The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.

LONDON – The World Health Organization (WHO) is stepping up its effort to try and ensure equitable access to any approved COVID-19 vaccines and therapies, putting in place a system for sharing all intellectual property, information and clinical trials data needed to enable generic manufacturing.

LONDON – The CEOs of Pfizer Inc. and Astrazeneca plc both say they are on track to make their COVID-19 vaccines available for use before the end of the year and have promised to manufacture at risk, supply at cost and ensure equitable access.

BEIJING – Besides advancing its recombinant adenovirus type-5 vector (Ad5) vaccine for COVID-19, Cansino Biologics Inc. is making a new attempt to develop an mRNA lipid nanoparticle (mRNA-LNP) vaccine together with Canadian company Precision Nanosystems Inc., of Vancouver, British Columbia.

DUBLIN – Merck & Co. Inc. is placing two separate bets on recombinant viral vector technology in a broad effort to tackle COVID-19, in which it is also in-licensing a small-molecule antiviral drug. Kenilworth, N.J.-based Merck is acquiring Austrian vaccine developer Themis Bioscience GmbH in a move that propels the latter firm’s COVID-19 vaccine program to the front ranks of the industry pipeline. It is entering a COVID-19 vaccine development collaboration with the not-for-profit vaccine research organization IAVI.

LONDON – Human challenge specialist Open Orphan plc has raised £12 million (US$14.6 million) in a placing to accelerate development of COVID-19 challenge study models, to meet demand from vaccines and therapeutics developers worldwide.

Scaling up to manufacture a massive volume of a COVID-19 vaccine, drug or innovative device that’s still in early stage development is easier said than done, especially in a global pandemic that has the supply chain stretched beyond capacity.

BEIJING – Besides advancing its recombinant adenovirus type-5 vector (Ad5) vaccine for COVID-19, Cansino Biologics Inc. is making a new attempt to develop an mRNA lipid nanoparticle (mRNA-LNP) vaccine together with Canadian company Precision Nanosystems Inc., of Vancouver, British Columbia.

LONDON – Astrazeneca plc is to get up to $1.2 billion from the new U.S. COVID-19 vaccines program, Operation Warp Speed, to support further development and manufacturing of a vaccine developed at Oxford University’s Jenner Institute. The company said it will begin to ship the product in September 2020, with the U.K. and U.S. first in line for deliveries.