Vaccination Against Hepatitis B

Prepared by Mufti Adil Farooki, MD, Mawlana Mateen Khan, MD and Dr. Ramzan Judge, PharmD

Summary:

The hepatitis B vaccines Engerix-B, Recombivax HB, and Heplisav B are permissible for Muslims to use, while PreHevBrio is not permissible. 

The combination vaccines Pediarix (Hepatitis B, DTaP, Polio) and Vaxelis (Hepatitis B, DTaP, Polio, HiB) are permissible to use.

The hepatitis A/B combination vaccine Twinrix is not permissible to use except in cases where hepatitis A vaccination is necessary (refer to Discussions and Recommendations below).

Background:

From the CDC^[i]:

“Hepatitis B is a liver disease that can cause mild illness lasting a few weeks, or it can lead to a serious, lifelong illness.  Acute hepatitis B infection is a short-term illness that can lead to fever, fatigue, loss of appetite, nausea, vomiting, jaundice (yellow skin or eyes, dark urine, clay-colored bowel movements), and pain in the muscles, joints, and stomach.

Chronic hepatitis B infection is a long-term illness that occurs when the hepatitis B virus remains in a person’s body. Most people who go on to develop chronic hepatitis B do not have symptoms, but it is still very serious and can lead to liver damage (cirrhosis), liver cancer, and death. Chronically-infected people can spread hepatitis B virus to others, even if they do not feel or look sick themselves.

Hepatitis B is spread when blood, semen, or other body fluid infected with the hepatitis B virus enters the body of a person who is not infected”

CDC Indications for Vaccination:

According to the CDC, hepatitis B vaccination is recommended as part of routine childhood immunization^[ii]:

·     Infants should get their first dose of hepatitis B vaccine at birth and will usually complete the series at 6 months of age (sometimes it will take longer than 6 months to complete the series).

·     Children and adolescents younger than 19 years of age who have not yet gotten the vaccine should also be vaccinated.

·     Hepatitis B vaccine is also recommended for certain unvaccinated adults:

o   People whose sex partners have hepatitis B

o   Sexually active persons who are not in a long-term monogamous relationship

o   Persons seeking evaluation or treatment for a sexually transmitted disease

o   Men who have sexual contact with other men

o   People who share needles, syringes, or other drug-injection equipment

o   People who have household contact with someone infected with the hepatitis B virus

o   Health care and public safety workers at risk for exposure to blood or body fluids

o   Residents and staff of facilities for developmentally disabled persons

o   Persons in correctional facilities

o   Victims of sexual assault or abuse

o   Travelers to regions with increased rates of hepatitis B

o   People with chronic liver disease, kidney disease, HIV infection, infection with hepatitis C, or diabetes

o   Anyone who wants to be protected from hepatitis B

Vaccines Available in the United States

There are seven forms of the hepatitis B vaccine available in the United States. Three of them only contain the hepatitis B vaccine, while four forms are combination vaccines.  A description of each vaccine is given below.

1) Engerix-B^[iii]  (Hepatitis B vaccine only)

a. Manufacturer: GlaxoSmithKline

b. Form: injection

c. Ages: all ages

d. Contains:  HBsAg, aluminum hydroxide, sodium chloride, phosphate buffers (disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate), yeast protein

e. Culture Medium: yeast cells

2) Recombivax HB[iv] (Hepatitis B vaccine only)

a. Manufacturer: Merck

b. Form: injection

c. Ages: all ages

d. Contains: HBsAg, aluminum hydroxide, formaldehyde, yeast protein

e. Culture Medium: yeast cells

3) Heplisav B[v] (Hepatitis B vaccine only)

a. Manufacturer: Dynavax

b. Form: injection

c. Ages: 18+

d. Contains: HBsAg, yeast protein, yeast DNA, deoxycholate, phosphorothioate linked oligodeoxynucleotide,sodium phosphate, dibasic dodecahydrate, sodium chloride, monobasic dehydrate,polysorbate 80

e. Culture Medium: yeast cells

4)  PreHevBrio ^[vi]    (Hepatitis B vaccine only)

   a. Manufacturer: VBI Vaccines

b. Form: injection

c. Ages: 18+

d. Contains: HBsAg, aluminum hydroxide, sodium chloride, potassium chloride,  disodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate anhydrous. “Each dose may contain residual amounts of CHO cell proteins (up to 2.5 ng/dose), CHO cell DNA (up to 10 pg/dose), Bovine Serum Albumin (up to 2.5 ng/dose) and Formaldehyde (up to 500 ng/dose) from the manufacturing process.”

e. Culture Medium: genetically modified CHO (Chinese Hamster Ovary) cells.

