- The Washington Times - Tuesday, November 24, 2020

The government is preparing to ship the first doses of COVID-19 vaccines in “just a few weeks,” Health and Human Services Secretary Alex M. Azar II said Tuesday as the Trump administration started to brief presumptive President-elect Joseph R. Biden’s transition team on coronavirus planning.

Mr. Azar said Rear Adm. Erica G. Schwartz of the U.S. Public Health Service spoke to the Biden team late Monday after the General Services Administration approved the transition process, ending a delay linked to President Trump’s decision to contest the results.

The secretary said Mr. Biden is receiving pre-prepared transition briefing materials and will coordinate briefings with them.

“Transition planning and execution will be professional, cooperative and collaborative in the best spirit of looking out for the health and well-being of the American people and in particular saving lives through this COVID-19 pandemic,” Mr. Azar said.

The handoff comes at a critical juncture.



Mr. Trump’s virus initiative, Operation Warp Speed, is poised to begin distributing a COVID-19 vaccine from Pfizer after the Food and Drug Administration vets the company’s request for emergency-use authorization.

The FDA is scheduled to discuss the application with an outside advisory panel on Dec. 10.

“If all goes well, we could be distributing vaccine soon after Dec. 10,” Mr. Azar said.

The administration plans to ship initial doses to all 64 health jurisdictions in the U.S. within 24 hours of approval.

CVS Health told the administration it can begin vaccinating nursing home residents, for instance, within 48 hours of getting the go-ahead.

Plans to roll out a successful vaccine are no longer theoretical. Three drugmakers have reported promising data and two are on the path to emergency approval before Christmas, making it crunch time for a team of military officers, health officials and logistics professionals who must get millions of vials into Americans’ arms through spring 2021.

Mr. Trump on Tuesday noted the stock market, buoyed by vaccine news, hit a record 30,000.

“I’m very thrilled with what’s happened on the vaccine front, that’s been absolutely incredible,” Mr. Trump said. “Nothing like that has ever happened medically, and I think people are acknowledging that. It’s having a big effect.”

The country is hurting in the meantime, however, as the FDA checks the companies’ work and Mr. Biden prepares his team. Hospitalizations reached a record high of 85,000 and an average of 1,500 people in the U.S. have died per day over the last week.

The Trump administration hopes newly approved “antibody cocktail” drugs keep more people with mild cases from ending up in the hospital.

Looking ahead, it plans to roll out 40 million doses of vaccine, enough for 20 million people to receive a two-dose course, by the end of the year. Health workers are slated to be first in line for the vaccines, though federal officials and advisory panels are finalizing recommendations.

Mr. Azar said the administration is running tabletop exercises and sending test shipments — though without the actual vaccines — to test their abilities.

“These are the kind of procedures you put in place to ensure a seamless logistical operation,” Mr. Azar said.

Army Gen. Gustave Perna, who is overseeing logistics, said Pfizer is conducting “dry rehearsals” to get distribution sites comfortable with proprietary shipping boxes that are packed with dry ice to maintain storage of the vaccine at minus-94 degrees Fahrenheit. The dry ice must be replenished every five days to extend storage for up to 15 days.

There is “initial hesitation” when distribution sites receive the boxes but users are getting a handle on the process, Gen. Perna said.

“We see growing confidence in everybody that’s using it,” he said. “That has been the story throughout every rehearsal so far.

“I’ve actually put my hands in the box. I’ve pulled trays out, I’ve watched and I’ve timed myself in execution,” the general said. “It is a very, very doable process.”

Moderna, which is also using messenger RNA in its vaccine, is set to request FDA approval soon. Its vaccine could be approved by late December.

“Its administration becomes easier to do and it will enable us to get to many places throughout the country,” Gen. Perna said.

The front-runner vaccines are administered in two doses, 21 days apart for Pfizer and 28 days for Moderna.

With supply limited at first, the administration plans to distribute the initial vaccines in careful allocations, so the stock of second doses are assured and on time.

A third promising vaccine, from AstraZeneca, showed an average of 70% efficacy in trials. It uses an adenovirus platform and requires two doses, though one dosing schedule was 90% effective and requires more study.

Another adenovirus vaccine being developed by Johnson and Johnson requires only a single dose. J&J may seek approval during the first quarter of 2021.

No matter which vaccine they receive, people will be getting the shots in places that are familiar.

“It will be in locations that they’re comfortable with,” Gen. Perna said. “Local hospitals, doctors’ offices, local pharmacies such as CVS and Walgreens or private pharmacies supporting rural areas.”

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