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update

Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access

By Gareth MacDonald+

08-Aug-2017
Last updated on 09-Aug-2017 at 09:36 GMT2017-08-09T09:36:28Z

iStock/jarun011
iStock/jarun011

Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK.

On August 7 the UK organisation - an executive agency of the Department of Health - put measures in place to allow the NHS to earmark remaining supplies of hepatitis B vaccine for people considered to be at highest risk. 

It said “there is currently a global shortage of hepatitis B vaccine which has been caused by problems in the manufacturing process.”

A spokeswoman told us “The shortage is being encountered by MSD and GSK."

Supply issues

Merck & Co - known as MSD outside the US - announced  that supplies of its hepatitis B vaccine - Recombivax HB - would be limited last month, citing updates to its manufacturing process and increased demand.

A company spokeswoman confirmed the shortage is ongoing, also telling us that "unexpected demand due to lack of competitive supply" had exacerbated the issue.

She went on to say that: "Merck does not expect to be distributing Recombivax HB between now and the end of 2018. Additionally, Merck expects its pediatric formulation of Recombivax HB/HPVAXPRO will be unavailable between early August 2017 until early 2018."

"Merck is taking steps to continue to increase our capacity to meet global demand by the end of 2018. This situation has no impact on the efficacy, safety or quality of Recombivax HB" she said.   

GSK supply constraint

The US Centers for Disease Control and prevention (CDC) lists the Recombivax HB shortage on its website as does the US Food and Drug Administration (FDA) on its vaccines page .

When Merck announced the shortage, both the CDC and the Connecticut Department of Health said GSK’s Engerix-B vaccine could be used instead.

Last week GSK announced it is experiencing an on-going supply constraint of Engerix-B in Australia due to a precautionary halt in the manufacturing process.

Production is now back to normal however it will take time to re-build capacity” the UK headquartered firm said, adding that “at this stage we are unable to confirm a re-supply date.”

Update

In an email sent after this article was published GSK told us: 

"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. 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." 

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