Trump trade adviser Peter Navarro wanted to make sure the administration’s top vaccine expert would be on board with a White House plan to distribute the unproven drug to hard-hit cities.
“The first thing out of his mouth was, ‘I want to know what team you are on,’ ” recalled Rick Bright, who at the time was responsible for stockpiling drugs for medical emergencies as director of the federal Biomedical Advanced Research and Development Authority.
The immunologist, who later filed a whistleblower complaint against the administration, said in an interview with The Washington Post that he told Navarro he was on the side of medical evidence. Navarro, Bright said, replied, “I won’t hold it against you, but we need to move this forward.” Navarro declined to comment on Bright’s account.
The White House decision to set aside the mandatory safety controls put in place by the Food and Drug Administration fueled one of the most disputed initiatives in the administration’s response to the pandemic: the distribution of millions of ineffective, potentially dangerous pills from a federally controlled cache of drugs called the Strategic National Stockpile.
Over a span of four days in early April, the White House ordered the distribution of 23 million hydroxychloroquine tablets from the stockpile to a dozen states, enough pills for 1.4 million covid-19 patients, according to public records obtained by The Post in response to a Freedom of Information Act request.
The Post review found that the process was marked by haphazard planning, little or no communication to local authorities about the flow of pills into their communities, and a lack of public accounting about where they ended up.
The documents also demonstrate the steps the administration took to bypass the FDA’s March 28 authorization for emergency use of the tablets, which limited their use to hospitals and clinical drug trials. According to FDA guidance at the time, state authorities were supposed to request stockpile supplies before they were delivered. But interviews and documents show that procedure was not followed in many cases.
The White House ordered more than a third of the tablets sent to the three major drug distributors in the United States with instructions to deliver them not only to hospitals but also retail pharmacies in five U.S. cities, despite the FDA controls, according to public records.
“At the direction of the White House, SNS did a one-time shipment of hydroxychloroquine to several commercial distributors to support further distribution of hydroxychloroquine directly to hospitals and retail pharmacies in the hard hit areas of NYC, Detroit, Chicago, and New Orleans,” a senior analyst at HHS said in an internal email exchange.
One major wholesaler said it shipped to long-term care facilities, which also were not covered in the FDA’s emergency authorization. All three distributors told The Post they did not ship to retail pharmacies, despite the administration’s request.
The Department of Health and Human Services, which oversees the stockpile, confirmed in an email to The Post that the pills were supposed to go
States say they lack federal funds to distribute coronavirus vaccines as CDC tells them to be ready by Nov. 15
State officials have been planning in earnest in recent weeks to get shots into arms even though no one knows which vaccine will be authorized by the Food and Drug Administration, what special storage and handling may be required and how many doses each state will receive.
Despite those uncertainties, the Centers for Disease Control and Prevention is asking states to be prepared to “preposition” doses in key locations throughout the country. Officials want to move quickly once the FDA authorizes a vaccine and a CDC advisory panel issues recommendations on which populations should be vaccinated, according to a letter the CDC sent Monday to state preparedness and immunization officials.
As part of that effort, the CDC is asking states to provide by Tuesday critical information, including a list of each jurisdiction’s top five sites capable of receiving and administering a vaccine that must be stored at ultracold temperatures of minus-70 Celsius (minus-94 Fahrenheit). The letter refers to the vaccine only as Vaccine A, but industry and health officials have identified it as Pfizer’s candidate.
Pfizer chief executive Albert Bourla said Tuesday that “hundreds of thousands” of doses had already been produced and that a first look at the data would occur soon. Pfizer will not apply for any authorization of its vaccine sooner than the third week of November, when it will have sufficient safety data.
“We acknowledge that you are being asked to do unprecedented work,” wrote Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, which is leading the CDC’s role in vaccine distribution. She added: “This is a new planning ask.”
State officials say they have been trying to raise the issue with federal officials but have received little response.
“It is absolutely ridiculous that the administration, after spending $10 billion for a Warp Speed effort to develop a vaccine, has no interest in a similar investment in a Warp Speed campaign to get the vaccine to every American as quickly as possible after it is approved,” said Michael Fraser, executive director of the Association of State and Territorial Health Officials.
Operation Warp Speed is the federal initiative, funded by more than $10 billion of taxpayer money, to fast-track development of coronavirus countermeasures.
“The now accelerated timeline underscores the need to address the issue of funding for state and territorial health agencies to make this all work,” Fraser said. “There are many other costs that have no clear way to be paid for at this point.”
Local officials still need to recruit thousands of people to staff vaccine clinics and enroll and train providers. They also have to ramp up information technology and data systems to track vaccine inventory and ordering to ensure people get the correct doses at the right times — most vaccines will require two shots — and to monitor for adverse events. They will need to develop locally tailored vaccination communications campaigns, too.
