U.S. FDA granted EUA for Novavax COVID-19 vaccine, adjuvanted for adolescents Aged 12 through 17
On Aug. 19, 2022, Novavax announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) had received expanded emergency use…
Novavax Nuvaxovid COVID-19 vaccine granted expanded provisional approval in New Zealand for adolescents aged 12 through 17
On Aug. 18, 2022, Novavax announced that New Zealand’s Medsafe had granted expanded provisional approval for Nuvaxovid (NVX-CoV2373)…
Medicines and Healthcare Products Regulatory Agency authorized Moderna’s Omicron-containing bivalent booster in the UK
On Aug. 15, 2022, Moderna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK…
Novavax Nuvaxovid COVID-19 vaccine approved in South Korea for use in adolescents aged 12 through 17
On Aug. 12, 2022, Novavax announced that partner, SK bioscience, had received a Post Approval Change Application approval…
Moderna’s Omicron-containing bivalent booster candidate, mRNA-1273.214, demonstrated higher neutralizing antibody response
On Aug. 9, 2022, Moderna announced an amendment to its agreement with the European Commission (EC) to convert…
Novavax announced initiation of phase 2b/3 Hummingbird global clinical trial for COVID-19 vaccine in children aged six months through 11 years
On Aug. 4, 2022, Novavax announced the initiation of its Phase 2b/3 Hummingbird global clinical trial. The trial…
HHS announced 66 million doses of Moderna’s variant-specific COVID-19 vaccine booster for potential use in Fall and Winter 2022
On Jul. 29, 2022, the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S….
Pfizer and BioNTech announced clinical trial of next-generation vaccine candidate based on enhanced spike protein design
On Jul. 27, 2022, Pfizer and BioNTech announced that the companies had initiated a randomized, active-controlled, observer-blind, Phase…
Novavax Nuvaxovid COVID-19 vaccine granted provisional registration in Australia for use in adolescents aged 12 through 17
On Jul. 26, 2022, Novavax announced that the Australian Therapeutic Goods Agency had granted expanded approval for provisional…
Novavax announced expanded approval of Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 in Japan
On Jul. 26, 2022, Novavax announced that Nuvaxovid (NVX-CoV2373) COVID-19 vaccine had received expanded manufacturing and marketing approval…
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COVID-19 Vacations Redux
COVID-19 Vacations Redux iIlustrates once again the pits and perils vacation travelers face as they begin their Summer…
EMA Committee for Medicinal Products for Human Use recommended use of the Moderna COVID-19 booster in adolescents (12-17 years)
On Jul. 22, 2022, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
CHMP adopted positive opinion recommending Vekluryﾮ (Remdesivir) receive full Marketing Authorization for teatment of patients with COVID-19
On Jul. 22, 2022, Gilead Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) of…
Novavax announced expanded agreement with SK bioscience to manufacture COVID-19 vaccine with Omicron variant
On Jul. 19, 2022, Novavax announced that it had signed agreements with its partner, SK bioscience, for the…
U.S. CDC endorsed Advisory Committee on Immunization Practices’ recommendation for Novavax COVID-19 vaccine
On Jul. 19, 2022, Novavax announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee…
Gilead Sciences signed joint procurement agreement with the European Commission for Vekluryﾮ (Remdesivir)
On Jul. 19, 2022, Gilead Sciences and the European Commission announced a new joint procurement agreement (JPA) that…
Vaccine-induced immune response to Omicron wanes substantially over time
On Jul. 19, 2022, the NIH announced that although COVID-19 booster vaccinations in adults elicit high levels of…
Australia TGA granted provisional approval for Moderna’s COVID-19 vaccine in children aged six months to five years
On Jul. 18, 2022, Moderna announced that the Therapeutic Goods Administration (TGA) in Australia had granted provisional registration…
Health Canada authorized Moderna’s COVID-19 vaccine in young children (6 months-5 years)
On Jul. 14, 2022, Moderna announced that Health Canada had approved the use of Moderna’s mRNA COVID-19 vaccine,…
Novavax Nuvaxovid COVID-19 vaccine conditionally authorized in EU for adolescents aged 12 through 17
On Jul. 13, 2022, Novavax announced that the European Commission (EC) had approved the expanded conditional marketing authorization…
U.S. FDA granted EUA for Novavax COVID-19 vaccine, adjuvanted for individuals aged 18 and over
On Jul. 13, 2022, Novavax announced that its COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) had received emergency use authorization from…
Moderna’s Omicron-containing bivalent booster candidate, mRNA-1273.214, demonstrated higher neutralizing antibody response
On Jul. 11, 2022, Moderna announced new clinical data on its bivalent Omicron (BA.1) booster candidate, mRNA-1273.214. One…
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U.S. Government secured 3.2 million doses of Novavax COVID-19 vaccine
On Jul. 11, 2022, Novavax announced an agreement with the U.S. Department of Health and Human Services (HHS),…
NIH launched clinical trial of mRNA Nipah virus vaccine
On Jul. 11, 2022, the National Institute of Allergy and Infectious Diseases (NIAID) launched an early-stage clinical trial…
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Pfizer and BioNTech submitted a variation to EMA for vaccination of children ages 6 months to less than 5 Years with COMIRNATY
On Jul. 8, 2022, Pfizer and BioNTech announced that the companies had submitted a variation to the European…
European Medicines Agency approved SK bioscience as supplier of Novavax Nuvaxovid COVID-19 vaccine
On Jul. 7, 2022, Novavax announced that the European Commission had approved a variation to allow SK bioscience…
Novavax Nuvaxovid COVID-19 vaccine conditionally authorized in EU for adolescents aged 12 through 17
On Jul. 5, 2022, Novavax announced that the European Commission (EC) had approved the expanded conditional marketing authorization…
COVID-19 was third leading cause of death in the United States in both 2020 and 2021
On Jul. 5, 2022, the National Institutes of Health and National Cancer Institute announced COVID-19 was the third…
NIH study revealed how immune response triggered by COVID-19 may damage the brain
On Jul. 5, 2022, the National Institutes of Health released a study that described the immune response triggered…
Pfizer announced submission of New Drug Application to the U.S. FDA for PAXLOVID
On Jun. 30 2022, Pfizer announced the submission of a New Drug Application (NDA) to the U.S. Food…