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US FDA Advisory Committee supports EUA for Moderna’s COVID-19 vaccine
expresspharma
December 18, 2020
Moderna confirmed that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an emergency use authorisation (EUA) for the company’s COVID-19 vaccine candidate ...
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Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
worldpharmanews
December 17, 2020
EMA's human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2 ...
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Valneva initiates Phase 1/2 clinical study of inactivated, adjuvanted COVID-19 vaccine candidate
worldpharmanews
December 17, 2020
Valneva SE, a specialty vaccine company focused on prevention against diseases with major unmet needs, announced the initiation of a Phase 1/2 clinical study for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001.
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Many people may not receive a COVID-19 vaccine until 2022
europeanpharmaceuticalreview
December 17, 2020
Studies show that more than a fifth of the global population, mostly in low- and middle-income countries, may have to wait until at least 2022 to receive a COVID-19 vaccine.
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Gavi collaborates with Salesforce for Covid-19 vaccine distribution
pharmaceutical-technology
December 17, 2020
Gavi, the Vaccine Alliance, has collaborated with Cloud-based software company Salesforce to help the former in handling critical information to fairly distribute two billion Covid-19 vaccines to 190 countries by the end of next year.
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British American Tobacco’s COVID-19 vaccine candidate from gets US FDA nod for human trials
expresspharma
December 17, 2020
The enrolment for the study is expected to start shortly, with results likely by mid-2021, the company said.
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CureVac initiates Phase IIb/III trial of Covid-19 vaccine candidate
pharmaceutical-technology
December 16, 2020
German company CureVac has enrolled the first participant in the pivotal Phase IIb/III HERALD study to evaluate the safety and efficacy of its mRNA vaccine candidate, CVnCoV, against Covid-19.
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US FDA report finds Moderna’s Covid-19 vaccine to have no specific safety concerns
pharmaceutical-technology
December 16, 2020
The US Food and Drug Administration (FDA) in its briefing document stated that Moderna’s experimental Covid-19 vaccine, mRNA-1273, is 94.1% effective in preventing symptomatic Covid-19.
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LogiNext launches COVID-19 vaccine supply chain management platform
expresspharma
December 16, 2020
The solution can be used for the entire chain or a part of the solution can be used for visibility and tracking, demand forecasting and order scheduling and detailed analytics.
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Pfizer’s COVID-19 vaccine data accessed in EMA cyber-attack
europeanpharmaceuticalreview
December 15, 2020
Pfizer and BioNTech told that documents relating to their COVID-19 vaccine approval were accessed during a cyber-attack on the European Medicines Agency (EMA).