5) Twinrix[vii] (Hepatitis B  and Hepatitis A vaccines)

a. Manufacturer: GlaxoSmithKline

b. Form: injection

c. Ages: 18+

d. Contains: MRC-5 human diploid cells, formalin, aluminum phosphate, aluminum hydroxide, amino acids, sodium chloride, phosphate buffer, polysorbate 20, neomycin sulfate, yeast protein,water

e. Culture Medium: MRC-5 human diploid cells (Hepatitis A) and yeast cells (Hepatitis B)

6) Pediarix^[viii] (Hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis vaccines)

a. Manufacturer: GlaxoSmithKline

b. Form: injection

c. Ages: 6 weeks to 6 years

d. Contains: aluminum hydroxide, aluminum phosphate as adjuvants , sodium chloride,  residual formaldehyde, polysorbate 80. Neomycin sulfate and polymyxin B sulfate,  yeast protein.

e. Culture Medium:

●     Diphtheria: Fenton medium containing a bovine extract

●     Tetanus: modified Latham medium, contains dairy casein digests of pancreatic enzymes (dairy)

●     Pertussis: synthetic modified Stainer-Scholte medium^[ix]

●     Hepatitis B: yeast cells

●     Poliovirus: VERO monkey kidney cells with calf serum

7) Vaxelis^[x]  (Hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, H. influenzae type b vaccines)

a. Manufacturer: MSP Vaccine Company

b. Form: injection

c. Ages: 6 weeks to 4 years of age

d. Contains: formaldehyde, glutaraldehyde, bovine serum albumin, neomycin,  streptomycin sulfate,  polymyxin B sulfate,  ammonium thiocyanate, yeast protein

e. Culture Medium:

●     Diphtheria: Mueller’s medium, contains beef extract^[xi]

●     Tetanus: modified Mueller-Miller casamino acid medium without bovine heart infusion, contains dairy casein digests of pancreatic enzymes^[xii]  

●     Pertussis: synthetic Stainer-Scholte medium

●     Hepatitis B: yeast cells

●     Poliovirus: VERO monkey kidney cells with calf serum

●     H. influenzae type b: yeast cells

Discussion and Recommendations:

Hepatitis B-Only Vaccines

Three forms of the hepatitis B vaccine available in the United States that exclusively contain the hepatitis B vaccine (Engerix-B, Recombivax HB, Heplisav B) do not contain any Islamically unlawful ingredients.  Therefore, it is permissible for Muslims to use these vaccines for vaccination against hepatitis B.

PreHevBrio contains residual material from hamster ovary cells.  Because these cells are from animals that were not Islamically slaughtered, they are considered impermissible to consume. Therefore, PreHevBrio is not permissible for Muslims to use. 

Combination Vaccines

a) Hepatitis A+B (Twinrix)

The form of the vaccine that is a combination of the hepatitis B and hepatitis A vaccines (Twinrix) is approved for adults (ages 18 and up), not for children, in the United States. It is a combination of the hepatitis B vaccine Engerix-B and the hepatitis A vaccine Havrix[xiii]. It contains residual material from MRC-5 human diploid cells used in the culture medium for the hepatitis A vaccine.

Ingredients derived from human sources are considered unlawful to consume.  Therefore, the use of Twinrix is not permissible for Muslim adults who only need vaccination from hepatitis B. In cases where vaccination from hepatitis A is also required, then the combination vaccine may be used due to the lack of permissible forms of hepatitis A vaccines.  

b) Hepatitis B, DTaP, Polio (Pediarix)

This combination vaccine is approved for children ages 6 weeks to 6 years in the United States, and contains vaccines for Hepatitis B, diphtheria, tetanus, pertussis, and poliomyelitis.

The tetanus component is grown in a synthetic medium, but casein broken down by pancreatic enzymes is used for nutritional support of the bacteria^[xiv]. Although the source of the pancreatic enzyme is not specified, this can be compared to providing food with impermissible ingredients to an animal.  The meat of such an animal would still be considered permissible to consume^[xv]. 

The diphtheria and poliovirus components are grown in culture mediums that have material from unlawfully slaughtered animals (cow, monkey).  According to the manufacturer, the bovine serum from the culture medium, along with cellular components, are purified by a 3-step process of precipitation, dialysis, and sterile filtration.  Although miniscule amounts of the material may remain in the final product[xvi] [xvii], this would not render it impermissible as explained in our article regarding Tdap, Dtap, and Polio Vaccines, as the Shariah can overlook unavoidable haram contaminants that remain despite attempted removal¹.

Also as explained in our article on Tdap, Dtap, and Polio Vaccines, although Poliomyelitis antigens are derived from the Vero (monkey) cell line, the antigens are actually produced from polioviruses, which are separate and distinct entities from the cell. They can be considered to be parasitic entities within the cell, and as mentioned in juristic texts, parasites do not carry the same impure status as their host cells, rather they are considered pure and permissible to use by default. Therefore the poliomyelitis antigen used in the vaccine is not considered to be a product of the impure cells, but rather the pure poliovirus material, and is therefore permissible to use.

 c) Hepatitis B, DTaP, Polio, H. influenzae type b (Vaxelis)

This combination vaccine is approved for children ages 6 weeks to 4 years in the United States, and contains vaccines for Hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b (HiB).   Unlike Pediarix, Vaxelis contains an HiB component, which is derived from yeast cells, which are permissible to use. Vaxelis also contains residual bovine albumin, but as with the bovine calf serum mentioned above, this was part of the growth medium that has been filtered out² with only an unavoidable, miniscule amount that remains that can be overlooked by the Shariah. Therefore, Vaxelis is considered permissible to use just as Pediarix.

