Manufacturing and logistic disruptions worldwide are affecting the distribution of Covid-19 vaccines.
‘Novasep site’ cuts AstraZeneca vaccine production ‘by 60%’
AstraZeneca (Cambridge, UK) has revealed that unspecified production problems at its CMO Novasep’s (Lyon, France) Belgian site mean it will produce only 40% of the doses it promised to the EU in Q1, according to Reuters. It will now deliver only 31 million doses. An EU official said AstraZeneca plans to begin deliveries to the EU from 15 February.
“Initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain,” said an AstraZeneca spokesperson.
AstraZeneca announced in June 2020 an agreement with Novasep for large-scale viral vector production for the vaccine AZD-1222 at Novasep’s Seneffe, Belgium site. The plant now belongs to Thermo Fisher (Waltham, MA, US), which acquired Novasep’s viral vector business, Henogen, for about €725M ($875M) on January 15, including a second Belgian site.
Upgrade at Brussels plant delays Pfizer doses
Pfizer (New York, NY, US) has reduced shipments of its Covid-19 vaccine to Europe and Canada while it upgrades its Puurs, Belgium plant to increase production capacity. The facility manufactures all doses of Pfizer’s vaccine intended for markets outside the US.
Pfizer announced that the delay will last several weeks from 15 January. Many governments have criticized the decision. The Italian foreign minister has threatened legal action against Pfizer, and European Council President Charles Michel told a European radio station, “We plan to make the pharmaceutical companies respect the contracts they have signed… by using the legal means at our disposal.”
Canada was set to receive no doses of the vaccine in the final week of January. The EU expects that Pfizer will have delivered 92% of what was expected in the second half of January and will make up the missing 8% during the week of 15 February, according to the Associated Press. Overall, Pfizer is contracted to provide up to 600 million doses to the EU.
Pfizer says that a small delay now will improve manufacturing speeds later this year. “We’ve explored innovative ways to increase the number of doses we’re able to supply this year, and we now believe that we can potentially deliver approximately two billion doses by the end of 2021,” the company said.
Moderna batch may be scrapped after anaphylaxis link in California
A batch of 330,000 doses of Moderna’s (Cambridge, MA, US) Covid-19 vaccine will be unusable after the discovery that it appeared to cause “severe” allergic reactions in “fewer than ten” people in California. The state epidemiologist advised against the use of the remaining doses from the same lot (41L20A) on 17 January.
The lot arrived in California between 5 and 12 January and was distributed to 287 providers across the state. It is not clear how many doses were administered before the problem was identified.
Manufacture of the vaccine is shared
by Lonza (Basel, Switzerland), Recipharm (Stockholm, Sweden), Catalent (Somerset, NJ, US), and Laboratorios Farmaceuticos Rovi (Madrid, Spain). Moderna, the CDC, and the FDA are investigating. The California Department of Public Health stated, “There are not immediate replacement doses during the pause in addition to pending orders scheduled for shipment in the next few days.”
Separately, nearly 900,000 vaccine doses are stuck in warehouses or in transit, California governor Gavin Newsom said on January 4.
Brexit delays Moderna shipments to UK
The UK approved Moderna’s vaccine on 8 January, but Brexit will delay shipments of the seven million doses ordered until April. The UK left the EU trading bloc at the start of this year.
No part of the pharmaceutical value chain is unaffected by Covid-19, with a wide range of activities from drug development to sales and marketing having to adapt. According to the GlobalData survey, The State of the Biopharmaceutical Industry, 2021 Edition, the supply chain will be the second most disrupted part of the pharmaceutical value chain by Covid-19 in 2021, after drug development.