Overnight Health Care — Presented by Emergent Biosolutions — Pfizer, US strike COVID-19 pill deal

View in your browser PRESENTED BY OVERNIGHT POLICY: Health Care Pfizer, US strike COVID-19 pill deal © iStock Welcome to Thursday’s Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. Subscribe here: thehill.com/newsletter-signup. President Biden’s first turkey pardons will be granted tomorrow to Peanut Butter and Jelly, who Sen. Mike Braun (R-Ind.) called “well-behaved.” The U.S. struck a nearly $5.3 million deal to purchase 10 million courses of Pfizer's COVID-19 antiviral pill.  For The Hill, we’re Peter Sullivan (psullivan@thehill.com), Nathaniel Weixel (nweixel@thehill.com) and Justine Coleman (jcoleman@thehill.com). Write to us with tips and feedback, and follow us on Twitter: @PeterSullivan4, @NateWeixel and @JustineColeman8. Let’s get started. US to buy 10M courses of Pfizer COVID-19 pill © Getty Images The Biden administration announced Thursday that it has reached a deal to buy 10 million courses of Pfizer’s COVID-19 treatment, in a move that officials hope will help hasten the end of the pandemic. The $5.29 billion deal will allow for the first deliveries of the pills to be made this year, with the order concluding next year. Pfizer’s pill, known as Paxlovid, has been shown to be very promising in trials, reducing the risk of hospitalization or death by 89 percent. Significance: Experts say that once the pill is available, it will help end the crisis phase of the pandemic, given that in addition to vaccines, it will help lower the risk from COVID-19 and make it more manageable.  “This promising treatment could help accelerate our path out of this pandemic by offering another life-saving tool for people who get sick with COVID-19,” said Health and Human Services Secretary Xavier Becerra.  What’s next: The drug still needs to be authorized by the Food and Drug Administration before it can be used. Pfizer applied for authorization earlier this week.  The company also announced a deal this week to share the formula for the pill to allow low-income countries to make it. Read more here.  A MESSAGE FROM EMERGENT BIOSOLUTIONS Emergent has produced over 100 million Covid-19 vaccine dose-equivalents. Today, these critically important doses are deployed around the world to help fight the pandemic. Get the latest on Emergent’s Covid-19 response. Package saves about $160B on drug prices © Greg Nash Provisions to lower prescription drug prices in President Biden's Build Back Better package would save the government about $160 billion over a decade, according to a Congressional Budget Office estimate released Thursday.  That includes about $80 billion in savings from allowing Medicare to negotiate lower drug prices in limited instances, and another roughly $80 billion in limiting drug price increases to the rate of inflation.  Republicans and pharmaceutical companies have attacked the legislation as harming innovation and leading to fewer treatments.  The CBO estimated that the measure would result in one fewer drug coming to market in the next decade, followed by four in the next decade and five in the decade after that. That's out of about 1,300 drugs expected to be approved in those 30 years.   The measure included in Democrats' legislation, which could pass the House as soon as Thursday night, is scaled back from earlier, more sweeping proposals Democrats have put forward to lower drug prices. For comparison, Speaker Nancy Pelosi's measure from 2019 would have saved about $450 billion from negotiating lower drug prices, though that measure also would have led to eight fewer drugs coming to market over a decade, CBO said in 2019, compared to one fewer drug in this bill.   Democrats had to scale back the measure to meet the demands of a handful of moderates, including Sen. Kyrsten Sinema (D-Ariz.) and Rep. Scott Peters (D-Calif.), who worried the more far-reaching version would harm innovation.   Read more here.  ASTRAZENECA ANTIBODY COCKTAIL 83 PERCENT EFFECTIVE AstraZeneca found its antibody cocktail to be more than 80 percent effective at preventing symptomatic COVID-19 in a company analysis released on Thursday — a strong result for a treatment that could help immunocompromised people avert severe illness from COVID-19. The pharmaceutical company said its study showed its long-acting antibody combination called AZD7442 reduced the risk of symptomatic COVID-19 by 83 percent over six months. The data has not yet been peer-reviewed but will be submitted for publication.  Researchers provided the one-time 300mg dose in two separate, sequential shots to participants, a majority of whom had comorbidities that put them at high risk of severe COVID-19.  Participants were not vaccinated, and researchers will continue to study them for 15 months. Since about 2 percent of the world’s population is estimated to not have an adequate immune response to the COVID-19 vaccine, the preventative treatment would be designed to help these at-risk people prevent serious illness from the virus.  