The Trump administration's Operation Warp Speed will miss its commitment to distribute 40 million doses of Pfizer Inc.'s and Moderna Inc.'s authorized COVID-19 vaccines to U.S. states and territories — enough to vaccinate 20 million people — by the end of December.

Only 15.5 million doses had been allocated by Dec. 23, said Gustave Perna, Warp Speed's COO. Another nearly 5 million doses are scheduled to be allocated on Dec. 29 but will not be distributed until early January, he told reporters.

Officials, including U.S. Health and Human Services Secretary Alex Azar, had earlier in the year said the Warp Speed project aimed to deliver 300 million doses of COVID-19 vaccines by the end of 2020.

But in mid-November — after the U.S. election — Azar significantly scaled the number of available doses for distribution by the end of December down to 40 million.

"We will be able to distribute enough vaccine to immunize 20 million people in the U.S. in December — that's 40 million doses," Moncef Slaoui, Warp Speed's chief scientific adviser, reiterated during a Dec. 2 briefing with reporters. Slaoui and Azar repeated that vow Dec. 6 on CBS and ABC Sunday morning political programs, respectively.

But on Dec. 23, Slaoui and Perna acknowledged the Trump administration will miss the mark of distributing enough doses before the year is over to fully vaccinate 20 million Americans.

Vaccinations in the U.S. started Dec. 14 with Pfizer's shot and Dec. 21 for Moderna's vaccine.

As of Dec. 26, about 9.5 million doses had been distributed in the U.S., though fewer than 2 million people had received the first dose, according the Centers for Disease Control and Prevention.

There could be a lag of up to four days in the number of vaccinations reported, Perna told reporters.

Brett Giroir, assistant secretary for health at HHS, tweeted Dec. 26 the Trump administration's lag in gathering vaccination information could be as long as seven days.

The second doses — the booster shots — must be given three weeks later for Pfizer's vaccine and four weeks for Moderna's product.

The Trump administration is holding back the second doses from states and territories and said Warp Speed will release them when it is time for the first-dose recipients to get the boosters. With Warp Speed running behind on its first-dose distribution commitment, it is unclear if the second doses will make it to vaccination sites on time.

Darkest days ahead

The U.S. is expected to soon reach 20 million COVID-19 reported cases. Over 333,000 Americans have died from the disease, according to Johns Hopkins University.

Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said Dec. 27 the darkest days of the pandemic for the U.S. are still ahead — agreeing with a Dec. 22 warning from President-elect Joe Biden.

"As we get into the next few weeks, it might actually get worse," Fauci said on CNN's "State of the Union."

Fauci said he had no "deleterious" side effects after receiving the first dose of Moderna's vaccine Dec. 22 other than a "little bit of an ache in my arm that lasted maybe 24 hours, a little bit more, then went away."

The first serious allergic reaction in the U.S. to Moderna's shot was reported Dec. 24 by a doctor at Boston Medical Center.

There have been at least six cases of anaphylaxis in the U.S. connected to Pfizer's vaccine.

Trump drug prices rule halted

A federal judge in Maryland Dec. 23 issued a 14-day temporary restraining order blocking the Trump administration from implementing a rule Jan. 1, 2021, that would require drugmakers to offer the U.S. government the lowest prices paid by foreign countries on expensive injectable medicines covered by the Medicare Part B program.

The court's ruling makes it highly unlikely President Donald Trump will fulfill any of his promises to lower drug prices in the U.S. before he leaves the White House Jan. 20 — pledges he made on the 2016 campaign trail but struggled over the past four years to keep.

The Trump administration in October 2018 initially sought to test an international pricing index model to pay for Part B drugs.

In November 2019, HHS' Azar said the administration was shifting the proposal to a favored nations approach. But the proposal sat idle.

Trump signed an executive order July 24 instructing HHS to implement the favored nations idea.

On Nov. 20, HHS said it was issuing an interim final rule for the favored nations model — publishing it Nov. 27 — though it said it would forgo the usual notice of proposed rulemaking and public comment period.

The U.S. drug industry has called the rule "socialism" and on Dec. 4, the Pharmaceutical Research and Manufacturers of America, or PhRMA, and the Biotechnology Innovation Organization led other groups in filing separate suits challenging the constitutionality of the rule and accusing HHS of lacking the authority to rush the measure through the administrative procedural process.

In response to the PhRMA suit, Judge Catherine Blake of the U.S. District Court for the District of Maryland said HHS had failed to show good cause for skipping the usual notice and comment period in trying to implement a regulation that for the first time would "use of a price control mechanism not provided for by Congress."

Blake also said the plaintiffs had shown "that they are likely to succeed on the merits" in the case.