CDC vaccine panel set to take up booster question if FDA acts

From: POLITICO's Prescription Pulse - Tuesday Sep 21,2021 04:02 pm

Sep 21, 2021

Presented by the Pharmaceutical Care Management Association (PCMA)

With help from Katherine Ellen Foley and Megan Wilson

On Tap

— Outside vaccine advisers to the CDC are set to meet Wednesday and Thursday to define who precisely should be eligible for Pfizer’s Covid-19 boosters, should the FDA authorize them.

— Pfizer and BioNTech say their Covid vaccine proved safe and effective in a late-stage clinical trial of children ages 5 to 11.

— A progressive group is staging a rally outside a major drug lobby’s Washington office with Sen. Bernie Sanders (I-Vt.) to tout efforts to lower prescription drug prices.

It’s Tuesday. Welcome back to Prescription Pulse. We’ve hit yet another grim pandemic milestone.

Be sure to send tips to David Lim ( dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

A message from the Pharmaceutical Care Management Association (PCMA):

Congress is considering repealing the Medicare prescription drug rebate rule. If not repealed, the rule will increase Medicare Part D premiums 25% and cost taxpayers $170 billion. The federal government should repeal this rule and instead focus on policies that would reduce prescription drug costs.

Coronavirus

THE BOOSTER CHRONICLES, CONTINUED — As of now, CDC’s advisory committee on vaccines is scheduled to gather Wednesday and Thursday to deliberate how to refine who should be permitted to get a booster dose of the Pfizer-BioNTech Covid-19 vaccine right now. But those meetings are contingent upon FDA granting emergency use authorization for that third dose after Friday’s messy meeting of its own immunization advisers.

Nothing is certain, everything is fine: As the agenda linked above shows, there’s a big block of “TBD” time on Thursday when you’d expect the committee to vote. But to do that, FDA needs to formally OK an EUA for giving booster doses to those 65 and older and who are at “high risk” of contracting a severe case of Covid — a category that is likely to include health care workers and could even be stretched to teachers. ACIP’s job will be to tailor that definition more narrowly. No matter how many times your Rx Pulse authors hit “refresh” on Monday, FDA had yet to post its decision.

To recap: Friday’s meeting was long and contentious, with the committee nearly united on batting down Pfizer’s (and by extension the Biden administration’s) appeal to broadly approve booster shots for Americans 16 and older. Members quickly regrouped and made it clear to the FDA and Pfizer what they were comfortable with endorsing: an EUA for boosters for the country’s oldest populations , plus a more amorphous group that are at a higher risk of developing severe disease. Most panelists said they weren’t comfortable agreeing to a broader rollout given the lack of safety data for young people and lingering questions about the boosters’ long-term benefit.

"I think this should demonstrate to the public that the members of this committee are independent of the FDA," said Archana Chatterjee, a pediatric infectious disease specialist at Rosalind Franklin University.

Woodcock weighs in: Acting FDA Commissioner Janet Woodcock seemed to align herself with the advisory committee during an appearance Monday on former Obama and Biden health adviser Andy Slavitt’s podcast, saying the need for boosters “scientifically” hasn’t been “nailed down.”

"I don't think we know enough about the impact of boosting on transmissibility,” she said. “We do not understand totally any what are called serologic correlates of immunity. Can you take an antibody titer, which you can in some diseases and say, oh, they're not going to get infected? … We don't have all that information yet.”

WWFD, booster edition: Anthony Fauci, President Joe Biden’s chief medical adviser, said during a Sunday show media blitz that data on Moderna’s and Johnson & Johnson’s booster shots “is literally a couple to a few weeks away.” Then, the FDA “will examine it in the same way as they did before and hopefully we'll get a recommendation that would provide equity among people who have had different products in their vaccination regimen,” he said Monday on CNN.

Some communications help: The Department of Health and Human Services has brought on an Obama-era health aide to help coordinate Covid-19 policy and messaging across the agencies under its umbrella, POLITICO’s Adam Cancryn reports. Leslie Dach is taking a temporary leave of absence from Protect Our Care, the pro-Affordable Care Act he founded.

Registration is OPEN for Breakthrough Summit 2021, the most important rare disease conference of the year! On Oct. 18 and 19, the National Organization for Rare Disorders will host the virtual Rare Disease and Orphan Products Breakthrough Summit. The Summit brings together the rare disease community from across the globe, including experts from patient advocacy, government, industry, media and academia, to discuss the current and critical topics in rare diseases. For access to two days of networking and dynamic programming on topics including drug pricing, genetic testing, Covid-19, equity and inclusivity, REGISTER NOW.

