AstraZeneca found itself in the middle of another controversy after Italian police discovered that the giant pharmaceutical company was keeping 29 million doses of its Wuhan coronavirus (COVID-19) vaccine in a drug factory near Rome.
Catalent Inc., a pharmaceutical company with headquarters in New Jersey, runs the factory. The Italian government confirmed that it launched an inspection of the site late last month following a request by the European Commission. A statement from the office of Italian Prime Minister Mario Draghi indicated that the doses were headed to Belgium, from where they would be exported to other countries.
It was unclear where the vaccine stocks would be distributed, but Italian newspaper La Stampa reported on March 24 that the doses were possibly being prepared for export to the United Kingdom. However, AstraZeneca claimed that 13 million of the doses would be sent to low and middle-income countries under COVAX, a global vaccine-sharing initiative, while the rest were for Europe.
“No other exports are currently planned,” the company said to “clarify some inaccurate statements.”
Mario Gargiulo, regional biologics president for Europe at Catalent, claimed that he had no idea whether the doses would be shipped to the U.K. He added that Catalent only sends its finished vials to AstraZeneca’s Belgian distribution center and is not involved in the vials’ further destinations.
This came after the Anglo-Swedish drugmaker and the U.K. found themselves in a supply dispute in January with the European Union. The issue emerged following reports that AstraZeneca planned not to fulfill its contracted deliveries to the European bloc. The EU responded by instructing AstraZeneca to divert supplies meant for the U.K. to Europe.
By March, the drug company failed to deliver more than half of the doses it promised to dispatch to the EU in the first quarter. The stocks at Catalent amounted to nearly twice as much as what the bloc had so far received as of last month. But the discovery of the doses suggested that AstraZeneca had a higher capacity for deliveries when pushed, according to an EU official who asked not to be named, Bloomberg reported. (Related: FLASHBACK: AstraZeneca illegally marketed drugs and committed fraud – why would anyone trust a vaccine from this corrupt company?.)
The police search is one in a series of controversies plaguing AstraZeneca and the coronavirus vaccine it developed alongside the University of Oxford. Last January, a number of European nations expressed their concerns about the vaccine’s efficacy in the over-65 age group.
Germany’s vaccine committee recommended that the shot should be administered only to people ages 18 to 64. The committee issued the recommendation after determining that the drugmaker’s trial data was not enough to assess the jab’s efficacy in people over 65.
German newspapers also reported that the vaccine had an efficacy rate of less than 10 percent in that age group. French President Emmanuel Macron further stoked concerns after saying that the vaccine appeared to be “quasi-ineffective” for the elderly.
Confidence in the AstraZeneca-Oxford vaccine dipped even more last month following several reports of people who developed blood clots shortly after receiving the jab. On April 1, British regulators identified 30 cases of blood clot events after vaccination, seven of whom died due to the condition.
The drugmaker defended its vaccine and said that the number of blood clots recorded post-vaccination was lower than could be expected to occur without vaccination. But despite AstraZeneca’s assurance, several countries, including France, Italy, Spain and Germany, still suspended the use of the vaccine.
The European Medicines Agency (EMA), the EU’s drug regulator, conducted a safety review into the vaccine and concluded that it was safe and effective and that its benefits outweighed its risks. However, EMA officials said that the agency at the moment “still cannot rule out definitively a link” between the vaccine and the blood clots. (Related: New research points to link between AstraZeneca vaccine and blood clots.)
Late last month, the Data Safety Monitoring Board, an American health agency that reviews drug trial data, raised the possibility that AstraZeneca provided “outdated” efficacy figures. The drug giant responded in a statement that the figures were based on a pre-specified interim analysis with a data cutoff of Feb. 17. It added that it would share its primary analysis containing updated data within two days after issuing its statement.
On March 24, the company changed the vaccine’s efficacy to 76 percent, which was lower than the 79 percent rate it released days earlier.
Learn more about the controversies surrounding AstraZeneca and other pharmaceutical giants at BigPharmaNews.com.