- The Trump administration is ready to help distribute coronavirus vaccines across the U.S. as soon as the FDA grants emergency use authorizations, Dr. Moncef Slaoui told CNBC.
- Pfizer and German partner BioNTech intend to apply with the FDA on Friday, the first companies to start the U.S. regulatory process.
- "As soon as the EUA is approved, within 24 hours, the vaccines will be in the immunization sites and people will be immunized," the Operation Warp Speed advisor said.
President Donald Trump's administration is ready to help distribute coronavirus vaccines across the United States should regulators grant emergency approvals, Operation Warp Speed advisor Dr. Moncef Slaoui told CNBC on Friday.
"As soon as the EUA is approved, within 24 hours, the vaccines will be in the immunization sites and people will be immunized," Slaoui said on "Squawk on the Street." He oversees the Trump administration's multi-agency vaccine program, which sought to accelerate the development and distribution process in order to end the devastating coronavirus pandemic.
The comments came shortly after Pfizer and German partner BioNTech announced their intentions to apply for emergency use authorization Friday from the U.S. Food and Drug Administration, the first companies to do so for a Covid-19 vaccine. The agency's review process is expected to take a few weeks.
While the companies didn't take any money from the federal government for research and development, they reached a nearly $2 billion agreement in July to supply 100 million doses to the U.S. government as part of Operation Warp Speed. Pfizer will directly ship its own vaccine, although Operation Warp Speed can provide the company logistical help, The Associated Press reported.
Pfizer CEO Dr. Albert Bourla recently told Sky News the company intends to begin shipping its vaccine, which requires ultra-cold storage, within "a couple of hours" of receiving regulatory clearance.
"We actually already have localized and are localizing all of the ancillaries — syringes, the cotton, alcohol, the masks, everything that's required to immunize individuals — is being moved," said Slaoui, stressing that individual states will instruct the administration where they need dosages sent.
Coronavirus vaccine or vaccines, if approved, would be limited at first. Health-care workers, along with elderly people and those who have underlying health conditions, are likely to receive the vaccine initially.
"We don't have 300 million doses. We will have, as the month goes by, within the month of December, up to 35 million to 40 million doses," Slaoui said. That is enough to vaccinate, "more or less, 20 million high-risk individuals," added Slaoui, who spent decades at British pharmaceutical giant GlaxoSmithKline.
The news of Pfizer's FDA application comes at a critical juncture in the U.S. coronavirus outbreak, with cases and hospitalizations for Covid patients rising to record levels. Deaths are surging to records not seen since early May, when the nation was still grappling with its initial wave of the coronavirus. Health experts expect this latest surge to intensify further into the winter months.
At a White House coronavirus task force briefing Thursday, Vice President Mike Pence told Americans that the country "has never been more prepared to combat this virus than we are today." He also touted the developments around Operation Warp Speed, contending one or more safe and effective vaccines may be available "in a short period of time."
In addition to Pfizer's vaccine, which final data showed was 95% effective in preventing Covid-19, Massachusetts-based biotech firm Moderna also is nearing the point of submitting for limited approval. The company's preliminary data released Monday showed its vaccine had efficacy of 94.5% and it hopes to apply for emergency use authorization in "the coming weeks."
Slaoui said "every day, every hour" counts for vaccine approvals, given the scale of the U.S. outbreak right now. For that reason, an FDA approval of the Pfizer vaccine and a potential application from Moderna may happen at different times, said Slaoui, who formerly served on Moderna's board.
"If the time difference in the review of the file is over five or six days, probably the FDA will hold a review for the Pfizer vaccine and a few days later, a review for the Moderna vaccine," he said. This will pan out, really, as the reviews go on. At this stage, it's more likely that they will make them a few days apart."
President-elect Joe Biden and his health advisory team has been expressing concern in recent days that a delay in the transition could complicate vaccine rollout efforts. "More people may die if we don't coordinate," Biden told reporters on Monday. "How do we get over 300 million Americans vaccinated? What's the game plan? It's a huge, huge, huge undertaking."
Trump has refused to concede the election to Biden, despite media organizations including NBC News calling the race almost two weeks ago. However, earlier this week, Slaoui told CNBC he hopes Operation Warp Speed is able to smoothly pursue its goals despite a new administration.
"We're not going to be distracted by circumstances or context," Slaoui said Monday on "Closing Bell." "We're going to continue running as fast as we can, as well as we can, always looking after safety and efficacy of the vaccines. And clearly, we would hope there is no disruption because of the transition."