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By DAVID LIM and KATHERINE ELLEN FOLEY
— Senior federal health officials and vaccine manufacturers are gathering today at the White House’s summit on next-generation vaccines.
— Biden’s Covid-19 infection continues to improve, with symptoms “almost completely resolved,” according to the White House physician.
— Democrats’ tweaked drug pricing package could clear the parliamentarian process by midweek.
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Ashish Jha is among the participants at the White House's summit on the future of Covid-19 vaccines today. | House Ways & Means Committee/YouTube
WHITE HOUSE CONVENES NEXT-GEN VACCINE SUMMIT — The White House is gathering vaccine manufacturers and senior officials today for a summit on the future of Covid-19 vaccines.
Government participants include White House Covid-19 Response Coordinator Ashish Jha, HHS Assistant Secretary for Preparedness and Response Dawn O’Connell, director of the National Institute of Allergy and Infectious Diseases Anthony Fauci and acting Science Adviser to the President Francis Collins.
“While our vaccines continue to protect Americans, a new generation of vaccines has the potential to better prevent infections and be more broadly effective against potential variants,” a draft agenda for the event says.
Pfizer’s Angela Hwang, group president of its biopharmaceuticals group, and Moderna’s president, Stephen Hoge, are set to participate on a panel moderated by O’Connell at 11:30 a.m. EDT on accelerating the development and production of broadly protective Covid-19 vaccines. Executives from other firms, including Vaxxinity, CyanVac, Micron Biomedical and Meissa, are also attending.
The summit comes after advisers to the Food and Drug Administration recommended in June that the agency authorize shots targeting the Omicron variant for fall boosters, with a strong preference for those that could offer protection against the BA.4 and BA.5 subvariants. Both Pfizer-BioNTech and Moderna have said their bivalent boosters provided better protection against Omicron than existing boosters, though the agency hasn’t yet evaluated either of these shots for the fall.
President Joe Biden, seen here in a virtual meeting yesterday, is on the road to a quick recovery, according to the White House physician. | Drew Angerer/Getty Images
BIDEN’S COVID SYMPTOMS ‘ALMOST COMPLETELY RESOLVED’ — President Joe Biden’s physician, Kevin O’Connor, said in a memo Monday that Biden is well on the mend from his Covid-19 infection, with his symptoms “almost completely resolved.” The only remaining symptoms the president feels are hoarseness and slight congestion. He has no trouble breathing, “excellent” oxygen saturation, no fever and no elevated blood pressure but will continue to isolate per Centers for Disease Control and Prevention guidelines.
As of today, the president will have completed a five-day course of Paxlovid, a coronavirus antiviral that reduces the risk of hospitalization and death from the infection. There is a chance that his symptoms could return after he discontinues the drug, as was the case for Anthony Fauci, Biden’s chief medical adviser. In that instance, Fauci’s physician prescribed a second course of Paxlovid for him after his brief Covid-19 rebound.
CALIFORNIA GETS RAPID COVID TEST DONATION — iHealth Labs announced Monday it is donating 1 million rapid at-home Covid-19 tests to California to be distributed to schools in time for students’ return in the fall.
Sens. Joe Manchin and Lisa Murkowski announced Monday they tested positive for Covid-19, which could complicate the path forward on the drug pricing plan. | Francis Chung/E&E News
DEMS TWEAKING DRUG PRICING PLAN — Democratic senators are adjusting language in their plan to have Medicare negotiate some drug prices after debating the reconciliation package with Republicans last week ahead of the Senate parliamentarian’s ruling on whether the plan meets budget reconciliation rules, POLITICO’s Caitlin Emma, Jennifer Scholtes, Marianne Levine and Burgess Everett report.
The revisions, which a Democratic aide characterized as minor, come ahead of the Democrats’ plan to submit the language to the Senate parliamentarian again. Vetting may wrap up as early as midweek. Should the parliamentarian decide that the bill’s text meets the reconciliation criteria, the package could sidestep a filibuster on the Senate floor.
But two important swing votes in the Senate — Sens. Joe Manchin (D-W.Va.) and Lisa Murkowski (R-Alaska) — announced on Monday they recently tested positive for Covid-19, further complicating the path forward for the package ahead of the August recess.
