President Donald Trump touted vaccine distribution plans in a Friday news conference and pledged 100 million vaccine doses by the year’s end, a promise that contradicts the Centers for Disease Control and Prevention’s most optimistic projections.
“We will have manufactured at least 100 million vaccine doses before the end of the year, and likely much more than that,” Trump said. “We expect to have enough vaccines for every American by April.”
The promise of 100 million vaccine doses this year represents the president’s latest contradiction of his own public health agency, and follows a week in which Trump repeatedly challenged CDC Director Robert Redfield about the importance of masks and when most Americans can expect a vaccine.
“We essentially have it,” the president said of a vaccine Friday. “We’ll be announcing it fairly soon.”
But the testing protocols for the two vaccines furthest along in clinical trials, manufactured by Moderna and Pfizer/BioNTech, which were released Thursday, show that analysis of the data will likely stretch into December 2020 and early 2021.
Internal CDC documents posted by The New York Times show that under the most optimistic scenario, if the two vaccines both prove to be safe and effective on an accelerated timeline, 35 million to 45 million doses could be available by late December. If just one of the vaccines is seen as safe and effective, only 20 million to 30 million doses will be available and if just the other vaccine is authorized, 15 million doses will be available, according to the documents. The internal documents were independently confirmed by CQ Roll Call as authentic.
Operation Warp Speed, the administration’s vaccine and therapeutics development initiative, has allocated at least $11 billion in public funds to research and manufacture a vaccine. CQ Roll Call has asked Operation Warp Speed, Moderna and Pfizer how many doses of vaccine are currently manufactured and ready to ship but has not yet received replies.
The CDC for years has overseen national immunization efforts, like the Vaccines for Children program, which gives out pediatric vaccines. But Trump described the coronavirus vaccine distribution enterprise as “relying on our military” and Operation Warp Speed.
“Distribution will begin within 24 hours after notice,” he said. “Massive amounts will be delivered through our great military.”
Operation Warp Speed leaders Moncef Slaoui and Gustave F. Perna were present at the news conference, while Redfield was not.
Slaoui wrote in a New England Journal of Medicine editorial that 300 million doses could be available by “mid-2021.”
Claire Hannan, executive director of the Association of Immunization Managers, who works with states and the CDC on vaccinations, expressed wariness about the president’s declaration.
“It’s important for us to be prepared for any distribution scenario, but it’s premature to make announcements on when any vaccine would demonstrate the safety and effectiveness necessary to be approved for distribution,” she said.
Carlos del Rio, Emory University School of Medicine professor of medicine, pointed out that it’s not yet certain any vaccines will be demonstrated to be safe and effective.
“There are several issues here but one is the clinical trials,” del Rio said in an email. “Through [the Biomedical Advanced Research and Development Authority] the government has paid for millions of doses of vaccines that are being produced. If the vaccines prove to be effective in clinical trials then those millions of doses will be ready and available. If the trials show the vaccine not to be effective then those vaccines are discarded.”
The CDC and Operation Warp Speed released guidance for states planning to distribute any COVID-19 vaccine earlier this week, including details on the help states can expect from the federal government on shipping and vaccine prioritization.
More detailed planning and prioritization decisions will fall to states, who have until Oct. 16 to submit their vaccine distribution plans to the CDC.
Experts say critical questions remain, such as how the federal government plans to cover consumers’ out-of-pocket costs.
State public health departments have received just a few million dollars for COVID-19 vaccine distribution — sometimes less than $1 million — while some states are still waiting on word from the CDC on whether they can expect funding. The District of Columbia has received no supplemental funding, a spokesperson told CQ Roll Call on Friday.
Redfield said in congressional testimony Wednesday that states urgently need $6 billion for vaccine distribution.
One major expense will be storing the vaccines at subzero temperatures. Medical deep freezers are not commonly available at the clinics and pharmacies where people often get vaccinated. Their cost can run from $10,000 to $15,000 a piece, according to Julie Swann, head of the engineering department at North Carolina State University.
CDC testing guidance
The conflicts between CDC scientists and the White House have raised questions about political interference with public health information.
Clashes between the White House and career scientists at the CDC have even shown up in the agency’s guidance, which is relied on by public health officials and health care providers across the country.
Guidance on testing was updated in late August to state that “you do not necessarily need a test” after prolonged contact with an infected person.
“If you have been in close contact (within 6 feet) of a person with a COVID-19 infection for at least 15 minutes but do not have symptoms, you do not necessarily need a test unless you are a vulnerable individual or your health care provider or State or local public health officials recommend you take one,” the guidance read.
Public health experts and epidemiologists had been saying for months that asymptomatic transmission is important to track, and the contradiction took many off guard, raising concerns that Trump loyalists were hoping to artificially suppress the number of COVID-19 cases. The language was inserted by Department of Health and Human Services officials outside the CDC, according to a New York Times report.
CDC quietly revised the language on Friday.
The new guidance states that “if you have been in close contact, such as within 6 feet of a person with documented SARS-CoV-2 infection for at least 15 minutes and do not have symptoms,” then “you need a test.”
“Testing is recommended for all close contacts of persons with SARS-CoV-2 infection,” the guidance reads. “Because of the potential for asymptomatic and pre-symptomatic transmission, it is important that contacts of individuals with SARS-CoV-2 infection be quickly identified and tested. Pending test results, you should self-quarantine/isolate at home and stay separated from household members to the extent possible and use a separate bedroom and bathroom, if available.”