A string of new manufacturing sites involved in the production of AstraZeneca, Moderna and Pfizer Covid-19 vaccines were added to the European Union's supply chain on Friday and rules for the transport of some doses were eased, in a boost to the continent's supply and rollout of doses.
A manufacturing site for AstraZeneca vaccines run by contractor Halix in Leiden in the Netherlands was approved by the European Medicines Agency (EMA), after a long wait for the company to submit its application.
This will “bring the total number of manufacturing sites licensed for the production of the active substance of the vaccine to four”, the EMA announced.
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In addition, a new manufacturing site in the German city of Marburg was approved for Cominarty, the BioNTech-Pfizer vaccine, which will produce “both active substance and the finished product”.
The EMA has also approved a new manufacturing site involved in the production process of Moderna's Covid-19 vaccine in Visp in Switzerland.
“The addition of the new manufacturing lines . . . together with other changes to the manufacturing processes that were greenlighted by the Committee are intended to scale-up production capacity and increase supply of the vaccine for the EU market,” the regulator said.
The approval of the Halix site in the Netherlands followed a long wait for AstraZeneca to submit an application to approve the plant for EU production. Vaccine manufacturing sites must be approved by the EMA and certified to be “capable of consistently producing high-quality vaccines according to agreed specifications”, which involves submitting evidence and being inspected by local authorities.
Officials say AstraZeneca has not explained why it waited until this week to apply for EU authorisation, but there are suspicions that this was a tactic to juggle competing international orders, as its production could not be delivered to the EU without the permit.
The Dutch plant is now a focus in intense negotiations between London and Brussels over vaccine supply chains after the bloc announced it would tighten vaccine export controls to prioritise unmet EU orders over exports.
Alongside the announcement of new manufacturing sites, the EMA announced an easing of guidelines for the transport of Pfizer vaccines that should help the speed of rollout across the continent, which was previously limited by the availability of special freezer storage.
Vials of Pfizer vaccines can safely be transported at at the standard pharmaceutical freezer temperature of -25 to -15 degrees for a one-off period of two weeks, rather than always needing to be stored and transported at -90 to -60 degrees in special freezers, the EMA announced.
“It is expected to facilitate the rapid rollout and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain,” the medical regulator said in a statement.
