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FDA could authorize coronavirus vaccine ‘within days,’ if hearing goes well: HHS secretary

MarsBars/iStockBY: ADAM KELSEY AND ADIA ROBINSON, ABC NEWS

(WASHINGTON) — Alex Azar, the U.S. Department of Health and Human Services secretary, offered an optimistic outlook Sunday on the timeline of the first coronavirus vaccine rollout, previewing that authorization is a possibility next week, following the outcome of a Food and Drug Administration hearing.

“If things are on track, the advisory committee goes well, I believe we could see FDA authorization within days,” Secretary Alex Azar told ABC News Chief Anchor George Stephanopoulos on “This Week,” referencing Thursday’s hearing on Pfizer’s vaccine. “But it’s going to go according to FDA gold-standard processes … and I’m going to make sure it does.”

The FDA’s deliberations on Pfizer’s vaccine this week and Moderna’s vaccine on Dec. 17, arrive after each company claimed its immunizations are over 90% effective in preventing COVID-19 in participants of the respective trials.

Last week, the United Kingdom granted emergency use approval for the Pfizer vaccine and is preparing to begin inoculations this week. On Sunday, Stephanopoulos asked Azar if the U.S. will follow suit after the FDA hearing.

“(Is there) any reason to believe that the vaccine will not receive emergency use approval?” Stephanopoulos asked.

“I’m going to protect the independence and integrity of that decision making,” Azar said, noting he wanted to “defer to the FDA career scientists.”

“I don’t know of any reason why the system is in any way off track,” he added.

A Centers for Disease Control and Prevention panel recommended last week that initial shots be directed to health care workers and long-term care facility residents. As for the general public, Azar pointed to February or March before vaccine availability is more widespread.

“We’re just going to progressively keep adding more and more people,” the secretary said. “By the second quarter of next year, we’ll have enough vaccine for every American that wants it.”

Over 14.5 million Americans have contracted the coronavirus since the pandemic began earlier this year, and this weekend the country eclipsed 280,000 deaths amid a recent surge of cases. The past week saw an average of nearly 200,000 cases and over 2,500 deaths per day.

Azar said that the Trump administration is “quite concerned” about where COVID-19 is spreading following Thanksgiving and “worried about people and the behaviors coming up with Christmas.”

White House Coronavirus Task Force member Dr. Anthony Fauci told “This Week” last Sunday that he did not foresee current government recommendations to avoid travel and large gatherings being rolled back prior to the new year.

“We want to make sure everyone’s loved ones are there next Christmas, especially when we have so much hope of vaccine,” Azar said Sunday.

Despite that guidance, Azar’s colleagues in the Trump administration appear as if they are moving forward with December events that ignore the recommendations.

“There are reports now that the Secretary of State Mike Pompeo, Vice President Mike Pence, the White House, President Trump (are) all having these huge holiday parties, up to 900 people,” pressed Stephanopoulos.

“Our advice remains the same in any context, which is wash your hands, watch your distance, wear face coverings when you can’t watch your distance, and be careful of those indoor settings,” the secretary said. “So my advice to anyone in any setting that’s indoors is keep your guard up. Don’t let your guard down. Just because you know people is not a reason to take that mask down. Be careful.”

“Have you advised the White House of that and the secretary of state?” Stephanopoulos followed-up.

“Our advice is the same for every setting, which is maintain social distance and when you can’t, wear face coverings,” Azar responded, without directly answering the question. “The data’s clear.”

State and local governments, citing the increasing number of cases, have also issued stricter guidance this month, with stay-at-home advisories again emerging in cities like Los Angeles and San Francisco. Azar argued interventions do need to take place with regard to “multi-household gatherings” and “overcrowded indoor restaurants and bars,” but said activities like air travel and school attendance “aren’t major vectors of disease transmission.”

In the immediate future, amid the expected “surge upon a surge” this winter — as Fauci labeled the expected continued rise in cases — and prior to the vaccines’ ability to control the pandemic, the secretary said HHS’s focus is on supporting hospitals and doctors treating those who have fallen ill.

“We have complete visibility into our hospital capacity. We’re making sure they’ve got supplies and staffing,” Azar said, noting later that the federal government has improved its data systems. “And we want to make sure the therapeutics we’ve got are being used by doctors most effectively to keep people out of the hospital so we increase our capacity.”

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