Pastocovac

& 

Pastocovac plus

Product Name

PastoCovac, PastoCovac Plus

 Recombinant Covid-19 vaccine

Description

PastoCovac vaccines against COVID-19 are intramuscularly-injectable suspensions produced from recombinantly-made receptor binding domain (RBD) of S1 protein of SARS-CoV-2 virus capable of attaching to human ACE2 receptor and consequent the virus entry.

Among the strategies to prevent COVID-19 is to induce neutralizing antibodies against SARS-CoV-2. Between the immunodominant proteins of the virus observed in antibodies of the convalescent patients, the spike (S) protein is the most abundant antigen on the surface of the virus.

Pharmacological Information

This protein uses its receptor-binding domain (RBD) to bind to the ACE2 protein on the human target cells for the virus entry. Protein S is found in the form of a trimer with two fundamental domains, namely S1 and S2. S1 contains an independent domain known as the receptor binding domain (RBD). Evidence in the literature indicates that RBD expressed as a recombinant protein is not toxic.

Composition

Receptor-binding domain (RBD) is conjugated to tetanus toxoid and adjuvanted with aluminum hydroxide gel. The vaccines are prepared in two forms, namely PastoCovac as the main vaccine (monovalent conjugate, applied twice within 28 days) and PastoCovac Plus (dimeric RBD as a booster) used as a third dose of a 2 + 1 regimen on the day 56.

The vaccine contains 0.01% thiomersal as preservative.

Pharmaceutical Form

Parenteral injectable suspension, multiple doses (10× 0.5ml doses) fillip off (10R) vial.

Dosage and Administration

PastoCovac is administered (0.5 ml) intramuscularly in 2 doses with 28 days interval. PastoCovac Plus is also administered intramuscularly with a single dose as a booster.

Administration Route

Intramuscular (IM) or deep subcutaneous injection. The deltoid muscle is the recommended site to inject.

Auto-disable syringes (0.5ml) and needle for injection (22 or 23×1) are needed.

Clinical Information Indications

PastoCovac prevents coronavirus disease (COVID-19) caused by the SARS-CoV-2 virus in apparently healthy individuals.

PastoCovac Plus reactivates the pre-existing immune response in the individual exposed to the coronavirus disease (COVID-19) caused

by the SARS-CoV-2 virus and in the individual who is fully vaccinated with other vaccines as a booster.

PastoCovac can be used as a booster.

Vaccination Recommendations:

          •        The vial should be well shaken before use avoiding the formation of foam

          •        Do not freeze

          •        The vaccine should not be diluted

          •        Like other injectable biological products, keep epinephrine vial in reach while vaccination, to be

used in the case of anaphylactic reaction

          •        It should not be administered intravenously or intradermally

          •        The vaccine should not be injected in the gluteal region, as the immunogenicity of the

vaccine is substantially lowered.

Precautions

This vaccine should not be used in the following conditions: 

          •        Receiving tetanus vaccine in recent 3 months.

          •        History of uncontrolled asthma attack in recent 3 months.

          •        Anaphylactic response to any vaccine.

          •        Using immune system suppressant medicines such as corticosteroids, cytostatic, interferon, immunoferon, transfer factor, Biomodulin T, gamma globulin, levamisole, heberferon and thymosin.

Side Effects

Local side effects: soreness, stiffness, redness, pain and swell around the injection site.

Systematic side effects: unusual tiredness or weakness, fatigue, fever, chill, diarrhea, vomiting, nausea and cold symptoms (cough, sore throat, runny nose, sneezing).

Contraindication

          •        Individuals with Febrile diseases, due to a moderate or severe infections, should postpone receiving the vaccine until their conditions improved.

          •        Anaphylactic shock to any type of COVID-19 vaccines.

          •        Severe allergy to vaccine components.

Drug Interactions

Chloroquine, corticosteroids and NSAIDS may reduce immune response and vaccine efficacy.

Pregnancy and Lactation

The effect of the COVID-antigen on fetal and infants development has not been assessed. It is not known whether COVID-19 vaccine passes into the breast milk.

Storage Conditions and Shelf Life

Store between +2°C to +8°C. Do not freeze. The shelf life in this condition is 1 year after production date.

Packaging

Each carton contains 48 boxes and each box contains 10 vials.

Manufactured by

Production and Research Complex, Pasteur institute of Iran.

If you need more information or see any unwanted side effects, please visit: PASTOVIGILANCE.IR