Title: Spain Faces Shortage of 1.7 Million JN.1-Adapted COVID-19 Vaccines Amidst High Incidence Rates
In the midst of the ongoing flu and COVID-19 vaccination campaign, Spain’s Ministry of Health has found itself short of 1.7 million protein recombinant COVID-19 vaccines, intended to tackle the coronavirus. The ministry had awarded the contract to Catalan pharmaceutical company Hipra for over €21 million, conditional upon the submission of required documentation. However, the public procurement portal has recently revealed that the procedure has been abandoned due to Hipra’s inability to fulfill the contract’s conditions.
Earlier in September, the Ministry orchestrated a negotiated procedure without advertisement, labeled as an "extreme urgency" case, aiming to acquire nearly two million JN.1-adapted vaccine doses for €21.25 million. Hipra was the sole bidder for this tender, and its proposal was subsequently ratified by the Contracting Party, contingent upon the presentation of the required documentation.
Upon reviewing the submitted documentation, the contracting authority discovered it to be incomplete. cruciaally, Hipra failed to furnish the European Commission’s authorization for the change in antigen to JN.1, as mandated by the contract’s specific stipulations. Consequently, the contracting authority reckoned that the inability to verify this particular authorization rendered it unfeasible to proceed with the contract’s adjudication. Therefore, the ministry pronounced the tender null and void, as no alternative offers existed.
This setback occurs during a period of elevated incidence rates for COVID-19, flu, and respiratory syncytial virus (RSV). According to Spain’s Ministry of Health, the combined incidence rate for these diseases stood at 665.5 cases per 100,000 inhabitants during the week of December 16 to 22, reflecting a substantial increase from the preceding weeks.
In May, Hipra had proudly announced its impending release of a COVID-19 vaccine tailored to the JN.1 variant, aligning with updated recommendations from European health authorities. The company guaranteed the vaccine’s availability in a monodose format. However, despite its earlier assertions, it seems that Hipra has yet to secure the European Commission’s endorsement for the switch to the JN.1 antigen.
The European Medicines Agency (EMA) recently noted that the JN.1 variant has superseded the previously dominant XBB family globally since December 2023 and January 2024. Belonging to the BA.2.86 subvariant branch of the Omicron family, JN.1 is evolving into a distinct variant group. While current COVID-19 vaccines remain effective in preventing severe illness, their protective power wanes over time, and the virus continues to mutate into antigenically distinct variants. Thus, EMA advises the adaptation of vaccines to ensure optimal protection against contemporary and emerging variants.
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