EU’s health regulator approves 3 new vaccine manufacturing sites

The new approvals come amid the 27-nation bloc’s struggles to ramp up COVID-19 vaccination and repeated delivery delays and manufacturing problems.

The EMA said it had approved a factory in Leiden, the Netherlands, to make the active substance for AstraZeneca’s vaccine, bringing the number of such licensed sites to four.

The EU regulator said it was also giving the green light to a site in Marburg, Germany, to make both the active substance and completed vaccine developed by BioNTech and Pfizer.

In addition, the EMA said it was granting “more flexible storage conditions” to the Pfizer-BioNTech vaccine — which was cleared on the basis that it needed ultra-cold freezer temperatures for storage and delivery.

BioNTech said in a release that it expects the first batches of vaccines manufactured at the Marburg site will be delivered in the second half of April.

“Currently, 400 BioNTech employees work in Marburg, 200 of them in 24/7 shifts in order to maximize the production’s output,” the company said.

Supply, distribution remain vexing issues

The approval “is expected to facilitate the rapid roll-out and distribution of the vaccine in the EU by reducing the need for ultra-low temperature cold storage conditions throughout the supply chain,” the regulator said.

Last week, an expert committee at the EMA recommended new manufacturing lines at a facility in Visp, Switzerland for the Moderna Inc. vaccine.

WATCH | Ottawa watching EU situation on vaccines carefully:

The federal government says it is ‘concerned,’ but does not expect Canada’s COVID-19 vaccine supply to be affected by a proposed export restriction by the European Union. It’s less clear if there’d be any impact from a temporary pause on exports of the AstraZeneca vaccine from the Serum Institute of India. 2:41

These changes are “intended to scale up production capacity and increase supply of the vaccine for the EU market,” the regulator said.

All COVID-19 vaccines meant for use in the EU must have their manufacturing sites approved by the EMA after a regulatory evaluation.

On Thursday, EU leaders failed to settle a fight about the distribution of COVID-19 shots among member states but pledged to strengthen vaccine export controls and production on EU soil amid a shortage of doses and spikes in new cases.

At the end of the summit, the bloc’s 27 nations were still locked in a dispute over how an upcoming batch of 10 million doses could be allocated to narrow the vaccine gap between member states, and the leaders decided to push the talks to a future meeting of their ambassadors.