluated in subjects 16 years of age or older in 2 clinical studies involving 21,744 participants who received at least one dose. The most common adverse reactions were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%) , pyrexia and swelling at the injection site (> 10%). These reactions were generally mild to moderate in intensity and resolved within a few days of vaccination. A slightly lower frequency of reactogenicity reactions was associated with higher age.
