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

Summary:

All three vaccines against hepatitis A that are available in the United States contain impermissible ingredients.  However, Muslims requiring vaccination against hepatitis A should only use Havrix or the combination Hepatitis A/B vaccine Twinrix. Vaqta should only be used when Havrix is unavailable or is contraindicated, because it contains an additional impermissible ingredient.  

Background:

From the CDC[1]:

“Hepatitis A is caused by infection with HAV…HAV is acquired by mouth (through fecal-oral transmission) and replicates in the liver. After 10-12 days, the virus is present in blood and is excreted via the biliary system into the feces… Virus excretion begins to decline at the onset of clinical illness, and decreases significantly 7-10 days after onset of symptoms. Most infected persons no longer excrete virus in the feces by the third week of illness. Children may excrete the virus longer than adults.

The incubation period of hepatitis A is approximately 28 days (range 15-50 days). The clinical course of acute hepatitis A is indistinguishable from that of other types of acute viral hepatitis. The illness typically has an abrupt onset of fever, malaise, anorexia, nausea, abdominal discomfort, dark urine and jaundice. Clinical illness usually does not last longer than 2 months, although 10%-15% of persons have prolonged or relapsing signs and symptoms for up to 6 months…

Severe clinical manifestations of hepatitis A infection are rare, however atypical complications may occur, including immunologic, neurologic, hematologic, pancreatic, and renal extrahepatic manifestations. Relapsing hepatitis, cholestatic hepatitis A, hepatitis A triggering autoimmune hepatitis, subfulminant hepatitis, and fulminant hepatitis have also been reported. Fulminant hepatitis is the most severe rare complication, with mortality estimates up to 80%. In the prevaccine era, fulminant hepatitis A caused about 100 deaths per year in the United States. The hepatitis A case-fatality rate among persons of all ages with reported cases was approximately 0.3% but may have been higher among older persons (approximately 2% among persons 40 years of age and older) More recent case-fatality estimates range from 0.3%-0.6% for all ages and up to 1.8% among adults aged >50 years. Vaccination of high risk groups and public health measures have significantly reduced the number of overall hepatitis A cases and fulminant HAV cases. Nonetheless, hepatitis A results in substantial morbidity, with associated costs caused by medical care and work loss.

The likelihood of symptomatic illness from HAV infection is directly related to age. In children younger than 6 years of age, most (70%) infections are asymptomatic. In older children and adults, infection is usually symptomatic, with jaundice occurring in more than 70% of patients.”

Vaccination against hepatitis A has significantly reduced the number of annual cases in the United States, with over 30,000 cases reported in 1997 and approximately 3,000 in 2017[2]. There have been several recent outbreaks of the disease in the United States, resulting in serious illness requiring hospitalization in approximately 67% of affected patients[3].

CDC Indications for Vaccination[4]:

o   All children at age 1 year

o   Travelers to countries where hepatitis A is common

o   Family and caregivers of adoptees from countries where hepatitis A is common

o   Men who have sexual encounters with other men

o   Users of recreational drugs, whether injected or not

o   People with unstable housing or experiencing homelessness

o   People with chronic or long-term liver disease, including hepatitis B or hepatitis C

o   People with clotting-factor disorders

o   People with direct contact with others who have hepatitis A

o   Any person wishing to obtain immunity (protection)

Vaccines Available in the United States

There are three forms of the hepatitis A vaccine available in the United States. Two only contain the hepatitis A vaccineو Havrix and Vaqta. The other, Twinrix, combines Havrix and the hepatitis B vaccine, Engerix-B.   A description of each vaccine is given below. Note that Islamically impermissible components are in red text:

1)    Havrix[5] (Hepatitis A vaccine only)

a.    Manufacturer: GlaxoSmithKline

b.    Form: injection

c.    Ages: 12 months and older

d.    Contains:  viral antigen, aluminum hydroxide, amino acid supplement in a phosphate-buffered saline solution, polysorbate 20, residual MRC-5 cellular proteins, neomycin sulfate

e.    Culture Medium: MRC-5 human diploid cells

2)    Vaqta[6] (Hepatitis A vaccine only)

a.    Manufacturer: Merck

b.    Form: injection

c.    Ages: 12 months and older

d.    Contains: viral antigen, nonviral protein (from MRC-5 cells), MRC-5 DNA, bovine albumin, formaldehyde, neomycin, amorphous aluminum hydroxyphosphate sulfate, sodium borate, sodium chloride

e.    Culture Medium: MRC-5 human diploid cells

3)    Twinrix[7] (Hepatitis B  and Hepatitis A vaccines)

a.    Manufacturer: GlaxoSmithKline

b.    Form: injection

c.    Ages: 18 years and older

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 (for hepatitis B)

Discussion and Recommendations:

Hepatitis A vaccination is included in the routine vaccination schedule for children in the United States.  Both forms of the hepatitis A vaccine (Havrix, Vaqta) that are approved for use in children (ages 12 months and older) contain residual material from MRC-5 human diploid cells that are used in the culture medium. 

