Health and Human Services Secretary Alex Azar said he would personally get vaccinated for COVID-19 in public and as soon as possible, emphasizing his confidence in any vaccine approved by U.S. regulators, a move that could now happen within weeks.
The drug manufacturer Pfizer announced it would submit its vaccine — which the company has said is 95 percent effective — for Emergency Use Authorization on Friday.
In an interview with Spectrum News, Secretary Azar said the Federal Drug Administration could approve Pfizer’s application within weeks of receiving it, a process that includes an advisory committee of independent experts to review the data. The agency’s scientific advisers are set to meet in public in early December.
“While we have a tremendous sense of urgency, no corners are getting cut,” Secretary Azar told Spectrum News. “I’ll have so much confidence in this vaccine program and the FDA’s determinations that, as soon as they’ll let me, I’ll get a vaccine on TV.”
Azar and other officials working on Operation Warp Speed — the administration’s accelerated effort to develop and distribute a vaccine — have repeatedly said as many as 20 million Americans could be vaccinated by the end of the year.
On Friday, Sec. Azar said that the initial group will include the country’s most vulnerable populations, such as nursing home patients and health care workers.
As for the rest of the U.S., Azar said millions of doses will continue to roll out starting in January, with most Americans being able to get a vaccine by spring of 2021.
“There’s not going to be a single moment in time,” Azar said. “We’re producing tens and tens of millions of doses of these vaccines every month … We’ve said that by the end of January we ought to have enough for all of our health care workers and first responders. And, from then, the product just continues to roll off the production lines.”
Sec. Azar said he hasn’t spoken with president-elect Joe Biden or his transition team about the administration’s vaccine plans, but he said he is prepared to do so if and when the time comes.
“We will work on any type of transition as soon as that’s appropriate,” Azar said. “We’ll make sure it’s professional, fully cooperative.”
He emphasized that nearly every official currently working on the vaccine will remain in their roles, even if a new HHS secretary is appointed.
“But not as if there’s any secret information right now,” he added. “They have as much visibility as anybody has into these programs, because we’ve been completely transparent.”
Sec. Azar also said the team working on Operation Warp Speed briefed members of congress on the vaccine’s distribution plans Thursday.
The HHS secretary also spoke with Spectrum News about President Trump’s Friday announcement of two rules that seek to lower drug prices for Americans covered by Medicare. Both are last-minute efforts to follow through on the president’s 2016 campaign pledge to lower drug prices and based on plans he’s floated throughout his presidency.
The first rule would eliminate the system of rebates for prescription drugs covered under Medicare Part D, which most often provides savings to insurers rather than patients. The rule seeks to bring those discounts directly to consumers, and it could amount to an average 30 percent savings on brand name drugs based on 2019 data, when rebates totaled nearly $40 billion, according to HHS.
“These special interests are powerful — the big pharma companies, the middlemen. They’ve run tens of millions of TV ads attacking the President, attacking me,” Azar said. “But he’s taking them on in a way that nobody would ever be willing to do.”
The second rule follows through on an executive order from the president earlier this year. It would lower the price of Medicare Part B drugs — mostly drugs given by a doctor inside health care facilities — to the lowest price charged in similar developed countries.
The rule, which employs the “Most Favored Nation model,” would apply to 50 of the most expensive Part B drugs and exist as a test for seven years. It could mean a total savings of $85 billion over that time period, according to HHS.
Both rules are sure to be challenged by members of the drug industry, but Sec. Azar said he’s confident in the rules’ legality.
“We think we’re on very sound legal footing,” he said. “Frankly, you’re talking about taking back from America’s seniors 30 percent average savings at the pharmacy counter …. [The president] is putting the American patient at the center of the healthcare system”
The Most Favored Nation rule is set to take effect on Jan. 1, 2021, and the rebate rule would go into effect a year later, assuming the incoming Biden administration doesn’t reverse the plans.