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May 13, 2020updated 01 Jun 2021 9:55am

FDA fast-tracks Moderna’s Covid-19 vaccine candidate

The US Food and Drug Administration (FDA) has awarded fast track designation to Moderna's mRNA vaccine candidate, mRNA-1273, developed to protect against Covid-19.

The US Food and Drug Administration (FDA) has awarded fast-track designation to Moderna mRNA vaccine candidate, mRNA-1273, developed to protect against Covid-19.

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Fast-track designation enables development and speed-up of the review of therapies and vaccines that target serious conditions and fill an unmet medical need.

Programmes with the designation could see early and frequent communication with the FDA, along with a rolling submission of the marketing application.

Previously, Moderna obtained fast-track designation for its investigational Zika vaccine, methylmalonic acidemia and propionic acidemia programmes.

Moderna chief medical officer Tal Zaks said: “Fast-track designation underscores the urgent need for a vaccine against the novel coronavirus.

“As we await the full set of clinical data from the NIAID-led Phase I study, we are actively preparing for our Phase II and Phase III clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”

The FDA completed its review of the investigational new drug (IND) filing for mRNA-1273 on 6 May, allowing the launch of a Phase II clinical trial.

The Phase II study will assess the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 administered 28 days apart. It will enrol 600 healthy volunteers aged 18 years and above.

Participants will be given placebo, a 50μg or a 250μg dose at both vaccinations and followed through 12 months following the second vaccination.

The company is finalising the protocol for a Phase III study. The Biomedical Advanced Research and Development Authority (BARDA) funding helped plan these studies and will support the late-stage clinical programmes.

In addition, the funding will be used to scale up manufacturing of the vaccine candidate at the company’s facilities and at that of its strategic partner, Lonza.

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Free Whitepaper
img

What is the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry?

While wanting to protect the country from being overwhelmed by Omicron, China’s adherence to a Zero-COVID policy is resulting in a significant economic downturn. COVID outbreaks in Shanghai, Beijing and many other Chinese cities will impact 2022’s economic growth as consumers and businesses experience rolling lockdowns, leading to a slowdown in domestic and international supply chains. China’s Zero-COVID policy is having a demonstrable impact on consumer-facing industries. Access GlobalData’s new whitepaper, China in 2022: the impact of China’s Zero-COVID lockdowns on economic activity, consumer goods and the foodservice industry, to examine the current situation in Shanghai and other cities in China, to better understand the worst-affected industry sectors, foodservice in particular, and to explore potential growth opportunities as China recovers. The white paper covers:
  • Which multinational companies have been affected?
  • What is the effect of lockdowns on foodservice?
  • What is the effect of lockdowns on Chinese ports?
  • Spotlight on Shanghai: what is the situation there?
  • How have Chinese consumers reacted?
  • How might the Chinese government react?
  • What are the potential growth opportunities?
by GlobalData
Enter your details here to receive your free Whitepaper.

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