LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.

Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.

As Johnson & Johnson (J&J) made public the launch of a phase III trial with its COVID-19 vaccine, officials from the company and others at the virtual Biopharm America meeting discussed modes of innovation in the pandemic era.

A Sept. 16 Senate hearing revisited the Trump administration’s response to the COVID-19 pandemic, and the CDC took the opportunity to post a vaccine distribution plan. CDC director Robert Redfield advised the committee, however, that sufficient quantities of vaccine to cover everyone in the U.S. might not be available until the third quarter of 2021, adding that now is the time to stand up a distribution network for a vaccine that will require cold-chain storage.

CAJICA, Colombia – Latin American countries are rushing to sign deals to gain access to SARS-CoV-2 vaccines, with Brazil, the largest in the region, right in the race. Already, the country has the third most COVID-19 cases globally, behind only India and the U.S.

LONDON – The EU is to set up an equivalent to the U.S. Biomedical Advanced Research and Development Authority (BARDA), after coming under criticism from pharma companies about Europe’s inability to swiftly seal advance purchase agreements for COVID-19 vaccines. The plan was announced on Sept. 16 by European Commission President Ursula von der Leyen, in her first state of the union address since coming into office at the start of 2020. The new agency will support capacity and readiness to respond to cross-border health threats and emergencies, “whether of natural or deliberate origin,” she said.

What’s the plan? The U.S. CDC is being asked that question a lot these days – not just about COVID-19, but also about preparing for what could be a tough influenza season as flu bugs circulate with the coronavirus.

The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year.