Generally, the consumption of human-derived material is considered Islamically impermissible.  However, in cases of necessity, the impermissible can become permissible according to the principles of Islamic jurisprudence[8].  Preventing harm to a population is considered to be a necessity, and such harm includes the prevention of serious illness and death that can be caused by infectious diseases such as hepatitis A[9].  Studies have shown that after hepatitis A vaccination was introduced, morbidity and mortality from the disease decreased significantly:

·         The incidence of hepatitis A decreased from 6 to 0.4 cases per 100,000 in the United States from 1999 to 2014[10]

·         Hospitalizations due to hepatitis A decreased by over 68% for all age groups[11]

·         Mortality from hepatitis A decreased significantly when vaccination was recommended for high-risk groups, and decreased further when routine vaccination was recommended for children[12]

Based on the necessity of preventing both individual and populational harm, routine vaccination against hepatitis A for children and for adults in high-risk populations can be permitted even though the vaccines contain residual material from human cells. 

However, unlike Havrix, Vaqta also contains bovine serum albumin, a protein that is extracted from bovine serum[13].  A general principle of Islamic jurisprudence is that in cases of necessity, the normally impermissible can be permissible, but only to the extent necessary[14].  For example, if a person is starving and only has impermissible food available to eat, he may eat from it only to the extent needed to survive. If he eats more than that, it would be beyond the extent of the necessity and would therefore be impermissible[15]. Both vaccines contain trace amounts of impermissible material from human cells, which cannot be avoided when a person needs hepatitis A vaccination.  However, the additional impermissible material extracted from bovine serum that is present in Vaqta can be avoided by using Havrix.  In this case, the extent of the necessity is limited to the use of the impermissible human cell material and does not extend to the use of material extracted from impermissible bovine serum.  Therefore, Muslims requiring vaccination against hepatitis A should only use Havrix. Vaqta should only be used when Havrix is unavailable or is contraindicated. 

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[1] https://www.cdc.gov/vaccines/pubs/pinkbook/hepa.html

[2] https://www.cdc.gov/hepatitis/statistics/2017surveillance/TablesFigures-HepA.htm

[3] https://www.hhs.gov/hepatitis/blog/2019/09/16/cdc-releases-2017-viral-hepatitis-surveillance-summary.html

[4] https://www.cdc.gov/hepatitis/hav/afaq.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines%2Fvpd%2Fhepa%2Fpublic%2Findex.html#prevention

[5] https://gsksource.com/pharma/content/gsk/source/us/en/brands/havrix.html

[6] https://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf

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

[8] الْأَشْبَاهُ وَالنَّظَائِرُ, دار الكتب العلمية   1:73

وَهَذِهِ الْقَاعِدَةُ مَعَ الَّتِي قَبْلَهَا مُتَّحِدَةٌ أَوْ مُتَدَاخِلَةٌ، وَتَتَعَلَّق بِهَا قَوَاعِدُ: الْأُولَى: الضَّرُورَاتُ تُبِيحُ الْمَحْظُورَاتِ،

[9] For a detailed discussion, see “An Islamic Basis for the Use of Vaccines with Impermissible Ingredients”, https://muslimmed.org/2019/11/13/an-islamic-basis-for-the-use-of-vaccines-with-impermissible-ingredients/

[10] MMWR Surveill Summ. 2009;58(3):1. 

[11] https://www.cdc.gov/vaccines/pubs/pinkbook/hepa.html

[12] [12] https://academic.oup.com/jid/article/197/9/1282/870664

[13] https://www.sigmaaldrich.com/life-science/biochemicals/biochemical-products.html?TablePage=103994915

[14] “ما أبيح للضرورة يقدر بقدرها”  الأشباه والنظائر, دار الكتب العلمية, 73  

[15] “المضطر لأ يأكل من الميتة الأ قدر سد الرمق”, ibid