03.29.21

EU Regulator Clears Manufacturing Sites to Boost COVID-19 Vaccine Supply

Source: FirstWord

The European Medicines Agency (EMA) said it adopted several actions aimed at boosting COVID-19 vaccine production and rollout in the EU. These include clearing the Halix production site in Leiden, the Netherlands that makes AstraZeneca’s vaccine AZD1222, as well as another facility located in Marburg, Germany for producing Pfizer and BioNTech’s Comirnaty, while the latter is also now permitted to be kept at lower temperatures under certain conditions. In addition, the agency approved a new manufacturing site and scaled-up processes for Moderna’s COVID-19 vaccine mRNA-1273.

The moves come within days of the EU implementing stricter controls on coronavirus vaccine exports in order to address supply shortfalls on its own territory. The Halix site approval for AstraZeneca’s AZD1222 comes just days after the company sought clearance, with EU health commissioner Stella Kyriakides promising a “swift” review in hopes of seeing deliveries from the plant starting “this month.”

Halix key to meeting delivery target

According to the EMA, the Leiden-based facility brings to four the number of manufacturing sites licensed to produce the active substance for AZD1222, including one in Belgium, where production delays have forced AstraZeneca to cut the number of doses it says it can deliver to the EU. Two other manufacturing sites are located in the UK, and have not yet exported to the EU. A recent report, citing an internal EU document, suggested that AstraZeneca’s ability to meet its vaccine delivery targets to the bloc this quarter of a maximum of 30 million doses, which is 50 million less than the EU initially expected, hinged on approval of the Halix site.

In regards to the Marburg factory for Pfizer and BioNTech’s Comirnaty, the EMA said it will produce both active substance and the finished product. BioNTech launched the new facility in February, saying it expected the first vaccines made there to be distributed in early April. According to the EMA, there are currently three active substance manufacturing sites supplying the EU included in the marketing authorisation for Comirnaty.

New rules cut need for ultra-cold storage

The agency also approved storage of Comirnaty at -25°C to -15°C for a total of 2 weeks, based on data showing it remains stable at these temperatures in standard pharmaceutical freezers. The move is expected to help broaden access to the vaccine in the EU as it “[reduces] the need for ultra-low temperature cold storage conditions throughout the supply chain.” The new storage option follows a similar change adopted by the FDA last month.

Meanwhile, the EMA indicated that it also expects a scale-up in manufacturing capacity for Moderna’s mRNA-1273, following the recent approval of a new site dedicated to producing active substance and finished product intermediates for the vaccine. The agency says the addition of new manufacturing lines at the Lonza facility, located in the Swiss city of Visp, together with other changes to the manufacturing processes that have been greenlighted, are going to bolster vaccine supply across the EU market.

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