Contradicting the Centers for Disease Control and Prevention director and other government officials, President Donald Trump incorrectly said in a press briefing that a coronavirus vaccine would be “immediately” available to the general public after an authorization.
Officials expect only a limited number of doses will be available in 2020 — and those will be given to prioritized groups. Members of the general public may not be able to receive a shot until well into 2021.
The president also claimed, without evidence, that the U.S. would “be able to distribute at least 100 million vaccine doses by the end of 2020.”
Trump made his remarks in a Sept. 16 press briefing. Earlier in the day, Dr. Robert Redfield, the head of the CDC, testified before the Senate, explaining the phased rollout.
Redfield, Sept. 16: I think there will be vaccine [that’ll] initially be available sometime between November and December, but very limited supply and will have to be prioritized. If you’re asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at late second quarter, third quarter 2021.
When asked about Redfield’s comments, Trump said Redfield was mistaken and may have been confused by the question.
“I think he made a mistake when he said that. It’s just incorrect information,” Trump said. “No, we’re ready to go immediately as the vaccine is announced, and it could be announced in October. It could be announced a little bit after October. But once we go, we’re ready.”
Later, when pressed on when the vaccine would be available to the general public, Trump incorrectly said that it would be available “immediately.”
Trump, Sept. 16: I would say that — yeah, we will start distributing it immediately.
Reporter: But to the general public.
Trump: To the general public, very shortly there — I mean, really, to the general public: immediately. When we go, we go. We’re not looking to say, “Gee, in six months, we’re going to start giving it to the general public.” No, we want to go immediately. No, it was an incorrect statement.
The president insisted that “it’s going to be a much faster distribution than” Redfield said.
“Our distribution is going to be very rapid and very — it’s going to be all-encompassing,” he said. “We are going to have a focus on certain groups that have problems — senior citizens, et cetera — but it’s a very powerful — it’s a — it’s going to be very powerful distribution. It’s going to cover everybody, and it’s going to cover them rapidly.”
Trump also moved up the timeline for distribution beyond what any expert or official has previously suggested, indicating a possible start as early as mid-October.
“We’re on track to deliver and distribute the vaccine in a very, very safe and effective manner,” he said. “We think we can start sometime in October. So as soon as it is announced, we’ll be able to start. That’ll be from mid-October on. It may be a little bit later than that, but we’ll be all set.”
As we have written, experts are doubtful that the ongoing phase 3 clinical trials will have progressed enough to be able to conclude a vaccine is safe and effective by the end of October or early November, let alone begin distribution.
National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said in a Sept. 8 interview that having an answer on a vaccine was “unlikely” by Election Day, and that a more reasonable expectation would be by the end of the year.
Moncef Slaoui, the chief adviser of Operation Warp Speed — the government’s effort to fast-track vaccine development — said on Sept. 3 that there was a “very, very low chance” that the trials would provide results by the end of October.
Three vaccine makers have started conducting large, placebo-controlled randomized trials of their coronavirus vaccines in the U.S.
Pfizer/BioNTech’s mRNA vaccine trial is the most advanced, with more than 29,000 enrollees out of a goal of 30,000, as of Sept. 14. Moderna’s trial, which is also testing an mRNA vaccine, is close behind, with more than 25,000 enrollees as of Sept. 16. AstraZeneca’s viral vector vaccine trial was halted after the identification of a possible serious adverse effect in a participant who received the vaccine. The trial has resumed in the U.K. but remains on hold in the U.S.
The CEO of Pfizer has stated that his company anticipates that it will know whether its vaccine works by the end of October, but that it “is only a prediction” and “only an answer.” Some scientists are skeptical of such a fast turnaround.
Moderna told CNBC on Sept. 17 that it expects to know an answer on its vaccine in November — and that while one could come in October, it would be unlikely.
Once a company believes it has enough data to justify an authorization, it would need to submit an application to the Food and Drug Administration and the agency would have to review it. The authorization could be as fast as a few days if the data are unambiguous.
Once approved, likely as an emergency use authorization, or EUA, any already produced vaccines would then need to be shipped out. The logistics head of Operation Warp Speed has said vaccines would begin to move to administration sites within 24 hours of the FDA’s decision.
