FDA advisers to consider giving green light to Pfizer booster

With help from Katherine Ellen Foley

On Tap

— The FDA’s advisory committee on vaccines will vote today on whether to recommend that the agency allow booster doses of the Pfizer-BioNTech Covid-19 shot.

— Centrist Democrats put a wrench in House leadership’s aspirations to slash drug prices.

— FDA has reorganized its IT unit to report directly to the agency chief.

It’s Friday. Welcome back to Prescription Pulse. Who’s ready to rumble?

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Coronavirus

BOOST ME UP, SCOTTY — It’s been a nonstop week of news on Covid-19 vaccines, and we’re not even getting into the Nicki Minaj tweet-heard-’round-the-world. Today a panel of independent advisers to the FDA will vote on whether to recommend that regulators approve booster doses of Pfizer’s Covid vaccine for Americans 16 and older. We’re expecting things to get a bit testy after weeks of tension over what some say is a White House not run by former President Donald Trump getting ahead of science.

Lay of the land: The meeting kicks off at 8:30 with roll call, followed by opening remarks from Center for Biologics Evaluation and Research Director Peter Marks and Office of Vaccines Research and Review Director Marion Gruber. Yes, the same Gruber who signed onto the Lancet essay panning widespread booster shots. Israeli scientists will present their data showing that boosters cut the risk of severe Covid in elderly citizens, and Pfizer will make its case before an afternoon of discussion and voting.

Tea leaves: FDA has yet to post its voting questions, making it unclear what exactly its advisers will be voting on. The discussion topic, per a document posted Wednesday, is “whether the data presented by Pfizer support the safety and effectiveness of a booster dose of COMIRNATY administered 6 months post primary vaccination series.”

The agency stayed neutral on the question in its briefing document and expressed skepticism toward some of Pfizer’s claims — namely that waning vaccine effectiveness is most likely a function of time rather than the Delta variant evading antibodies, and that the Israeli data made the case for boosters. “US-based studies of post-authorization effectiveness of [the Pfizer-BioNTech vaccine] may most accurately represent vaccine effectiveness in the US population,” regulators said.

The Israeli data’s limitations — short follow-up window, sparse information about the booster’s effects on younger populations — has some public health experts worried. “In an ideal world, we’re not talking about Israeli real-world data when we’re deciding if we’re going to give millions of people an extra dose of the vaccine,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.

The roster: Several advisory committee members are marked as absent for the meeting. One of them, Paul Spearman of Cincinnati Children’s Hospital Medical Center, told Rx Pulse he has a conflict of interest since he’s involved in ongoing vaccine trials, as are other members. Temporary voting members have been added to the docket.

Looking ahead: Should the FDA give regulatory approval to the booster following the meeting, CDC’s own advisory panel will meet Wednesday and Thursday to consider clinical recommendations for the third dose’s administration.

White House spokesperson Jen Psaki said the Biden administration is “prepared” to act on boosters — once, of course, the government follows the proper regulatory channels. “Our objective is to be prepared should all of this process move forward,” she said Thursday. “It’s always been pending the approval of the ACIP and the FDA.”

ICYMI: Pfizer and BioNTech plan to seek approval from FDA to give the vaccine to children between 6 months and 5 years old in November, provided the data holds up, POLITICO Europe’s Jules Darmanin reports.

MODERNA PLUGS DATA IT ARGUES SUPPORTS AUTHORIZATION OF BOOSTER — Moderna announced Wednesday it intends to seek emergency use authorization of a third dose of its vaccine, citing data it says demonstrates a booster minimizes the chance of breakthrough infection.

Moderna executives insisted Wednesday that it was essential to move fast on boosters and forecast that waning immunity among people with two doses would drive 600,000 additional Covid-19 cases in the U.S. this fall and winter. “We think the time to [administer boosters] is too early rather than too late,” Moderna President Stephen Hoge said in a briefing.

