US HHS expedites development and manufacture of Covid-19 vaccines

The US Department of Health and Human Services (HHS) is accelerating the development and manufacture of vaccines against the Covid-19 coronavirus infection.

HHS collaborated with Johnson & Johnson (J&J) unit Janssen Research & Development (R&D) and biotechnology company Moderna to advance vaccine candidates.

The Biomedical Advanced Research and Development Authority (BARDA) at HHS agreed to support non-clinical studies and a Phase I trial of Janssen’s vaccine candidate, Ad26 SARS-CoV-2, for Covid-19.

In the clinical trial, the vaccine will be assessed for its safety and ability to generate an immune response in healthy participants.

HHS noted that the trial will start in the coming months. The aim is to provide a Covid-19 vaccine for emergency use in the country by early next year.

BARDA and Janssen will also speed-up advanced clinical trials, regulatory support and large-scale manufacturing to generate up to 300 million vaccine doses in the US per year.

As part of the alliance, J&J committed more than $1bn to co-fund research and development (R&D), and clinical testing, of Covid-19 vaccines.

Meanwhile, BARDA will work with Moderna on preparations for Phase II and III clinical trials of a Covid-19 vaccine, SARS-CoV-2 mRNA-1273.

The company is developing the investigational vaccine in alliance with the US National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID).

These trials are set to enrol a larger population to validate the product’s safety and effectiveness.

BARDA is offering expertise and funding to boost manufacturing to generate a large quantity of the investigational vaccine doses for these studies.

According to the HHS, these preparations would enable immediate transition into later studies after successful completion of the ongoing Phase I trial.

BARDA director Rick Bright said: "Vaccines are essential to saving lives. Delivering a safe and effective vaccine for a rapidly spreading disease like Covid-19 requires accelerated action with parallel development streams.

"The rapid progress we are making with industry partners clearly demonstrates a commitment to protecting people at home and abroad."

BARDA and the companies will team up with the US Food and Drug Administration (FDA) on the development and regulatory processes.

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