Several drugmakers are already stockpiling drugs in case of a no-deal Brexit. However, one crucial product simply cannot be reserved because it’s not possible to be made in advance: the seasonal flu vaccine.

As the possibility of Britain leaving the EU next March without a deal looms large, pharmas are worried their key drug deliveries will be held up at borders. For Sanofi, the world’s largest flu vaccine supplier, that means extreme measures may be needed to ensure the seasonal shot reaches the sales stand in time, Sanofi’s U.K. chief Hugo Fry recently told The Times.

Each year, scientists need to determine the circulating flu strains for the upcoming flu season months in advance. Vaccine makers then culture the viruses to make the shots, and after passing regulatory tests, millions of doses would start reaching markets in the Northern Hemisphere in August.

That would leave just a two-month window for early vaccination before October, when influenza activity usually begins to increase. A delay in the vaccines’ delivery could give people a shorter time to be vaccinated and protected.

"You often live hand to mouth in vaccine production because of the complexity of the manufacturing and the testing," said Fry, as quoted by The Times. For the 2017-2018 season, Sanofi sold more than 5.7 million doses of its quadrivalent flu vaccine in the U.K., Louise Brant, a Sanofi spokeswoman, told FiercePharma.

The French pharma is now working on some contingency plans as it braces for the worst-case scenario in the 2019-2020 flu season.

Distribution of all of Sanofi’s vaccines is currently handled at Val de Reuil in Northwest France, and doses are transported to the U.K. via the English Channel, said Brant. The company is considering flying supplies to a predetermined spot in the U.K. where the government would release the delivery instantly, Fry told the British newspaper. Another option would be to mark trucks so that they can pass customs without the usual checks.

"We are considering all options and will work closely with Public Health England and NHS England to ensure we are prepared to mitigate any potential challenges, should they arise next year," said Brant.

Earlier in August, Sanofi announced it is increasing its inventory of drugs for the U.K. from the usual 10 weeks to 14 instead, to ensure smooth supplies as it prepares for a no-deal Brexit. AstraZeneca has also said it is stockpiling drugs supplied by the U.K. and EU for each other. Merck & Co. is making its own plans, including reserving as much as six months’ worth of product in the face of a possible "temporary supply blackout" next March.

It is not yet clear whether the other two top flu vaccine makers—Seqirus and GlaxoSmithKline—are making their own flu-specific backup plans. A GSK spokesman told FiercePharma in general that it will work to ensure seamless supplies of medicines, vaccines and consumer healthcare products to patients after breakup. Measures it is implementing include expanding its ability in the region to conduct retesting and certification of medicines. Representative from Seqirus didn’t immediately reply to a request for comments.

About a month ago, the U.K.’s health secretary, Matthew Hancock, said he had met with pharma industry leaders to discuss growing NHS reserves of vaccines and medicines, according to The Independent. The plan includes options for industry stockpiling of vaccines, medical devices, clinical consumables and blood products.

 --------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.