The company said people who received their second shot roughly eight months ago were 36 percent less likely than people vaccinated 13 months ago to experience a breakthrough infection, suggesting immunity wanes over time. Eighty-eight people in the more recent vaccination batch reported breakthrough cases compared to 162 cases in the group vaccinated last year. Among those cases, 19 were severe but there was not a significant difference between the two groups on serious illness.

NOVAVAX RE-EMERGES — The company said Thursday that participants in the ongoing Phase III trial of its Covid-19 vaccine are considered fully vaccinated by the CDC two weeks after their last dose. That means those volunteers won’t have to drop out of the trial to get additional shots to meet Covid vaccination requirements, such as President Joe Biden’s mandate for companies with 100 or more employees. The CDC’s guidance applies to clinical trial participants who have received any vaccine that FDA has not yet authorized or approved but which has been listed for emergency use by the World Health Organization.

BIDEN PREPS GLOBAL COVID PLAN AHEAD OF UN SUMMIT — The Biden administration met Wednesday with several groups to discuss a slate of proposals expected to be announced at a virtual global Covid-19 summit on the sidelines of the United Nations General Assembly next Wednesday.

A document obtained by POLITICO proposes detailed global targets on vaccination, treatments and testing amid surging global infections fueled by the Delta variant and criticism of the U.S. for pushing ahead on booster plans while low- and middle-income countries struggle to obtain initial vaccine doses. The Washington Post first reported the top-line goals of Biden’s vision, including a goal to vaccinate 70 percent of the world population by this time next year.

The U.S. wants to gather at least $12 billion to fund the global vaccination effort and address a global shortage of oxygen. It also wants to make authorized Covid-19 therapeutics available for 12 million severe and critical patients and expand global manufacturing by promoting technology transfers. Another goal is to donate at least 1 billion tests by 2022 and make antigen tests available for no more than $1 per kit in low- and middle-income countries.

Drug Pricing

CENTRIST DEMS DERAIL DRUG PLAN AT E&C MARKUP — The future of House Democrats’ drug pricing efforts is in disarray after a trio of centrist lawmakers blocked a plan Wednesday to allow direct government negotiations of drug prices, POLITICO’s Alice Miranda Ollstein and Sarah Ferris report. The drug pricing plan isn’t dead; the Ways and Means Committee separately advanced identical language later in the day.

Reps. Scott Peters (D-Calif.), Kathleen Rice (D-N.Y.) and Kurt Schrader (D-Ore.) joined Republicans in voting against leadership-backed drug pricing language at the end of a three-day House Energy and Commerce Committee markup of the party’s $3.5 trillion social spending package.

The rebellion came despite appeals from Democratic leaders, with E&C Chair Frank Pallone(D-N.J.) calling the drug provision an essential piece to negotiating a final agreement with the Senate. The three lawmakers, he pointed out, had also supported the same language when it first came up in 2019.

The opposition served as a warning shot that Democratic leaders may not yet have the votes to pass it as part of the larger bill. That could complicate the broader effort since Democrats were counting on up to $700 billion in savings over a decade from the provision to help pay for the $3.5 trillion price tag.

Eye on FDA

OFFICE OF DIGITAL TRANSFORMATION ELEVATED, REORGANIZED — FDA announced Wednesday it is combining its information technology, data management and cybersecurity units into an elevated Office of Digital Transformation that now reports directly to the leader of the agency.

“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said Acting FDA Commissioner Janet Woodcock.

FDA, EMA EXPAND ADVICE PROGRAM TO COMPLEX GENERIC ANDAs — FDA announced Wednesday it has launched a pilot program with the European Medicines Agency to expand the Parallel Scientific Advice program to sponsors submitting abbreviated new drug applications for complex generic drug products.

“The goal of the PSA pilot program is to provide a mechanism for FDA and EMA assessors to concurrently exchange their views on scientific issues with applicants during the development phase of complex generic drug/hybrid products, which are generally more challenging to develop with traditional bioequivalence methods,” FDA said.

Around the Agencies

FTC PULLS BACK TRUMP-ERA MERGER GUIDANCE — The FTC voted 3-2 along party lines Wednesday to rescind Trump-era guidance on when it will challenge mergers between companies that aren’t direct competitors, POLITICO’s Leah Nylen reports.