In summary, Engerix-B and Recombivax HB are indicated for all ages for hepatitis B vaccination and are permissible for Muslims to use.  Heplisav B is indicated for adults (18+) and is also permissible to use. PreHevBrio is indicated for adults (18+), but it contains unlawful ingredients and is therefore not permissible for Muslims to use.

The hepatitis A/B combination vaccine Twinrix contains unlawful ingredients and is not permissible for Muslims to use, except in cases where hepatitis A vaccination is required , due to lack of permissible alternatives.

The combination vaccines Pediarix (Hepatitis B, DTaP, Polio) and Vaxelis (Hepatitis B, DTaP, Polio, HiB)  are permissible to use.

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^[i] https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html

^[ii] https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html

^[iii] https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Engerix-B/pdf/ENGERIX-B.PDF

[iv] https://www.merck.com/product/usa/pi_circulars/r/recombivax_hb/recombivax_pi.pdf

[v]  https://www.heplisavb.com/assets/pdfs/HEPLISAV-B-Prescribing-Information.pdf

^[vi]  https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html

[vii] https://gsksource.com/twinrix

^[viii] https://www.fda.gov/media/79830/download

^[ix] https://www.microbiologyresearch.org/content/journal/micro/10.1099/00221287-63-2-211

^[x] https://www.fda.gov/media/119465/download

^[xi] https://journals.asm.org/doi/10.1128/JCM.02464-08

^[xii] Vaccine: Volume 23, Issues 46–47, 16 November 2005, Pages 5420-5423

[xiii] https://www.rxlist.com/twinrix-drug.htm

^[xiv] https://www.fishersci.com/shop/products/remel-pancreatic-digest-casein-peptone-2/R451102

^[xv] (بدائع الصنائع في ترتيب الشرائع (5/ 40

ولا يكره أكل الدجاج المحلي وإن كان يتناول النجاسة؛ لأنه لا يغلب عليه أكل النجاسة بل يخلطها بغيرها وهو الحب فيأكل ذا وذا، وقيل إنما لا يكره؛ لأنه لا ينتن كما ينتن الإبل والحكم متعلق بالنتن؛ ولهذا قال أصحابنا في جدي ارتضع بلبن خنزير حتى كبر: إنه لا يكره أكله؛ لأن لحمه لا يتغير ولا ينتن فهذا يدل على أن الكراهة في الجلالة لمكان التغير والنتن لا لتناول النجاسة

[xvi] This statement was made by the manufacturer GSK in reference to its DTaP enzyme Boostrix, which contains the same antigens as its DTaP vaccine Infanrix, although “BOOSTRIX is formulated with reduced quantities of these antigens.” according to the package insert. Pediarix contains the Infanrix vaccine:

https://gskusmedicalaffairs.com/docviewer.html?cmd=GSKMedicalInformation&medcommid=MED–US-1402&token=23108-caf1af07-640d-478c-a81e-89c1720de814&dns=gsk-medcomms.veevavault.com

Click to access BOOSTRIX.PDF

https://www.cdc.gov/vaccines/vpd/hepb/hcp/faqs-hcp-pediarix.html#:~:text=Pediarix%20contains%20the%20same%20DTaP,in%20other%20countries%20since%201996.

https://academic.oup.com/cid/article-abstract/6/Supplement_2/S341/367704?redirectedFrom=fulltext

[xvii] https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-IPOL.pdf

^[xviii] الأشباه والنظائر, دار الكتب العلمية, 49

الْأَصْلُ بَقَاءُ مَا كَانَ عَلَى مَا كَانَ

وَتَتَفَرَّعُ عَلَيْهَا مَسَائِلُ مِنْهَا:

مَنْ تَيَقَّنَ الطَّهَارَةَ وَشَكَّ فِي الْحَدَثِ فَهُوَ مُتَطَهِّرٌ، وَمَنْ تَيَقَّنَ الْحَدَثَ وَشَكَّ فِي الطَّهَارَةِ فَهُوَ مُحْدِثٌ

^[xix] لأشباه والنظائر, دار الكتب العلمية, 62

خَاتِمَةٌ تَشْمَلُ عَلىَ فَوَائدَ فِي تِلْكَ الْقَاعِدَةِ أَعْنِي: الْيَقِينُ لَا يَزُولُ بِالشَّكِّ

وَجَدَ فَأْرَةً مَيِّتَةً وَلَمْ يَدْرِ مَتَى وَقَعَتْ وَكَانَ قَدْ تَوَضَّأَ مِنْهَا، قَدَّمْنَا وُجُوبَ الْإِعَادَةِ عَلَيْهِ مُفَصَّلًا مَعَ الشَّكِّ

^[xx]  الأشباه والنظائر, دار الكتب العلمية, 73 

ما أبيح للضرورة يقدر بقدرها

^[xxi] https://www.fda.gov/media/74395/download