In a separate analysis of another trial, one 600mg dose of AstraZeneca’s long-acting antibody combination was found to reduce the risk of severe COVID-19 and death by 88 percent among patients who were treated within three days of developing symptoms.  In the works: AstraZeneca previously submitted a request to the Food and Drug Administration (FDA) to grant an emergency use authorization for AZD7442 last month.  Read more here. A MESSAGE FROM EMERGENT BIOSOLUTIONS At Emergent, we develop, manufacture, and deliver protections against public health threats. Find out how we’ve enhanced and reinforced quality control and oversight practices on our vaccine bulk drug substance manufacturing in support of Covid-19 vaccine production. House panel subpoenas Navarro ​​ © Greg Nash The House select subcommittee on the pandemic has issued a subpoena to Peter Navarro, a former senior adviser to then-President Trump, asking for documents and a deposition related to the committee's investigation into political interference from the former administration.  Subcommittee chairman Rep. James Clyburn (D-S.C.) alleges Navarro prioritized politics and promoted the lie that the 2020 election was stolen over the COVID-19 response. Clyburn is alleging Navarro also steered millions of dollars in contracts for pandemic supplies to unprepared or politically connected companies, like Eastman Kodak and Phlow. Clyburn said Navarro, Trump’s former deputy assistant and trade adviser, has refused to voluntarily comply with repeated requests for documents since the select subcommittee first contacted him on Sept. 14.  "Mr. Navarro has demonstrated his unwillingness to voluntarily cooperate with the Select Subcommittee’s investigation. Given his central role in the pandemic response, the importance of the Select Subcommittee’s investigation, and his continued refusal to cooperate voluntarily, this subpoena is necessary," Clyburn said in a memo. Flashback: According to previously released emails and documents in the committee's investigation, Navarro sounded an early alarm about the scope of the pandemic and urged Trump to move faster to stay ahead of the virus and secure tests, personal protective equipment and other supplies. But he was ignored, and Trump continued to publicly downplay the severity of the virus. Committee Democrats allege Navarro then pursued his own ad hoc strategy for procuring key medical supplies, spending more than $1 billion in federal money for noncompetitive contracts with little oversight. What’s next: The subpoena compels Navarro to produce all documents and information related to his involvement in the federal response to the coronavirus pandemic by December 8, and his appearance at a deposition on December 15. Read more here.  CANADA, MEXICO TO ANNOUNCE VACCINE DEAL The heads of Canada and Mexico on Thursday will pledge to share millions of vaccine doses with other countries in need at the first gathering of North American leaders at the White House since 2016. Canadian Prime Minister Justin Trudeau and Mexican President Andrés Manuel López Obrador will meet with President Biden for the North American Leaders Summit, where the three will discuss economic initiatives, migration, climate change and the pandemic. The leaders will announce that Canada and Mexico will send millions of vaccines to other nations in the region as part of an agreement to pay forward doses after the U.S. first shared millions of the shots with its neighbors, a senior Biden administration official told reporters on a call previewing the summit. The exact number of doses, recipients and timing of the donations will be determined by health experts and announced at a later date, the official said, but it will be part of a broader effort to expand vaccine production capabilities in the region.  "We're going to have public health experts determine the timing and the amount and the types of doses so that we're working — North America — not just for our own well-being and competitiveness, but as a way to project in supporting our regional partners to come back from the pandemic stronger than before," a senior administration official said. Read more here. WHAT WE’RE READING Schools, pediatricians look to make up lost ground on non-Covid vaccinations (Kaiser Health News) The pandemic’s next turn hinges on three unknowns (The Atlantic) Holiday COVID alarm as cases rise 20% (Axios) STATE BY STATE Virus surge worsens in Midwest as states expand boosters (The Associated Press) Michigan kids hospitalized with COVID-19 nears peak. Doctor: 'We're a little bit on edge.' (Detroit Free Press) As G.O.P. fights mask and vaccine mandates, Florida takes the lead (The New York Times) OP-EDS IN THE HILL Two cheers for Democrats' proposed drug payment reforms That’s it for today, thanks for reading. Check out The Hill’s health care page for the latest news and coverage. See you Friday. Sign Up for Health Care Forward Health Care Privacy Policy  |   Manage Subscriptions  |   Unsubscribe Email to a friend  |   Sign Up for Other Newsletters The Hill 1625 K Street, NW 9th Floor, Washington DC 20006 © 1998 - 2021 Nexstar Media Inc. | All Rights Reserved.

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