Latest news with #DariusHughes
Yahoo
15-05-2025
- Health
- Yahoo
Moderna opens UK vaccine manufacturing lab
Covid vaccine manufacturer Moderna has completed a new site in the UK, which it says will help prepare the the country against future pandemics. The Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire, is now fully operational and has its manufacturer's license by the Medicines and Healthcare products Regulatory Agency. Moderna's UK general manager Darius Hughes calls it an "an important pillar of our pandemic preparedness". US company Moderna became a household name during the Covid pandemic, creating successful vaccines using a new technology called mRNA. It used genetic code to create an immune response by giving the body the instructions to protect against the virus. It proved to be one of the fastest routes to developing vaccines during the pandemic, and experts believe the technology could help in other areas such as cancer, flu, and heart disease. Mr Hughes describes the new set up as an "onshore supply chain manufacturing process" that will "really enable us to scale up within 100 days to make British vaccines for the UK public". He adds: "We are working very closely with the UK Health Security Agency (UKHSA) and with other government agencies to make sure we are learning from the previous pandemic, and applying those learnings, and getting ourselves a little bit better prepared should another pandemic be declared." One of the key features of the facility is speed. It is set up to react quickly so manufacturing can change from one vaccine to another as the country needs it. Mr Hughes says: "One week we could be making a couple of million Covid vaccines, the next week we could be making a couple of million norovirus vaccines. It's that level of flexibility. "And even within a season, if the virus might change or mutate... we could get a new code, a new set of messages, and make a new vaccine within weeks." Aside from vaccine production, labs will also process samples from clinical trials working on the development of new drugs, and scientists have already starting looking at the effectiveness of new protections against norovirus. Previously a government-funded facility, known as the Vaccine Manufacturing and Innovation Centre (VMIC), was based in Harwell. It ended up being sold to pharmaceutical company Catalent in 2022 before it was finished. The VMIC had been set up as a not-for-profit company with the aim of combining vaccine research and manufacturing in one place. The establishment of the MITC is part of a ten-year strategic partnership between Moderna and the government, managed by the UKHSA. The government will buy the vaccines made here as part of the deal. The first priority is a new covid vaccine for the NHS for next winter. You can follow BBC Oxfordshire on Facebook, X (Twitter), or Instagram. Science park chosen for new Moderna vaccine base New vaccine centre sold to company Moderna United Kingdom Medicines and Healthcare products Regulatory Agency
BBC News
15-05-2025
- Business
- BBC News
Moderna opens UK vaccine manufacturing lab in Harwell
Covid vaccine manufacturer Moderna has completed a new site in the UK, which it says will help prepare the the country against future Moderna Innovation and Technology Centre (MITC) in Harwell, Oxfordshire, is now fully operational and has its manufacturer's license by the Medicines and Healthcare products Regulatory UK general manager Darius Hughes calls it an "an important pillar of our pandemic preparedness".US company Moderna became a household name during the Covid pandemic, creating successful vaccines using a new technology called mRNA. It used genetic code to create an immune response by giving the body the instructions to protect against the proved to be one of the fastest routes to developing vaccines during the pandemic, and experts believe the technology could help in other areas such as cancer, flu, and heart disease. 'Better prepared' Mr Hughes describes the new set up as an "onshore supply chain manufacturing process" that will "really enable us to scale up within 100 days to make British vaccines for the UK public".He adds: "We are working very closely with the UK Health Security Agency (UKHSA) and with other government agencies to make sure we are learning from the previous pandemic, and applying those learnings, and getting ourselves a little bit better prepared should another pandemic be declared." One of the key features of the facility is speed. It is set up to react quickly so manufacturing can change from one vaccine to another as the country needs Hughes says: "One week we could be making a couple of million Covid vaccines, the next week we could be making a couple of million norovirus vaccines. It's that level of flexibility."And even within a season, if the virus might change or mutate... we could get a new code, a new set of messages, and make a new vaccine within weeks."Aside from vaccine production, labs will also process samples from clinical trials working on the development of new drugs, and scientists have already starting looking at the effectiveness of new protections against norovirus. Previously a government-funded facility, known as the Vaccine Manufacturing and Innovation Centre (VMIC), was based in ended up being sold to pharmaceutical company Catalent in 2022 before it was VMIC had been set up as a not-for-profit company with the aim of combining vaccine research and manufacturing in one establishment of the MITC is part of a ten-year strategic partnership between Moderna and the government, managed by the UKHSA. The government will buy the vaccines made here as part of the first priority is a new covid vaccine for the NHS for next winter. You can follow BBC Oxfordshire on Facebook, X (Twitter), or Instagram.
Yahoo
28-02-2025
- Health
- Yahoo
Moderna Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine
mRESVIA® is Moderna's second approved product in the UK CAMBRIDGE, MA / / February 28, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorization for mRESVIA (mRNA-1345), indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. "The MHRA's authorization of our RSV vaccine is an important milestone for Moderna's efforts toward respiratory disease preparedness," said Stéphane Bancel, Chief Executive Officer of Moderna. "Our RSV vaccine will be manufactured at the Moderna Innovation and Technology Centre in Oxfordshire, which will be fully operational later this year." RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. In the UK, RSV has an impact on elderly adults and is responsible for 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths in adults 65 years of age and older per year.[i] "Given the serious consequences of RSV for older people, which can lead to hospitalization and severe outcomes, we are delighted that the MHRA has authorized our RSV vaccine," said Darius Hughes, UK General Manager of Moderna. "With the MHRA decision, mRESVIA becomes Moderna's second approved product in the UK, further demonstrating the role of mRNA vaccines in helping to protect the public from respiratory diseases." The approval is based on positive data from the Phase 3 clinical trial ConquerRSV, a randomized, placebo-controlled, observer-blind, case-driven clinical study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. No serious safety concerns were identified in the Phase 3 trial. About mRNA-1345 (Respiratory Syncytial Virus Vaccine) mRNA-1345 is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. To date, Moderna has received marketing authorizations for its RSV vaccine in the United States, the European Union, Canada, Qatar, the United Arab Emirates, and Taiwan and has submitted regulatory applications in other markets worldwide. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the vaccine efficacy and safety of mRNA-1345; the potential for mRESVIA to reduce disease burden from RSV; Moderna's expectation that the MITC will be fully operational later this year; and Moderna's regulatory applications worldwide. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts International Media:Luke Mircea-WillatsSenior Director, International UK Media:Emma Gilgunn-JonesDirector, UK Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 1. Fleming, D.M., Taylor, R.J., Lustig, R.L. et al. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis 15, 443 (2015). SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire Sign in to access your portfolio
