By Kate Goodwin Pictured: A researcher at work in a Novavax laboratory/Novavax, Patrick Siebert Combination vaccines are nothing new for the healthcare industry. Childhood vaccines, as well as a single shot for tetanus, diphtheria and pertussis for adults, have long been combined for ease of administration and increased compliance rates. Now, as vaccines for COVID-19 and, for older people, RSV and pneumococcal disease join the annual flu shot as routine care recommendations for adults, healthcare professionals are increasingly concerned over getting the word out, vaccine fatigue and logistical hurdles. Biopharma companies are betting there will be a market for vaccines that combine protection against two or more diseases in a single jab. Benefit to the Population “The data are pretty unequivocal that when there are combo vaccines available, people generally prefer [them],” said Andrea C. Love, an immunologist and microbiologist and founder of the Unbiased Science Podcast. Love pointed out ...
Novavax has announced that its updated COVID-19 vaccine, Nuvaxovid XBB.1.5, has been approved by the European Commission (EC) for active immunisation in individuals aged 12 and older. The decision follows a positive opinion for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Developed to target the Omicron XBB sublineage, the updated vaccine prepares the body’s defences against COVID-19 and contains a version of the spike protein of the Omicron XBB.1.5 subvariant, as well as Matrix-M adjuvant to strengthen immune response. The approval was based on non-clinical data which showed that the vaccine induced functional immune responses against the COVID-19 variants XBB.1.5, XBB.1.16 and XBB.2.3. Additionally, the updated vaccine induced neutralising antibody responses to newly emerging subvariants of the SARS-CoV-2 virus, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6, as well as strong CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. Based on previous recommendations by ...
Gonorrhea, a sexually transmitted bacterial infection that affects more than 80 million people worldwide every year, has become resistant to almost all known antibiotics. That makes it notoriously difficult to treat, but left untreated, an infection could lead to serious or even fatal complications. It also increases a person’s risk of contracting HIV. A new study suggests artificial intelligence (AI) may help identify a vaccine’s key ingredients. This week in mBio, an international collaboration between academic and commercial researchers reported the identification of 2 promising antigens as candidates for a gonorrhea vaccine. The researchers used an AI model called Efficacy Discriminative Educated Network, or EDEN, to identify the protective proteins. They also used EDEN to generate scores that accurately predicted how well antigen combinations would reduce pathogenic bacterial populations of Neisseria gonorrhoeae, the microbe that causes gonorrhea. “To the best of our knowledge, this correlation has not been shown before,” ...
Pictured: Artistic rendering of doctor diagnosing lungs on screen/iStock, greenbutterfly Despite missing the primary endpoint mark in June 2023, Ultimovacs hasn’t given up on trying to prove its universal cancer vaccine has a benefit for deadly mesothelioma. The Norwegian biotech reported new data Tuesday, proving strong clinical responses with extended overall survival in a follow up analysis. When combined with Bristol Myers Squibb’s Opdivo and Yervoy as a second-line treatment to platinum chemotherapy, Ultimovacs’ UV1 reduced risk of death by 27% for patients with malignant pleural mesothelioma, a cancer in the lining of the lungs. Caused by asbestos fibers that have embedded in the pleura, eventually leading to mesothelioma tumors, this cancer is aggressive and often incurable. The five-year survival rate for localized pleural mesothelioma, the most treatable type, is 24%. Median overall survival for patients receiving the vaccine combined with the checkpoint inhibitors was 15.4 months, compared to 11.1 months on the immunotherapy treatments alone. ...
New raw vaccine materials that could make vaccines more accessible, sustainable, and ethical have been discovered. Adjuvants are vaccine ingredients that boost a person’s immune response to a vaccine, providing greater protection against disease. One of the most prevalent adjuvant materials used in vaccines is squalene, which is typically sourced from shark livers. Researchers at the University of Nottingham collaborated with the Access to Advanced Health Institute (AAHI) to identify synthetic alternatives to squalene that ensure sustainable, reliable, and ethical sourcing of adjuvant raw materials for vaccines moving forward. New synthetic adjuvant materials were developed from commercially available methacrylate monomers, ensuring that a reliable supply of the material is continually available. The combination of these adjuvant materials are scalable through catalytic chain transfer polymerization, a process that allows high levels of control over the molecular weight of the product polymer. Controlling the molecular weight is key to the use of ...
