“We are on track,” a spokesperson for the contract development and manufacturing organization (CDMO) told this publication today.
Large-scale output could begin within days so that vaccine deliveries to the European Union (EU) could start as soon as the Moderna candidate gets the green light from EU officials.
The European Medicines Agency (EMA) is reviewing the biotech’s request for authorization of its vaccine on Wednesday [January 6]. The US authorized the vaccine on December 18, while Canada did so on December 23.
The EU Commission has ordered 160 million doses of Moderna's vaccine in total, while Switzerland has purchased 7.5 million doses of the drug.
Lonza, which in May last year announced it had signed a 10-year worldwide partnership with Moderna to enable larger scale manufacture of its mRNA technology based vaccine and additional products “in the future”, is already producing the vaccine at its US plant in New Hampshire.
Over time, the parties intend to establish additional production suites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of the COVID-19 vaccine per year.
Spain based ROVI has been enlisted as a fill-finish partner in the roll-out of the biotech’s vaccine in Europe. And, at the end of December, Moderna announced it had also signed a deal with Recipharm in relation to formulation and fill-finish for its COVID-19 vaccine at that CDMO’s manufacturing facility located in France.
EU ‘slow rollout’ criticized
Meanwhile, some EU member states are coming under fire for the slow roll-out of the Pfizer-BioNTech vaccine, which was approved in the EU on December 21.
The EU's vaccine approval system has also been criticized for being overly sluggish.
EU health commissioner, Stella Kyriakides, said on Saturday [January 2] that any delay in getting approved vaccines out was down to production capacity shortage, not EU planning, according to German news agency, DPA.
“The bottleneck at the moment is not the volume of orders but the worldwide shortage of production capacity,” said the EU official.
The EU is ready to support pharmaceutical companies expand COVID-19 vaccine production to clear a “bottleneck” in distribution, she added.
BioNtech CEO, Uğur Şahin, has criticized the EU’s failure to order more doses of its vaccine, telling Der Spiegel that it and partner Pfizer are now looking to rapidly boost production as concerns grow of a European ‘gap’ left by the lack of other approved vaccines.
He said BioNTech was also aiming to get a new production facility online in Marburg, Germany, in February “far earlier than planned”. It should be able to produce 250 million doses in the first half of 2021.