Emails shed new light on last year's convalescent plasma debate — CDC backs Pfizer vaccine for kids 12 and older — GOP senators oppose vaccine IP waiver

From: POLITICO's Prescription Pulse - Friday May 14,2021 04:02 pm
Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
May 14, 2021 View in browser
 
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By David Lim and Lauren Gardner

Presented by CVS Health

With Katherine Ellen Foley and Lauraine Genota.

On Tap

The CDC supports administering Pfizer’s Covid vaccine to kids 12 and older.

Trump-era emails shed new light on the debate over convalescent plasma last year.

GOP senators oppose the Biden administration’s support for temporarily waiving intellectual property protections for Covid shots.

It’s Friday, welcome back to Prescription Pulse. The only thing the pandemic has done to your co-host’s nails is compel them to always be painted (at-home manis, so relaxing!).

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

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Throughout the COVID-19 pandemic, CVS Health has been there. We’re more than 300,000 employees ensuring millions of Americans can access health care services. We’ve opened 4,800 COVID-19 test sites and administered more than 23 million tests. We’ve given more than 17 million vaccine doses and are offering vaccines at over 8,300 stores. We’ve been on the frontlines, making health care easier to access and afford. Learn more.

 
Coronavirus

CDC OKAYS PFIZER VACCINE FOR TEENS — The CDC’s vaccine advisory committee on Wednesday endorsed Pfizer’s Covid-19 shot for 12- to-15-year-olds. CDC Director Rochelle Walensky officially adopted the recommendation hours later.

Federal health officials have said that vaccinating teens is key to ending the pandemic, and will make it safer for them to return to school in the fall. President Joe Biden said 15,000 pharmacies are ready to immunize the youngsters, along with school-based clinics, family health centers and pediatricians' offices.

All in one go: At the meeting, CDC staff announced that Covid-19 vaccines can now be given at the same time as other shots, after previously recommending a two-week waiting period before or after a Covid shot. That could help teens getting Covid vaccines catch up on any other shots they missed during the pandemic.

The advisory panel recommended that children (or adults) receive any vaccine they may be missing along with their Covid-19 shot, in line with recommendations from the American Academy of Pediatrics.

"[The advisory committee is] trying to weigh two competing facts," Paul Offit, a pediatrician at the Children's Hospital of Philadelphia, told POLITICO. On the one hand, there's no data on co-administering Covid-19 vaccines with other vaccines; but on the other, scientists know that missed vaccinations lead to spikes in other infectious diseases, like measles. Early on in the pandemic, measles vaccinations in the U.S. slipped below their usual level as fewer people ventured to doctors' offices for routine visits.

"Whenever you put limitations on windows, you create opportunities for missed vaccination," said Eleanor Menzin, a pediatrician at Longwood Pediatrics in Boston and professor at Harvard Medical School. Best practices for pediatrics are to give any overdue vaccinations to children whenever they come into the doctor's office, Menzin says. Because children or young teens generally need more vaccinations than adults, including HPV and meningitis, it's easier to administer multiple shots at once.

MORE J&J-LINKED CLOTTING CASES REPORTED The CDC confirmed at Wednesday’s meeting that it has identified 28 cases of a rare blood clotting disorder among roughly 8.73 million people who received the Johnson & Johnson Covid-19 vaccine, nearly double the number previously known.

The cases predominantly occurred in women, though six were reported in men. Those affected ranged in age from 18 to 59, slightly older than previously found. But most cases have occurred in people ages 30 to 49, with reporting rates for the syndrome higher for women in all age categories.

Available evidence suggests a "plausible causal association" with the J&J vaccine, but still no definitive link, said Tom Shimabukuro of the CDC's Covid-19 vaccine task force.

Lingering concerns: One member of the advisory panel said that amending its warning label to increase the age range of potentially affected populations might be warranted. But Arthur Caplan, a bioethics professor at NYU, told POLITICO he doesn’t think the new data justifies such a change. “Every time you expand the warning label, you better mean it,” he said.

Leana Wen, an emergency physician and public health professor at George Washington University, told POLITICO that the group that appears most at risk for the clotting syndrome — women ages 30 to 49 — should have the option of getting the Pfizer or Moderna shots first. If they still prefer J&J, she said, “absolutely that is a reasonable choice, but they need to be given information to make that decision, as well as the option for other vaccines.” That nuance should be more easily communicated now that Covid vaccine administration is shifting from mass sites to pharmacies and doctor’s offices.

EMAILS SHED LIGHT ON LAST SUMMER'S CONVALESCENT PLASMA DEBATE Newly obtained emails reveal intense disagreement among federal health officials over convalescent plasma — and the scramble to organize their messaging around the treatment — in the days leading up to FDA’s controversial decision to authorize its use against the coronavirus last summer, POLITICO's Sarah Owermohle and Adam Cancryn report.

