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September 9, 2020

Company coronavirus news summary – big pharma pledge to uphold safety and efficacy standards in Covid-19 vaccine race – AstraZeneca temporarily halts its Covid-19 vaccines trials

By Allie Nawrat

9 September 2020 

Nine biopharmaceutical companies in the US and Europe have pledged to uphold the scientific standards in developing and testing their Covid-19 vaccine candidates. The companies, including Pfizer, AstraZeneca and Johnson & Johnson, unveiled the pledge over rising concerns that safety and efficacy standards may be undermined in the race to find a vaccine. In a statement, the companies said that 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.”

AstraZeneca has put on hold all global clinical trials of its Covid-19 vaccine candidate over a suspected adverse event in a study participant. The company said that it voluntarily paused the trials to facilitate a review of safety data by an independent committee. The move comes after a participant in the UK trial experienced an unexplained illness. The nature of the adverse reaction was not immediately known, but the participant is expected to recover, according to STAT News citing an individual familiar with the matter. Read the full story here.

Inovio has signed a letter of intent with Thermo Fisher Scientific to produce its DNA-based Covid-19 vaccine candidate, INO-4800. Thermo Fisher joins Inovio’s consortium of third-party manufacturers, which aims to manufacture a total of 100 million doses of INO-4800 in 2021.

South Korea-based Celltrion is set to start commercial production of its investigational antibody drug against Covid-19 this month. The company has plans to seek emergency use authorisation for the drug candidate, but intends to begin mass production prior to securing the approval. Celltrion received regulatory approval in July to assess the therapeutic in clinical trial in South Korea, marking the country’s first antibody drug to be tested in humans.

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