Keeping tabs on Covid-19: FDA authorizes restart of AstraZeneca clinical trial and Novavax expands its Maryland manufacturing sites

As pharma companies look to advance their Covid-19 vaccine candidates through early-stage testing, discover the latest from AstraZeneca as it restarts its phase 3 clinical trial and find out how Novavax is planning for mass manufacturing and distribution

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In this week’s round up, Pharma IQ explores how AstraZeneca and Novavax are developing their cultures of continuous improvement as they look to cross-team collaboration to advance regulatory approval for a Covid-19 vaccine.

FDA authorizes restart of AstraZeneca’s Covid-19 phase 3 trial

The US Food and Drug Administration (FDA) has authorized the restart of AstraZeneca’s clinical trial for the Oxford coronavirus vaccine AZD1222 in the US, after regulators in the UK, Brazil, South Africa and Japan had already confirmed it was safe to proceed. 

As part of the standard review process for trial safety events, global regulators implemented a voluntary pause to vaccination trials across the globe on September 6 to allow for the examination of safety data by independent monitoring committees. The recommendations from these reviews were supported by international regulators.

Pascal Soriot, CEO of AstraZeneca, said: “The restart of clinical trials across the world is great news as it allows us to continue our efforts to develop this vaccine to help defeat this terrible pandemic. We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

AstraZeneca announced results from the late-stage trials should be anticipated before the New Year, depending on the rate of infection within the communities where the clinical trials have been conducted. Data readouts will also continue to be submitted to regulations while trails are ongoing in accordance to clinical trial and regulatory standards.

Novavax announces expansion of manufacturing facility to support global vaccine development

Novavax has announced the expansion of its Maryland campus to accommodate for the company’s growth as it works to develop its candidate vaccine against Covid-19 and advance its influenza vaccine for global markets.

Novavax secured two additional properties in Gaithersburg, Maryland, to support the company’s immediate need for additional laboratory and office space for manufacturing, research and development and business operations.

Additionally, Novavax has created a global production network to enable manufacturing and rapid distribution across the US, Asia and Europe if and when its Covid-19 vaccine is approved for use.

Stanley C. Erck, president and CEO of Novavax, said: “The expansion of our physical footprint reflects Novavax’s significant growth as we work to both rapidly deliver a Covid-19 vaccine and progress NanoFlu, our influenza vaccine candidate, for regulatory submission and potential commercialization.”

As the life sciences industry continues its essential research and development work in a physical lab during the Covid-19 pandemic, discover how lab and office spaces are taking the necessary steps to keep the workforce safe while attending to the needs of the business.

If you also missed last week’s Covid-19 update, head to our Pharma IQ’s Keeping tabs content hub to read more.