- Still grappling with a global shortage of hepatitis B vaccines, the English government on Monday announced it will prioritize treatment for patients who have the highest immediate risk of contracting the viral infection.
- "While supplies are limited, vaccine will be prioritised for those at highest immediate risk based on their doctor’s assessment. For other people, a doctor may advise that hepatitis B vaccine can be deferred until later," Public Health England, part of the U.K.'s Department of Health, said in an Aug. 7 statement.
- The decision comes as major hep B drug developers Merck & Co. and GlaxoSmithKline plc work to iron out manufacturing issues. Increased demand for the adult version of Merck's Recombivax HB has led to a shortage that the company doesn't expect will end until 2019 at the earliest. GSK has tried to pick up the slack, but is facing supply challenges as well for its drug Engerix-B.
Hep B is much more infectious than HIV/AIDS and kills about one million people each year due to liver-related complications, according to the Hepatitis B Foundation. Yet, it is particularly devastating in underdeveloped or developing countries where healthcare infrastructures aren't as strong, thereby allowing the disease to more easily spread.
In England, government officials note that the risk of contracting hep B is low. Certain populations are more susceptible, however, including babies born to mothers with hep B or adults that have infected sexual partners.
Despite the large patient populations, there aren't a ton of pharmaceutical companies making hep B vaccinations. Merck and GSK are the main two.
Manufacturing constraints for the adult formulation of Recombivax HB started in the first quarter of 2017. Merck doesn't see distribution of that formulation kicking back up before the end of 2018. Recombivax HB's pediatric formulation should also be unavailable from August 2017 to early 2018. Meanwhile, the company doesn't foresee problems keeping adequate supplies of the drug's dialysis formulation.
"Merck is taking steps to continue to increase our capacity to meet global demand by the end of 2018," a spokeswoman from the Kenilworth, New Jersey-based company said in an email to BioPharma Dive. "This situation has no impact on the efficacy, safety or quality of Recombivax HB. We apologize for any inconvenience this supply constraint may cause and are working to resolve this situation as quickly as possible."
GSK is shouldering a good portion of global hep B vaccine production. The Centers for Disease Control and Prevention says the British pharma has sufficient stores of adult and pediatric hep B vaccines to address make up for the lower Merck product on the market.
Still, manufacturing hurdles are widespread.
"GSK has a global shortage of hepatitis A, hepatitis B and combination hepatitis A and B vaccines. This is due to reduced manufacturing capacity for hepatitis A and B antigens, which we are working hard to return to normal supply, " the British drugmaker said in a statement to BioPharma Dive.
"GSK is working closely with the Department of Health and Public Health England to secure supply, to ensure that high risk adults and children are not affected and continue to get access to these vaccines," the company added.