Search Results for “vaccine” – Page 14 – media

Novavax’s COVID-19 Vaccine Granted Full Marketing Authorisation in EU

Novavax has announced that its COVID-19 vaccine, Nuvaxovid, has been granted full marketing authorisation in the EU. The vaccine is now fully authorised for use as a primary series in individuals aged 12 and older for COVID-19 prevention and as a booster dose in adults aged 18 and older, the company said. Novavax’s protein-based vaccine, which was originally granted a conditional marketing authorisation in the EU for these indications, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies. The European Commission’s latest decision follows a recommendation by the European Medicines Agency’s human medicines committee earlier this year and is supported by positive results from the phase 3 PREVENT trial that evaluated the safety, immunogenicity, and efficacy of Nuvaxovid. John Jacobs, president and chief executive officer of Novavax, said: “This marketing authorisation establishes the foundation for all ...
- Source: drugdu
- 197
- July 12, 2023
EU grants full marketing authorisation for Novavax’s Covid-19 vaccine

US-based Novavax received its first full marketing authorisation for its Covid-19 vaccine Nuvaxovid (NVX-CoV2373) in the EU. Nuvaxovid is now fully authorised as a primary series vaccine for general Covid-19 prevention for individuals aged 12 years and older and as a booster dose in adults aged 18 years and older. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in May 2023, surrounding the vaccine’s full approval. The full authorisation comes a few years after the European Medicines Agency (EMA) granted the prophylactic a conditional marketing authorisation, in December 2021. At the time, Nuvaxovid was the fifth vaccine recommended for Covid-19 prevention in the EU. Novavax has authorised its vaccine in more than 40 markets worldwide. Nuvaxovid is a novel Matrix-M adjuvant protein-based vaccine that has received a US Food and Drug Administration (FDA) emergency use authorisation but has not yet received full ...
- Source: drugdu
- 107
- July 10, 2023
EMA-endorsed statement targets Covid-19 vaccine misinformation

In an age where Covid-19 vaccine misinformation is rife, the International Coalition of Medicines Regulatory Authorities (ICMRA) issued a statement tackling the exaggerations of side effect severity and frequency. The 5 July statement, which was swiftly endorsed by the European Medicines Agency (EMA), points to overwhelming evidence demonstrating a good safety profile across all age groups. There have so far been more than 13 billion vaccine doses given worldwide. ICMRA says the vast majority of side effects due to Covid-19 vaccines are mild and temporary. Any serious side effects identified by safety monitoring systems, such as myocarditis and blood clots, are very rare – meaning they occur in less than one in 10,000 people. The statement pointed towards false and misleading information being spread, especially on social media, that exaggerates the frequency and severity of side effects. The statement read: “As for all medicines, reports of medical events after Covid-19 ...
- Source: drugdu
- 116
- July 8, 2023
Sanofi inks deal to help Saudi Arabia manufacture vaccines locally

Tyler Patchen News Reporter https://endpts.com/ In June, Saudi Arabia’s Public Investment Fund established Lifera, a contract developer and manufacturer in the pharmaceutical field, and now the company has secured a major client. On Wednesday, Lifera and the Saudi-based vaccine manufacturer Arab Pharmaceutical Company, or Arabio, signed a memorandum of understanding with Sanofi to boost the local vaccine production within Saudi Arabia. Under the terms of the agreement, all three companies will search for opportunities to collaborate to form a localization strategy for developing and producing vaccines. This will include Lifera acting as a contract manufacturer to Sanofi and leveraging Arabio’s distribution experience as well. According to the release, the French pharma will plan to manufacture seven vaccines that are part of the “mandatory immunization schedule” with the intention of making these vaccines more readily available in Saudi Arabia and to potentially export as well. However, the specific vaccines that will be ...
- Source: drugdu
- 199
- July 7, 2023
Sanofi partners with local drugmakers to crank out vaccines at new manufacturing plant in Saudi Arabia

After AstraZeneca and National Resilience made recent inroads into the United Arab Emirates, Sanofi has emerged as the next pharmaceutical giant setting its sights on the Middle East.The French pharma is linking up with Saudi drugmakers Arabio and Lifera—the latter of which is wholly owned by the kingdom’s sovereign wealth fund PIF—to bolster production of vaccines in Saudi Arabia. Under a newly minted memorandum of understanding, the companies will explore a range of potential prophylactic initiatives, including the enlistment of Lifera as a contract manufacturer to Sanofi, plus the build-out of a new manufacturing plant utilizing the latest vaccine tech. Sanofi will further share biotechnological know-how to initially manufacture seven vaccines included in Saudi Arabia’s mandatory immunization schedule, the partners said in a press release Wednesday. Arabio, for its part, will leverage its local and regional distribution strength to help supply the shots and other biopharmaceutical products to the Saudi ...
- Source: drugdu
- 106
- July 7, 2023
Sanofi outlines five-pronged approach to reel in €10B in vaccine sales by 2030

