Search Results for “vaccine” – Page 11 – media

NIH clinical trial for universal influenza vaccine begins

The universal vaccine could protect people against more strains of flu The National Institutes of Health (NIH) has announced that it has begun dosing patients in a phase 1 clinical trial of a new influenza (flu) vaccine candidate, FluMos-v2, to evaluate the vaccine for safety and its ability to elicit an immune response. Designed by researchers at the National Institute of Allergy and Infectious Diseases’s (NIAID) Vaccine Research Center (VRC), FluMos-v2 works to induce antibodies against various influenza strains by displaying part of the influenza virus haemagglutinin (HA) protein in repeating patterns on self-assembling nanoparticle scaffolds, preparing the immune system to recognise and fight the actual virus. Sponsored by NIAID, the trial is expected to enrol 24 healthy individuals, aged 18 to 50 years, to receive two intramuscular injections of the vaccine candidate, 16 weeks apart. The researchers aim to enrol 12 participants in a lower dose group (60mcg per ...
- Source: drugdu
- 106
- September 30, 2023
mRNA Vaccine Manufacturing Comes to Africa

By Clemence Manyukwe Pictured: The first BioNTainer arrives in Rwanda/BioNTech German biotech company BioNTech has said it will start manufacturing vaccines in Africa within 18 months after completing a manufacturing facility in Rwanda, a milestone the company stated it expects to reach by the end of this year. The company is also planning to set up plants in two other African countries, South Africa and Senegal, as part of what it describes as an effort to democratize access to novel medicines around the globe. “Core to BioNTech’s business practices is to improve the health of people worldwide,” a company spokesperson told BioSpace in an email. To launch its manufacturing presence in Africa, BioNTech introduced its BioNTainer, a flexible container solution delivering turnkey mRNA manufacturing facilities for scalable mRNA vaccine production. “The BioNTainer was developed to help ensure sustainable, equitable access to mRNA-based medicines in countries and regions where they are ...
- Source: drugdu
- 95
- September 29, 2023
WuXi debuts first vaccine CDMO site in China, where it plans to employ more than 500

Amid a global expansion spree at WuXi Biologics, the company’s immunization-focused subsidiary has christened its inaugural CDMO site in China. Tuesday, WuXi Vaccines launched its first standalone vaccines contract manufacturing facility in Suzhou. With the plant, the company adds drug substance and drug product capacity for projects in various stages of development. WuXi Vaccines is a contract development and manufacturing organization that helps its partners tackle clinical- and commercial-stage vaccine projects across a range of modalities, including protein-, virus- and mRNA-based shots. The new site’s drug substance production area houses two cell culture lines and one purification line, teeing up drug substance production scales ranging from 50 liters to 1,000 liters, according to a release. WuXi Vaccines says it will also maintain 2,000 liters of reserve capacity at the facility. Meanwhile, the drug product facility is equipped with an automatic vial washing, sterilizing, filling and capping line, which can support ...
- Source: drugdu
- 114
- September 28, 2023
CSL Seqirus highlights impact of flu vaccines on reducing strain on healthcare resources

CSL Seqirus has unveiled new data highlighting the potential impact of influenza vaccines on reducing the burden seasonal flu has on hospitals and broader healthcare systems. The analyses were presented at this year’s European Scientific Working Group on Influenza (ESWI) Conference. Seasonal flu is an acute respiratory infection caused by influenza viruses, which circulate in all parts of the world. Although most people can recover within a week without requiring medical attention, the flu can cause severe illness among high-risk groups such as young children, older adults, pregnant individuals and those with serious medical conditions. In France, approximately 2 to 6 million people are affected by influenza every year, leading to over 20,000 hospitalisations and 10,000 excess deaths, 90% of which occur in older adults. According to findings from a dynamic transmission model, standard-dose quadrivalent flu vaccines for older adults could reduce hospitalisations by 11.1% to 30.0% and cut ICU ...
- Source: drugdu
- 114
- September 21, 2023
FDA approves Pfizer/BioNTech and Moderna’s adapted COVID-19 vaccines

The updated vaccines more closely target current circulating variants The US Food and Drug Administration (FDA) has granted approval for Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, to tackle currently circulating variants. As previously recommended by the FDA, both vaccines have been adapted to closely target the XBB.1.5. Omicron variant by including a monovalent component. Both companies’ mRNA vaccines are approved for use in individuals aged 12 years and older and authorised for emergency use in those aged six months to 11 years. The FDA has said that it is “confident in the safety and effectiveness” of the two updated vaccines and that its risk assessment demonstrated that the benefits of both vaccines for individuals aged six months and older outweighed the risks. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Peter Marks, director of the ...
- Source: drugdu
- 147
- September 20, 2023
EMA CHMP recommends approval for Moderna’s updated Covid-19 vaccine

