Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. The companies plan to request similar rulings by other regulatory authorities worldwide in coming days.
New insights into the immune response to SARS-CoV-2 infections could bring better treatments for COVID-19 cases.
An international team of researchers unexpectedly found that a biochemical pathway, known as the immune complement system, is triggered in lung cells by the virus, which might explain why the disease is so difficult to treat.
EMA's safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group.
Social distancing and lockdowns may have reduced the spread of COVID-19, but researchers from Penn State College of Medicine also report those actions may have affected clinical researchers' ability to finish trials. Study completion rates dropped worldwide between 13% and 23%, depending on the type of research sponsor and geographic location, between April and October 2020.
A team led by scientists in the Perelman School of Medicine at the University of Pennsylvania has identified nine potential new COVID-19 treatments, including three that are already approved by the Food and Drug Administration (FDA) for treating other diseases.
Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced positive data for Part A of the Phase 1/2 clinical trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
Convalescent plasma, the use of survivors' antibodies transfused into sick COVID-19 patients is safe and significantly improves clinical outcomes when using high levels of antibodies, according to a new publication by scientists at Hackensack Meridian Health, New Jersey's largest and most comprehensive health network.
Waiting for your turn can be frustrating, especially when it comes to COVID-19 vaccinations. But prioritizing who receives the limited supply of vaccines available saves lives and reduces spread of infection, according to a study published in the journal PNAS from the University of California, Davis.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021, showing that the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose.
A highly contagious SARS-CoV-2 variant was unknowingly spreading for months in the United States by October 2020, according to a new study from researchers with The University of Texas at Austin COVID-19 Modeling Consortium. Scientists first discovered it in early December in the United Kingdom, where the highly contagious and more lethal variant is thought to have originated.
A single dose of the Pfizer-BioNTech vaccine for individuals who previously had COVID-19 generates an immunologic response similar to that of individuals receiving the two-dose recommended sequence, according to a Cedars-Sinai study published today by the journal Nature Medicine.
The faster-spreading B.1.1.7 variant of SARS-CoV-2 first detected in the United Kingdom, the coronavirus that causes COVID-19, is quickly on its way to becoming the dominant variant of the virus in the United States, according to a study from scientists at Scripps Research and the COVID-19 test maker Helix.
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated.
Mount Sinai researchers have found that a widely available and inexpensive drug targeting inflammatory genes has reduced morbidity and mortality in mice infected with SARS-CoV-2, the virus that causes COVID-19. In a study published today in the journal Cell, the team reported that the drug, Topotecan (TPT), inhibited the expression of inflammatory genes in the lungs of mice as late as four days after infection, a finding with potential implications for treatment of humans.
GSK has reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up to 60 million doses of Novavax' COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide 'fill and finish' manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately.
Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Trust (AVAT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union's 55 member states with delivery beginning in the third quarter of 2021.
EMA's human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU.
BioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part of the process, EMA has approved the production of the drug substance, the mRNA, at the Marburg site over the course of this week.
Influenza vaccines need to be evaluated every year to ensure they remain effective against new influenza viruses. Will the same apply to COVID-19 vaccines? In order to gauge whether and to what extent this may be necessary, a team of researchers from Charité - Universitätsmedizin Berlin compared the evolution of endemic 'common cold' coronaviruses with that of influenza viruses.
Roche (SIX: RO, ROG; OTCQX: RHHBY) confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients (n=4,567; REGN-COV 2067). The phase III outcomes trial in high-risk non-hospitalised patients with COVID-19 met its primary endpoint, showing the investigational antibody cocktail of casirivimab and imdevimab significantly reduced the risk of hospitalisation or death by 70% (1,200 mg intravenously [IV]) and 71% (2,400 mg IV) compared to placebo.
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