Posts tagged with "Operation Warp Speed"

Millions of COVID-19 vaccine doses stuck in warehouses until federal orders, Pfizer says

December 21, 2020

Millions of doses of the Pfizer-BioNTech COVID-19 vaccine are languishing in warehouses awaiting shipment instructions from the Trump administration—even as states and first responders are clamoring for them—vaccine manufacturer Pzifer said in a statement on Thursday, December 17.

The startling bottleneck is occurring as America is breaking daily COVID-19 death tolls, The Huffington Post reports. The nation lost more people on Decemeber 16, alone (3,611), than the number of people who died in the terrorist attack on the World Trade Center on 9/11.

Officials in several states said they were told Wednesday that their second shipments of Pfizer-BioNTech’s vaccine next week has been mysteriously reduced, CNN reported. That triggered fears by states that the Trump Administration may be incapable of hitting the target of delivering enough vaccine doses for 20 million injections by the end of the year.

Indeed, Illinois Governjor J.B. Pritzker (D) said Wednesday that federal officials informed states that the expected total shipments of doses nationally over the next two weeks have been cut in half to about 4.3 million doses for each week.

Washington State Governor Jay Inslee (D) tweeted Thursday that the state’s vaccine allocation will be cut by 40% next week and that “no explanation was given.” He called it “disruptive and frustrating.”

States are reportedly already scrambling to cut back and reorganize planned vaccinations.

A source told The Washington Post that Pfizer executives were “baffled” that the Trump administration wasn’t immediately shipping out all of the vaccine.

Pfizer defended itself amid the rising fears about vaccine delivery, noting that it has no production problems—and has doses ready to go.

“This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. government to the locations specified by them,” Pzifer said in its statement. “We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” the company added.

A unidentified federal official blamed the delivery change on states’ requests for expedited delivery, leaving less time for inspection and clearing of supplies, the Post reported. “We are sending doses that have been produced, verified and released,” the official said. But that would appear to be contradicted by Pfizer’s statement that millions of doses have been ready for inspection, the newspaper

Pfizer said it has continually kept President Donald Trump’s Operation Warp Speed program, as well as his administration’s Department of Health and Human Services up to date on “every aspect of our production and distribution capabilities,” and officials have “walked the production lines” at company facilities.

Pfizer has a successful and long track record of producing and distributing large volumes of complex vaccines that the world can trust―and we are continuing to extend this track record with our COVID-19 vaccine,” it said.

On top of Pfizer’s 2.9 million doses already shipped, millions of more doses of Moderna’s vaccine are ready to go out next week if they’re approved, which is likely. Pfizer will provide an additional 2 million doses next week, according to HHS Secretary Alex Azar.

The Post characterized the upcoming number as a sharp dropoff from what states were expecting.

Research contact: @HuffPost

Shot to be ‘heard’ around the world: Pfizer says its coronavirus vaccine is more than 90% effective

November 9, 2020

A coronavirus vaccine developed by New York City-based pharmaceutical firm Pfizer is more than 90% effective, according to the first look at data from a late-stage U.S. trial involving nearly 44,000 participants, Politico rerports.

An analysis of 94 trial participants who contracted COVID-19 showed that the vaccine was 94% effective, the company and its partner BioNTech of Germany said in a press release on November 9.

The pair added that they expect to apply to the U.S. Food & Drug Administration (FDA) for an emergency-use authorization before the end of the month, after they have collected sufficient data on the vaccine’s safety.

The better-than-expected result is the first Phase III data from any of the four candidates now in the final stage of testing in the United States.

“I can’t imagine better news on the vaccine front,” Walid Gellad, director for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told Politico.  Not only is it highly effective based on the press release, but there were 90 cases so we don’t have to deal with the skeptics about interim analyses, and there appeared to be no safety signals.”

Others noted that the information Pfizer had released was promising but still incomplete. “We should remain a little cautious, said Michael Head, a senior research fellow in Global Health at the University of Southampton in the U.K. “The provisional findings are made available in a press release, and the study is ongoing.”

President Donald Trump, who pushed unsuccessfully for a vaccine by Election Day, cheered the Pfizer result. “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he wrote on Twitter.

Although Ivanka Trump tried to link the new vaccine to the Administration’s Operation Warp Speed, a top scientist for Pfizer told the New York Times that her company had not partnered with the Trump administration’s program meant to speed vaccine development.

President-elect Joe Biden issued a statement congratulating “the brilliant women and men who helped produce this breakthrough,” but he cautioned that “the end of the battle against COVID-19 is still months away.”

Even if a shot is authorized by late November, it will take many months before vaccination is widespread, Biden noted. “Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” he said.

Research contact: @politico