British and US regulators continued their inspection of a contaminated vaccine factory in Liverpool, England, as the health agencies for both countries sought on Saturday to clarify how the problems unfolded that have probably cut this year's US' flu-vaccine supply by nearly half.
Both the company that produced the vaccine, Chiron, and the Food and Drug Administration (FDA) say that the company notified the agency of a contamination problem at the factory in late August. Both said reports from the company's internal investigation indicated that the problem was probably of limited scope. They said they first became aware of the potential for severe disruption when the Medicines and Healthcare Products Regulatory Agency, the British drug regulator, revoked Chiron's manufacturing license for the vaccine Fluvirin last Tuesday.
The company had been expected to provide 48 million doses of the flu vaccine to the US, about half of the nation's supply.
In written testimony submitted to Congress on Friday, Howard Pien, the chief executive of Chiron, said that before receiving the letter, Chiron did not anticipate that the British agency "would temporarily suspend our manufacturer's license for Fluvirin."
A statement from the Food and Drug Administration said, "None of the FDA Center for Biologics Evaluation and Re-search staff who were in regular communication with Chiron since Aug. 25, 2004, were notified by Chiron that there was an increased level of concern regarding the company's investigation of the bacterial contamination."
That statement also said that in the weekly updates between Chiron and the FDA, the company indicated that the contamination was limited, that the internal investigation was progressing with an expected completion in early October, and that the vaccine lots that had previously tested negative for contamination were negative on retesting.
Chiron notified the British agency on Sept. 13 of the alert it had sent to the FDA, and both agencies say there was no communication between them from then until last Tuesday.
What remains unclear is when the British regulators became concerned enough about the situation to order contingency supplies of vaccines for use in Britain. The Liverpool factory has had a history of quality problems.
The regulator ordered an additional 1.2 million doses of the flu vaccine to be delivered to doctors' offices by the end of this month and a million more by mid-next month.
"We are confident that we have sufficient vaccines for this winter's campaign," the agency said in a statement on Wednesday. Chiron supplies 10 percent to 20 percent of Britain's flu vaccines.
The agency has not publicly answered questions about when it ordered backup vaccines. However, flu vaccines, which are grown in chicken eggs, take at least three months, and sometimes as long as six months, to produce.
MONEY MATTERS: Xi was to highlight projects such as a new high-speed railway between Belgrade and Budapest, as Serbia is entirely open to Chinese trade and investment Serbian President Aleksandar Vucic yesterday said that “Taiwan is China” as he made a speech welcoming Chinese President Xi Jinping (習近平) to Belgrade, state broadcaster Radio Television of Serbia (RTS) said. “We have a clear and simple position regarding Chinese territorial integrity,” he told a crowd outside the government offices while Xi applauded him. “Yes, Taiwan is China.” Xi landed in Belgrade on Tuesday night on the second leg of his European tour, and was greeted by Vucic and most government ministers. Xi had just completed a two-day trip to France, where he held talks with French President Emmanuel Macron as the
With the midday sun blazing, an experimental orange and white F-16 fighter jet launched with a familiar roar that is a hallmark of US airpower, but the aerial combat that followed was unlike any other: This F-16 was controlled by artificial intelligence (AI), not a human pilot, and riding in the front seat was US Secretary of the Air Force Frank Kendall. AI marks one of the biggest advances in military aviation since the introduction of stealth in the early 1990s, and the US Air Force has aggressively leaned in. Even though the technology is not fully developed, the service is planning
INTERNATIONAL PROBE: Australian and US authorities were helping coordinate the investigation of the case, which follows the 2015 murder of Australian surfers in Mexico Three bodies were found in Mexico’s Baja California state, the FBI said on Friday, days after two Australians and an American went missing during a surfing trip in an area hit by cartel violence. Authorities used a pulley system to hoist what appeared to be lifeless bodies covered in mud from a shaft on a cliff high above the Pacific. “We confirm there were three individuals found deceased in Santo Tomas, Baja California,” a statement from the FBI’s office in San Diego, California, said without providing the identities of the victims. Australian brothers Jake and Callum Robinson and their American friend Jack Carter
CUSTOMS DUTIES: France’s cognac industry was closely watching the talks, fearing that an anti-dumping investigation opened by China is retaliation for trade tensions French President Emmanuel Macron yesterday hosted Chinese President Xi Jinping (習近平) at one of his beloved childhood haunts in the Pyrenees, seeking to press a message to Beijing not to support Russia’s war against Ukraine and to accept fairer trade. The first day of Xi’s state visit to France, his first to Europe since 2019, saw respectful, but sometimes robust exchanges between the two men during a succession of talks on Monday. Macron, joined initially by EU Commission President Ursula von der Leyen, urged Xi not to allow the export of any technology that could be used by Russia in its invasion