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Can people with liver disease receive the Covid-19 vaccine?

By: Yayasan Peduli Hati Bangsa, 11 February 2021 (from various sources)

When was the COVID-19 vaccine approved for the first time in Indonesia?

On Monday, January 11, 2021, the POM gave an Emergency Use Authorization (EUA) approval for the CoronaVac vaccine, produced by Sinovac Biotech Inc. in collaboration with PT. Bio Farma.


This decision making is based on recommendations received by the BPOM (Indonesian’s Food and Drug Administration) in the form of discussion results formulated in a plenary meeting of members of the National Committee (Komnas) of Drug Evaluation, Expert Team in the field of Immunology, Indonesian Technical Advisory Group on Immunization (ITAGI) and Epidemiologists on the 10th. January 2021. This decision is made based on the results of comprehensive evaluation and discussion of supporting data and scientific evidence that supports the safety, efficacy and quality aspects of vaccines. This emergency use agreement is limited to people aged 18-59 years.

When will Indonesia carry out the first COVID-19 vaccination?

On January 13, 2021, Indonesia carried out its first Covid-19 vaccination.


The implementation of the Covid-19 vaccination has started at 09.00 am WIB at the State Palace, Merdeka, Central Jakarta. The implementation of this first vaccination was initiated by President Joko Widodo (Jokowi) as the first person to be injected. Not only Jokowi, a number of state officials also participated in the implementation of the COVID-19 vaccine.

What is the plan to procure the COVID-19 vaccine in Indonesia?

Change of age restriction for emergency use consent

On February 5, 2021, the Food and Drug Administration (BPOM) made changes to the permit to use CoronaVac which was issued on January 11, 2021. This change includes use for groups of elderly people (seniors) or over 60 years1. More details, information a product from the National Drug Information Center2 states that seniors aged 60 years or over can receive the CoronaVac vaccine (changing the previous license which limits it only to people aged 18-59 years), this vaccine will be injected into the muscle (intramuscular) as much as 0.5 mL in two doses with an interval of 28 days.

What about patients with liver disease?

The following is the research of the Yayasan Peduli Hati Bangsa team for patients with special conditions, especially patients with liver disease:

  1. January 18, 2021: PAPDI’s recommendation regarding the Covid-193 Vaccination3
    1. Patients with liver disease is feasible to be given the COVID-19 vaccine (Sinovac / Inactivated) provided that:
      1. Vaccination loses its effectiveness as liver disease progresses. Therefore, an assessment of the need for vaccination in patients with chronic liver disease should be assessed from the start, when vaccination is most effective / vaccination response is optimal.
      2. If possible, vaccinations are given before liver transplantation..
      3. Vaksin Inactivated lebih dipilih pada pasien sirosis hati
  1. 9 February 2021 (PAPDI’s Recommendation on Giving Covid-19 CoronaVac Vaccination to Patients with Complementary Diseases / Comorbidity) 4
    1. It is not yet feasible to be vaccinated against CoronaVac:
      1. Allergic reactions in the form of anaphylaxis and severe allergic reactions due to the first dose of Coronavac vaccine or due to the same components contained in the Coronavac vaccine.
      2. Systemic autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Sjogren’s, Rheumatoid Arthritis, Vasculitis. Especially for autoimmune thyroid, autoimmune disease, hematology and inflammatory bowel disease (IBD) deserves vaccination during remission and is controlled, consult a doctor in the related field..
      3. Individuals who are experiencing an acute infection. If the infection is resolved, Coronavac vaccination can be done. In TB infection, OAT treatment needs at least 2 weeks to be eligible for vaccination.
      4. Blood cancer, solid tumor cancer, blood disorders such as thalassemia, immunohematology, hemophilia, coagulation disorders, so the eligibility of individuals with this condition is determined by a specialist in the related field, consult before giving Coronavac vaccine.
      5. Individuals using immunosuppressant drugs, cytostatics and radiotherapy.
      6. Chronic disease (such as COPD and asthma, heart disease, metabolic disease, hypertension, kidney problems) who are in acute condition or are not under control.

