Covid-19 manufacturing roundup: After Emergent disaster, AstraZeneca in talks to move to Catalent plant — report; Sinopharm says it has capacity to produce 5B vaccines
After months of production of its vaccine plagued by a mixup at a Baltimore Emergent plant that has been taken over by the FDA, AstraZeneca is in talks with the US government to move production to a factory owned by Catalent, the New York Times reports.
The news comes just days after news broke that J&J is expecting to announce that the contamination problems at the plant have been resolved and production is set to resume. Emergent announced that after a month of the FDA taking over the Bayview site, a laundry list of issues has been solved, it said in a statement. With an agreement with the FDA, millions of the doses of the J&J vaccine that were quarantined could be freed up for delivery and administration.
Catalent, a New Jersey-based CDMO, will use its Maryland factory in which it already produces the drug substances used in AstraZeneca’s jab to manufacture the vaccine, the Times reports.
Early in the manufacturing process, Emergent was forced to trash millions of materials tied to AstraZeneca’s vaccine, something CEO Bob Kramer blamed on a flawed manufacturing process sent over by the drugmaker.
The vaccine has been approved in several countries around the world, but not the US because of a rare but serious blood clot in the brain that has been reported in some who’ve received that vaccine.
Meanwhile, Emergent is now trying to overcome the effects that come with shutting down operations for two months. Materials from AstraZeneca’s vaccine came in close contact with media prepared for a J&J run, causing cross contamination. Later, a Form 483 from the FDA revealed that the plant had unsanitary conditions, including black and brown substances — and mold — present in the building and a failure to decontaminate waste before disposing of them.
Kramer was called in front of the US House of Representatives Subcommittee on the Coronavirus Pandemic on May 19 and said that his plant would be good to resume operations within a few days if it was given the OK by the FDA.
Sinopharm says it has capacity to supply 1B doses outside China
Sinopharm has the capacity to supply the world with more than 1 billion Covid-19 vaccine doses outside China, and has the capacity to produce 5 billion doses annually in total, its chairman Liu Jingzhen said Wednesday.
Right now, two vaccines from Sinopharm are being used in China, and one of them has been granted emergency use authorization by the WHO. Sinopharm has also planned a manufacturing facility for its third vaccine, which is in early-stage clinical trials.
Liu would not say how many doses have been pledged to COVAX, however. In February, the Chinese government pledged 10 million doses to the organization.