While Dupixent often steals the show, Sanofi isn’t sleeping on its vaccine franchise. Boasting prophylactic prospects in respiratory syncytial virus (RSV), pneumococcal disease and flu—including a clutch of promising mRNA candidates—the French pharma feels confident its shots can deliver billions of dollars by the end of the decade. By 2030, Sanofi figures its immunizations could generate more than €10 billion in annual sales, the company said during a vaccines R&D event Thursday. Much of that momentum hinges on Sanofi’s pipeline, where the company is targeting an “accelerated pace of innovation” in a bid to launch at least five innovative phase 3 vaccine programs by 2025. “When developing new vaccines, our scientists can now choose from nine distinct platforms—probably the largest number in the industry,” Thomas Triomphe, Sanofi’s executive vice president of vaccines, said of the company’s future immunization prospects. And despite big things on the horizon—principally in the form of ...
- Source: drugdu
- 111
- July 3, 2023
Gates Foundation and Wellcome to fund late-stage trial of tuberculosis vaccine candidate

The Bill & Melinda Gates Foundation and Wellcome have joined forces to fund the late-stage development of what could be the first tuberculosis (TB) vaccine in over a century. TB is a bacterial infection spread by inhaling tiny droplets from the coughs or sneezes of an infected person. Despite being both curable and preventable, the disease continues to affect around ten million people every year, and 1.6 million people died from it in 2021, almost entirely in low and middle-income countries. The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first used in 1921. It helps protect babies and young children against severe systemic forms of TB, but offers limited protection against pulmonary TB – a form of active TB – among adolescents and adults. The Gates Foundation and Wellcome will invest around $550m to support the phase 3 trial of the M72/AS01E (M72) vaccine, which will be ...
- Source: drugdu
- 121
- July 2, 2023
CDC recommends RSV vaccines from Pfizer, GSK for adults 60 and older

The Centers for Disease Control and Prevention on Thursday recommended that adults ages 60 and above receive a single dose of RSV vaccines from Pfizer and GSK after consulting their doctors. Outgoing CDC Director Rochelle Walensky signed off on the recommendation, which an advisory panel of outside experts made last week. That endorsement says seniors should work with their health-care providers to decide if taking a shot is right for them. The CDC said the shots are expected to be available to the public this fall, when respiratory syncytial virus – along with Covid and the flu – typically begins to spread at higher levels. “These vaccines provide an opportunity to help protect older adults against severe RSV illness at a time when multiple respiratory infections are likely to circulate,” the CDC said in a statement. The virus is a common respiratory infection that usually causes mild, cold-like symptoms, but ...
- Source: drugdu
- 111
- July 2, 2023
‘Aging’ immune cell levels could predict how well we respond to vaccines

Cambridge scientists have identified a signature in the blood that could help predict how well an individual will respond to vaccines. The discovery, published today in Nature Communications, may explain why, even among vulnerable patient groups, some individuals have better responses to vaccines than others. During the COVID-19 pandemic, it has become clear that some patients are better protected by vaccination than others. Many studies have shown that SARS-CoV-2 vaccines are less effective in people with weakened immune systems, but also that this effect is not uniform. Vaccination involves priming the immune system to look for—and get rid of—invading pathogens, such as viruses and bacteria. In part, this involves stimulating the production of antibodies uniquely programmed to identify a particular invader. These antibodies are themselves produced by a type of immune cell known as a B cell. One specific subset of B cells is known as age-associated B cells (ABCs). ...
- Source: drugdu
- 101
- June 29, 2023
Race for universal flu vaccine ramps up as Osivax kicks off Phase IIa trial

France-based biotech company Osivax has thrown its hat into the influenza ring by dosing the first subject with its vaccine candidate OVX836. The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs). The developer has tested OVX836 in four completed clinical trials. In a company statement announcing the latest trial kick-off, Osivax said a recently completed separate Phase IIa trial demonstrated that the candidate in combination with QIVs had a good safety profile with no impairment of immune response by the QIVs. The aim of the latest ongoing trial is to evaluate the vaccine in a larger and more diverse population. The company aims to enrol more than 500 participants aged 18-60 across multiple clinical sites in Australia. The OVX836 vaccine targets nucleoprotein – a conserved internal antigen. Internal antigens, unlike surface antigens, have a lower probability of ...
- Source: drugdu
- 102
- June 20, 2023

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