J&J shots should be used broadly in vaccine equity effort — Novavax aims for 110m doses by July — An at-home Covid test is here

By Sarah Owermohle and David Lim

Presented by the Pharmaceutical Care Management Association

With help from Emily Martin

— J&J shots should be used broadly as health officials worry about growing vaccine inequities.

— Novavax aims for 110m doses by July after filing for U.S. authorization this summer.

— An at-home Covid test is here after FDA authorized Quidel on Monday.

It’s Tuesday, welcome back to Prescription Pulse. Happy March, where it’s still acting like February! Send sun lamps, pharma news and 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.

J&J SHOT SHOULD BE USED BROADLY, SAY HEALTH OFFICIALS — Scientists and public health experts cautioned Monday against recommending the newly authorized Johnson and Johnson vaccine for specific groups of people, saying it could fuel ideas that the shot is different from others and even exacerbate already significant inequities in nationwide distribution.

“In our rush to administer vaccines, we cannot sacrifice equity,” said José Romero, chair of CDC’s Advisory Committee on Immunization Practices. “That has been a primary principle of the ACIP in developing vaccine guidelines and I think we need to stand by that.”

The questions on the table: The panel already recommended use of the vaccine in people 18 and older in a meeting this weekend, the day after FDA authorized emergency use. Monday’s meeting focused on whether the CDC should advise that people in certain age groups or with specific high-risk conditions are prioritized for the shot. Members also discussed whether the vaccine’s logistical advantages — it is given as a single dose and can be stored in a refrigerator — should factor into state and local distribution plans.

But the experts ultimately recommended against it.

“I think that the states and other local jurisdictions appreciate the nimbleness that this vaccine provides,” said Lynn Bahta, vaccine expert at the Minnesota Department of Health. Channeling it to certain areas could send “an indirect message that it’s not equivalent” to other vaccines, she added.

And giving priority for the vaccine to people with high-risk conditions could put providers in a “precarious position” of pushing for patients’ protected health information, said Jason Goldman, a professor of biomedical science at Florida Atlantic University who represented the American College of Physicians at the meeting. “Or for those who do not have access to health care, to be then put in that position of not getting a vaccine because they have no one to certify.”

What happens now: The ACIP discussion mirrors comments made by the Biden administration’s coronavirus task force members at a White House press briefing the same day. If states target the vaccine to specific populations, the White House will intervene with “technical assistance,” coronavirus coordinator Jeff Zients said.

The administration is distributing four million Johnson & Johnson doses this week, with half going to state leaders and the others heading to pharmacies and community health providers.

NOVAVAX AIMS TO SHIP 110M DOSES TO U.S. BY JULY — Novavax CEO Stanley Erck told investors on Monday the company hopes to be able to ship about 110 million doses of its Covid-19 vaccine doses to the U.S. by July. The company expects to complete its application for FDA emergency use authorization in the second quarter.

Novavax, similar to other vaccine manufacturers, is researching if a six-month booster shot of its vaccine helps further boost protection against Covid-19. It is also developing variant strain vaccines that could be standalone or bivalent shots, with clinical evaluation targeted for mid-2021.

FEDS BOOST TEST COVERAGE REQUIREMENTS — The Biden administration on Friday revised a policy that let health insurers deny coverage of a broad swath of Covid-19 tests, but the change falls short of forcing insurers to pay for screenings meant to monitor public health or reopen workplaces.

Health plans will now have to pay for more screenings for the virus, regardless of whether doctors order the tests or if patients seeking a test are asymptomatic. Insurers must also pay for point-of-care diagnostic tests administered at state or local testing sites.

“Plans and issuers cannot require the presence of symptoms or a recent known or suspected exposure, or otherwise impose medical screening criteria on coverage of tests,” the guidance states.

QUIDEL GETS GREENLIGHT FOR AT-HOME COVID TEST —The FDA on Monday granted emergency use authorization for a prescription at-home rapid antigen test made by San Diego-based Quidel.

