Registered Rwanda · Rwanda FDA

CYVAC

R21 Malaria Vaccine (Recombinant, Adjuvanted)

Rwanda FDA-HBP-MA-0142 Solution for Injection 5mcg per 0.5mL

What it does

Malaria is a serious disease caused by parasites transmitted through mosquito bites. It can cause fever, chills, and flu-like symptoms.

Commonly used for: malaria (malaria infection)

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
Rwanda FDA-HBP-MA-0142
Registration date
04/02/2025
Expiry date
03/02/2030
Status
Registered
Active ingredient
R21 Malaria Vaccine (Recombinant, Adjuvanted)
Strength
5mcg per 0.5mL
Pack size
Pack of 50 Vials
Therapeutic class
-
Manufacturer / MAH
Serum Institute Of India
Country of origin
India
Manufacturer location
Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-21 02:30:19

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About malaria

Malaria is a serious disease caused by parasites transmitted through mosquito bites. It can cause fever, chills, and flu-like symptoms.

What it treats

  • malaria (malaria infection)

How it works

Medicines for malaria work by killing the parasites that cause the disease or preventing them from multiplying.

Who it's for

Malaria treatment is for anyone diagnosed with malaria, especially those living in or traveling to areas where the disease is common.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About vaccine

Vaccines help protect against certain diseases by training your immune system to recognize and fight off specific germs.

What it treats

  • prevention of infectious diseases
  • immunization against viruses and bacteria

How it works

Vaccines stimulate your body's immune system to produce a response, creating memory cells that help fight off future infections.

Who it's for

Vaccines are for everyone, especially infants, children, and adults who need protection against certain diseases.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: malaria

Malaria is a serious, potentially fatal disease caused by Plasmodium parasites, transmitted to humans through the bite of infected female Anopheles mosquitoes. The primary symptoms include fever, chills, and flu-like illness, which can progress to severe complications if left untreated. Antimalarial drugs are essential for treatment and prevention, targeting various stages of the parasite's lifecycle.

Indications

  • Acute uncomplicated malaria
  • Severe malaria
  • Malaria prophylaxis
  • Relapse prevention in vivax malaria

Dosage

Children: Refer to BNF for Children for paediatric dosing, as it is determined by age and weight.

Adults: Refer to specific BNF text for adult dosing as it varies by drug and indication.

Mechanism of action

Antimalarial drugs act through various mechanisms depending on the specific medication. For example, chloroquine inhibits the heme polymerase enzyme, preventing the detoxification of heme, which accumulates to toxic levels in the malaria parasite. Quinine interferes with the parasite's ability to metabolize glucose, affecting energy production. Artemisinin derivatives produce reactive oxygen species and alkylate proteins, leading to parasite death.

Pharmacodynamics

Antimalarials exhibit a range of pharmacodynamic properties, including rapid onset of action, with some like artemisinin providing quick relief from symptoms. The efficacy of treatment can vary depending on the drug used, the species of Plasmodium, and the presence of drug-resistant strains. The goal of treatment is to eliminate the parasite, prevent relapse, and reduce transmission.

Pharmacokinetics

Pharmacokinetics of antimalarial drugs varies widely. For example, chloroquine has a long half-life, allowing for once-daily dosing, while artemisinin has a short half-life, necessitating combination therapy for sustained efficacy. Absorption rates can be affected by food intake, and distribution is typically extensive with high protein binding. Metabolism primarily occurs in the liver, and excretion is mainly through urine.

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain
  • Headache
  • Dizziness
  • Rash
  • Visual disturbances
  • Hearing loss
  • Severe allergic reactions

Interactions

  • Antacids may reduce absorption of certain antimalarials
  • Drug metabolism may be altered by concomitant use of other medications, such as certain anticonvulsants or antibiotics

Precautions

  • Use cautiously in patients with hepatic or renal impairment
  • Monitor for signs of hematological reactions in patients receiving long-term therapy
  • Consider potential resistance in endemic areas

Pregnancy

Some antimalarials are contraindicated in pregnancy, while others are considered safe. Consult local guidelines for specific medications.

Breast-feeding

Many antimalarials are excreted in breast milk, but some are considered safe for use during breastfeeding. Consult local guidelines for specific medications.

Storage

Store at room temperature, away from moisture and heat. Check specific product labeling for detailed storage instructions.

Formulations

  • Oral tablets
  • Intravenous formulations
  • Suspensions
  • Combination therapies

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: vaccine

Vaccines are biological preparations that provide acquired immunity to a particular infectious disease. They contain antigens that stimulate the immune system to recognize and fight pathogens without causing the disease itself. Vaccines can be made from live attenuated pathogens, inactivated pathogens, subunit components, or mRNA. They are crucial in preventing infectious diseases and have significantly reduced morbidity and mortality worldwide.

Indications

  • Prevention of infectious diseases such as measles, mumps, rubella, hepatitis B, influenza, and human papillomavirus (HPV)
  • Travel vaccinations for diseases endemic to certain regions
  • Vaccination for at-risk populations, such as those with compromised immune systems or specific occupational exposures

Dosage

Children: Dosage varies by vaccine type and age; refer to the BNF for Children for specific dosing information.

Adults: Dosage varies by vaccine type and indication; refer to specific guidelines for each vaccine.

Mechanism of action

Vaccines work by mimicking an infection. They introduce a harmless component of a pathogen (antigen) to the immune system, prompting the body to produce an immune response. This includes the generation of antibodies and memory cells that provide long-term immunity. Upon subsequent exposure to the actual pathogen, the immune system is primed to respond more rapidly and effectively.

Pharmacodynamics

The pharmacodynamics of vaccines involves the activation of both humoral and cellular immunity. Vaccines stimulate B cells to produce antibodies against the pathogen, while T cells are activated to destroy infected cells. This dual response helps to establish immunological memory, which enables a faster and more robust response upon re-exposure to the pathogen.

Pharmacokinetics

Vaccines are administered via various routes, including intramuscular, subcutaneous, and oral. After administration, the antigens are presented to antigen-presenting cells, which activate T cells and stimulate B cell proliferation and differentiation. The half-life of vaccine-induced immunity varies depending on the type of vaccine, with some providing lifelong immunity and others requiring booster doses to maintain protection.

Contra-indications

  • Severe allergic reaction (anaphylaxis) to a component of the vaccine
  • Severe immunocompromised state for live attenuated vaccines

Adverse effects

  • Local reactions at the injection site (pain, redness, swelling)
  • Fever
  • Fatigue
  • Headache
  • Muscle pain
  • Joint pain
  • Nausea

Interactions

  • Immunosuppressive medications may reduce vaccine efficacy
  • Concurrent administration of some vaccines may require spacing to optimize immune response

Precautions

  • History of allergic reactions to vaccines or vaccine components
  • Pregnancy (specific vaccines may be contraindicated)
  • Moderate to severe acute illness with or without fever

Pregnancy

Consult healthcare provider. Some vaccines are contraindicated during pregnancy, while others are recommended.

Breast-feeding

Generally considered safe, but consult healthcare provider regarding specific vaccines.

Storage

Store in a refrigerator at 2-8°C. Do not freeze. Protect from light.

Formulations

  • Liquid suspension for injection
  • Lyophilized powder for reconstitution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.