Northwest Arkansas Democrat-Gazette
Gathering lauds coming vaccine
Trump sees ‘miracle,’ vows abundance of shots by spring
WASHINGTON — President Donald Trump on Tuesday celebrated the expected approval of the first U. S. vaccine for the coronavirus as the White House worked to instill confidence in the distribution effort that will largely be executed by President-elect Joe Biden.
Trump said the expected approvals are coming before most people thought possible. “They say it’s somewhat of a miracle and I think that’s true,” he said.
Trump led Tuesday’s White House event celebrating “Operation Warp Speed,” his administration’s effort to produce and distribute safe and effective vaccines for covid-19. The first vaccine, from drugmaker Pfizer, is expected to receive endorsement by a panel of Food and Drug Administration advisers as soon as this week, with delivery of 100 million doses — enough for 50 million Americans — expected in
coming months.
“Every American who wants the vaccine will be able to get the vaccine and we think by spring we’re going to be in a position nobody would have believed possible just a few months ago,” Trump said.
Pfizer developed its vaccine outside of the “Operation Warp Speed” initiative, but is partnering with the federal government on manufacturing and distribution.
England began its first vaccinations earlier Tuesday as the world mounts its fight against the pandemic that has killed more than 285,000 Americans and some 1.5 million people worldwide.
Trump and his aides hope to tamp down skepticism among some Americans about the vaccines and help build the outgoing Republican president’s legacy.
However, Trump’s administration was facing new scrutiny Tuesday after failing to lock in a chance to buy millions of additional doses of Pfizer’s vaccine, which has been shown to be highly effective against covid-19. That decision could delay the delivery of a second batch of doses until Pfizer fulfills other international contracts.
Trump used Tuesday’s event to sign an executive order in which the secretary of health and human services is directed to ensure that Americans have priority access to the vaccine. A senior administration official said the order would restrict the federal government from delivering doses to other nations until there is excess supply to meet domestic demand.
Tuesday’s “Operation Warp Speed” event featured Trump, Vice President Mike Pence and a host of government experts, state leaders and business executives, as the White House looked to explain that the vaccine is safe and lay out the administration’s plans to get it to the American people.
Biden said last week that in meetings with Trump administration officials his aides have discovered that “there’s no detailed plan that we’ve seen” for how to get the vaccines out of containers, into syringes and then into people’s arms.
Trump administration officials insist that such plans have been developed, with the bulk of the work falling to states and local governments to ensure their most vulnerable populations are vaccinated first. In all, about 50,000 vaccination sites are enrolled in the government’s distribution system.
But career officials insisted it was still too early to declare victory.
“We don’t want to get out in front of ourselves,” said Army Gen. Gustave Perna, responsible for overseeing the logistical and distribution efforts. “As my father used to say, ‘You can only spike the football when you’re in the end zone.’ Well, what is the end zone described to us here? Shots in arms.”
BIDEN’S PLANS
Speaking Tuesday in Wilmington, Del., Biden promised to distribute “100 million shots in the first 100 days” of his administration — roughly on pace with Trump’s projections for vaccination.
Biden also introduced his pandemic response team Tuesday. Topping the roster of picks was health secretary nominee Xavier Becerra, a Hispanic politician who served in Congress and as California’s attorney general. Others include a businessman renowned for his crisis management skills and a quartet of medical doctors, among them Anthony Fauci, the government’s top infectious-disease specialist.
Biden laid out his priorities for the start of his new government. He repeated his previous calls for all Americans to wear masks for 100 days to prevent the spread of the virus and said he’d mandate doing so in federal buildings and on public transportation. Biden also said he believed the virus could be brought under enough control to reopen “the majority of schools” within his first 100 days as president.
Those pledges were made even as Biden struck a somber tone about the toll the coronavirus has already taken. He said that, after about nine months of living with the pandemic, the U.S. is “at risk of becoming numb to its toll on all of us” and “resigned to feel that there’s nothing we can do.”
“I know that out of our collective pain, we will find our collective purpose: to control the pandemic, to save lives, and to heal as a nation,” he said.
