The Guardian website reports (August 7) that a global shortage of hepatitis B vaccine, caused by manufacturing difficulties, has led Public Health England (PHE) to restrict vaccine access to those people at the highest risk of contracting hepatitis B.

The Hepatitis B virus (HBV) affects the liver and is easily transmitted by contact with infected body fluids. It is both preventable and treatable, and a majority of people will spontaneously clear the infection. However, chronic HBV infections can lead to life-threatening complications for the carrier, such as cirrhosis and liver cancer, as well as the increased risk of infecting other people.

HBV is endemic in the U.K. but at a low-carriage rate of between 0.1-0.5 percent, which, as with Canada, varies depending on the group and the area of the country.

Usually, explains the Guardian, the vaccine is offered and/or given to those in the U.K. at specific risk of being exposed to body fluids from infected persons, such as babies born to mothers who are infected with HBV, the sexual partners of infected individuals, men who have sex with men, health-care workers and intravenous drug users.

The Guardian quotes a Public Health England’s (PHE) spokesperson as explaining:

“The most common route of transmission is when a baby is born to a mother who has it but the paediatric vaccine is not affected by the shortage.”

The most common transmission route of HBV infections also carries the highest risk, both to individuals and society, according to the UK’s Heath Safety Executive website:

“The likelihood of a patient developing chronic infection is inversely related to age at the time of infection. Chronic infection occurs in at least 90% of infected neonates, 25% of children aged 1-5 years and 5% or less of adults. Chronically infected individuals are often referred to as HBV carriers.”

PHE’s temporary recommendations for use of the hepatitis B vaccine during the supply constraint, released August 4th, prioritize post-exposure over pre-exposure, according to risk and urgency:

1. Infants born to hepatitis B infected mothers.
2. Exposure to body fluids from known acute case of hepatitis B, through needlestick or sexual contact.
3. Injuries from discarded needles, sexual assault, or a major incident.
   1. Clinical healthcare workers with regular exposure to blood.
   2. Sex workers, MSM (gay men) with multiple partners, PWID (people who inject drugs), prisoners, people traveling to endemic countries for medical treatment and renal dialysis patients.
4. Household contacts of people with hepatitis B, most other health care workers and occupations at risk of percutaneous exposures.
   1. People traveling to medium and high endemicity countries.
5. Boosting and reinforcing doses for people who have completed a primary three-dose course of immunization.

But if the U.K.’s public health-care system has seen the need to put in place written guidelines to ration access in the face of a global shortage of hepatitis B vaccine, there is no sign of Canada’s medicare system following suit.

There are indications that Canada is affected by the hepatitis B vaccine shortage but there is very little to suggest that either our provincial or federal levels of governments are terribly concerned at this point.

Ironically, July 28, was, in Canada and elsewhere, World Hepatitis Day. 

How the shortage is being felt (or not felt) in Canada

In Canada, two injectable recombinant HBV vaccines are listed as either in short supply, or not in supply at all: GlaxoSmithKline’s (GSK) Energix-B and Merck Canada’s Remomivax HB.

According to a Drug Shortages Canada database listing, starting in April, GSK’s 2-ml formulation of Energix-B was expected to experience “supply disruptions” until the end of 2017, due to “demand increase for the drug”.

And, according to another listing in the same online database, as of the beginning of August, Merck Canada’s 1-ml formulation of Remombivax HB (preservative-free) is projected to be available in limited quantities until July of 2018, due to “disruption of the manufacture of the drug”.

Which is actually to say that any disruptions in the supply of GSK’s Energix-B will be entirely due to the increased demand caused by the absence of Merck’s Remomivax HB!

The U.S. Centers for Disease Control and Prevention (CDC) categorically says that Merck is not and does not expect to be distributing its adult HBV vaccine at all until the end of 2018. Likewise the company’s pediatric HBV vaccine will be unavailable between early August 2017 and early 2018. However, the CDC says, Merck does not expect supplies of its dialysis formulation of Hepatitis B vaccine to be affected.

The CDC believes that GSK has sufficient supplies of adult and pediatric Hepatitis B vaccines to address the anticipated gap in Merck’s production.

A June 22 government of Manitoba advisory on the province’s immunization program touches on the shortage of the Merck’s HBV vaccine but, like the CDC, Manitoba expects GSK’s alternatives to make up the difference:

“Due to a national hepatitis B vaccine shortage, Manitoba’s supply of Recombivax HB (pediatric) has been reduced. Therefore, children 11 to less than 16 years of age who have had one or more pediatric doses (0.5mL/dose) can finish the series with a 1.0mL Engerix-B dose, if necessary. Usage of Recombivax HB is being closely monitored.”

