The UK regulatory authorities have cleared Chiron to resume production of its influenza vaccine Fluvirin at its facility in Liverpool, lifting a ban imposed in October because of contamination problems at the plant.
The news reduces the risk that flu vaccine shortages that emerged over the last flu season will be repeated in 2005/6. The suspension of Chiron's license to make the vaccine at Liverpool had a significant impact as the plant supplied a sixth of the UK market for flu vaccines. Moreover, Chiron was due to supply fully half the US order for flu vaccines in the 2004-2005 season.
The abrupt resolution of the issue comes as something of a surprise, given that in January the UK's Medical and Healthcare products Regulatory Agency extended the halt on production until the beginning of April, and the FDA sent the firm a warning letter about the plant, raising concerns that Chiron may be unable to meet commitments for the next flu season.
The issue is still not wholly resolved: Chiron must provide the MHRA with regular weekly updates to ensure that progress on its various projects proceeds to the remediation plan, and the agency may conduct further inspections.
Meanwhile, Chiron has yet to comment on whether it will be able to play a full role next season, although more details may emerge from a press conference to be held later today. A successful return to the US market will also depend on the outcome of a US Food and Drug Administration (FDA) inspection of the facility, which will only take place after 'all critical stages of manufacturing are in full swing, and needed corrective actions can be fully evaluated', according to the US agency.
No date has yet been set for this inspection, and yesterday the director of the FDA's Center for Biologics Evaluation and Research, Dr Jesse Goodman, said in a statement that the MHRA green light was "an extremely important milestone in Chiron's efforts to supply influenza vaccine for the US market for the coming flu season, but work remains."
Meanwhile, Chiron could feel the ramifications of the suspension keenly as it will likely face increased competition when it returns to the US market. At present, Chiron and Sanofi-Aventis are the only two companies licensed to sell flu vaccine in the US. But GlaxoSmithKline and Canada's ID Biomedical Corp. are now seeking accelerated FDA approval of their flu vaccines, and if cleared could together supply a third of the country's flu vaccine needs.
Meanwhile, the US Justice Department and Securities and Exchange Commission are investigating whether Chiron was prompt enough in publicising the problems at the Liverpool plant.