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Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Children between the ages of five and 36 months are at highest risk of death from malaria.
As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 1 variant of concern.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. In addition, no serious safety concerns linked to the vaccine were observed.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 Each booster dosage contains 15?g 1 vaccine as well as the safety results from a clinical trial underway.
A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. for serogroup W to 20.5
The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.
The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60 years and above. The vaccine is indicated for active immunisation to prevent RSV-related lower respiratory tract disease (LRTD) in older adults.
Vaccination alone is unlikely to contain COVID-19 infections in the UK but gradual reopening and high vaccine uptake could minimize future waves of infection COVID-19 vaccines being rolled out in the UK are effective in preventing severe disease, but the extent to which they prevent against infection is still unclear.
Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 1 Adapted Bivalent Vaccine Candidate. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.1 1 Adapted Bivalent Vaccine Candidate. 1 as compared to the companies’ current COVID-19 vaccine.
Hungary is to order a consignment of Russia’s Sputnik V COVID-19 vaccine, as the country struggles to contain the infection rate. According to press reports , the decision puts Hungary on “collision course” with the EU, which has not approved the vaccine or plans to review it either. The country has had more than 1.8
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), Due To The Potential Presence of Visible Particulate. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a single patient use fliptop vial.
Hospira Issues A Voluntary Nationwide Recall For One Lot of Propofol Injectable Emulsion (containing benzyl alcohol), Due To The Potential Presence of Visible Particulates. It is a sterile, nonpyrogenic emulsion containing 10 mg/mL of propofol suitable for intravenous administration supplied in a Single Patient Use Glass Fliptop Vial.
Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Vaccine Booster in Children 5 Through 11 Years of Age. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5-Adapted 5-adapted bivalent vaccine. 5) AUTHORIZED USES .
Moderna’s new version of its COVID-19 vaccine, which targets two virus variants including Omicron, has outperformed the company’s original Spikevax shot in a head-to-head clinical trial. It has predicted sales of COVID-19 vaccines will be around $21 billion this year. Three-month data will be reported later this summer.
AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.
BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.
European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.
It is ultra-rare,” says Jesús Rodriguez Requena, PhD, associate professor in the Department of Medicine at the University of Santiago de Compostela. Since research needs to be done under containment conditions, samples cannot be moved across different facilities, he explains. And then comes the question of the right target.
Tuesday has been dubbed “V-day” in the UK, when the first doses of Pfizer/BioNTech’s coronavirus vaccine will be distributed to the public outside of a clinical trial. Health secretary Matt Hancock reportedly came up with the wartime analogy to describe what will be the largest scale vaccination programme in the country’s history.
The World Health Organization (WHO) has backed Novavax’s COVID-19 vaccine, Covovax (NVX-CoV2373), by granting it an emergency use listing (EUL). The company is awaiting on authorization of its vaccine from regulatory health bodies around the world, including the US Food and Drug Administration (FDA) and Health Canada.
Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.
Credit: Tumisu from Pixabay New research suggests that the impact of natural and vaccine-induced immunity will be key factors in shaping the future trajectory of the global coronavirus pandemic, known as COVID-19.
Meanwhile, expanded malaria vaccine access in 17 countries offers hope, poised to save tens of thousands of lives annually. Preparing for these events involves strengthening early detection systems, expanding vaccine distribution networks and addressing critical public health gaps.
The UK has appointed Nadhim Zahawi as vaccine rollout minister as the country prepares for a potential approval of Pfizer/BioNTech’s ground-breaking COVID-19 vaccine. The vaccines can only be kept in a fridge for up to five days before being administered, although Pfizer has designed a “pizza box” style transportation container.
In 2021, a group of scientists led by researchers at the University of North Carolina at Chapel Hill, Weill Cornell Medicine and NewYork-Presbyterian reported that the Moderna mRNA vaccine and a protein-based vaccine candidate containing an adjuvant, a substance that enhances immune responses, elicited durable neutralizing antibody responses to SARS-CoV-2 (..)
million grant by the US government to develop an intranasal vaccine for gonorrhoea, a sexually-transmitted infection that is on the rise around the world. million in National Institutes of Health (NIH) funding to further develop a prophylactic vaccine based on its proprietary outer membrane vesicles (OMV) platform technology.
