Members of the U.S. military will be among the first wave to receive coronavirus vaccines under “Operation Warp Speed,” (OWS), according to senior Trump administration officials who spoke with Military.com.
“Our role, as the federal government, is to ensure anyone who is vulnerable, cannot afford it and desire it can get it, those critical to infrastructure get it, essential workers get it, and those associated with national defense get it. That’s our obligation,” an official told Military.com on condition of anonymity.
OWS represents the Trump administration’s plan to speed vaccine development and mass distribute it by year’s end. Nearly $10 billion has already gone into the rapid vaccine development effort under OWS.
A Department of Health and Human Services (HHS) fact sheet released Tuesday has detailed the plan to speedily develop the vaccine and deliver more than 100 million doses by the end of 2020. The normal estimated timeline for creating a vaccine can be between 12 and 18 months, however, the OWS is working to shrink that development time and rapidly deliver a vaccine.
In terms of developing the vaccine, OWS has selected 14 of the top vaccine candidates out more than 100 potential vaccines currently in development. The top 14 candidates are currently being narrowed to about seven.
“Protocols for the demonstration of safety and efficacy are being aligned, which will allow the trials to proceed more quickly, and the protocols for the trials will be overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols,” the HHS fact sheet states.
While the development phase is ongoing, efforts are already being made to prepare mass manufacturing and distribution of the eventual vaccine OWS is aiming for.
“Rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally,” the HHS fact sheet states. “This increases the financial risk, but not the product risk.”
The HHS is investing in manufacturing AstraZeneca, Moderna, and Johnson & Johnson for producing the eventual vaccine. The manufacturing capacity developed will be used for whichever vaccine proves successful.
The distribution network to make a vaccine widely available to the public is already being prepared even before any vaccine has been approved.
The Department of Defense and HHS already filled a $138 million contract with ApiJect for more than 100 million prefilled syringes. There is also a goal to have around prefilled 500 million syringes in 2021.
The HHS then has a tiered allocation methodology for delivering the vaccine. President Donald Trump previously indicated the distribution plan is to focus on getting vaccines to vulnerable populations, such as the elderly and those with preexisting conditions first.
Trump also indicated in a May interview that the U.S. military would play a key role in the distribution effort.
The effort to quickly develop a vaccine has raised concerns about risks of a vaccine being dangerous or ineffective, though the HHS has tried to quell concerns about safety in explaining its simultaneous efforts to develop the vaccine while also preparing manufacturing and distribution.
“As you all know, there are no sure things in science,”an official told Military.com. “What we can tell Americans is that we’ve taken every possible step to maximize the probability of success and shorten the timelines to getting safe and effective vaccines and therapeutics.”