Moderna’s new Covid vaccine generated a robust immune response against the now-dominant Eris variant and another rapidly spreading strain of the virus in an early clinical trial, the biotech company said Thursday. The updated shot is designed to target omicron subvariant XBB.1.5, but the results suggest that the jab may still be effective against newer variants of the virus that are gaining ground nationwide. That includes Eris and another variant nicknamed Fornax, both of which are also descendants of the omicron virus variant. Moderna’s vaccine and new shots from Pfizer and Novavax are slated to roll out within weeks, pending potential approvals from the U.S. Food and Drug Administration. Meanwhile, Covid-related hospitalizations fueled by Eris and other variants continue to accelerate but remain below the summer peak that strained hospitals this time last year. Eris, also known as EG.5, accounted for 17.3% of all cases as of earlier this month, ...
As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
The NHS has announced that millions of children in England will be offered a flu vaccine as of September 2023 as part of its “life-saving” vaccination programme to protect the country against deadly viruses ahead of winter. School-aged children will receive the flu vaccine either at school or at community clinics, and those who are aged two and three years or have long-term health condition will be offered the vaccine at GP surgeries. The rollout follows the NHS’s winter flu and COVID-19 vaccination programme to provide protection to those eligible from developing serious illnesses and minimise hospitalisations during the winter months. Professor Sir Stephen Powis, NHS England medical director, said: “Vaccinations are our best defence against flu and COVID-19 ahead of what could be a very challenging winter.” By prioritising flu vaccinations for children, the NHS aims to “break the chain of transmission” to the wider population. Earlier this month, ...
The Joint Committee on Vaccination and Immunisation (JCVI) has announced its advice in relation to details surrounding the eligibility of this autumn’s COVID-19 booster vaccine. As the UK COVID-19 vaccination programme enters its third autumn season, the Committee has advised offering the booster to those at high risk of serious disease and who are therefore more likely to benefit from the vaccination. This includes all adults aged 65 years and older, residents in care homes for older adults, those aged six months to 64 years in a clinical risk group, those aged 16 to 64 years who are carers and staff working in care homes for adults. The COVID-19 booster vaccine helps to protect against severe illness, hospitalisations and deaths from COVID-19. Dr Mary Ramsay, director of public health programmes at the UK Health Security Agency, said the COVID-19 virus is “circling more widely over the winter months, with the ...
Bavarian Nordic has shared positive top-line results from a late-stage study of its chikungunya virus vaccine candidate in adults and adolescents. Chikungunya is a mosquito-borne viral disease for which there is currently no approved vaccine or effective treatment. Infection leads to symptomatic disease after four to eight days following the bite of an infected mosquito, with clinical symptoms including acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia. More than 3,200 people aged 12 to 64 years were enrolled and randomised to receive either a single intramuscular injection of Bavarian Nordic’s virus-like particle-based vaccine candidate, CHIKV VLP (PXVX0317), or placebo. Results showed that the vaccine was highly immunogenic in healthy adolescents and adults at up to 22 days post-vaccination, as demonstrated by the strong induction of chikungunya neutralising antibodies in 98% of those in the active group. CHIKV VLP induced significant neutralising antibodies in ...
After coming to the rescue during the mpox outbreak in 2022, vaccine maker Bavarian Nordic has agreed to help replenish U.S. stores of its smallpox/mpox shot. The U.S. Biomedical Advanced Research and Development Authority (BARDA) is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product, the company said in a press release Thursday. The bulk product order represents $96 million of the contract value. That portion will be manufactured and invoiced in 2023 and will “only partly restore the inventory,” Bavarian Nordic said. Bavarian Nordic will also manufacture and supply an additional $3 million worth of liquid-frozen doses in 2023. The rest of the contract will cover “additional services” totaling $21 million, with Bavarian Nordic getting its hands on most of that sum over the next two years. Throughout 2022 and 2023, Bavarian Nordic says it’s manufactured around 5.5 million smallpox/mpox ...
GSK has sued Pfizer in a US court, alleging infringement of the patents it holds on vaccines for respiratory syncytial virus (RSV). The lawsuit claims that Pfizer’s Abrysvo infringes on four of GSK’s patents that cover its rival vaccine, Arexvy. In May, Arexvy became the first RSV vaccine to be approved anywhere in the world after it received approval from the US Food and Drug Administration (FDA). The US approval of Pfizer’s vaccine followed shortly afterwards. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. Both companies’ vaccines aim to prevent lower respiratory tract disease caused by RSV in individuals aged 60 years or older and are expected to be available in the US before the next RSV season. A GSK spokesperson said that “intellectual property protections ...
A new study published in BMJ Global Health has revealed that over 500,000 deaths associated with antimicrobial resistance (AMR) could be averted each year with the effective use of existing vaccines and continued development of new vaccines to tackle priority pathogens. The modelling study, Global and regional burden of attributable and associated bacterial antimicrobial resistance avertable by vaccination, was carried out by the World Health Organization (WHO), the International Vaccine Institute, Korea (IVI) and the London School of Hygiene and Tropical Medicine. AMR occurs when bacteria, viruses, fungi and parasites change over time and become resistant to medicines. The condition has been declared by WHO as one of the top ten global threats to global public health, associated with around 4.95 million deaths globally per year. Science has been playing catch-up to mitigate AMR due to the strain that was faced by health systems worldwide throughout the COVID-19 pandemic. Using ...
Merck and Moderna announced Wednesday the initiation of a pivotal Phase III high-risk melanoma trial combining the companies’ mRNA-based personalized cancer vaccine with Merck’s blockbuster Keytruda checkpoint inhibitor. After a successful Phase IIb in stage III/IV melanoma patients with high risk of recurrence after surgery, Phase III is expanding the population to include stage IIb-IV patients. The study will enroll around 1,089 patients at more than 165 sites and in over 25 countries. The primary endpoint is recurrence-free survival. Secondary endpoints include distant metastasis-free survival and overall survival. Patients will receive either V940 (mRNA-4157), being co-developed and commercialized by Merck and Moderna, in combination with Keytruda or Keytruda alone for comparison. Phase IIb results shared earlier this year showed the cancer vaccine combined with Keytruda reduced risk of recurrence or death by 44% compared to Keytruda alone. Additional data in June 2023 showed the vaccine combo reduced risk of distant metastasis or death by 65% over ...
Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
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