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Moderna and Gilead reported billions in sales for their coronavirus treatments, but Regeneron's antibody drug cocktail hasn't gained traction. BioNTech, meanwhile, could report critical new vaccine results in days.
The US Food and Drug Administration (FDA) has made changes to the emergency use authorisations (EUAs) of the Pfizer -BioNTech and Moderna bivalent mRNA Covid-19 vaccines. The latest amendment aims to simplify the vaccination schedule for most people. The changes mean that the current bivalent vaccines for the original and Omicron BA.4/BA.5
Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.
SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.
Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.
5+delta) protein vaccine (Sf9 cell). This marks the world’s first Covid-19 vaccine approved for emergency use against XBB descendent lineages of SARS-CoV-2. The vaccine has been developed by WestVac Biopharma along with the West China Medical Center and Sichuan University. recombinant Covid-19 trivalent (XBB.1.5+BA.5+delta)
The US government is reportedly investing more than $5bn in a programme to accelerate the development of new Covid-19 vaccines and treatments. Health experts have lent their support to the new programme as the existing vaccines may not be as effective against future virus threats.
Health Canada has granted approval for the usage of Moderna’s messenger RNA (mRNA) Covid-19 vaccine, Spikevax, in a 25µg two-dose regimen for active immunisation to prevent Covid-19 in children aged six months to five years. So far, children aged below five years were not eligible to receive the Covid-19 vaccine in Canada.
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. 1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4
Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. As a result of huge global sales of mRNA Covid-19 vaccines, the split in profits between Pfizer and BioNTech’s Comirnaty contributed towards revenues of $81.3bn and $22.4bn last year, respectively. YoY revenue growth.
Many vaccines work by introducing a protein to the body that resembles part of a virus. Ideally, the immune system will produce long-lasting antibodies recognizing that specific virus, thereby providing protection.
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. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1
The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.
The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.
Sanofi announced data from a real-world clinical trial that demonstrated its RSV antibody nirsevimab delivered an 83% reduction in hospitalisations in infants with respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD). Nirsevimab is being jointly developed between Sanofi and AstraZeneca.
A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.
A third dose of vaccine has been shown to effectively neutralise the Omicron variant of covid-19, according to researchers. Research led by UCLH, UCL and the Francis Crick Institute found that the booster dose successfully stimulates antibody levels that neutralise Omicron. Overall, antibody levels were nearly 2.5
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Anti-influenza antibody compositions. However, not all innovations are equal and nor do they follow a constant upward trend.
Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.
QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Based on the virus a number of vaccines targeting the spike protein were designed, tested in animal models and found to be quite promising against SARS and other coronavirus illnesses like Middle East respiratory syndrome.
RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.
Moreover, in low- and middle-income countries, lack of healthcare access increases the disease’s impact, as limited diagnostics, vaccination coverage and medical resources limit early detection and treatment. Monoclonal Antibody Therapies Monoclonal antibodies are gaining traction as targeted treatments for bacterial and viral infections.
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.
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. There are hopes that its mRNA approach, which proved so effective against COVID-19, could succeed where traditional vaccine technologies have failed in HIV.
Belgium researchers compared the Moderna and Pfizer-BioNTech COVID-19 vaccines and found that the Moderna jabs generated twice the antibodies than the Pfizer-BioNTech vaccine.
Buoyed by the success of its COVID-19 vaccine, Moderna has started a phase 1/2 trials of its mRNA-based shot for seasonal influenza, targeting four different flu strains. . Ultimately, the goal is to develop a shot that combines seasonal flu, COVID-19 and respiratory syncytial virus (RSV) protection with a single vaccine, said the biotech.
The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for pregnant women during their third trimester to prevent pertussis (whooping cough) in newborn infants.
The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.
MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.
In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. One area that is gathering increasing levels of interest is the development of cancer vaccines. A broad front.
A new study is raising concerns about the effectiveness of the monkeypox vaccine being used in the United States and other parts of the world. Read the rest…
New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday. The companies said the levels of neutralizing antibodies that target the BA.4
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax ’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as a booster for use in people aged 18 years and above. The booster is indicated for use after a minimum of six months following a vaccine regimen with an authorised or approved Covid-19 shot.
The shot, which the Danish company acquired from Emergent BioSolutions, spurred protective antibodies against the mosquito-borne virus in older adults.
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Coronavirus vaccine components. The vaccine also contains other inactive ingredients such as cholesterol.
In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Flavivirus vaccine components. Sanofi is one of the leading patent filers for Flavivirus vaccine components.
A COVID-19 vaccine candidate developed by Chinese pharmaceutical company Sinopharm triggered antibody-based immune responses in early and mid-stage trials.
The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination. 1273.214, a bivalent Omicron-targeting Covid-19 vaccine of the company. 5), mRNA-1273.
Moderna has received provisional registration from the Australian Therapeutic Goods Administration (TGA) for its messenger RNA (mRNA) Covid-19 vaccine, Spikevax, for kids aged six months to five years. The 25µg two-dose vaccine regimen is indicated for active immunisation for the prevention of Covid-19.
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