“States have received some funding, but it’s not nearly enough” to support the scale, scope and
ANNAPOLIS, MD — Maryland is preparing to roll out a coronavirus vaccine as soon one is authorized, Gov. Larry Hogan announced Tuesday. Though the hype for an immunization is swirling, the governor reminds Marylanders that vaccinating the entire state will take some time.
Hogan’s draft plan calls for a two-step rollout of a potential coronavirus shot. A person’s job and living situation would determine when they get an immunization, he says.
“In anticipation of a COVID-19 vaccine, Maryland stands ready to order, distribute, and administer it effectively and rapidly as soon as a vaccine becomes available,” Hogan said in a press release sharing the state’s proposal.
Hogan submitted a tentative strategy to the Centers for Disease Control and Prevention for approval last week. It is not yet finalized, and it is merely an overview of what the vaccination period could look like.
Health care and essential workers would get the immunization first, according to Hogan’s suggestion. Staff members and residents of nursing homes would also be eligible for the shot in the first phase.
“The State of Maryland’s plan for this historic undertaking will immediately make the vaccine available to Marylanders at highest risk of developing complications from COVID-19 as well as our critical frontline health care workers and essential workers in public safety and education,” Hogan added.
The Maryland Department of Health would track several key metrics to evaluate the state’s vaccination progress, according to the proposition. The state would create an immunization dashboard to keep an eye on:
Percent of Phase 1 population vaccinated
Percent and number of residents and staff at long-term care facilities vaccinated
Determination of an equitable distribution of COVID-19 vaccine throughout the state for the Phase 1 population
Percent and number of Phase 1 population pre-registered
Once Maryland makes substantial progress in these areas and after the CDC approves, the state will offer the coronavirus shot to the general public. This could take a while though.
Vaccines must be stored at low temperatures, meaning high-tech equipment is necessary to chill the immunization during shipping. This specialization could slow the process down.
Furthermore, patients will need two doses of the shot, doubling the amount of product that needs to pass through a competitive shipping market. The doses will be separated by 21 to 28 days, adding time to the process.
The state hopes to sort out some of these logistics beforehand by pre-registering vaccine distributors and receivers. Maryland will handle ordering and scheduling in advance through a state database called ImmuNet.
“From provider recruitment and enrollment to vaccine storage and reminders about second doses, MDH has taken a very calculated approach to ensure the logistics, operations, and execution of this plan are thorough and efficient,” said Acting Deputy Secretary of Public Health Dr. Jinlene Chan.
Hogan’s plan could only start if a company finalizes an immunization, gets the proper authorization and mass produces millions of doses. Scientists are not there yet, but it is a competitive race to the finish line.
The two drugstore chains are the best placed to send out mobile units to vaccinate seniors and other vulnerable people on site, Paul Mango, deputy chief of staff for policy at the Health and Human Services Department, told reporters in a telephone briefing.
“This is a completely voluntary program on the part of every nursing home. This is an opt-in program,” Mango said.
It will be up to the drugstore chains to figure out how to deliver the vaccines, including cold storage requirements and personal protective equipment. The retailers also will have to determine how to collect fees from Medicare, Medicaid or private insurers for administering the vaccines, which must be provided to people free of charge, officials said.
Mango said the Operation Warp Speed team did not have any idea of how many nursing homes would choose to use the retailers. “We are not imposing our solution on anyone,” he said.
Dr. Jay Butler, deputy director of infectious diseases at the US Centers for Disease Control and Prevention, noted that a third of coronavirus deaths in the US have been among residents of long-term care facilities.
“We believe that this plan will be the quickest and easiest way to provide vaccines to long-term care facility residents,” Butler told reporters.
Staff and residents of long-term care facilities are expected to be among the first to get vaccinated.
“We fully anticipate that both Pfizer and Moderna will have data of both safety and effectiveness of their vaccines very shortly. We are very encouraged because their clinical trials are going extraordinarily well,” Mango said.
“Part of the reason we are doing this is within 24 to 48 hours of the time the emergency use authorization is authorized, we expect to be putting needles into people’s arms,” Mango said. “This is pre-staging for what we believe will be rapid deployment.”
The CDC had asked states to submit plans for vaccine distribution by Friday. Army Maj. Gen. Christopher Sharpsten, director of supply and distribution for Operation Warp Speed, said this plan would help provide centralized management and “ensure there is comprehensive vaccine coverage for the American people.”
“Our goal is to broaden vaccine coverage,” Sharpsten said on the call.
Earlier Friday, President Trump said seniors would be the first to get any vaccine.
“Seniors will be the first in line for the vaccine. And we will soon be ending this pandemic,” Trump said during a visit to Ft. Myers, Florida.