SUPPLY WORRIES CONTRIBUTED TO EARLY BOOSTER PLAN — Concerns about a vaccine shortage if boosters were found to be needed partly drove the Biden administration’s initial plan to offer additional doses more broadly, POLITICO’s Erin Banco reports. The internal debate shows that vaccine performance data was just one piece of the booster puzzle the White House has been trying to put together.

GOVERNORS GET ANTSY TO PUT THIRD SHOTS IN ARMS — With Washington’s booster messaging muddy at best, some governors are taking matters into their own hands as they work to tamp down Covid spikes in their states and protect their most vulnerable residents, Lauren writes. Biden’s August announcement giving Sept. 20 as the expected booster rollout date plus CDC’s signoff on permitting additional doses for the immunocompromised opened the floodgates for state leaders to prod their citizens toward third jabs.

Maryland’s Larry Hogan decreed this month that residents 65 and older living in “congregate settings” could get boosters, while Jared Polis has urged elderly Coloradans and those with weak immune systems to “go ahead and get that booster.” That’s despite CDC’s specific guidance about who’s considered immunocompromised, which notably allows people to attest to their conditions, making wildcat recipients difficult to police.

Mountaineer push for antibody data: West Virginia’s Jim Justice, another governor who’s been eagerly awaiting a booster rollout, announced Monday that his state plans to conduct a study of the Covid antibody levels in residents aged 50 to 64 in an effort to study whether additional doses may already be needed in that age group. During the pre-vaccine pandemic era, 95 percent of the state’s Covid deaths occurred in people 50 and older, West Virginia’s Covid czar, Clay Marsh, told Lauren last week. Marsh said Monday some in that group could count as immunocompromised “if their antibody levels are not measurable or very low.”

It’s not clear what that threshold will be, though, since a correlate of protection has yet to be determined. “We’re ready to go,” Justice said Monday. “We’ll be standing there ready to put shots in arms as we’ve done before.”

PFIZER TOUTS SAFETY, EFFICACY OF LOWER DOSE FOR KIDS 5–11 — The loud cheers you heard Monday morning were parents stoked that Pfizer-BioNTech reported positive safety and efficacy results from their late-stage clinical trial for kids ages 5 to 11. The immune response was comparable to that seen in teens and young adults but with just one-third the amount of vaccine used in the regimen for people ages 12 and up.

The companies said they plan to soon file for an EUA for the vaccine’s use in that age group, and Fauci said Monday those children could be getting immunized as soon as Halloween. Still, they didn’t release detailed data Monday nor have they published their findings in a peer-reviewed journal. And any effort to allow Covid vaccines for kids will be heavily scrutinized for safety issues, given the messenger RNA shots’ link to myocarditis in young males.

FEDS BUY $647M OF RAPID TESTS — The Biden administration is buying at least 60 million over-the-counter Covid-19 test kits from four diagnostic manufacturers for $647 million, according to contract details released by the Department of Defense.

Distribution of the rapid tests, procured from OraSure Technologies, Quidel, Abbott Rapid Dx North America and Intrivo, will begin in October.

“These awards are one procurement that form part of the President’s broader effort to expand access to high-quality testing for Americans," a White House official told POLITICO. "We will continue to make more and more announcements in expansion of testing.”

A message from the Pharmaceutical Care Management Association (PCMA):

Drug Pricing

SANDERS RALLIES OUTSIDE PhRMA OVER DRUG PRICING — People's Action, a progressive group, is hosting a rally with Sanders outside the headquarters of PhRMA to highlight the drug pricing debate in reconciliation, POLITICO’s Megan Wilson reports.

The group is lining up speakers who will tell stories about being unable to afford their medications against a backdrop of a banner emblazoned with the text "STOP PHARMA GREED" and a giant pill bottle surrounded by shackles. Sanders, who leads the Senate Budget Committee, is speaking at the event and delivering a letter signed by more than two dozen progressive advocacy groups.

"Organizations like yours, whose sole job it is to represent the interest of corporations, are trying to force policy makers into a false choice between affordable drugs for millions of Americans now, or the continued development of new medicines in the future," the letter reads.

PhRMA and other groups oppose a plan moving through Congress that would allow the government to negotiate drug prices.

