Trump Signs ‘America First’ Vaccine Executive Order, Vows to Use Emergency Law to Bolster Supplies if Needed

As accusations fly that the Trump administration passed on securing doses of Pfizer’s highly effective COVID-19 vaccine beyond an initial supply contract, the president signed an executive order Tuesday that intends to prioritize American access to vaccines supported or procured by the government and threatened to invoke emergency legislation, if needed, to bolster supplies.

The executive order and threats to use the Defense Production Act, a federal law that can force industry to produce emergency supplies, comes as reports circulate — and the White House strongly denies — that the administration turned down additional Pfizer vaccine shots offered by the drugmaker after the federal government entered into a supply agreement earlier this year.

Now that the Pfizer vaccine is on the verge of Emergency Use Authorization by the FDA and COVID-19 infections have surged nationwide, the federal government is seeking millions more doses of the promising drug than initially contracted for.

Former FDA commissioner and current Pfizer board member Scott Gottlieb claimed during an interview Tuesday that the U.S. government did indeed turn down extra dose allocations from Pfizer, who he said subsequently entered into supply agreements with other nations for its highly desired vaccine.

“Pfizer did offer an additional allotment … to the U.S. government multiple times and as recently as after the interim data came out and we knew this vaccine looked to be effective,” Gottlieb said. “I think the government made a bet that they are going to option or advance purchase vaccines from multiple manufacturers. They want to spread those bets. I think they’re betting that more than one vaccine gets authorized.”

White House Press Secretary Kayleigh McEnany contended that the claims are “just simply not true that [Pfizer] offered extra doses,” citing people that were involved in the negotiations. “With each and every company, we contracted for 100 million doses, so it’s just simply not the case that we were offered more and rejected them,” she said.

McEnany also denied reports that Pfizer may be unable to provide more doses to the U.S. until late June or July due to the deals it has made with other nations, claiming that the U.S. will “absolutely” receive more supplies of Pfizer vaccine doses before next summer.

“We can only supply countries once regulatory authorization or approval has been granted and we will supply each country with vaccine doses through a robust process, consistent with supply agreements we’ve entered into with individual countries,” Francesco Marzullo, manager of Pfizer’s Global Supply Communications, told FDAnews Tuesday.

The U.S. government secured 100 million doses of the Pfizer vaccine back in July through a massive $1.95 billion contract that includes a provision to purchase an additional 500 million doses (DID, July 23), an amount that won’t be nearly enough to meet U.S. demands.

Currently, 6.4 million vaccines will comprise the initial U.S. rollout should an EUA be given, an Operation Warp Speed official said. The official estimated that 40 million Pfizer and Moderna vaccine doses will be distributed by the end of the year (DID, Nov. 25).

The executive order, unveiled during Tuesday’s Operation Warp Speed vaccine summit at the White House, will “ensure that American citizens have first priority to receive American vaccines,” the president said. After it’s determined that the U.S. has a sufficient supply of doses for its own citizens, the order directs the government to then work to enable international access to those vaccines.

Though the executive order doesn’t explicitly say how its prioritization goals will be accomplished, it tasks the HHS Secretary with collaborating with the Secretary of Defense and the heads of other appropriate agencies to ensure Americans have priority access to vaccines funded by the U.S. government, with the most vulnerable patients getting them first. The White House declined to elaborate on the specific mechanisms of the order.

Moncef Slaoui, chief adviser for Operation Warp Speed and a former Moderna executive, said he was not up to speed on the president’s executive order and declined to comment on it.

“Frankly, I don’t know, and frankly, I’m staying out of this, so I can’t comment,” he said Tuesday. “I don’t know exactly what this order is about.”

Tuesday’s vaccine summit of federal, state and local officials in addition to pharma industry executives was viewed by some as a largely political move by the president. It was reportedly snubbed by Pfizer and Moderna, possibly because Center for Biologics Evaluation and Research Director Peter Marks was in attendance and could have created a conflict of interest, as he leads the FDA’s approval process for vaccines. The president, however, has openly criticized Pfizer and Moderna, accusing the companies of purposely delaying the results of their late-stage vaccine trials until after the presidential election.

Pfizer and Moderna did not respond to a request for comment. — James Miessler