Manufacturing constraints have led to supply issues concerning GlaxoSmithKline’s HPV vaccine, Cervarix, which are set to continue until June.

In a letter sent to French health professionals last month, GlaxoSmithKline (GSK) reported supply issues regarding its product Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant affecting the first half of this year.

According to the letter, published by the French authorities the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week, the shortage is due to a technical problem at GSK’s manufacturing site and not related to the quality or safety.

Image: iStock/Samara Heisz

A GSK spokesperson confirmed to Bioprocess Insider that there is temporary limited supply of Cervarix due to manufacturing constraints.

“These constraints affect supply globally but how it affects markets locally varies depending on local stock levels and delivery schedules.”

The firm expects to resolve the issues and resume normal supply by early June, both the spokesperson and the ANSM confirmed.

GSK did not divulge where the vaccine is made, but the firm has a production network serving its vaccines portfolio that includes a site in Wavre, Belgium it claims is the largest vaccines manufacturing site in the world with a total size of 550,000 m².

Cervarix has had a turbulent time for GSK. The HPV vaccine has sat in the shadows of competitor products. Merck & Co.’s Gardasil (Human Papillomavirus 9-valent Vaccine, Recombinant), for example, pulled in $3.2 billion (€2.8 billion) in global sales in 2018, while Cervarix sales stood at $138 million.

GSK pulled Cervarix from the US in 2016 due to low demand and now focuses on the European and international market.