The European Medicines Agency approved on Friday two factories for the production of COVID-19 vaccines, with the European Union banking on them to boost deliveries in the second quarter and accelerate the slow pace of inoculations in the bloc.
The EMA said in statement it had cleared the Halix production site in the Netherlands that makes the AstraZeneca vaccine and a facility in Marburg in Germany producing BioNTech/Pfizer shots.
The European Union has blamed massive shortfalls of AstraZeneca doses for the slow roll-out of vaccines across the bloc, while BioNTech/Pfizer has plans to sharply increase its deliveries in the second quarter.
European Internal Markets Commissioner Thierry Breton said vaccines produced by AstraZeneca within the bloc would stay there until the company returns to fulfilling its delivery commitments.
His comments echoed those of Commission President Ursula von der Leyen after a video conference summit of EU leaders on Thursday. Of 300 million doses due to be delivered to EU countries by the end of June, AstraZeneca aims to deliver only 100 million.
AstraZeneca’s request to the EMA for authorisation of its Dutch plant run by subcontractor Halix was only confirmed on Wednesday by EU Health Commissioner Stella Kyriakides.
It is not clear why the request only came now despite Halix being listed as a supplier in the company’s contract with the European Union in August. AstraZeneca has declined to comment on the timing, but said Halix is a relatively small part of its vaccine supply chain. Halix says its monthly production is about 5 million doses.
Kyriakides said she expected vaccines from this plant to be delivered to EU countries in the coming days as part of AstraZeneca’s commitment to EU citizens.
It is also unclear whether the approval of Halix will allow the distribution of 16 million doses of AstraZeneca vaccines seized this week by the Italian authorities, and which AstraZeneca said were waiting approval before being shipped to EU countries. AstraZeneca declined to comment on this.
If the doses seized in Italy were manufactured at Halix, as European Union sources had suspected, the green light for the site would mean the batch is cleared for use.
Under an AstraZeneca internal schedule dated March 10 and seen by Reuters, the company expected to deliver to the EU nearly 10 million doses of vaccines next week, a third of its entire supply to the EU so far.
The supply forecast hinged on the approval of the Halix site, the document said.
Italian Prime Minister Mario Draghi reiterated on Friday his threat to put export blocks on companies that failed to honour vaccine delivery commitments, and ruled out getting into trade disputes with countries such as Britain over supplies.
“I don’t want to go into details and without naming names, but one has the impression that some companies deliberately sold the doses two or three times,” he said with a laugh, and without elaborating.
Draghi said he expected at least 4 million more vaccine doses to get to Italy before the end of the month, with production slowly being ramped up in various sites.
Underscoring the growing output capacity, the EU’s drugs regulator also granted German biotech firm BioNTech approval for the use of COVID-19 vaccines produced at its new site in Marburg.
BioNTech launched production in February at the site, which it purchased from Novartis last year. The firm said on Friday the Marburg site had an annual capacity of 1 billion doses, up from 750 million doses flagged previously.
That makes it a key element of BioNTech and partner Pfizer’s global delivery plans of 2.3 billion to 2.4 billion doses this year.
The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April.
Kyriakides called the approval “very good news” that should enable the expected acceleration of production and deliveries.