The US Food and Drug Administration (FDA) has found no misconduct by contract research organisation (CRO) Care Access in Pfizer and French partner Valneva’s Lyme disease vaccine trial. The FDA did not issue a Form 483 – a document sent to a company indicating violations after an inspection. The outcome comes after a nine-day for-cause FDA Good Clinical Practices (GCP) inspection into sites managed by Care Access in Pfizer’s VALOR trial. The inspection reviewed Care Access’s contributions to the trial, including GCP requirements, patient safety and data integrity, the CRO said in an 11 October statement. Care Access CEO Ahmad Namvargolian said in a company statement: “We’re very glad to have had the opportunity finally to undergo this independent, searching review by an FDA expert, which confirmed what we’ve always said about our performance on the VALOR trial and beyond.” In February 2023, Pfizer and Valneva announced it was halting ...
The study will offer new insights into the immune system’s response to iGAS Spencer Dayman Meningitis Research has announced that scientists at the University of Bristol have begun a research project to aid in the development of a vaccine against invasive group A streptococcus (iGAS). The study will offer new and unique insights into the adaptive immune response to iGAS. iGAS is a severe infection caused by bacteria invading parts of the body, including the blood, deep muscle, fat tissues or lungs, which can lead to diseases such as meningitis and sepsis. Since April 2023, there have been 3,287 cases of iGAS in the UK, 761 of which occurred in children aged 18 years and under. There is currently no vaccine to protect individuals from group A streptococcus, which can also cause rheumatic fever and scarlet fever. Funded by Spencer Dayman Meningitis Research, scientists Dr Ana Goenka, Dr Alice Halliday ...
The Bill & Melinda Gates Foundation is providing $40m in funding to advance the accessibility of Quantoom Biosciences’ affordable mRNA vaccine research and manufacturing platform. The platform was developed with an early-research Grand Challenges grant awarded to its parent company, Univercells. The new investments will advance access to mRNA research and vaccine manufacturing technology that will support the capacity of low and middle-income countries (LMICs) to develop vaccines at scale. Senegal’s Institut Pasteur de Dakar and South Africa’s Biovac, both experienced in vaccine manufacturing, will each receive a $5m grant to acquire the technology to develop locally relevant vaccines. Quantoom Biosciences will receive $20m to further advance the technology and reduce commercialisation costs. The foundation will grant a further $10m to other LMIC vaccine manufacturers. The new funding builds on its earlier $55m investment in mRNA manufacturing technology. Biovac CEO Morena Makhoana stated: “This collaboration will help close critical gaps ...
Takeda today announced that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). In the coming months, the WHO will consider the SAGE recommendation and update its position paper on dengue vaccines to include final guidance on the use of QDENGA in public vaccination programs. SAGE made the following recommendations: The vaccine to be considered for introduction in settings with high dengue disease burden and high transmission intensity to maximize the public health impact and minimize any potential risk in seronegative persons. The vaccine to be introduced to children aged 6 to 16 years of age. Within this age range, the vaccine should be introduced about 1-2 years prior to the age-specific peak incidence of dengue-related hospitalizations. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses. The vaccine ...
The Danish artificial intelligence (AI) biotech Evaxion has announced plans to develop an mRNA vaccine against gonorrhea in partnership with Afrigen Biologics. Gonorrhea antigens identified through Evaxion’s EDEN platform have shown strong protective effects in preclinical trials, as per the company. The partnership will investigate the function of these antigens when presented in the mRNA form. After the validation phase, the partners will discuss an agreement for clinical development and commercialisation, with the opportunity to involve additional collaborators. Cape Town, South Africa-based Afrigen Biologics is set up as a specialised centre to support mRNA vaccine development and technology transfer, will take charge of developing the mRNA vaccine in low and middle-income countries and African territories. Gonorrhea is a sexually transmitted infection, caused by the bacteria Neisseria gonorrhoeae. It heightens the vulnerability to HIV, a prevalent health concern in many low and middle-income countries (LMICs). Birgitte Rønø, Evaxion’s Chief Scientific Officer ...
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