Conditions that are outside the above criteria, it is worth giving the CoronaVac vaccine..

  1. If COVID-19 survivors have recovered for at least 3 months, they deserve to be given the COVID-19 vaccine.
  2. For individuals aged> 59 years, the eligibility of Coronavac vaccination is determined by the frailty condition of the individual obtained from the RAPUH questionnaire. If the value obtained is above 2, then the individual is not suitable for Coronavac vaccination..
  1. February 2, 2021 (American Association Panel of Experts’ Consensus Statement for the Study of the Liver Diseases / AASLD on Vaccines to Prevent COVID-19 Infection in Patients with Liver Disease)5
  1. Until February 2, 2021, the US Food and Drug Administration has given approval for use in an emergency (Emergency Use Authorization / EUA) for 2 mRNA type vaccines, namely Pfizer-BioNTech and Moderna.
  2. Chronic liver disease patients are recommended to receive the COVID-19 vaccine provided that Pfizer-BioNTech vaccine users must be ≥16 years old and Moderna vaccine users must be ≥18 years old
  3. Serology tests before and after vaccination are not recommended because there are no studies on their impact on outcome.
  4. Both vaccines can be used for all patients with chronic (compensated or decompensated) liver disease and organ transplant recipients who are immunosuppressed. (Note from the Peduli Hati Bangsa Foundation team: CoronaVac used in Indonesia is a different type of vaccine, namely Inactivated).
  5. Patients with chronic liver disease who are receiving antiviral therapy for Hepatitis B (HBV) or Hepatitis C (HCV) or medical therapy for primary biliary cholangitis or autoimmune hepatitis can still use their medication while receiving the approved COVID-19 vaccine.
  6. Patients with hepatocellular carcinoma undergoing locoregional or systemic therapy should also be considered for vaccination without stopping their treatment..
  7. Patients with a recent infection or fever should not receive the COVID-19 vaccine until they are cured and medically stable.

Can the COVID-10 vaccine be used together with other vaccines? If not, how long is the distance between the COVID-19 vaccine and other types of vaccines, for example Hepatitis B that was given 3 times?

The Association of Indonesian Internal Medicine Specialists (PAPDI) suggested 6 that even though the vaccine can actually be done, the CoronaVac vaccine used in Indonesia is still new and requires close observation for Post-Immunization Follow-Up Events (AEFI), therefore it is best to avoid being given together with other vaccines. It is recommended to be given a minimum distance of 1 month. For the hepatitis B vaccine, the first and second vaccines that increase antibodies are preferred. The third Hepatitis B vaccine may be postponed by 1 month if it coincides with the COVID-19 vaccine schedule.

References:

  1. Surat BPOM Nomor: T-RG.01.03.32.322.02.21.00605/NE pada 5 Februari 2021 perihal Perubahan Obat Coronavac.
  2. EUA-Product Information for Patients (PIL) CoronaVac-Approved version 05/02/2021, BPOM, ID EREG10040912100012. http://pionas.pom.go.id/obat-baru/coronavac-suspensi-injeksi-3-mcg05-ml (diakses pada tanggal 11 Februari 2021)
  3. https://www.papdi.or.id/berita/info-papdi/998-rekomendasi-papdi-tentang-pemberian-vaksinasi-covid-19)
  4. https://www.papdi.or.id/berita/info-papdi/1009-rekomendasi-papdi-tentang-pemberian-vaksinasi-covid-1
  5. https://www.aasld.org/sites/default/files/2021-02/AASLD-COVID19-VaccineDocument-February2021-FINAL.pdf?utm_source=informz&utm_medium=email&utm_campaign=mailings&_zs=vkSCe1&_zl=4TVO7
  6. FAQ – Pertanyaan yang Sering Ditanyakan tentang Vaksin COVID-19 Infografis Pertanyaan Seputar Vaksin COVID-19 (Revisi) (diakses pada tanggal 11 Februari 2021)

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