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Moderna would seek EUA in US for COVID-19 vaccine based on early data
expresspharma
September 18, 2020
If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90 per cent efficacy, we will indeed consider approval, said company CEO.
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EC concludes talks with Pfizer, BioNTech for Covid-19 vaccine supply
pharmaceutical-technology
September 18, 2020
The European Commission (EC) has concluded exploratory talks with Pfizer and BioNTech for the potential supply of 200 million doses of the companies’ BNT162 mRNA-based Covid-19 vaccine candidate to the European Union (EU) Member States.
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AstraZeneca stops COVID-19 vaccine trial due to unexplained illness in participant
expresspharma
September 18, 2020
A UK participant was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections, according to a New York Times report.
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DCGI issues notice to Serum Institute over AstraZeneca-Oxford COVID-19 vaccine trial suspension
expresspharma
September 18, 2020
If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocol, said SII in response to show cause notice.
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Oral COVID-19 vaccine candidate to enter Phase I human trials
europeanpharmaceuticalreview
September 17, 2020
Vaxart’s application for a Phase I clinical trial to evaluate its oral COVID-19 vaccine candidate has been cleared by the FDA.
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Germany awards €750m to BioNTech and CureVac for Covid-19 vaccines
pharmaceutical-technology
September 17, 2020
The German Government has granted a total of up to €750m in funding to domestic firms BioNTech and CureVac to support the work on their respective Covid-19 vaccine candidates.
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FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine
contractpharma
September 17, 2020
ecruitment for the Phase 1 clinical study is expected to start this month.
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Serum Institute receives DCGI approval to resume trials of Oxford COVID-19 vaccine
expresspharma
September 17, 2020
The DCGI has, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study.
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Australia enters $1.2bn Covid-19 vaccine supply agreement
pharmaceutical-technology
September 17, 2020
The Government of Australia has signed a supply and production agreement valued at A$1.7bn ($1.2bn) to potentially offer a free Covid-19 vaccine to its citizens next year.
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Nine COVID-19 vaccine makers sign safety pledge
expresspharma
September 17, 2020
The companies said in a statement they would uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.