Much of the groundwork for vaccine development was laid over the past decade, after new research into messenger RNA, or mRNA, vaccines — of the sort developed by both Pfizer and Moderna.
“The speed is a reflection of years of work that went before,” Fauci said this month. “That’s what the public has to understand.”
Fauci appeared virtually at the president-elect’s event, but did not attend the White House summit.
Fauci on Tuesday called Biden’s 100-day plan “bold but doable, and essential to help the public avoid unnecessary risks and help us save lives.”
The Trump administration insists that between the Pfizer vaccine, the vaccine from Moderna and others in the pipeline, the U.S. will be able to accommodate any American who wants to be vaccinated by the end of the second quarter of 2021.
The Food and Drug Administration’s panel of outside vaccine experts is to meet Thursday to conduct a final review of the Pfizer vaccine, and it will meet later this month on the Moderna version.
FDA decisions on the two vaccines are expected within days of each meeting. Both have been determined to be 95% effective against the virus that causes covid-19. Plans call for distributing and then administering about 40 million doses of the two companies’ vaccines by the end of the year — with the first doses shipping within hours of FDA clearance.
The decision not to secure additional Pfizer purchases last summer was first reported by The New York Times. Health and Human Services Secretary Alex Azar told NBC the administration is “continuing to work across manufacturers to expand the availability of releasable, of FDA-approved vaccine as quickly as possible. … We do still have that option for an additional 500 million doses.”
Dr. Moncef Slaoui, who is leading the government’s vaccine effort, noted the Trump administration had been looking at a number of different vaccines during the summer. He told ABC’s “Good Morning America” on Tuesday that “no one reasonably would buy more from any one of those vaccines because we didn’t know which one would work and which one would be better than the other.”
PERSONAL DATA
Meanwhile, the Trump administration is requiring states to submit personal information of people vaccinated against covid-19 — including names, birth dates, ethnicities and addresses — raising alarms among state officials who fear that a federal vaccine registry could be misused.
The Centers for Disease Control and Prevention is instructing states to sign socalled data-use agreements that commit them for the first time to provide personal information in existing registries to the federal government. Some states, such as New York, are pushing back, either refusing to sign or signing while refusing to provide the information.
Gov. Andrew Cuomo of New York warned that the collection of personal data could dissuade people in the country illegally from participating in the vaccination program. He called it “another example of them trying to extort the state of New York to get information that they can use at the Department of Homeland Security and [U.S. Immigration and Customs Enforcement] and that they’ll use to deport people.”
Administration officials say that the information will not be provided to other federal agencies and that it is “critically necessary” for several reasons: to ensure that people who move across state lines receive their follow-up doses; to track adverse reactions and address safety issues; and to assess the effectiveness of the vaccine among different demographic groups.
At a briefing Monday, officials from the government’s vaccine initiative defended the plan. They said all but a handful of states had signed data agreements, and the rest would sign by the end of the week, although it is not clear how many states will submit personal information.
“There is no Social Security number being asked for; there is no driver’s license number,” said Deacon Maddox, who runs the operation’s data and analysis system. “The only number I would say that is asked is the date of birth.”
A spokesman for the White House, Michael Bars, said the information “would only be used to support the unprecedented private-public partnership,” including the military, that the administration has deployed “to combat the coronavirus and save lives.”
Tracking immunizations, including collecting personal data, is not a new practice, and experts say it is especially important with a vaccine that requires two doses. But in the United States, it has been a purely state-by-state effort. A push two decades ago to develop a federal registry imploded after an uproar over patient privacy and how the data would be used.
“The general philosophy in this country is states manage public health, so the concept that federally we are going to be tracking identified information is concerning,” said Dr. Shaun Grannis, a professor of medical informatics at Indiana University, who has advised the CDC on data gathering.
“We are 50 different states with a patchwork quilt of regulations and different perspectives on privacy and security,” Grannis added. “And I think people are going to be asking the question: What does the CDC do that we can’t do regionally?”
While there are ways to encrypt personally identifiable data, the CDC is not yet using such a system. CDC officials did not respond to requests for comment.