A March 2017 circular from the health department of Peterboro, Ontario, talks a bit about HBV vaccines but makes no mention of any shortage issue.

Hepatitis B in Canada

According to Canadian government numbers, there were 2,011 reported cases of acute and chronic HBV in Canada in 2008, which, against a population of 33.25 million, equals a tiny incidence of 0.006 percent. However, the prevalence of HBV in Canada varies quite a bit by group and by geography.

For example, the government of Canada says that the seroprevalence rates of HBsAg (the HBV surface antigen) among Canadians have been various estimated—in one unidentified northern Ontario town, at between 0.24 percent to 0.47 percent for people aged 14 to 30; at 5 percent to 15 percent among adult Southeast Asians and at 0.1 percent to 0.5 percent among Canadian first-time blood donors. And a 1995 survey of  1,200 Québec school kids found none that were positive for HBsAg.

Government figures collected between 1999 and 2008 show that Aboriginal Canadians have been about 146 percent more likely than non-Aboriginal Canadians to contract acute HBV (1.92 cases to 0.78 cases, per 100,000 inhabitants) but that the incidence rate between Aboriginals and non-Aboriginals in Canada has narrowed since 2003.

According to the federal government, Canada’s HBV monitoring and prevention measures include the following:

• All pregnant women are tested for the hepatitis B surface antigen HBsAg.
• Infants born to infected mothers receive the first of three HBV vaccinations within 12 hours of birth.
• Public school-based HBV vaccination programs (since the early 1990s) to immunize children aged nine to 13.

So far, there is nothing that I can find on the Canadian government’s website that even alludes to a shortage of HBV vaccines.

How can there be a shortage of such a common vaccine?

Near as I can tell, the entire root of this HBV vaccine shortage lies with Merck, a.k.a., Merck & Co., or Merck Canada, or Merck Sharp & Dohme (MSD), depending where you are in the world.

However you style the name, Merck is a Top 10 pharmaceutical multinational and what could once be said of the United States can now also be said of Merck and the other members of the pantheon of Big Pharma—that when they sneeze the world catches a cold.

This so-called global HBV vaccine shortage is actually just a shortage of  Merck’s (Big Pharma #6) Recombivax HB, which, everyone hopes, will be offset by GSK’s (Big Pharma #10) Engerix-B.

If nothing else, this shortage suggests how Merck and the other ever-shrinking number of ever-growing pharmaceutical giants can carve up the world and create monopoly positions for themselves, just as the petroleum majors used to do back in the 20th century.

The thing is, the reasons given by Merck for this shortage of Recombivax HB in 2017, namely “demand around the world and manufacturing process updates“, are kind of similar to the reasons given by the company for the shortage of Recombivax seven years ago.

The shortage in 2010 actually began in 2009, when Merck announced that equipment upgrades at its vaccine plant in West Point, Pennsylvania, would disrupt production of the adult version of Recombivax HB, such that it would be unavailable for the near future.

Explained Merck spokesperson Jennifer Allen Woodruff in an email:

“We do not anticipate availability of the adult formulation of our Hepatitis B vaccine for the rest of 2010 and will provide an update on availability of the adult formulation when more information is available. Over the last couple of years, supply disruptions have occurred due to unexpected manufacturing issues that prompted modification to some of our processes and equipment. As a result, some of our vaccines have been in back order and other vaccines have been unavailable for order for some time.”

In 2010, the website of the Canadian Medical Association Journal (CMAJ) reported that Merck’s inability to produce its  vaccine was causing a worldwide shortage and that GSK would try to fill the hole by “ramping-up” production of Engerix-B.

And here we are again, right back in another hole dug by Merck, or are we still in the 2009 hole?

I can find nothing that actually says that Merck ever finished updating its plant and resumed full-scale production of the.Recombivax HB vaccine.

Back in 2010 the CMAJ website reported that the HBV shortage created by Merck led the government of Ontario to suspend its Grade 7 hepatitis B inoculation program for the upcoming school year. Other provinces and territories had also been forced to amend immunization programs.

The CMAJ said that the lengthy and ongoing shortage of HBV vaccine in 2010 baffled some Canadian health practitioners and quoted a Dr. Vinita Dubey, associate medical officer of health for Toronto, Ontario, Public Health’s division of communicable diseases, as asking:

“Why is there a shortage for a stable vaccine that has been around for years?. This is a real public health concern.”

It was about 31 years ago, in fact, in 1986, when the biotech company Chhiron invented the first recombinant HBV vaccine. (Chiron’s vaccine tech, by the way, ended up, through Big Pharma’s usual circuitous route of merger and acquisition, with GSK.)

As for Dr. Dubey’s excellent question—why a shortage? I’m guessing that the answer is because Big Pharma said so.