Although that timeline is rapid, it still involves extra days, and makes it even more improbable that vaccine distribution and delivery would occur in October, even if everything goes along without a hitch and a trial does provide results at the end of that month.
As one sign of a reasonable timeline, the CDC’s COVID-19 vaccination interim playbook, which the president held up during the presser, doesn’t require states seeking grant funds to even submit their COVID-19 vaccination plans to the agency until Oct. 16.
Perhaps most important, Trump misleads by saying that the distribution plan would get shots to the general public “immediately” — and much faster than Redfield suggested.
Some news outlets reported that the CDC issued a statement clarifying that Redfield’s estimates were for when Americans could expect to have completed their vaccinations, not when doses would first be available. Other news organizations said that the agency later retracted the statement.
Regardless, Redfield’s description is consistent with what other officials have said and jibes with the tiered approach the government has proposed.
“We may have enough vaccine by the end of the year to immunize probably, I would say, between 20 and 25 million people,” Operation Warp Speed’s Slaoui told NPR earlier this month. “And then we will ramp up the manufacturing of vaccine doses to be able to, based on our plans, have enough vaccine to immunize the U.S. population by the middle of 2021.”
In July 31 Senate testimony, Fauci cautioned that the vaccine would be limited at first.
“I don’t think that … we will have everybody getting it immediately in the beginning, it probably will be phased in. And that’s the reason why we have the committees to do the prioritization of who should get it first,” Fauci said. “But ultimately, within a reasonable period of time, the plans now allow for any American who needs a vaccine to get it within the year 2021.”
The CDC playbook also explains that the vaccine supply will initially be constrained — and that the general public will not have immediate access.
“A key point to consider is that vaccine supply will be limited at the beginning of the program, so the allocation of doses must focus on vaccination providers and settings for vaccination of limited critical populations as well as outreach to these populations,” the playbook reads. “The vaccine supply is projected to increase quickly over the proceeding months, allowing vaccination efforts to be expanded to additional critical populations and the general public.”
The document includes tentative scenarios noting that if both vaccines A and B — references to the Pfizer and Moderna vaccines — were authorized under an EUA, only about 3 million doses, or enough for 1.5 million people to get two doses, would be available by the end of October. By the end of November, the number of cumulative doses could rise to 20 million to 30 million and 35 million to 45 million by the end of December.
Those numbers would mean only a fraction of those prioritized would be able to be vaccinated in 2020, assuming there is a vaccine. Although it’s not known yet exactly which groups will be prioritized — that will be determined only after there is vaccine data — some of the first groups are likely to include health care workers as well as adults with underlying conditions that put them at higher risk for COVID-19 and older individuals who live in places such as nursing homes.
August meeting slides from the CDC’s Advisory Committee on Immunization Practices, which will provide guidance on which groups should get first dibs, estimate that there are 17 million to 20 million health care workers in the U.S. and some 3 million seniors in long-term care facilities, along with as many as 100 million adults with underlying health conditions.
100 Million Doses?
Notably, neither Slaoui’s estimates nor the CDC numbers fit with Trump’s other claim that “we’ll be able to distribute at least 100 million vaccine doses by the end of 2020.”
The Department of Health and Human Services issued a press release the same day as Trump’s remarks and quoted Redfield as using the number, but in a different context. “Through the Advisory Committee on Immunization Practices, CDC will play a vital role in deciding, based on input from experts and stakeholders, how initial, limited vaccine doses will be allocated and distributed while reliably producing more than 100 million doses by January 2021,” he said.
But having 100 million doses produced by January is different from having those doses distributed by the close of 2020 — and distribution assumes the vaccine is approved, which is still unknown. Neither HHS nor the White House responded to our inquiry asking about the dose projection.
Pfizer’s website says that if its vaccine receives authorization, the company expects “to manufacture globally up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021.” Since it’s a global number, that again suggests 100 million doses would not be available to Americans before the year ends.
The company declined to provide more specific information about its dose number and timeline in the U.S., although the CEO said on Sept. 13 that Pfizer had already manufactured “hundreds of thousands of doses.”
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