Furthering its goal to grow the reach of its mRNA vaccines and guard against future pandemics, Moderna cleared a key regulatory hurdle at its flagship production plant in the United Kingdom.
The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) has granted Moderna a manufacturer and importer's license at its vaccine facility in Harwell, Oxfordshire.
With license in hand and the plant now fully operational, Moderna is free to use the site for commercial production of mRNA shots, which will then be beholden to MHRA's standard review process, the company said in an April 15 press release.
The facility, dubbed the Moderna Innovation and Technology Centre, forms a major component of the company’s 10-year partnership with the U.K. government and its Health Security Agency to prepare for future pandemics. The pact is designed to shore up domestic vaccine production in the U.K., bolster the country's R&D prowess and ensure "priority access" to mRNA vaccines in the event of an emergency, Moderna noted in its release.
“This significant achievement marks a major step forward in our mission to establish end-to-end mRNA manufacturing capabilities in the U.K., and we are proud to have reached it in less than two years since breaking ground on the site,” Darius Hughes, Moderna’s U.K. general manager, said in a statement.
As it stands, Moderna figures the Harwell facility should be able to crank out at least 250 million mRNA vaccine doses for the U.K. public and the country's National Health Service during a pandemic.
The Harwell facility, along with plants in Australia and Canada, forms part of a global network of manufacturing sites ready to respond in the event of a pandemic, Moderna said. The sites have been placed strategically to "maximize geographic coverage and minimize response times, ensuring that vaccines and therapeutics can be distributed quickly and efficiently when needed," the company explained.
Moderna first telegraphed its plans to build a U.K. plant in June 2022. Aside from shots for COVID-19, the facility was also tipped to produce vaccines for other conditions like respiratory syncytial virus (RSV) and seasonal flu, Moderna said at the time.
So far, Moderna has snagged approvals for its coronavirus vaccine and its RSV shot mRESVIA in the U.K., the latter of which was greenlit in late February.
The MHRA approval comes amid a torrent of uncertainty in the pharmaceutical and biotech industry, thanks to on-again, off-again threats of tariffs proposed by the White House.
A large part of President Donald Trump's goal with the trade penalties is to motivate manufacturers to return to or set up operations in the U.S.
As it stands, pharmaceutical products have been specifically exempted from the base and reciprocal tariffs Trump unveiled in early April. Still, the industry isn't out of the woods just yet.
During an appearance Sunday on ABC News’ “This Week,” Commerce Secretary Howard Lutnick said U.S. tariffs on pharmaceuticals and semiconductors would likely be unveiled “in the next month or two.”
Separately, the CDC's Advisory Committee on Immunization Practices (ACIP) this week hinted that it might recommend reduced use of immunizations for both COVID and human papillomavirus (HPV).
“It looks likely ACIP will shift to risk-based from universal booster vaccine recommendations,” analysts at Leerink Partners said of the potential COVID vaccine blow in an investor note. Such a decision would likely put pressure on Moderna, as well as Pfizer and BioNTech both this year and next, the analysts said.