Prepare for the J&J shot — Pfizer CEO: Get used to annual shots — Senators re-introduce import bill

By Sarah Owermohle and David Lim

Presented by the Pharmaceutical Care Management Association

With help from Emily Martin and Brianna Ehley

— Prepare for the J&J shot with questions about seniors.

— Pfizer CEO: Get used to annual shots as variants spread.

— Senators re-introduce import bill amid consumer calls for change

It’s Friday, welcome back to Prescription Pulse. As always, send tips to Sarah Owermohle (sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim).

A message from The Pharmaceutical Care Management Association:

Pharmacy benefit managers (PBMs): the only part of the drug supply and payor chain working to lower prescription drug costs. Learn more about PBMs’ 21 policy recommendations for the Biden Administration and the new Congress to increase competition and reduce prescription drug costs for patients.

Cheryl Gerber/Johnson & Johnson via AP

PREPARE FOR THE J&J SHOT — An expert FDA panel kicks off discussion of Johnson & Johnson’s single-dose vaccine this morning, readying the stage for a third option in the nation’s supply to inoculate millions.

Settle in. Today’s meeting of the Vaccines and Related Biological Products Advisory Committee could be a long one. On the table: The vaccine’s efficacy against prominent variants, especially B.1.351(first identified in South Africa) limited data on seniors with health risks and other questions, like why some people who received the vaccine (but mostly had other health conditions) developed blood clots.

Above all, J&J and many public health experts seem keen to emphasize that the vaccine is super effective at preventing severe disease and death, which is the ultimate goal in curbing the coronavirus pandemic.

“I’ll take it. I’d recommend it to my parents and older relatives too,” Angela Rasmussen, a virologist at the Georgetown Center for Global Health Science and Security, tweeted.

State and local officials are also excited. The single shot and easy refrigerator storage bring obvious benefits in the drive to vaccinate people all over the country. It’s not in the FDA panel’s purview to discuss the public health benefits: They are there to debate safety and efficacy. But the topic could still arise, especially as experts discuss national need amid variants.

But speaking of public health talk. CDC’s Advisory Committee on Immunization Practices meets this weekend to sketch out more specific recommendations on who should get the J&J vaccine and what health officials should consider in the rollout.

BIDEN BOOSTS VAX EXPECTATIONS — President Joe Biden says readily available vaccines could be a reality as soon as April, just days after vaccine manufacturers pledged a major influx in supplies.

“As hard as it is now to believe, we're going to hit a phase in this effort maybe as late as April or may where many predict that instead of long lines of people waiting to get a shot, we'll face a very different scenario. We'll have the vaccine waiting,” Biden said at a White House event commemorating the 50 millionth coronavirus vaccine shot in the country.

A J&J executive told a House panel earlier this week that the company has four million shots on hand and will have 20 million by the end of March. Including Pfizer/BioNTech and Moderna — which each expect to produce millions more a week by next month — the U.S. could soon have three million shots readily available per day.

Biden is still managing expectations. “The question I'm asked most often is when will things get back to normal,” he said. “I can't give you a date. I can only promise that we'll work as hard as we can to make that day come as soon as possible.”

PFIZER CEO: GET USED TO COVID SHOTS — Americans may need to get ready for annual coronavirus vaccinations. While Pfizer CEO Albert Bourla is confident that a third dose of the company’s vaccine — aimed at specific variants like B.1.351 — could be very effective, boosters could be the new norm, especially as other variants arise.

“We will have an annual re-vaccination likely with one dose of the vaccine and that could be an annual booster either with the same vaccine or if there is a change in the variant with an adapted to the new variant vaccine,” Bourla told NBC News’ Lester Holt on Nightly News.

Bourla compared the effort to annual flu shots: “It's going to be the same with Covid. In a year, you will have to go and get your annual shot for Covid to be protected."

PFIZER COVID VAX CAN BE STORED AT HIGHER TEMPS — FDA announced late Thursday it is allowing Pfizer’s Covid-19 vaccine to be transported and stored at temperatures commonly found in pharmaceutical freezers.

“The alternative temperature for transportation and storage will help ease the burden of procuring ultra-low cold storage equipment for vaccination sites and should help to get vaccine to more sites,” FDA vaccine regulator Peter Marks said in a statement.

MODERNA, PFIZER STUDYING BOOSTER SHOTS — Moderna and Pfizer announced this week they are studying whether a booster shot of their already-authorized vaccines can provide additional protection against the virus and its variants.

Both companies also said they are developing updated versions of their Covid-19 vaccine to target the B.1.351 variant of

“As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2,” Moderna CEO Stéphane Bancel said in a statement.

SCHRIER PUSHES FDA ON RAPID TESTS — Rep. Kim Schrier (D-Wash.) held a call with top FDA officials Thursday to ask why the agency has not yet authorized more over-the-counter rapid tests that do not require a prescription. Only one test, made by Ellume, has obtained such an authorization to date.

“I'm still looking for where the barriers are, because I feel a real urgency to get these tests into people's hands,” Schrier told POLITICO. “I still don’t have any answers yet on why there seems to be a stalling on this process.”

SENATORS RE-INTRODUCE IMPORT BILL — A bipartisan bill to let consumers import cheaper medicines from Canada is back, sponsored by Sens. Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa). 11 other senators are signed on and a companion bill from Reps. Chellie Pingree (D-Maine) and Jaime Herrera Beutler (R-Wash.) was introduced in the House.

