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COVID19: EMA OKs more EU sites for vaccine production

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The European Union’s medicines regulator has approved new sites for the manufacture of the Pfizer-BioNTech, Moderna and AstraZeneca coronavirus vaccines, in a bid to significantly boost Europe’s supply of COVID-19 jabs.

In a statement issued on Friday afternoon, the European Medicines Agency (EMA) said that it had approved sites in the Netherlands, Germany and Switzerland for the manufacture of COVID-19 vaccines.

The new approvals come amid criticism over the EU’s struggle to ramp up COVID-19 vaccinations, as it faces 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 the firm’s licensed sites in the EU to four.

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

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

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.

“The EMA has also given a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks,” said the EMA announcement.

The EMA said this is an alternative to the long-term storage of the vials at a temperature between -90 to -60˚C in special freezers. It 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.

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 dispute about the distribution of COVID-19 shots among member states, but pledged to strengthen vaccine export controls and production in the EU amid a shortage of doses and spikes in new cases.