US outlines plan for readying coronavirus vaccine by start of 2021
On Friday of last week, the US government made a two-fold announcement: a project to have an effective vaccine ready and available for US citizens by January 2021, and the leadership team that will be responsible for achieving this aim.
The national program, officially called ‘Operation Warp Speed’, will focus on three areas: the development, manufacture and distribution of potential vaccines.
The government provided further details on what this would look like in each area, with the US Department of Health & Human Services (HHS) noting that there are 14 potential vaccines chosen for further development and plans to reduce these down to eight strong candidates.
In addition, the clinical trial process would see the government set protocols, allowing “trials to proceed more quickly.”
The HHS noted that, of these, three to five candidates would enter large-scale randomized trials, though it did not specify timescale, and added that manufacturing capacity for these potential vaccines would be scaled up ahead of approval.
Broadly, the government will make investments in manufacturing at risk and any capacity established during the scale-up for potential vaccines will be utilized, “regardless of which firms have developed the capacity.”
In terms of distribution, the project will focus on expanding supplies of specialized materials and resources, such as a cold-chain storage, glass vials, and other materials. Last week, the US secured a $138m (€127m) deal for the manufacture of single-use plastic syringes to mitigate any potential shortages of glass syringes.
In order to manage the project, Moncef Slaoui was brought on board as chief advisor. Previously, Slaoui held the role of chairman of R&D at GSK and chairman of its global vaccines division.
During his time leading GSK’s vaccines division, he oversaw the creation of 14 vaccines, including preventatives for shingles and malaria.
After leaving GSK, Slaoui became chairman at Galvani Bioelectronics and a partner at Medicxi Venture Capital.
Joining Slaoui is Gustave Perna, who will perform the role of chief operating officer. Perna is a general and commander of the US Army Material Command, with a history of working in the management and procurement of equipment and supplies for the US army.