FTC Chair Lina Khan said the agency would work with the Justice Department to craft a replacement. But she said the commission should rescind the guidance now to prevent courts from relying on the current version, which she described as offering “speculative theories” about the benefits of vertical deals. The FTC has challenged DNA-sequencing giant Illumina’s merger with cancer start-up Grail, a vertical deal.

NIH LAUNCHES LONG-COVID REGISTRY — The NIH has awarded nearly $470 million in funding for researchers across the country as part of its REsearching COVID to Enhance Recovery Initiative. The goal of the initiative is to study diverse populations experiencing forms of long Covid, characterized by prolonged Covid-19 symptoms, or new symptoms after recovery. The funding, which is part of the American Rescue Plan, went initially to NYU’s Langone Health, which will serve as the Initiative’s Clinical Science Core. NYU will make further funding awards to over 100 researchers at 30 institutions across the country.

Industry Intel

PHILIP MORRIS INTERNATIONAL ACQUIRES INHALER COMPANY — The tobacco giant announced Thursday it had acquired over 74 percent of the market shares of Vectura, a British inhaler manufacturer. In a statement, PMI’s chief executive officer Jacek Olczak said the move was part of the company’s strategy to bring in more than $1 billion in revenue from non-cigarette products by 2025.

Pharma Moves

Biden nominated Robert Otto Valdez on Thursday to be HHS assistant secretary for planning and evaluation. Valdez is the Robert Wood Johnson Foundation professor emeritus of Family & Community Medicine and Economics at the University of New Mexico.

Pharma Worldwide

HEALTH CANADA GRANTS FIRST FULL APPROVAL TO MODERNA’S COVID-19 VACCINE — Moderna announced Thursday that the Canadian drug regulatory authority became the first to fully approve Spikevax for children 12 and older.

Inside AgencyIQ

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

The FDA’s OTC drug problem: Nonpayment of fees — Almost 500 nonprescription drug facilities have failed to pay facility fees established as part of the new Over-the-Counter Monograph User Fee Program created by the CARES Act of 2020, according to a review by AgencyIQ. The number amounts to about 40 percent of facilities expected to register by the FDA in its March 2021 notice that set user fees for the fiscal year. The failures to pay could cause major compliance issues for companies and also hinder the FDA’s plans to hire new staff. The FDA’s plan was to hire 30 new staffers for the OTC program in fiscal year 2021. Without those fees — estimated by AgencyIQ to be just shy of $10 million — the FDA may need to put some of that hiring on hold.

FDA’s Peter Marks previews focus for 2022 — Speaking this week at the Regulatory Affairs Professionals Society’s conference, the FDA’s top biologics regulator, Peter Marks, previewed eight topics the FDA plans to focus on in 2022 related to biologics. The Center for Biologics Evaluation and Research plans to: (1) continue to expedite the development and availability of vaccines for Covid-19, (2) implement a “bespoke” gene therapy program, (3) improve compliance with tissue regulations, especially for stem cell companies, (4) advance research informing blood donation policies, especially related to the risk of HIV, (5) advance blood component pathogen reduction research, (6) address staff resource needs for gene therapy reviews, (7) ensure workforce resilience during the remainder of the pandemic and (8) evaluate the structure of CBER and “implement any needed changes.”

Document Drawer

CMS will hold a MEDCAC meeting on Sept. 22 to discuss what health outcomes are important when evaluating studies for cerebrovascular disease treatment, especially those that focus on new technologies.

FDA issued revised guidance outlining its enforcement policy toward face masks and respirators during the Covid-19 pandemic.

FDA announced Thursday it revised the emergency use authorization for monoclonal antibody therapy bamlanivimab and etesevimab to include post-exposure prophylaxis use for adults and certain older children at high risk for progression to severe Covid-19.

The Office of Management and Budget announced this week that it had completed its review of the HHS and FDA’s rules on format and content of reports intended to demonstrate substantial equivalence, and premarket tobacco applications and recordkeeping requirements.