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VACCINE MALARIA R21, 1 dose, multidose 1ml vial

https://medicalguidelines.msf.org/en/node/258
https://unicat.msf.org/cat/product/91808
STD DVACVMAL1VD

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Article is intended to be used with children (<12 years) ONLY.
19.3 - Vaccines
Classification of the medicines in groups and subgroups according to their therapeutic use. The classification used by MSF is based on the WHO Model List of Essential Medicines.
J07XA01
Anatomical Therapeutic Chemical Classification according to WHOCC
0208
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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VACCINE MALARIA R21

CAUTION

This vaccine is worded and codified by unit (= 1 dose) to make the order easier, but it is usually packaged in multidose vial of 2doses.

Full Name

Synonym: R21 Malaria Vaccine/Matrix-M1

Therapeutic Action

Recombinant, adjuvanted vaccine composed of:

  • R21 malaria antigen
  • Matrix-M1 (adjuvant)

The R21 Malaria Vaccine is a pre-erythrocytic vaccine intended to limit the ability of Plasmodium falciparum to infect, mature and multiply in the liver. It works by predominantly inducing immunity to the circumsporozoite (CS) protein found on the surface of the sporozoite.

Indications

Active immunisation of children aged 5 to 36 months for malaria prevention due to Plasmodium falciparum.

Malaria vaccines are considered “an additional tool” in the malaria prevention arsenal and should not replace existing prevention measures.

Since the malaria vaccine is a new vaccine, pharmaco-vigilance will be an important point of attention in countries introducing the vaccine.

Check the country's malaria vaccine implementation plan to determine if and how MSF can provide support.

Instructions for use

Must be given by IM route in the anterolateral thigh or deltoid muscle.

Each 0.5 ml dose contains 5 mcg R21 malaria antigen and 50 mcg Matrix-M1 (adjuvant)

Posology:

  • Three doses, given one month apart
  • A fourth dose is recommended 12 months after the third dose.

Remark:

Be aware of the operational challenges associated with the 3-dose primary series (plus booster) and the short duration of efficacy of malaria vaccines. Countries will likely to face challenges when integrating malaria vaccines into the EPI program.

Precautions for Use

The R21 malaria vaccine does not provide complete protection against malaria caused by P. falciparum. Other malaria control measures should not be interrupted.

Co-administration of the R21 malaria vaccine with other vaccines is not currently recommended due to the lack of clinical data. If the R21 malaria vaccine must be given at the same time with another injectable vaccine, ensure they are administered at different injection sites.

As with all injectable vaccines and/or immunoglobulins, appropriate medical treatment should be readily available in case of rare anaphylactic reactions following administration of the product.

Storage

  • Keep refrigerated between 2ºC and 8ºC - Protect from sunlight
  • Do not freeze.
  • After vial opening: keep refrigerated between 2ºC and 8ºC for 6 hours maximum