The parliamentarian process comes as the pharmaceutical industry ramps up opposition campaigns against the drug pricing bill. The National Association of Manufacturers announced on Monday it is running a six-figure television advertising campaign against the reconciliation package.
Insulin legislation on the cutting-room floor: A proposal to cap a patient’s insulin cost at $35 a month remains in a separate bipartisan bill that lawmakers and advocates fear has stalled, POLITICO’s Alice Miranda Ollstein reports.
That effort — led by Sens. Jeanne Shaheen (D-N.H.) and Susan Collins (R-Maine) with language drafted by Sen. Raphael Warnock (D-Ga.) — has languished for months despite a promise from Senate Majority Leader Chuck Schumer for a vote just after Easter. The bill, which also targets pharmacy middlemen, still lacks enough Republican support to hit the 60-vote threshold needed for passage.
DEMOCRATIC LAWMAKERS REQUEST $100M IN FEDERAL FUNDING FOR MONKEYPOX RESPONSE — More than 100 House Democrats signed a letter sent to the White House, HHS and the CDC on Monday, requesting $100 million in federal funding to bolster testing, vaccines and other resources in response to the monkeypox outbreak.
The letter, spearheaded by David Cicilline (D-R.I.), the chair of the Congressional LGBTQ+ Equality Caucus, and Rep. Jerry Nadler (D-N.Y.), requested that $30 million of the funding go specifically to the CDC’s Division of STD Prevention, which supports the sexual health clinics that have been uniquely burdened by the outbreak so far with most cases appearing among men who have sex with men.
FDA TO ISSUE COURT-ORDERED UPDATE ON E-CIG REGULATION — The FDA’s Center for Tobacco Products is coming up against its next deadline to provide an update to the U.S. District Court for the District of Maryland on its reviews of e-cigarette marketing applications from the industry’s largest players. District Judge Paul Grimm directed the agency to provide a status update on or before July 29. In the previous update, issued in May, the agency said it didn’t expect to finish its review of the largest market share players before June 2023.
PHILIPS, DOJ DISCUSSING PROPOSED CONSENT DECREE — Philips and the U.S. Department of Justice are discussing terms of a proposed consent decree to address issues with the company’s CPAP, BiPAP and mechanical ventilator devices, the company told investors on Monday.
Roy Jakobs, Philips’ chief business leader for connected care, said on the company’s earnings call that the proposed consent decree was received on July 18 from the DOJ, acting on behalf of the FDA.
“This followed their inspection of certain of Philips Respironics facilities in the U.S. in 2021,” Jakobs said. “While we understand you may like to know more about it, we are in confidential discussions with the DOJ on the terms of a consent decree and cannot speculate on the outcome, the content or the timing of any agreement. It's still early stages.”
He added that it is unlikely the company would be able to estimate the potential exposure from personal injury claims before the end of 2023 due to litigation being in “early stages.”
WHO DECLARES MONKEYPOX AN INTERNATIONAL HEALTH EMERGENCY — Monkeypox outbreaks worldwide constitute a public health emergency of international concern, the World Health Organization announced Saturday, POLITICO’s Daniel Payne reports.
“The WHO’s assessment is that the risk of monkeypox is moderate globally except in the European region, where we assess the risk is high,” WHO Director-General Tedros Adhanom Ghebreyesus said in his announcement. “With the tools we have right now, we can stop transmission and bring this outbreak under control.”
The Biden administration is still weighing whether to declare a public health emergency for the virus in the U.S., Jha told reporters at a Friday briefing.
Pfizer will host its Q2 earnings call at 10 a.m. EDT.
FDA Commissioner Robert Califf is slated to speak at the Alliance for Health Policy at 2 p.m. EDT.
Camille Stewart Gloster is being named as deputy national cyber director for technology and ecosystem security, the Office of the National Cyber Director said Monday.
iRhythm Technologies announced Brice Bobzien will step in as its chief financial officer on Aug. 8. Reyna Fernandez is joining the company on July 25 as its chief human resources officer.
The FDA published guidance on Monday outlining its unique device identification system enforcement policy for class I and unclassified devices.