[ad_1]
Florence, December 7, 2020 – The Covid Vaccine Pfizer / BioNTech got the green light in United Kingdom. It was the first to be authorized by MHRA, the British institution independent of the European Medicines Agency (EMA). A procedure was used for the ok emergency authorization, based on a continuous review (continuous cyclical review).
Despite being the American vaccine, this choice was also ruled out by Food and Drug Administration, the United States government agency for drug regulation. Ema takes more time to evaluate the data: the decision could be made for the Pfizer vaccine within December 29, that’s why Modern inside January 12. We went to search the British government documents: we found the official information given to the medical staff. For the first time, they are read in black and white. possible interactions, side effects, Pfizer vaccine administration method, efficacy data, people enrolled in the trial phases.
Immunization
The vaccine must be administered twice after at least 21 days. Immunization is achieved 7 days after inoculation of the second dose. Interchangeability with other Covid vaccines has not been studied, so those who perform the first vaccination with a dose of Pfizer should always do the booster. with the same vaccine. Administration is by intramuscular injection in the deltoid: in the arm.
Who can do it
The vaccine can be administered to people of legal age. over 16 years old. Pregnant or nursing women cannot do this. Women of childbearing potential should avoid pregnancy for up to two months after receiving the second dose of the vaccine.
Reactions adverse
The doctor should be informed of any allergic reaction: from redness of the skin to difficulty in breathing, swelling of the face or tongue.
Before the vaccine
Before administration, you should discuss the following with your doctor: any allergic reactions previous administration of vaccines, current severe illness or high fever (whereas intermediate fevers or illnesses such as colds or upper respiratory tract infections do not justify postponement of vaccination), immunosuppressive status, bleeding or clotting disorders, or use of drugs anticoagulants.
Side effects
Among the recurring effects, which occur in more than 10% of people who receive the vaccine: pain in the area where the injection is given, feeling of fatigue, headache, muscle aches, joint pain, chills, fever. Common effects, experienced by 10% of those who received the vaccine: swelling and / or redness at the injection site, redness at the injection site, nausea. Among the rare effects, reported by more than 1% of those who administer the vaccine: swelling of the lymph nodes, general malaise.
Warnings
This medicine does not have a marketing authorization, but the Ministry of Health and UK social assistance from the Regulatory Agency for Active Immunization to prevent Covid 19 disease caused by the SARS-CoV-2 virus in individuals 16 years or older. As with any new medicine in the UK, this product will be closely monitored to allow rapid identification of new safety information. Healthcare professionals are advised to report any suspected adverse reactions.
Safety profile
The safety of the COVID-19 mRNA BNT162b2 vaccine was evaluated in participants aged 16 and older in two clinical trials conducted in the United States, Europe, Turkey, South Africa, and South America. Study BNT162-01 (Study 1) recruited 60 participants, aged 18 to 55 years. Study C4591001 (Study 2) recruited approximately 44,000 participants, 12 years of age and older. In Study 2, a total of 21,720 participants 16 years and older received at least one dose of the COVID-19 mRNA vaccine BNT162b and 21,728 participants 16 years or older received placebo. Of these, 19067 (9531 COVID-19 mRNA Vaccine BNT162b2 and 9536 placebo) were evaluated for safety at the time of analysis 2 months after the second dose of vaccine COVID-19 mRNA BNT162b2 Demographic Characteristics Among trial participants who received the COVID-19 mRNA vaccine and those who received placebo, demographic characteristics were generally similar in age, sex, race, and ethnicity. Overall, among the participants who received the COVID-19 BNT162b2 mRNA vaccine, 51.5% were male and 48.5% female, 82.1% White, 9.6% Black, or African American. 26.1% Hispanic / Latino, 4.3% Asian, and 0.7% Native American / Alaskan.
Adverse reactions
The most common adverse reactions in participants aged 16 years and older were pain during injection (> 80%), fatigue (> 60%), headache (> 50%), muscle aches (> 30%), chills (> 30%), joint pain (> 20%), very high fever (> 10%) and were generally mild or moderate in intensity and resolved within days after vaccination.
Effectiveness
Information is based on participants 16 years of age or older. In this analysis, compared to placebo, the efficacy of the COVID-19 BNT162b2 mRNA vaccine in participants with or without evidence of prior SARS-CoV-2 infection was 94.6% (range 89.9% to 97%). , 3%). There were no significant clinical differences in the overall efficacy of the vaccine in participants who were at risk for severe COVID-19 disease, including those with one or more comorbidities that increase the risk of severe cases (such as asthma, obesity, chronic lung disease, diabetes mellitus, hypertension). Immunosuppressed individuals and people with serious illnesses excluded from the trial. Patients with HIV, HCV, and hepatitis B (Hbv) were enrolled.
The product
Each multidose vial must diluted before use. One vial (0.45 ml) contains 5 doses of 30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles). The Covid-19 mRNA vaccine BNT162b2 is a highly purified 5 ‘encapsulated single-stranded messenger RNA (mRNA) (mRNA) produced by cell-free in vitro transcription from corresponding DNA templates, which encodes the peak protein (S ) SARS-CoV -2 virus.
All stages of preparation
1) Frozen vials should be transferred to 2-8 degrees to thaw; A package of 195 vials can take three hours to thaw. Alternatively, the vials can also be thawed for 30 minutes at temperatures up to 25 degrees for immediate use. Once thawed, the undiluted vaccine can be stored for up to 5 days at 2-8 degrees and up to 2 hours at temperatures up to 25 degrees.
2) Before dilution, the vial should be gently inverted 10 times. Do not tremble. Before dilution, the vaccine should appear as a whitish solution with no visible particles. Discard the vaccine if there are particles or discoloration.
3) The thawed vaccine should be diluted in its original vial with 1.8 ml of sodium chloride (saline), 9 mg / ml (0.9%) solution for injection, using a 21 gauge needle or narrower. Warning: Preservative-free Sodium Chloride – The 9 mg / ml (0.9%) solution for injection is the only diluent to be used. This diluent is not included in the vaccine package.
4) Balance the pressure in the vial before removing the needle from the vial by drawing 1.8 ml of air into the empty syringe.
5) Gently invert the diluted solution 10 times. Be careful not to shake.
6) The diluted vaccine should appear as a whitish solution with no visible particles. Discard the diluted vaccine if particles are visible or if there are signs of discoloration.
7) Diluted vials should be time stamped and stored at 2-25 degrees. Use immediately or within 6 hours after dilution.
8) After dilution, the vial contains 5 doses of 0.3 ml. Withdraw the required dose of 0.3 ml of diluted vaccine using a syringe with a sterile needle and discard any unused vaccine remaining in the vial 6 hours after dilution.
© All rights reserved