The emails , obtained through a Freedom of Information Act request, shed new light on the interagency battle that forced FDA to hold off on its authorization for days, frustrating top officials and contributing to public confusion around the treatment's effectiveness. The FDA’s authorization in late August came shortly after then-President Donald Trump attacked the agency for moving too slowly to clear the treatment, stoking further concerns over politics driving decision-making at the nation’s top science agencies during the pandemic.

The back-and-forth between NIH and FDA officials leading up to authorization of the treatment to some extent played out in public last summer. But the new batch of emails reviewed by POLITICO shows how top officials, including some still leading the government’s Covid response, struggled to navigate differences over plasma’s usefulness amid intense White House pressure to declare it a breakthrough treatment.

Several have since taken lead roles in the Biden administration’s effort to restore public trust in the pandemic response — including NIH Director Francis Collins and Anthony Fauci, the agency’s top infectious-disease specialist, who had aired concerns in the weeks before authorization that the evidence on plasma’s effectiveness was too thin. That didn’t sit well with FDA’s top vaccine official, Peter Marks, who in emails complained that NIH scientists should not comment on regulatory reviews that are squarely within FDA’s authority.

REPUBLICANS BLAST VACCINE IP WAIVER — U.S. Trade Representative Katherine Tai faced intense Republican criticism on Wednesday over the administration's support of a WTO proposal that would temporarily lift intellectual property protections for Covid-19 vaccines, POLITICO’s Doug Palmer and Steven Overly report.

Nearly every Republican on the Senate Finance Committee said they opposed the move, which they argue could set off a scramble for vaccine ingredients and complicate manufacturing efforts in the U.S.

Finance Committee Chair Ron Wyden (D-Ore.) said he wants “a balanced vaccine IP waiver” that enables the timely and safe production of vaccines and the distribution of those shots to people in need. He also told Tai to tackle other health care trade barriers.

 

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Eye on FDA

WHITE OAK WATCH Biden has spent 114 days in office without nominating a permanent FDA commissioner.

FDA TAKES ITS SHOT Acting FDA Commissioner Janet Woodcock said in January that one of her top priorities was to vaccinate agency staff against Covid-19 — especially drug and device inspectors whose work has largely paused during the pandemic over safety concerns.

Now, “those who wish to be vaccinated are,” Woodcock said during Wednesday’s Reagan-Udall Foundation meeting, POLITICO’s Darius Tahir reports. It is not clear how many agency employees have sought out vaccination.

FDA WARNS OF MAGNET IMPACT ON IMPLANTED DEVICES The FDA on Thursday cautioned certain consumer electronics like new cell phones and smart watches that contain high-strength magnets can “temporarily affect” implanted medical devices like pacemakers. Some magnets might place medical devices into “magnet mode,” which can impact their operation.

“We believe the risk to patients is low and the agency is not aware of any adverse events associated with this issue at this time,” FDA medical device director Jeff Shuren said in a statement.

The FDA recommends keeping electronics at least six inches away from implanted medical devices. People should talk to their health care provider about potential risks, Shuren said.

 

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Drug Pricing

PELOSI DRUG PRICING PLAN THREATENED BY CENTRIST DEMS At least 10 caucus moderates are signaling opposition to House Democrats’ drug pricing bill — more than enough to potentially force Speaker Nancy Pelosi into dropping the reforms from infrastructure legislation Democrats hope to pass along party lines, POLITICO’s Alice Miranda Ollstein and Susannah Luthi report.

In a letter to Pelosi earlier this month, a copy of which was obtained by POLITICO, the group of moderate House Democrats called for a more modest drug pricing reform that’s bipartisan and would “preserve our invaluable innovation ecosystem.”

Early resistance to the legislation, H.R. 3 (117), indicates that drugmakers may escape what they consider a worst-case scenario — one in which Democrats extract huge savings from the industry to bankroll a range of party priorities in infrastructure legislation.

RARE DISEASE LOBBY FORMS AS DRUG PRICE BILL LOOMS A group of small life-sciences companies has launched the Rare Disease Company Coalition to advocate for policies “that enable cost-effective and more timely delivery of treatments” for diseases with small patient populations.

BIDEN MAKES AN APPEARANCE AT RESEARCH!AMERICA — The president taped a brief video for Research!America’s 2021 Advocacy Awards thanking the group for its work.

“It matters that we lead with science and invest in research — it isn’t just about Covid-19 — we have a chance to alleviate so much pain and bring hope to so many people, to put an end to cancer, Alzheimer's, diabetes and so many other diseases as we know them,” Biden said.

In Congress

BROOKS-LASURE CLEARS PROCEDURAL HURDLE — Chiquita Brooks-LaSure is one step closer to becoming President Joe Biden's Medicare and Medicaid chief after the Senate on Wednesday narrowly advanced her nomination in a 51-48 procedural vote, POLITICO’s Rachel Roubein reports . The Senate will have to take another procedural vote before a final vote, which is expected this month.

