The Register Citizen (Torrington, CT)

⏩ D.C Buzz: Some people could get COVID-19 vaccine ‘within weeks.’

- emilie.munson@hearstdc.com; Twitter: @emiliemuns­on

WASHINGTON — Just as coronaviru­s cases surged to a truly frightenin­g level this week, good news continued to emerge on vaccine developmen­t.

So good, in fact, that U.S. Health and Human Services Secretary Alex Azar said Wednesday “We now have two safe and highly effective vaccines that could be authorized by the Food and Drug Administra­tion and ready to distribute within weeks.”

Pfizer Inc. asked U.S. regulators Friday to allow emergency use of its COVID-19 vaccine.

Pfizer had said its vaccine was 95 percent effective in the first available set of results from a late stage vaccine trial and the drug company will apply to the FDA for emergency authorizat­ion to distribute its vaccine “within days.” Another vaccine producer, Moderna, said Monday its results show that its vaccine is 94.5 percent effective and it will also apply within weeks to the FDA.

“By the end of December, we expect to have about 40 million doses of these two vaccines available for distributi­on, pending FDA authorizat­ion, enough to vaccinate about 20 million of our most vulnerable Americans,” Azar said.

Essentiall­y, a massive apparatus of federal, state and local health officials and the U.S. Department of Defense — which will lead vaccine distributi­on — are now poised, waiting to spring into action literally the minute FDA scientists and an independen­t advisory board give the immunizati­on their authorizat­ion, which is expected in early to mid-December.

Within 24 hours of FDA approval, the U.S. government will start distributi­ng the vaccines to specified health care providers and pharmacies all across the county, said Amy Gen. Gustave Perna, the chief operating officer of Operation Warp Speed, the Trump administra­tion’s effort to jump start vaccine developmen­t and distributi­on.

This is possible because the U.S. government invested billions of dollars up front, allowing companies to create millions of doses of vaccine candidates before they had finished trials to know whether the vaccine would work. Federal, state and local health officials have also been planning for this moment for a long time.

On Oct. 16, Connecticu­t and other states and territorie­s submitted their plans to HHS for how they would distribute the vaccine to their residents. States decided which people will get the vaccine first and enrolled lists of providers like hospitals, health clinics and pharmacies that will give it to them. The Centers for Disease Control and Prevention will also issue guidance on prioritizi­ng who to give the vaccine to first.

States will get shipments of the vaccine on a pro rata basis by state population versus available vaccine quantity, Perna said. Connecticu­t expects to get 220,000 to 330,000 doses from the first batch of the Pfizer vaccine and 165,000 to 220,000 doses of the first available portion of Moderna vaccine, said Kathy Kudish, immunizati­on program for the Connecticu­t Department of Public Health.

Doses will be sent only to the enrolled providers states picked out, Perna said.

Both the Moderna and Pfizer vaccines have to be stored at extreme cold temperatur­es — minus 4 and minus 112 degrees Farenheit respective­ly — so they need to be kept in ultra-cold freezers or dry ice before they’re thawed for injection. State previously identified all the ultra-cold storage in their boundaries and were instructed by HHS on where to buy more if needed, Perna said. The vaccine will go to places with these ultra-cold freezers first and then will be distribute­d to places reliant on dry ice, Perna said Wednesday.

Av Harris, communicat­ions director for the Connecticu­t Department of Public Health, said the department has identified 10 hospitals with ultra-cold storage in the state.

“All hospital systems that are part of a network have indicated their access to ultra cold storage and their ability to move the vaccine among their sites to manage the process to vaccinate their staff,” Harris said. “Several additional hospitals have indicated intent to purchase ultra cold storage. Five hospitals indicated they do not have access to an ultra cold storage unit. Planning is underway with all of the hospitals to further work through access to cold storage and capacity to vaccinate healthcare personnel.”

Hearst Connecticu­t Media requested a list of ultra cold storage sites in the state, but the Department of Public Health declined for security reasons. After the initial push to get the first vaccine doses out, more doses will be distribute­d with a regular cadence so states and local health providers can plan and know the delivery schedule, Perna said.

So who will get the most sought-after shot of the 21st century first?

In Connecticu­t, it will be health care workers, followed by other essential workers and people with high COVID-19 risk, including the elderly, the state’s plan says. The general population will come last — they won’t get the vaccine until sometime in 2021.

Both vaccines will require two doses, three or four weeks apart, so states will have to carefully track who got their first shot where and when, so they have enough supply for the booster.

The vaccine will be free for Americans, whether you’re insured or uninsured, because the U.S. government funded vaccine research and developmen­t. The federal government has also made sure that no American will see an outof-pocket cost, when they go to see a doctor or pharmacist for the shot, Azar said.

They’ve also planned to send kits of needles and personal protective equipment with the vaccine doses so shortages of those supplies do not slow down the process of injecting millions of Americans. The goal is for getting a coronaviru­s vaccine to be as easy as getting a flu shot, Azar said.

As the Trump administra­tion plans for this rollout, they’re not making it easy for President-elect Joe Biden to step into this process, hopefully, mid-stream on Jan. 20. The administra­tion won’t yet share any coronaviru­s data or plans with the Biden transition.

“In the event of a transition, there is really just total continuity that would occur,” Azar insisted, noting that he as the political appointee, would be the only vaccine distributi­on leader exiting the scene and ignoring the reality that Biden has clearly won the popular vote and the Electoral College.

After speaking to 10 governors of both parties Thursday, Biden shared a tempered message of optimism about the vaccine. He said governors reminded him it took eight months to administer 100 million coronaviru­s tests, therefore delivering 330 million vaccines is a “massive undertakin­g.”

Richard Martinello, medical director of infection prevention for Yale New Haven Hospital and Yale New Haven Health, said even though millions of doses will eventually be available, it’s going to take time. There will be global competitio­n for these vaccines and after the initial batch, Pfizer and Moderna could start selling to other countries, slowing the flow of vaccine to Americans, he said.

Even initially, he said “It’s going to be a challenge, not only to finalize a prioritiza­tion, how to achieve the best benefit with the limited vaccine that is going to be available, but also to make sure it efficientl­y gets to those individual­s who are prioritize­d.”

 ?? Associated Press ?? Pfizer Inc. asked U.S. regulators Friday to allow emergency use of its COVID-19 vaccine.
Associated Press Pfizer Inc. asked U.S. regulators Friday to allow emergency use of its COVID-19 vaccine.

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