Japan approved partial change to a NDA for Omicron-targeting bivalent booster COVID-19 vaccine
On Oct. 31, 2022, Moderna announced that it had received approval from the Ministry of Health, Labour and…
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U.S. FDA recommended Novavax COVID-19 vaccine, adjuvanted as a booster in adults
On Oct. 19, 2022, the U.S. Food and Drug Administration (FDA) recommended the use of the Novavax COVID-19…
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EMA’s CHMP for Human Use issued positive opinion recommending authorization for use of Spikevax in children 6 months – 5 years in EU
On Oct. 19, 2022, Moderna announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human…
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90-Day analysis showed Moderna’s Omicron BA.1-targeting bivalent vaccine, mRNA-1273.214, demonstrated superior antibody response
On Oct. 19, 2022, Moderna announced new clinical data on its bivalent Omicron-containing booster, mRNA-1273.214. Ninety days after…
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Moderna received Authorization for Emergency Use from FDA of Omicron-targeting bivalent COVID-19 booster vaccine for children
On Oct. 12, 2022, Moderna announced that it had received emergency use authorization from the U.S. Food and…
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Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster received Health Canada authorization for individuals 12 years of age and older
On Oct. 7, 2022, Pfizer and BioNTech announced that Health Canada had authorized COMIRNATY Original & Omicron BA.4/BA.5…
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EMA accepted Moderna’s conditional Marketing Authorization filing for omicron BA.4/BA.5 targeting bivalent COVID-19 vaccine
On Sept. 28, 2022, Moderna announced that the European Medicines Agency (EMA) had accepted a variation for the…
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Novavax Nuvaxovid COVID-19 vaccine became available in Israel for individuals aged 12 and older
On Sept. 16, 2022, Novavax announced that the Israel Ministry of Health had granted an import and use…
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Moderna completed application to U.S. FDA for EUA of omicron-targeting bivalent Covid-19 booster vaccine
On Aug. 22, 2022, Moderna announced it has applied for an U.S. Food and Drug Administration (FDA) emergency…
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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…
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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…
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Biotechnology | COVID-19 | NIH | Therapeutics | Vaccine
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….
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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…
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EMA Committee for Medicinal Products for Human Use recommended use of the Moderna COVID-19 booster in adolescents (12-17 years)
On Jul. 23, 2022, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended…
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Yale-developed vaccine offers superior protection against Omicron variants
On Jul. 19, 2022, Yale scientists announced they had developed a novel Omicron-specific mRNA vaccine that offers superior…
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Australia TGA granted provisional approval for Moderna’s COVID-19 vaccine in children aged six months to five years
On Jul. 19, 2022, Moderna said that Australia’s drug regulator Therapeutic Goods Administration (TGA) has provisionally approved its…
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Health Canada authorized Moderna’s COVID-19 vaccine in young children (6 months-5 years)
On Jul. 14, 2022, Health Canada announced it had authorized the use of the Moderna Spikevax COVID-19 vaccine…
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Moderna’s Omicron-containing bivalent booster candidate, mRNA-1273.214, demonstrated higher neutralizing antibody response
On Jul. 13, 2022, Moderna announced it has now demonstrated significantly higher antibody titers against all tested variants,…
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BioNTech started construction of first mRNA vaccine manufacturing facility in Africa
On Jun. 23, 2022, BioNTech announced it had has reached the next milestone in the establishment of scalable…
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Moderna received FDA authorization for EUA of Its COVID-19 vaccine for children 6 months of age and older
On Jun. 17, 2022, the U.S. Food and Drug Administration (FDA) authorized emergency use of the Moderna COVID-19…
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Roche received FDA EUA for cobas SARS-CoV-2 Duo, the first PCR test to simultaneously detect COVID-19 and measure viral load levels of COVID-19
On Jun. 14, 2022, Roche announced that the US Food and Drug Administration had issued Emergency Use Authorization…
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Moderna announced Omicron-containing bivalent booster candidate mRNA-1273.214 demonstrated superior antibody response against Omicron
On Jun. 8, 2022, Moderna announced new clinical data on its Omicron-containing bivalent COVID booster candidate, mRNA-1273.214, containing…
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Moderna and the European Commission agreed on amendment to COVID-19 vaccine supply agreement
On Jun. 2, 2022, The European Commission and the vaccine developer Moderna announced they have reached an agreement…
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Novavax initiated phase 3 trial of its COVID-19 Omicron strain vaccine as a booster
On May 31, 2022, Novavax announced the initiation of its Phase 3 strain change trial to determine if…
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Moderna and Takeda announced plans to transfer Marketing Authorization for Spikevax(TM) COVID-19 vaccine in Japan
On May 31, 2022, Moderna and Takeda announced the transfer of the marketing authorization for Moderna’s COVID-19 vaccine…
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IAVI and Moderna launched first-in-Africa clinical trial of mRNA HIV vaccine development program
On May 18, 2022, Moderna and the nonprofit scientific research organization IAVI announced that the first participant screenings…
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SARS-CoV-2 RNA can persist in stool months after respiratory tract clears virus
On May 18, 2022, SARS-CoV-2, or at least pieces of it, sticks around longer in some infected individuals…
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Tabula Sapiens multiple-organ, single-cell transcriptomic atlas of humans published
On May 13, 2022, the Tabula Sapiens Consortium announced it had published a molecular reference atlas for more…
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Moderna finalized plan for long-term strategic partnership with the Government of Canada
On Apr. 29, 2022, Moderna announced its plan to build a state-of-the-art mRNA vaccine manufacturing facility in Quebec…
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Moderna filed for authorization of Its COVID-19 vaccine in young children six months to under six years of age
On Apr. 28, 2022, Moderna announced that it had submitted a request for emergency use authorization (EUA) for…