KHAN GETS BIPARTISAN SUPPORT IN COMMITTEE The Senate Commerce Committee voted on a bipartisan basis on Wednesday to support Biden FTC nominee Lina Khan, POLITICO’s Leah Nylen reports.

LUJÁN INTROS BILL TO CREATE DOE BIOTECH PROGRAM Sen. Ben Ray Luján (D-N.M.) on Thursday introduced a bill that would establish a National Laboratory Biotechnology program at the Department of Energy tasked with studying the Covid-19 pandemic and other biothreats.

BIDEN BUDGET DROP The White House will release its full fiscal 2022 budget request on May 27, POLITICO’s Caitlin Emma writes.

 

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MEDICAL DEVICES

MEDTRONIC LOBBIES WHITE HOUSE ON MCIT Medical device giant Medtronic was scheduled to meet with the White House Office of Management and Budget to discuss the Medicare Coverage of Innovative Technology final rule on Thursday, according to a public notice.

The meeting comes amid a sustained push by the medical device industry for the proposal, which would automatically grant four years of Medicare coverage to breakthrough designated medical devices that garner a green light from FDA. AdvaMed on Wednesday touted a letter sent in early May by 37 House Democrats to acting CMS Administrator Liz Richter asking the agency to implement the regulation.

LABCORP HOME COLLECTION KIT AUTHORIZATION EXPANDED LabCorp announced Thursday its Pixel home collection kit for its Covid-19 PCR test received an expanded emergency use authorization to allow its use in children 2 years and older.

Pharma Moves

Former Trump HHS spokesperson Caitlin Oakley is now a director of corporate communications and media relations at Bristol Myers Squibb.

Pharma Worldwide

WTO PRESSURES DRUG COMPANIES FOR EQUITABLE VACCINE DISTRIBUTION — To facilitate broader distribution of Covid-19 vaccines, World Trade Organization Director-General Ngozi Okonjo-Iweala is pressing drug companies to work with lower-income countries to get as many vaccines into arms as possible.

SPUTNIK’S SUCCESS SPUTTERS WITHOUT EMA AUTHORIZATION Russia's Sputnik, the first Covid-19 vaccine to gain any kind of authorization worldwide, is on a downward spiral. Despite early interest from countries in Europe, South America and Asia, regulators are becoming increasingly skeptical as data backing the vaccine fails to add up. Emerging concerns include data discrepancies between clinical trials, as well as overall concerns about the safety of the vaccine’s design.

A message from CVS Health:

At CVS Health, we have a long history of working to address physical and mental well-being to help people on a better path to overall health. With many still staying home, we’re supporting safer pregnancies by expanding access to prenatal and postpartum care via telemedicine. Nothing should stand in the way of mental health and wellbeing, so we’re increasing remote access to mental health services. Recognizing the strong connection between housing and health, we’re investing in affordable housing to support underserved populations and build healthier communities. Every day, CVS Health works to bring quality, affordable health care into neighborhoods, homes and hands—so it’s never out of reach for anyone. That’s health care, from the heart. Learn more.

 
Inside AgencyIQ

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

FDA rescinds Zika virus blood testing requirements — Five years after the initial Zika virus outbreak, the FDA this week announced that it will no longer consider the virus a Relevant Transfusion Transmitted Infection. The change means that blood donations no longer need to be screened or treated for potential Zika infection. The change in policy follows a dramatic drop in Zika infections in the U.S. For example, FDA has not received any reports of transfusion-transmitted Zika since March 2018. In 2020, there were just 4 cases of Zika virus reported in the U.S., down from 28 cases in 2019.

Evolving recommendations for Covid-19 test developers — The FDA is urging developers of tests and diagnostics for Covid-19 to consider submitting full market access applications to the FDA rather than continuing to rely on the emergency use authorization pathway. At a Town Hall meeting this week , the FDA’s top diagnostics regulator, Tim Stenzel, said the agency is continuing to make use of the EUA process, but only for “priority” diagnostics. The agency considers priority tests those that can be used at the point of care, in the home or as part of “extremely high throughput” laboratories. For non-priority tests, which would be placed at the back of a long list of pending EUAs, FDA officials said it makes more sense to start collecting the data needed for a complete application for non-emergency marketing. Stenzel noted that the collection of data on a product’s accuracy and sensitivity may become increasingly difficult as more people are vaccinated and Covid-19 cases drop, resulting in less testing.

Quick Hits

The U.S. is pausing shipments of Eli Lilly’s Covid-19 antibody combo to Illinois, as the state sees more cases of the coronavirus variant first identified in Brazil, Endpoint News’ Zachary Brennan reports. The FDA is concerned about the therapy’s effectiveness against the variant and is recommending the use of Regeneron’s combo therapy instead until further notice.

Document Drawer

FDA issued a series of guidance and draft guidance documents on Tuesday on a number of International Council for Harmonisation drug development topics.

FDA announced a public meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee on June 3, 2021.

FDA is seeking public comment for Philip Morris Products’ modified risk tobacco product application for its IQOS 3 System Holder and Charger.

 

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