CDC panel on deck to back Pfizer’s Covid vaccine for some kids

From: POLITICO's Prescription Pulse - Tuesday Nov 02,2021 04:02 pm
Presented by Biogen: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
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By Lauren Gardner and David Lim

Presented by Biogen

With Katherine Ellen Foley

On Tap

— The Centers for Disease Control and Prevention’s independent vaccine advisers will vote today on recommendations for administering the Pfizer-BioNTech Covid-19 vaccine to kids ages 5 to 11.

— Democrats are close to clinching a deal to allow the government to negotiate the prices of certain drugs in their trillion-plus-dollar social spending bill.

— FDA has released performance goals for reauthorizing user fees for generic drugs.

It’s Tuesday. Welcome back to Prescription Pulse. They’ll need to start making these vaccine card charms bigger for people to engrave their booster dates.

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).

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For more than a century, scientists have been trying to better understand the role the two proteins, tau and amyloid, play in Alzheimer’s. At Biogen, our scientists are leading in a new era of neuroscience innovation, using imaging tools to look inside the brain and confirm the presence of these proteins and see whether potential therapeutics are reaching their targets. Learn more about Biogen’s efforts to solve the Alzheimer’s puzzle.

 
Coronavirus

CDC PANEL TO WEIGH WHICH KIDS SHOULD BE VACCINE-ELIGIBLE — Today marks the last major regulatory hurdle for Pfizer and BioNTech to clear to get their pediatric Covid vaccine doses into younger kids’ arms. CDC Director Rochelle Walensky is expected to quickly endorse the shots’ administration; the main question is whether her agency’s external advisory panel will try to recommend limiting the vaccines to high-risk children as opposed to everyone in the 5-11 age group.

Some members of FDA’s independent vaccine advisory committee last week suggested they would have been more comfortable supporting emergency use authorization if the shot would be recommended only for kids of color or those with certain underlying health conditions, given the higher risk for those groups and the paucity of safety data so far. Ultimately, the panel backed an EUA without that caveat, punting to the CDC group. But if the CDC panel does take that approach, Walensky could always override it and recommend the shots for all kids 5 and up.

A former FDA official’s take: Joshua Sharfstein, vice dean for public health practice and community engagement at Johns Hopkins’ Bloomberg School of Public Health and FDA’s former principal deputy commissioner, said “the benefit-risk [balance] looks pretty, pretty good” in the favor of authorizing pediatric doses. “I don't know that they really have justification to limit it to a smaller group of kids,” he told our Katherine Ellen Foley, though he declined to predict the meeting’s outcome.

The CDC can help prepare parents for making vaccine decisions for their kids by making it clear the agency will track safety data closely and will “continually communicate with the public as it receives more data,” Sharfstein said. “What we hope is that, as we get more data, it will be reassuring and encouragement for people to move off the fence” and get their children immunized, he added.

The CDC meeting comes days after FDA authorized Pfizer-BioNtech’s Covid-19 vaccine for children 5-11 years old.

"Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” acting FDA Commissioner Janet Woodcock said.

The White House Covid-19 Task Force said Monday 15 million pediatric Pfizer doses, which are one-third the amount of an adult dose, are being sent to distribution centers in preparation for the CDC’s recommendation.

“Over the next couple of days, several million doses will start arriving at local pediatricians and family doctors offices, pharmacies, children's hospitals, community health centers, rural health clinics and other locations,” White House Covid-19 Coordinator Jeff Zients told reporters. “More doses will be packed and shipped and delivered each and every day over the next week or so.”

Zients said the federal government has enough Pfizer vaccine to vaccinate for every child 5-11 years old.

“We're in great shape on supply, and the whole plan is based on Pfizer vaccines,” Zients said.

MODERNA PUTS KID COVID SHOTS ON HOLDAnother issue for CDC advisers to chew on is that Pfizer’s vaccine is the only offering young kids will have for the foreseeable future. Moderna announced Sunday that it will delay applying to FDA for authorization of its own messenger RNA shot for kids ages 6 to 11 while the agency continues to assess its myocarditis risk in adolescents, Lauren reports.

That review may not wrap up until January, the company said, noting FDA notified Moderna of the timeline on Friday. While both Pfizer’s and Moderna’s vaccines have been linked to an elevated risk of myocarditis in adolescent and young adult males, some countries’ side effect surveillance systems — including one in the U.S. — has noted a stronger correlation between the condition and the Moderna product.

BIDEN ADMIN LAYS OUT VAX REQUIREMENT FOR FEDERAL CONTRACTORSFederal contractors subject to President Joe Biden’s vaccine mandate will largely be in charge of policing noncompliant employees, according to guidance the White House released Monday.

If a worker refuses to get vaccinated and hasn't requested an accommodation, federal contractors “should determine the appropriate means of enforcement,” according to the guidance from the Safer Federal Workforce Task Force.