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting marketing authorisation for Moderna’s Spikevax, an updated Covid-19 vaccine targeting the SARS-CoV-2’s XBB.1.5 sublineage. The vaccine is intended for active immunisation for the prevention of Covid-19 in those aged six months and above. The latest development comes after the company filed a regulatory application seeking approval for the updated vaccine in July 2023. Based on the positive opinion from the committee, the European Commission will adopt a decision on the vaccine approval for autumn/winter 2023. Moderna has obtained clinical results for the monovalent XBB.1.5 vaccine candidate which offered an immune response against sublineages of XBB, XBB.1.5, XBB.1.16, and XBB.2.3.2, apart from BA.2.86, EG.5 and FL.1.5.1 variants. Injection site pain was reported to be the most frequently solicited local adverse event for the updated vaccine. Fatigue, myalgia, headache, chills and arthralgia were the ...
- Source: drugdu
- 149
- September 18, 2023
ICON partners with US Government for clinical trials of Covid-19 vaccines

US Biomedical Advanced Research and Development Authority (BARDA) has partnered with Ireland-based ICON to conduct clinical trials of Covid-19 vaccine candidates selected as part of “Project NextGen”. A part of the US Government’s Strategic Preparedness and Response division, BARDA has launched Project NextGen to develop Covid-19 vaccines and therapies for current and future strains. To achieve this, BARDA plans to leverage its public-private partnerships. The government has plans to invest more than $5bn in the Project NextGen programme. In June, the European Medicines Agency (EMA) identified the need to update the Covid-19 vaccines to include the XBB Omicron variant. The US Government seconded that sentiment, and last month, BARDA partnered with Regeneron to develop a Covid-19 monoclonal antibody vaccine candidate. ICON’s government and public health solutions team will conduct a Phase IIb active comparator clinical trial to evaluate the efficacy of the next-generation Covid-19 vaccine, selected by BARDA, compared to ...
- Source: drugdu
- 123
- September 18, 2023
Moderna, Pfizer-BioNTech’s Updated COVID-19 Vaccines Approved by FDA

By Hayley Shasteen Pictured: Syringe drawing up vaccine/iStock, Diy13 The FDA approved two updated COVID-19 booster shots from Pfizer-BioNTech and Moderna Monday afternoon, just in time for the fall vaccination season. The reformulated mRNA vaccines are specifically tailored to provide protection against circulating Omicron-related variants, including subvariant XBB.1.5, which the FDA had recommended vaccines be updated to cover in June 2023. The CDC is anticipated to release its recommendation guidance on the boosters Tuesday. A positive endorsement by the agency could see boosters available at pharmacies and doctors’ offices by the end of the week, The New York Times reported. CDC Director Mandy Cohen is expected to recommend the updated vaccines and sign off on their use, having previously made remarks favoring an updated booster. The approval for both boosters covers individuals ages 12 years and up, with Emergency Use Authorization granted for individuals ages six months to 11 years. ...
- Source: drugdu
- 232
- September 13, 2023
Pfizer, Moderna score FDA nods for next round of seasonal COVID-19 vaccines

Out with the old and in with the new: Monday, the U.S. FDA approved retooled mRNA shots against COVID-19 from Pfizer-BioNTech and Moderna, simultaneously bidding adieu to the companies’ bivalent shots in the U.S.The FDA has approved Pfizer-BioNTech and Moderna’s separate vaccine formulations that are more closely targeted to current variants of the disease, the agency said in a release. Specifically, each company’s shot is approved for people ages 12 and up and emergency authorized for patients 6 months old to 11 years old. The vaccines have been updated to include a monovalent component aimed at omicron variant XBB.1.5, according to the companies and the FDA. Meanwhile, Novavax’s revised shot is still pending regulatory approval. Moderna noted the COVID is “on the rise again” and warned of a “’tripledemic’” of COVID, flu and respiratory syncytial virus this winter and fall. Vaccines should remain “top of mind,” the company said. Following ...
- Source: drugdu
- 109
- September 13, 2023
FDA fast tracks Mendus’s acute myeloid leukaemia vaccine vividencel

The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML). The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress. According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study. Prior to this, the company published data on the drug’s effects on measurable residual ...
- Source: drugdu
- 166
- September 12, 2023

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