Frequently Asked Questions (FAQs) About CORBEVAX

These FAQs are excerpts from the Fact Sheet

  • COVID-19 disease is caused by a coronavirus called SARS-CoV-2. This type of coronavirus has not been seen before. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory illness that can affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever or chills; cough; shortness of breath; fatigue; muscle or body aches; headache; new loss of taste or smell; sore throat; congestion or runny nose; nausea or vomiting; diarrhoea.

  • CORBEVAX is a protein sub-unit vaccine, developed from a component of the spike protein on the virus's surface, which helps the body build the immune response against the virus.

    The vaccine has the Receptor Binding Domain (RBD) protein as an antigen, CpG 1018 and Aluminium hydroxide as adjuvants formulated in Tris buffer.

    • Tell the healthcare provider/Doctor about all of your medical conditions, including:
    • If you have ever had a severe allergic reaction (anaphylaxis) after any drug, food, any vaccine or any ingredients of CORBEVAX
    • If you have fever or severe infection
    • If you have a bleeding disorder or are on a blood thinner
    • If you are immunocompromised or are on a medicine that affects your immune system
    • If you are pregnant or plan to become pregnant and lactating women
    • If you have received another COVID-19 vaccine

    If you have any of the above conditions, you should consult your healthcare provider/Doctor before deciding to take the vaccine.

  • CORBEVAX has been approved for restricted use in emergency situation in individuals aged 5 years and above.

    CORBEVAX can also be administered as a booster dose in individuals aged 18 years and above at ≥6 months after completion of primary immunization with 2 doses of CovishieldTM or Covaxin

  • You should not get the CORBEVAX if you:

    • Had a severe allergic reaction after a previous dose of this vaccine
    • Hypersensitivity to any component of a vaccine or a vaccine containing similar components
    • History of severe allergic reactions
    • If you are suffering from common cold, runny nose, fever, cough, body ache or loose motions etc
    • Pregnancy and the period of lactation
    • Individuals aged below 5 years
  • The CORBEVAX includes the following ingredients:

    • Aluminium Hydroxide gel as Al+++
    • CpG 1018
    • Buffer (Tris and NaCl in WFI)
  • The CORBEVAX will be given to you as an intramuscular (IM) injection only, preferably in the deltoid muscle. The CORBEVAX vaccination course consists of two separate doses of 0.5 mL each.

    If you receive one dose of the CORBEVAX , then the second dose should be administered at least 4 weeks after the first dose. After the vaccine is administered, you will be monitored by a healthcare professional for 30 minutes.

    If you miss your second dose;

    If you forget to go back at the scheduled time, ask your healthcare provider/Doctor for advice. It is important that you return for your second dose of CORBEVAX .

  • The CORBEVAX is used in clinical trials, a number of participants received one or two doses in Indian trials.

    The vaccine is also being in use in individuals aged 12 years to 14 years as part of immunization program in India.

  • In ongoing clinical trials, the CORBEVAX has been shown to prevent COVID-19 disease following 2 doses given at 4 weeks' interval. The duration of protection against COVID-19 disease is currently unknown. You may get protective immune response 4 weeks after the second dose of CORBEVAX .

    It is important to appreciate that receiving the vaccine does not mean that other precautions related to COVID-19 need not be followed. All Covid-19 precautions such as maintaining physical distance from others, wearing mask in public and cleaning your hands frequently with alcohol-based hand rub or soap and water need to followed even after receiving the vaccine dose.

  • Side effects that have been reported with the CORBEVAX include:

    Systemic:

    Common (may affect up to 1 in 10 people)

    • Fever/Pyrexia
    • Headache
    • Fatigue
    • Body pain
    • Myalgia
    • Nausea

    Uncommon (may affect up to 1 in 100 people)

    • Arthralgia
    • Urticaria
    • Chills
    • Lethargy

    Local:

    Very common (may affect up to ≥1 in 10 people)

    • Injection site pain

    Common (may affect up to 1 in 10 people)

    • Injection site erythema

    Uncommon (may affect up to 1 in 100 people)

    • Injection site swelling
    • Injection site rash
    • Injection site pruritus

    Rare (may affect up to 1 in 1000 people)

    • Injection site irritation

    These may not be all the possible side effects of the CORBEVAX . Serious and unexpected side effects may occur.

    If you notice any side effects not mentioned in this leaflet, please inform your healthcare provider / doctor.

  • If you experience a severe allergic reaction, call or go to the nearest hospital. Call the healthcare provider if you have any side effects that bother you or do not go away.

    In addition, you can report side effects after vaccination to Biological E. Limited, who is the manufacturer of CORBEVAX as below.

    • 24x7 Toll-free Number (For Medical and Adverse Event Related Queries Only): 1800 309 0150 or pharmacovigilance@biologicale.com.

    All adverse events reported will be entered in COWIN App by the health care provider.

  • It is your choice to receive or not receive the CORBEVAX . You may prefer to consult your healthcare provider.

  • There is no information on the use of the CORBEVAX with other vaccines.

  • Yes. The CORBEVAX can be administered as a booster dose in individuals aged 18 years and above at ≥6 months after completion of primary immunization with 2 doses of CovishieldTM or Covaxin .

    The Phase lll clinical trials conducted with CORBEVAX as a booster dose showed significant increase in neutralizating antibodies (PRNT50) in individuals who completed primary immunization with 2 doses of CovishieldTM or Covaxin .

  • You may discuss your options with the healthcare provider/Doctor.

  • No. The CORBEVAX COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19 infection.

  • When you get your dose, please discuss with your healthcare provider regarding the option of your vaccination record on digital platform, if available.

    • Ask the healthcare provider/Doctor.
    • Consult your local or state public health department.

    For further details, you can write to us using our appropriate email IDs provided in the Contact Us.

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The information on this website is intended for use only by residents of the United States of America. The product information on this site is provided for general information purposes only and is not intended to be a substitute for the actual approved product information. This information is neither medical advice nor a substitute for discussions with a qualified medical professional. The products listed are available only through prescription by a qualified medical professional. BE Pharmaceuticals Inc. and its affiliates shall not be responsible for the reliance on or use of any information contained herein. The reader understands and agrees to the foregoing.

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