Federal contractors have until Dec. 8 to ensure their workforces received the Covid-19 vaccine, except where an employee needs a religious or disability accommodation, POLITICO’s Rebecca Rainey reports.

DC HEALTH LAUNCHES PORTAL FOR AT-HOME COVID TEST RESULTS — Local readers who use at-home Covid-19 tests can report results to DC Health via an online portal launched Monday.

FDA EXPANDS ORASURE AUTHORIZATION — OraSure Technologies’ emergency use authorization for its InteliSwab Covid-19 test was expanded Monday to include labeling as a non-prescription single test for those with symptoms of Covid-19.

 

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Drug Pricing

DEMS DRIVE TOWARD DRUG PRICING DEALIn what’s likely the only time reporters were happy to see a lawmaker absorbed in his cell phone, Senate Finance Chair Ron Wyden (D-Ore.) read off the parameters of a tentative agreement Monday night, POLITICO’s Alice Miranda Ollstein reports. The deal-in-waiting would allow the feds to negotiate with pharmaceutical companies over certain drugs in Medicare Part B and Part D, including insulin, which has seen its price sky-rocket in recent years.

House Ways and Means Chair Richard Neal (D-Mass.) said an outstanding issue remains the exclusion of drugs that still have market exclusivity from government negotiation. Drug pricing reform advocates fear any carveout for drugs under patent would spur drug companies to employ gimmicks to extend those protections for as long as possible.

MCEACHIN, DAVIS INTRO BILL TO PROHIBIT COPAY ACCUMULATOR PROGRAMS — Reps. Donald McEachin (D-Va.) and Rodney Davis (R-Ill.) on Monday introduced a bill that aims to stop insurers from excluding cost-sharing assistance from counting toward a patient’s out-of-pocket maximum via copay accumulator adjustment programs. The bill comes in response to a policy change during the Trump administration in the 2021 Notice of Benefit and Payment Parameters permitting insurers and pharmacy benefit managers to use such programs.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
Eye on FDA

FDA PUBLISHES GDUFA III PERFORMANCE GOALS — FDA last week published performance goals for the reauthorization of the Generic Drug User Fee Act, laying out what appears to be an agreement with the generic drug industry on the next iteration of the user fee program.

Pharma Moves

Bristol Myers Squibb announced Pamela Fisher is the company’s new chief diversity and inclusion officer.

Pharma Worldwide

INDONESIA AUTHORIZES NOVAVAX COVID VACCINE FOR EMERGENCY USE — The Southeast Asian country became the first to green-light the American company’s shot, which has been beset with quality control issues in the U.S. The Serum Institute of India will make the vaccine.

 

BECOME A GLOBAL INSIDER: The world is more connected than ever. It has never been more essential to identify, unpack and analyze important news, trends and decisions shaping our future — and we’ve got you covered! Every Monday, Wednesday and Friday, Global Insider author Ryan Heath navigates the global news maze and connects you to power players and events changing our world. Don’t miss out on this influential global community. Subscribe now.

 
 
Inside AgencyIQ

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

FDA-support consortium to support gene therapies — A new consortium supported by the FDA, NIH and biotechnology industry — and $76.5 million in collective funding – aims to support the development of gene therapies . A primary goal of the Bespoke Gene Therapy Consortium is to better understand the biology of adeno-associated virus vector (AAVs), a common virus used to administer modified genes into patients. AAVs accounted for 24% of all global gene therapy studies as of 2019, and a recent FDA advisory committee meeting expressed concerns about potential safety concerns associated with aspects of their production. Another primary goal of the consortium is to improve and accelerate manufacturing and production processes for gene therapies, including through the development of a standardized set of analytical tests and streamlining regulatory requirements.

Quick Hits

ProPublica’s Caroline Chen explores why the number of congenital syphilis cases over the past five years quadrupled to 1,870.

BioPharma Dive’s Jonathan Gardner takes a deep dive into the patent thicket surrounding Amgen’s top-selling arthritis drug Enbrel.

China tested nearly 34,000 visitors at Shanghai Disneyland before they could leave the resort because of a confirmed Covid-19 case, the Wall Street Journal’s Natasha Khan reports.

Document Drawer

FDA on Friday announced it is investigating certain imported medical gloves because they may have been “reprocessed, cleaned or recycled and sold as new.”

CMS on Friday published its End Stage Renal Disease Prospective Payment System Final Rule for 2022.

A message from Biogen:

Biogen’s commitment to Alzheimer’s stems from our passion to advance scientific research and understanding for people living with the disease and their families. But, like many diseases, this work is an arduous and time-intensive journey, one that has required a significant investment in research and development. Our scientists believe innovation is about connecting the dots, from experiments in academic labs to clinical trials. Advancing Alzheimer’s research is about seeing what is possible and striving towards it. Biogen’s team is on an unrelenting mission to help the those living with Alzheimer’s. But we can’t do it alone. We learn from those who came before us and listen to patients and caregivers. Learn more about Biogen’s work to transform the future of Alzheimer’s.

 
 

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