June 23, 2020
Ease of manufacturing scale up may determine which candidates advance furthest in the US government’s partnership with industry to speed COVID-19 vaccines to patients. Senior government officials also discussed approval standards, how a vaccine would be distributed, and how much the government and Americans could pay in a 16 June press call.
The ability for a COVID-19 vaccine to be manufactured quickly and at scale will be a key factor in determining which potential candidates advance through Operation Warp Speed, a senior administration official said on a 16 June press call on the US government’s partnership with industry to accelerate coronavirus development.
Operation Warp Speed is in the process of narrowing down 14 vaccine candidates to seven, which will then go through testing in early clinical trials. The field will likely be furthered narrowed down before large-scale randomized trials are conducted on an anticipated three to five candidates.
On 4 June the New York Times reported that the project had already unofficially selected the five top candidates; however, the comments from government officials on the 16 June call and previous industry statements suggest that final decisions have not yet been made.
While safety and efficacy of the candidates will be the starting point for narrowing down the group, manufacturing capability could be what distinguishes the winners from the losers.
“We are looking at technologies where you can produce these vaccines quickly,” one senior administration official said. Companies will “need to be able to scale to millions of doses to meet the goals of Operation Warp speed.”
“You can see that there are a lot of amazing vaccine technologies that are out there but only a few that can reach those criteria of significant quantities and [FDA] approval to meet the goals of warp speed.
HHS has said the goal of Warp Speed is to deliver 300 million doses of a safe, effective vaccine by January 2021 – enough for almost every US resident to get one dose.
The administration may be slightly walking back expectations for how much vaccine they will have by that time point. The official said that while there are “no sure things in science” and that Operation Warp Speed cannot promise “100 percent chance of success” they were confident they would be able to vaccinate all Americans who are vulnerable by the height of the flu season in 2021.
There are a range of vaccine platforms being studied. Some newer platforms, like the mRNA vaccines being developed by Moderna and Pfizer, should allow for a more rapid scale-up early on, but are unproven compared with established approaches like egg-based production.
On the other hand, Moderna has raised concerns about the scale up of raw materials needed to make its vaccine because of the newness of its platform.
A key focus of Warp Speed is ramping up the production of vaccines and planning the distribution strategy as the clinical trials are ongoing so administration can commence shortly following FDA clearance.
The US government plans to use a tiered approach for vaccine distribution, using its pandemic influenza vaccine distribution strategy as a basis with modifications based on what it has learned about COVID-19.
In such a system, the elderly, people with pre-existing conditions and people performing essential services would be placed on higher tiers and vaccinated first, the senior government officials told reporters. Americans who have strong antibodies to the virus post COVID-19 infection – perhaps as many as 20 to 40 million people – would be lower on the priority list.
A government pandemic flu exercise conducted from January through May 2019 dubbed Crimson Contagion estimated about 26 million Americans would be in the first tier of vaccination including manufacturers of vaccine and antivirals, many health care workers, law enforcement and fire services and pregnant woman. Another 16 million would be in the second tier, including household contacts of high-risk children, the national guard and intelligence services.
Data from clinical trials may alter tiering decisions since some vaccines may work better or worse, or be safer in different populations, government officials said.
It is not clear how the government will decide how to allocate different COVID-19 vaccines if multiple products end up being cleared by FDA. The officials said they had discussed comparing vaccines in head-to-head studies but seemed to suggest that was not a route that was being followed through with at the moment.
The officials said the government is looking at designing clinical trials so it can collect information on the various vaccine candidates “in the same sort of way,” using “common data elements” that will allow for “apples to apples” comparisons.
The US will be prioritizing vaccinating its citizens, the officials added, though they emphasized the country is in “no way inhibiting the rest of the world from getting the same vaccines,” saying companies with whom the U.S. is working are free to and have entered into separate manufacturing and distributions agreements with other parts of the world.
Tensions have already emerged over concerns countries will be competing with each other for limited resources.
Sanofi got in political trouble in France after its CEO said in May the US would have the right to the largest pre-order due to the support it was receiving from the American government.
Once all Americans are vaccinated the US officials said it would be in the country’s interest “to ensure that a good part of the rest of the world is vaccinated,” noting that the outbreak in the US started because of international travel to the country.
“Our priorities are very clear. Let’s take care of Americans first. To the extent there is surplus, we have an interest in ensuring folks around the world are vaccinated.”
The government officials stressed that while Warp Speed is moving fast, the standards for safety and efficacy are not being lowered. They acknowledged awareness of a growing trend of vaccine skepticism in the country and said HHS would continue to fight back against this trend. Survey results have already indicated that many Americans are wary of receiving a vaccine approved too quickly.
In terms of accessibility, the senior government officials pledged that “any American who is vulnerable, who cannot afford the vaccine,” will be able to receive it for free. HHS declined to elaborate on how it would determine which Americans qualified for a free vaccine. However it did say this statement applied specifically to vaccines participating in the Operation Warp Speed program.
The government has also been in communicating with commercial health insurance companies and said they have expressed interest in covering the vaccines with zero copays, but said no contracts have been signed.
The COVID-19 relief law known as the CARES Act requires that Medicare Part B benefices and people with private insurance have access without cost-sharing to any COVID-19 vaccines has an “A” or “B” rating from the United States Preventive Services Task Force or a recommendation from the CDC’s Advisory Committee on Immunization Practices.
As for how much the US will pay the vaccine manufacturers, the officials said that the government has entered into a variety of different contracts with Warp Speed participants. For vaccines where the US invested in the research and development of the product the cost will be amortized. For products for which the government hasn’t contributed to research and development, officials said it has entered into advanced purchasing agreements and expects to pay more on a per vaccine basis.
HHS told the Pink Sheet that some of these contracts are still in the works.
This article was first published on 16 June 2020 in The Pink Sheet.
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