Officials promise effective vaccine
No sacrificing safety for Warp Speed, they say
The Trump administration is “taking every possible step” to maximize the likelihood there will be a safe, effective vaccine against COVID-19 available by the first of next year, administration officials said Tuesday.
Speaking to reporters on condition of background, two leading members of the administration’s Operation Warp Speed pledged safety would not be sacrificed in the push to quickly develop, manufacture and deliver a vaccine.
“All of the professionals working on Operation Warp Speed see this as a solemn obligation to make sure these vaccines are safe and effective,” one official said.
The administration is on the defensive after accusations that Operation Warp Speed is going too fast and raising the anxiety level of people already hesitant to get vaccinated. Surveys show only about half of Americans would be willing to take a vaccine against the virus, although experts generally agree widespread vaccination will be needed to stop the spread.
Vaccine supporters said Tuesday that they were glad to hear that the federal process will focus on safety.
“I hope it translates to a redoubled commitment for adequately testing the efficacy and safety of these vaccine candidates,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at the Baylor College of Medicine in Texas. “Ensuring that the COVID-19 vaccine program will adhere to the highest standards of vaccine testing is the best means to defuse anti-vaccine misinformation, which is now pervasive.”
The administration officials said the vaccine development time frame is being shortened by overlapping many of the usual steps rather than taking them one after another, and safety corners aren’t being cut.
They said they can’t guarantee a vaccine will be ready by January because there are too many vagaries in science.
But, stressed one official, “we are
taking every possible step to maximize the probability of success and shorten the timeline to getting safe and effective vaccines and therapeutics for COVID-19. The timelines are being modified, but the science is not.”
Added the other: “It’s my pledge to be working 24/7 until we get there.”
Dr. Paul Offit, a vaccine expert at the University of Pennsylvania, said he wishes the administration officials had said they plan to rely on outside experts to determine whether a trial has proven a vaccine candidate’s safety and effectiveness.
“There’s an election coming up,” Offit noted. The administration has consistently put politics ahead of science, he said, and he wants to be sure the vaccine development process will be guided solely by science. “It can’t be the administration that steps up and says, ‘I think we’ve done enough.’ ”
Robert F. Kennedy, a leader in the vaccine hesitancy movement, remains skeptical about the effort. He says more energy should be devoted to developing treatments for COVID-19, particularly inexpensive, off-patent ones.
But he said he would support a vaccine if it were effective and caused injury in fewer than 1 in 1 million people.
“If they came up with a vaccine that did something close to that, we would support it,” Kennedy said. “We’re not against vaccination, we just want it to have the same kinds of standards as other medications.”
Congress has allocated more than $10 billion to COVID-19 science. As part of that effort, Operation Warp Speed aims to deliver 300 million vaccine doses by January. The government also is working to develop therapies and diagnostics against COVID-19, the disease caused by the new coronavirus.
So far, Operation Warp Speed, a collaboration across many parts of the government, has narrowed 100 candidate vaccines down to 14 being considered for funding. The list will further be shortened to about seven of the most promising that will be funded at least through early clinical trials. A few will be supported through larger, more expensive testing in people.
The government already has invested in three companies with candidate vaccines: $456 million for Johnson & Johnson; $483 million for Moderna Therapeutics; and up to $1.2 billion for AstraZeneca’s candidate vaccine, developed in conjunction with the University of Oxford. Large-scale trials will begin this summer, with Moderna’s mRNA-1273 to be tested in 30,000 volunteers, and the first vaccine doses will be delivered as soon as October.
Government funding will enable Americans who cannot afford the vaccine to get it and remove some of the risk companies usually face in developing a vaccine, the officials said. It also will be used to begin manufacturing millions of doses before safety trials are finished, so any vaccine that does meet safety and effectiveness standards will be ready for delivery almost immediately after approval, rather than waiting months or years for manufacturing to scale up.
The administration officials said they expect insurance companies will cover the cost of vaccination, without a copay, as they have for other costs of COVID-19 care.
Any vaccine that has been proven safe and effective by early next year will be distributed in a “tiered” system, with top priority given to health care workers, vulnerable people such as the elderly, and those essential to national defense, they said.
Some of the candidate vaccines may be shown to work better in some populations than others, one of the officials said, so, for instance, a vaccine that wasn’t as effective in the elderly might be targeted to healthcare workers, instead. To understand the strengths and weaknesses of each candidate vaccine and better target its distribution will require testing in large numbers of people, he said.
“The only way we’re really going to know how this vaccine works is in the context of appropriately conducted clinical trials,” he said.
Not everyone will need a vaccine. Americans who have had the virus and developed antibodies against it will be a “significantly lower priority” for vaccination, he said, because they presumably already have immunity.
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.