SINEMA OPPOSED TO DEM PRESCRIPTION DRUG PLAN — Sen. Kyrsten Sinema is opposed to the current prescription drug pricing proposals in both the House and Senate bills, two sources familiar with her thinking told POLITICO’s Laura Barrón-López. They added that, at this point, the Arizona Democrat also doesn’t support a pared-back alternative being pitched by House Democratic centrists that would limit the drugs subject to Medicare negotiation.

Sinema has made her resistance to the current House prescription drug negotiation proposal clear to the White House, according to one of the sources, but it’s unclear if she’s completely immovable.

“As she committed, Kyrsten is working directly in good faith with her colleagues and President Biden on the proposed budget reconciliation package,” said John LaBombard, a Sinema spokesperson, who declined to discuss the prescription drug measure. “Given the size and scope of the proposal, while those discussions are ongoing we are not offering detailed comment on any one proposed piece of the package.”

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Eye on FDA

FDA APPROVES LUCENTIS BIOSIMILAR — FDA announced Friday it approved the first biosimilar to Lucentis, used to treat macular degeneration.

“Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs,” Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars, said in a statement.

MEDICAL DEVICES

MEDTRONIC RECALLS PIPELINE FLEX EMBOLIZATION DEVICES — More than 8,800 medical devices used to treat brain aneurysms are being recalled by Medtronic because of a risk of wires and tubes fracturing during procedures. Pieces might be left in patients’ bloodstream. According to the FDA notice , 59 reported device malfunctions, 10 serious injuries and two deaths have been reported.

Around the Agencies

CDC RECOMMENDS WAITING PERIOD FOR AFGHAN FLIGHTS AMID MEASLES CASES — CDC is recommending the Biden administration halt flights of Afghan evacuees from military bases overseas to the U.S. for at least 21 days following a measles vaccination, Erin reports. The U.S. government began vaccinations among evacuees last week, and so far, 60 percent of evacuees have received a measles inoculation. Cases have been reported among several Afghans in the U.S. and international military bases, and more than 100 people are isolating after having been exposed.

Pharma Worldwide

MANUFACTURERS URGE BIDEN TO DROP VACCINE IP WAIVER PUSH — The National Association of Manufacturers, an influential industry group, pressed the Biden administration to abandon World Trade Organization talks on waiving intellectual property protections for Covid vaccines ahead of a virtual Covid-19 summit Wednesday, POLITICO’s Doug Palmer reports. Instead, the association is pushing for other means to speed up vaccine availability, such as cutting tariffs on medical goods and limiting export restrictions.

U.S. TO LIFT TRAVEL BAN FOR VACCINATED FOREIGNERS — The U.S. will again allow vaccinated travelers into the country starting in November, POLITICO reported Monday. Jeff Zients, the head of the White House’s COVID-19 Response Team, told reporters the decision would be on an individual basis instead of a country-based approach. The decision answers a growing grievance among European countries that the EU had opened its skies to nonessential U.S. travelers but Washington wasn't reciprocating.

The Office of Management and Budget is reviewing an HHS/CDC notice outlining requirements on airlines to collect and transmit certain information pertaining to passengers and crew arriving in the U.S. The notice also appears to require passengers to “provide designated information.”

Inside AgencyIQ

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

FDA medical device rule publication imminent — The White House’s Office of Information and Regulatory Affairs on Friday concluded its review of an FDA’s final rule that could streamline and clarify the processes for the De Novo pathway, including codifying and harmonizing policies that have changed over the years. The De Novo pathway is intended for use by sponsors of novel devices for which no regulatory precedent or classification exists. Under the De Novo process, a sponsor can make the case that their product should be given a specific risk-based classification based on the attributes of the device. Otherwise, the FDA’s default position is that previously unmarketed products without regulatory precedents should be treated as high-risk products. FDA’s 2018 proposed rule clarified the information to be included in a De Novo submission, FDA’s flexibility to refuse to accept certain De Novo submissions, and the process for reviewing and granting a De Novo request. Following OIRA’s review, the rule should be published in the coming weeks.

Document Drawer

FDA issued draft guidance Monday answering questions about the agency’s thinking on issues pertaining to sponsors’ controlled correspondence submissions.

FDA on Friday issued revised guidance answering questions on biosimilar development. It also issued draft guidance on a third revision of questions and answers.

A message from the Pharmaceutical Care Management Association (PCMA):

Congress has shown bipartisan support to delay the Medicare prescription drug rebate rule and avoid increasing Medicare premiums by 25%. Now Congress should permanently repeal this rule to avoid disrupting Medicare beneficiaries’ affordable Part D prescription drug coverage and to save taxpayers $170 billion.

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