Moderna has won approval from the European Medicines Association (EMA) for branding its COVID-19 vaccine with the name Spikevax. Now the vaccine maker is awaiting the same approval from the US Food and Drug Administration (FDA). Pfizer’s Comirnaty was the first COVID-19 vaccine brand name created by the company.
COVID-19 vaccine makers Pfizer/BioNTech and Moderna have both commenced trials for their new variant-specific vaccines targeting omicron. Pfizer and BioNTech have started to enroll participants in a study that will evaluate the new version of their COVID-19 vaccine that targets the omicron variant of SARS-CoV-2.
Bergstrom, PhD Professor, Department of Biology University of Washington Slides Keywords Research, Misinformation, Media, Social Media Key Points Misinformation abounds in medicine and about medicine. If you’re working on a paper about vaccine safety, you have to understand the conversation about vaccine safety.
Food and Drug Administration gave a red flag to FibroGen’s anemia pill roxadustat, for the use in patients suffering from kidney diseases owing to safety concerns that arose after results, which in turn are concluded for the presentation of further clinical studies to assess safety for future medicinal use. 45 years ago.
Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.
The company has signed on to help manufacture AstraZeneca’s COVID-19 vaccine candidate, AZD1222, intended to protect against the SARS-CoV-2 novel coronavirus. AMRI is proud to partner with AstraZeneca in pursuit of a vaccine that could protect people against the coronavirus pandemic,” said John Ratliff, CEO of AMRI, in a statement.
FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. FDA Approval of their COVID-19 Vaccine COMIRNATY® For Adolescents 12 through 15 Years of Age. The vaccine was previously made available to this age group in the U.S. Fri, 07/08/2022 - 11:48. Pfizer and BioNTech Announce U.S.
Health regulators in the UK have become the first in the world to approve Moderna’s next generation COVID-19 vaccine booster that includes targeting of the Omicron variant. The primary series of Moderna’s COVID vaccine remains at two doses. Related: Menarini Diagnostics’ New COVID-19 Test Detects Variants Including Omicron.
Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Wed, 11/02/2022 - 15:44. Thursday, November 03, 2022 - 06:45am. Ugur Sahin, M.D.,
Six Velocity Principal Investigators coauthored an article recently published in Nature Medicine. 5-containing bivalent mRNA-1273.222 vaccine with the ancestral Wuhan-Hu-1 mRNA-1273 as booster doses. The article covers the results of a Phase 2/3 trial of the Omicron BA.4/BA.5-containing
Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program kimkevin Thu, 02/09/2023 - 15:05 Pfizer and BioNTech Initiate Phase 1/2 Study of First mRNA-based Shingles Vaccine Program Friday, February 10, 2023 - 06:45am Share Phase 1/2 trial will enroll up to 900 healthy U.S.
who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.
FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza. INDICATION & AUTHORIZED USE Pfizer-BioNTech COVID-19 Vaccine, Bivalent, (Original and Omicron BA.4/BA.5) AUTHORIZED USE .
Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer and BioNTech Submit a Variation to EMA for the Vaccination of Children 6 Months to less than 5 Years with COMIRNATY®. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide: Primary Series.
Within the emerging innovation stage, cell therapy for ocular disorders, coronavirus vaccine components, and DNA polymerase compositions are disruptive technologies that are in the early stages of application and should be tracked closely. Editas Medicine is one of the most important players concerning innovation surrounding CRISPR nucleases.
GlaxoSmithKline announced the US Food and Drug Administration approval for its vaccine, Shingrix (Zoster Vaccine Recombinant, Adjuvanted) under trials in 18+ adults who are vulnerable or at an increased risk to Shingles , which is already commercialized for patient group aged 50 and above.
The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.
The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac, renal and inherited metabolic disorders. COVID-19, Vaccines.
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