COVID-19 Vaccine Pfizer-BioNTech mRNA (Nucleoside Modified)

Registered indications:

• Active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus

Contraindications

International manufacturer recommendations

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

International manufacturer recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment 
• Acute severe febrile illness or acute infection (See additional prescribing points)
• Thrombocytopenia
• Any coagulation disorder, such as haemophilia
• Immunocompromised or immunosuppressed individuals
• Coadministration with anticoagulant therapy
• Coadministration with immunosuppressant therapy
• May impair ability to drive or operate machinery

Forms avail. in SA and covered in this monograph: inj

Dosages below include:

• International manufacturer recommendations
• South African recommendations (In practice)

International manufacturer recommendations

Active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus

• IM: 1st dose: 0.3ml; 2nd dose: 0.3ml, given 3 weeks (21 days) after the 1st dose

 Although according to international manufacturer recommendations it is recommended to administer the second dose 3 weeks after the first dose, the use of this vaccine should be in accordance with official recommendations

The vaccine should be administered intramuscularly (IM). The preferred site is the deltoid muscle of the upper arm

The vaccine should be administered after dilution (See additional prescribing points)

There are no data available on the interchangeability with other COVID-19 vaccines to complete the vaccination course. Individuals who have received 1 dose of COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified) should receive a 2^nd dose of the same vaccine to complete the vaccination course

Close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified)

See additional prescribing points for handling instructions

South African recommendations (In practice)

Active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus 

• IM: 1st dose: 0.3ml; 2nd dose: 0.3ml, given 6 weeks (42 days) after the 1st dose
  Refer to South African National Department of Health: Vaccination Information Portal

There are no South African manufacturer recommendations available for COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified). The above information is according to official guidelines available on the South African National Department of Health's Vaccine Information Portal

There is limited information available regarding the current scheduling status of the COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified) in South Africa

Forms avail. in SA and covered in this monograph: inj

Dosages below include:

• International manufacturer recommendations
• South African recommendations (In practice)

International manufacturer recommendations

Active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus

Younger than 12 years

• Not established for use

12 years and older

• See adult dosage

South African recommendations (In practice)

Active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus 

Younger than 16 years

• Not established for use

16 years and older

• See adult dosage
  Refer to South African National Department of Health: Vaccination Information Portal

There are no South African manufacturer recommendations available for COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified). The above information is according to official guidelines available on the South African National Department of Health's Vaccine Information Portal

There is limited information available regarding the current scheduling status of the COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified) in South Africa

Pregnancy

International manufacturer recommendations

• Caution
• There is limited experience with use of COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified) in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/ foetal development, parturition or post-natal development
• Administration in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus

Breastfeeding

International manufacturer recommendations

• Caution; no information available
• It is unknown whether COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified) is excreted in human milk

Fertility

International manufacturer recommendations

• Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity

Renal Impairment

International manufacturer recommendations

• Caution; no information available 

Hepatic Impairment

International manufacturer recommendations

• Caution; no information available

Elderly

International manufacturer recommendations

• No dose adjustment recommended

Drugs in Sport

• Permitted - No warnings
  See COVID-19: Athlete Q&A

Central Nervous System Disorders

• Headache
• Acute peripheral facial paralysis
• Fatigue
• Insomnia

Cardiovascular Disorders

• Myocarditis
• Pericarditis

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting

Musculoskeletal Disorders

• Arthralgia
• Myalgia
• Pain in extremity (In vaccinated arm)

Skin and Subcutaneous Tissue Disorders

• Injection site reactions:
  - Pain
  - Swelling
  - Pruritus
  - Redness

Immune, Blood and Lymphatic System Disorders

• Lymphadenopathy
• Hypersensitivity reactions
  - Rash
  - Pruritus
  - Urticaria
  - Angioedema
• Anaphylaxis
• Chills
• Fever

Others

• Extensive swelling of vaccinated limb
• Facial swelling (In patients with a history of injection of dermatological fillers)

None known 

• Hypersensitivity and anaphylaxis (for 15mins following administration)
  - Observe for 30mins following administration in patients with a history of anaphylaxis, allergic reaction of any severity or a contraindication to a different type of COVID-19 vaccine

Additional observations

• Signs and symptoms of anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions

Handling instructions

- Thawing prior to dilution

• The multidose vial is stored frozen and must be thawed prior to dilution
• Frozen vials should be transferred to an environment of 2°C-8°C to thaw. A 195 vial pack may take 3 hours to thaw. Alternatively, frozen vials may also be thawed for 30 minutes at temperatures up to 30°C for immediate use
• The unopened vial can be stored for up to 1 month at 2°C-8°C. Within the 1-month shelf-life at 2°C-8°C, up to 12 hours may be used for transportation
• Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake
• Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles

 Once thawed, the vaccine should not be re-frozen

- Dilution

• The thawed vaccine must be diluted in its original vial with 1.8ml sodium chloride 9mg/ml (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques
• Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.8ml air into the empty diluent syringe
• Gently invert the diluted dispersion 10 times. Do not shake
• The diluted vaccine should present as an off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present
• The diluted vials should be marked with the appropriate date and time
• After dilution, store at 2°C-30°C and use within 6 hours, including any transportation time
• Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use

- Preparation of individual (0.3ml) doses

• After dilution, the vial contains 2.25ml from which 6 doses of 0.3ml can be extracted
• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab
• Withdraw 0.3ml of the vaccine
• Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres
• If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial
• Each dose must contain 0.3ml of vaccine
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3ml, discard the vial and any excess volume
• Discard any unused vaccine within 6 hours after dilution

Acute severe febrile illness or acute infection

• Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination

Traceability

• In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded

Coadministration with other vaccines 

• The concomitant administration of COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified) with other vaccines has not been studied

Limitations of vaccine effectiveness

• As with any vaccine, vaccination with administration of COVID-19 vaccine Pfizer-BioNTech mRNA (nucleoside modified) may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine

The nucleoside-modified messenger RNA is formulated in lipid nanoparticles, which enable delivery of the non replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen. The mRNA codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.

Injection (per 0.45ml vial) (180μg)

• Comirnaty (BioNTech-Pfizer)

There is limited information regarding the available formulations in South Africa