Background: Klobuchar first introduced the legislation with late Arizona senator John McCain years ago. It’s one of several proposals to import medicines that have floated around Congress, even as former President Donald Trump proposed a plan to let states import certain drugs from Canada.

What’s different: The bill, Safe and Affordable Drugs from Canada Act, is aimed at letting consumers ship cheaper options. Trump’s finalized rule lets states submit plans to import drugs from Canada as long as they can prove savings and safety. No state has cleared that bar yet, though Florida submitted their proposal in November.

LAWMAKERS REINTRODUCE PUSH TO NIX THE X-WAIVER — A bipartisan, bicameral group of lawmakers has reintroduced the Mainstreaming Addiction Treatment Act which would eliminate the so-called “x-waiver” requirement, in which physicians, already registered to prescribe a controlled substance, must obtain a waiver showing they have completed an eight-hour training course to be eligible to administer buprenorphine to treat opioid addiction. Provider groups say the X-waiver is burdensome and has created unnecessary barriers amid the worsening opioid crisis.

During the final days of the Trump presidency, officials released guidelines that eliminated the x-waiver — a move widely celebrated by physician groups. However, it was short-lived. Biden administration officials pulled the guidance back, saying it was issued prematurely, the Washington Post first reported.

The Biden administration has not signaled whether it will pursue guidance eliminating the x-waiver. Biden’s acting Drug Czar, Regina LaBelle, during a recent interview with POLITICO, said the administration is committed to working to “reduce barriers to access” and removing the x-waiver is not the only way to do that.

CONSUMER GROUPS PUSH TO END THE REBATE CAP — More than two dozen consumer advocacy organizations are backing a Medicaid provision in the coronavirus relief package that would allow states to penalize drug companies for big price hikes, arguing it would lower drug costs and save billions of dollars.

In a letter to congressional leaders, the group, led by Public Citizen, endorsed its inclusion in the Senate version of the Covid aid bill but also urged lawmakers to pursue a broader crackdown on drug pricing that would permit Medicare to directly negotiate the cost of medicines.

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NEW JERSEY TRIES TO CAP INSULIN PRICE — The New Jersey Assembly Appropriations Committee advanced legislation that would cap insulin co-payments at $50 for a 30-day supply, POLITICO’s Daniel Han reported.

The bill would also bar insulin from being subject to deductible costs, which proponents said would make the drug more accessible. Representatives of the insurance industry and consumer advocates, however, took issue with the bill, saying it lets pharmaceutical manufacturers off the hook for the high price of insulin.

“[This bill] requires pharma to do absolutely nothing,” Maura Collinsgru from New Jersey Citizen Action told the committee. “We cannot give them a pass.”

DESANTIS RAMPS UP VACCINE EFFORTS IN BLACK COMMUNITIES — Florida Gov. Ron DeSantis opened six new Covid-19 vaccination sites in underserved communities across Florida to address worries they would be left behind, POLITICO’s Arek Sarkissian reported.

The six sites are expected to be open seven days a week and administer 200 vaccine doses a day.

DeSantis made the announcement as he faces criticism this week over his selection of pop-up “pod” sites in upscale residential communities developed by wealthy GOP campaign contributors. The Republican governor hit back, saying those neighborhoods were heavily populated by seniors.

“I don’t think it’s an effective political attack to attack me for vaccinating seniors,” DeSantis said during a news briefing. “And I don’t care who you vote for or anything like that.”

EU LOOKING FOR ANSWERS ON SLOW VACCINATION RATE — EU heads of state and government are looking to the European Commission for answers as they face increased pressure to show progress in vaccination rates, but the Commission has nothing to report yet, POLITICO EU reported.

Efforts to ramp up vaccine manufacturing and increase the sequencing of virus samples to detect more contagious mutations are slow-going, and plans to speed up regulatory approval won’t kick in until next fall with a new round of vaccines meant for the variants quickly spreading across the EU.

Some officials and diplomats insist that cooperation among EU countries is much better than at the start of the pandemic, but there have still been a lack of deliverables.

“On the coordination, it’s a real difficult matter and we are walking on thin ice on this,” a senior German official conceded. “Because leaders' main focus is to do the best for their population and the way you do that is subject to differences in member states.”

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The Biden administration tapped Lauren Silvis, former FDA chief of staff, to consult on its Covid-19 response team.

— Beth Macy writes in the New York Times about opposition to Janet Woodcock’s candidacy for FDA commissioner, including by parents who’ve lost children to opioid addiction.

— Sinopharm and CanSino are each seeking market approval in China for their coronavirus vaccines with 72 percent and 69 percent efficacy respectively, NPR reported.

— Pfizer is challenging an enforcement effort against charity partnerships, proposing that it cover copays for heart medicines with a high list price, Bloomberg Law reported.

— Europe’s drug regulator expects to give an opinion before the summer on whether remdesivir can be used to treat Covid-19 patients who do not need oxygen support, Reuters reported.

— Consumer advocates including Public Citizen, providers and patient groups rallied in support of Medicaid reform that could be included in the next coronavirus relief package.

A message from The Pharmaceutical Care Management Association:

The 21 policy solutions supported by America’s PBMs are aimed at reducing prescription drug costs for patients and health plan sponsors. For the Biden Administration and new Congress, these 21 policy solutions should be a guide to effective ways to increase competition and reduce patients’ prescription drug costs.

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