The nucleoside-modified messenger RNA in COVID-19 mRNA vaccine BNT162b2 is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen.
The vaccine elicits both neutralizing antibody and cellular immune responses to the spike ( S ) antigen, which may contribute to protection against COVID-19 disease.
Special warnings and precautions for use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
The administration of COVID-19 mRNA vaccine BNT162b2 should be postponed in individuals suffering from acute severe febrile illness.
Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection, should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration.
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. No data are available about concomitant use of immunosuppressants.
As with any vaccine, vaccination with BNT162b2 vaccine may not protect all vaccine recipients.
No data are available on the use of BNT162b2 in persons that have previously received a full or partial vaccine series with another COVID-19 vaccine.
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of vaccine BNT162b2 with other vaccines has not been studied.
It is advisable not to mix vaccine BNT162b2 with other vaccines / products in the same syringe.
Fertility, pregnancy and lactation
Pregnancy - There are no or limited amount of data from the use of BNT162b2 vaccine.
Animal reproductive toxicity studies have not been completed. Vaccine BNT162b2 is not recommended during pregnancy.
For women of childbearing age, pregnancy should be excluded before vaccination.
In addition, women of childbearing age should be advised to avoid pregnancy for at least 2 months after their second dose.
Breast-feeding - It is unknown whether vaccine BNT162b2 is excreted in human milk. A risk to the newborns / infants cannot be excluded.
Vaccine BNT162b2 should not be used during breast-feeding.
Fertility - It is unknown whether vaccine BNT162b2 has an impact on fertility.
Effects on ability to drive and use machines
Vaccine BNT162b2 has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions may temporarily affect the ability to drive or use machines.
The safety of BNT162b2 vaccine was evaluated in participants 16 years of age and older in two clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America.
Study BNT162-01 ( Study 1 ) enrolled 60 participants, 18 through 55 years of age. Study C4591001 ( Study 2 ) enrolled approximately 44,000 participants, 12 years of age or older.
In Study 2, a total of 21,720 participants 16 years of age or older received at least one dose of BNT162b vaccine and 21,728 participants 16 years of age or older received placebo.
Out of these, at the time of the analysis, 19,067 ( 9531 vaccine BNT162b2 and 9536 placebo ) were evaluated for safety 2 months after the second dose of BNT162b2 vaccine.
Demographic characteristics were generally similar with regard to age, gender, race and ethnicity among participants who received COVID-19 mRNA vaccine and those who received placebo. Overall, among the participants who received BNT162b2, 51.5% were male and 48.5% were female, 82.1% were White, 9.6% were Black or African American, 26.1% were Hispanic / Latino, 4.3% were Asian and 0.7% were Native American / Alaskan native.
The most frequent adverse reactions in participants 16 years of age and older were pain at the injection site ( more than 80% ), fatigue ( more than 60% ), headache ( more than 50% ), myalgia ( more than 30% ), chills ( more than 30% ), arthralgia ( more than 20% ) and pyrexia ( more than 10% ) and were usually mild or moderate in intensity and resolved within a few days after vaccination.
If required, symptomatic treatment with analgesic and/or anti-pyretic medicinal products ( e.g. Paracetamol-containing products ) may be used.
Adverse reactions reported in clinical studies are listed per MedDRA system organ class, in decreasing order of frequency and seriousness: Very common: headache, injection-site pain, fatigue, chills, pyrexia, arthralgia, myalgia; Common: nausea, redness at injection site, injection site swelling; Uncommon: lymphadenopathy, malaise. ( Xagena )
Source: MHRA - Medicines and Healthcare products Regulatory Agency, 2020