Trump administration lays out path to 300M COVID-19 doses by January, safety questions linger

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Path to 300M doses

The Trump administration Tuesday presented a high-level road map to its plans to produce 300 million COVID-19 vaccine doses by January. In a briefing for reporters, senior administration officials involved with Operation Warp Speed stressed that the accelerated development program will not compromise on FDA’s safety and efficacy standards, but they did not indicate how less than six months of human exposure can provide robust assurances of safety.

The officials, who provided the briefing on the condition that they are not identified, said that COVID-19 vaccines will be available to all Americans at no out-of-pocket cost. The U.S. government will provide vaccines to vulnerable populations, critical workers and individuals associated with national defense. Other Americans will be able to access the vaccines through commercial insurers who are expected to provide them with no co-pays, the officials said.

Warp Speed identified a list of 14 vaccine candidates and is narrowing the list “about seven candidates, representing the most promising candidates from a range of technology options, which will go through further testing in early-stage clinical trials,” according to an HHS fact sheet.

The most promising candidates will be tested in large-scale randomized trials. Rather than stand-up master protocols, Warp Speed is working with Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership led by NIH, to develop standard protocols with common data elements (see “ACTIV Coming Into Focus”).

Standard protocols for COVID-19 vaccine candidates funded by Warp Speed “will be overseen by the federal government, rather than have private companies design their own as in traditional drug development,” a senior government official said.

Operation Warp Speed is operating in parallel with ACTIV.

Warp Speed brings together agencies in the Department of Health and Human Services, including the CDC, FDA, NIH and BARDA, as well as the Department of Defense. It is operating from offices in HHS headquarters, but much of its leadership are serving or former military officials.

While the officials expressed confidence in the U.S. government-funded COVID-19 vaccine development process, they acknowledged that success is not guaranteed. They reiterated that safety is integral to the process and said that FDA will use its normal criteria for assessing vaccine candidates.

“Success in our minds is defined as delivering a safe, effective vaccine by the same standards applied in any other circumstances,” one of the officials said. “We are well aware of the crisis of vaccine confidence in recent years in the United States and countries around the world and HHS has undertaken significant steps to fight back against these steps.” The official added: “All of the professionals working on ows see this as a solemn obligation to make sure these vaccines are safe and effective.”

Senior officials at HHS and other public health officials, however, have expressed concern to BioCentury that it is not possible to adequately characterize safety in the timeline Operation Warp Speed has committed to meet.

To speed availability of vaccines, Operation Warp Speed is funding manufacturing of vaccines at-risk, with the understanding some vaccine candidates may be abandoned.

The U.S. government expects to manufacture three to five vaccine candidates and has plans to shift manufacturing resources based on the outcomes of clinical trials. “Capacity will be used for whatever vaccine is eventually successful regardless of which firms have developed their capacity.”

In addition to facilitating development and manufacturing of vaccines, Operation Warp Speed is responsible for distribution.

Plans are being developed for a tiered approach to COVID-19 vaccine distribution. “This approach,” a senior government official said, “will be based on the methodology that has been used for pandemic influenza planning for decades, as well as what we’ve learned from the first wave of the COVID-19 pandemic. For example in a tiered system, the elderly, those with preexisting conditions, people performing essential services would be given higher tiers.”

Distribution plans, however, will be adjusted based on the outcomes of trials and the epidemiology of COVID-19. These could preclude certain populations, if, for example, vaccines do not provide protection or pose higher risks for individuals with certain characteristics.

A senior official made it clear that Operation Warp Speed will ensure that any and all Americans who need or want vaccination against COVID-19 will receive access before supplies are provided to individuals in other countries. “Our priorities are very clear: Let’s take of Americans first. To the extent there is surplus, we have an interest in ensuring folks around the world are vaccinated.” He added that many of the vaccine manufacturers that have signed contracts with the U.S. government have separate manufacturing capacity in other countries. “In no way are we inhibiting those vaccines from getting to others around the world.”

The official stated that “our top priority is obviously to ensure that those vulnerable Americans and others that desire the vaccine get it. Once we get beyond that point, it is obviously in our interest to ensure that a good part of the rest of the world is vaccinated.”

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