The test, called the QuickVue At-Home COVID-19 Test, can be used by patients 14 years and older with suspected Covid-19 within six days of symptom onset. Adults also can administer the test to kids 8 years or older.

Researchers at the National Institutes of Health also announced Monday they’re studying if a companion smartphone app for the QuickVue test can help “inform future efforts to advance at-home COVID-19 testing.”

FIRST IN PRESCRIPTION PULSE: ABBOTT, APHL EXPAND BINAXNOW TEST REPORTING — The Association of Public Health Laboratories and Abbott said Tuesday that public health departments across the country will be able to more easily collect BinaxNOW Covid-19 rapid antigen test results.

Organizations — such as schools — will be able to use Abbott’s NAVICA app to send encrypted results to APHL’s AIMS+ electronic reporting system as part of the effort to boost reporting of the point-of-care test.

“Collecting timely results will allow public health officials to better track the spread of the virus and determine appropriate responses to protect all Americans and ensure equitable health outcomes,” APHL CEO Scott Becker said in a statement.

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SENATE TAKING UP RELIEF BILL AS SOON AS WEDNESDAY — The Senate will move forward as soon as Wednesday on President Joe Biden’s $1.9 trillion coronavirus aid package , with Majority Leader Chuck Schumer predicting Monday that the chamber would face "some late nights" ahead this week, Marianne Levine writes.

Besides boosted unemployment benefits and stimulus checks, the package also includes millions in funding for state and local vaccine distribution efforts.

Given the lack of GOP support, Senate Democrats will likely need votes from the entire 50-person caucus to pass the Biden plan, with Vice President Kamala Harris casting the tiebreaker. The legislation will then be sent back for a second round of consideration in the House, where it's expected to pass.

FDA AUTHORIZES SURGICAL SYSTEM FOR HYSTERECTOMY — FDA on Monday granted marketing authorization to the first robot-assisted surgical device for benign hysterectomies with salpingo-oophorectomy. The device, made by Memic Innovative Surgery, was reviewed under the FDA’s De Novo pathway.

ADVAMED WANTS TO KEEP AUTOMATIC BREAKTHROUGH DEVICE COVERAGE — AdvaMed CEO Scott Whitaker, the lobbyist for the medical device industry, is pushing CMS to retain a Trump-era regulation that would confer automatic Medicare coverage of FDA-designated breakthrough devices that obtain marketing authorization.

Democrat Reps. Suzan DelBene (Wash.), Terri Sewell (Ala.), Tony Cárdenas (Calif.) and Andy Kim (N.J.) also wrote to CMS Acting Administrator Liz Richter last week to ask the agency to allow the final rule to become effective on March 15.

For regulatory affairs professionals: AgencyIQ FDA Forecast 2021. In its inaugural year, AgencyIQ’s FDA Forecast predicts the FDA regulatory changes coming in 2021 and how they will impact the life sciences industry. Follow this link to learn more and download the summary.

SEC SETS UP FOR PROXY SEASON BATTLE — The SEC ruled late Friday that major companies like Pfizer and other drugmakers have no legal basis to exclude shareholder proposals related to racial equity, lobbying and even federal subsidies for coronavirus vaccine development, POLITICO’s Kellie Mejdrich reports.

The staff rulings issued late Friday will have a direct impact on the upcoming proxy season. Shareholders could see votes on how government support affects vaccine prices and access at Johnson & Johnson and Pfizer, among other companies.

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

— The FDA is looking to create its own Covid-19 testing program for staff that should permit it to resume inspections of foreign drug manufacturers and other critical regulatory functions. Sens. Elizabeth Warren (D-Mass.) and Tina Smith (D-Minn.) have previously pressed the agency to provide details on how it will resume foreign inspections of manufacturing facilities, which have mostly been on hold since the start of the pandemic.

— The agency is seeking help to make vaccine manufacturing processes more efficient, support gene therapies using adeno-associated viruses, and use and regulate artificial intelligence, according to a trio of contracting notices posted last week. For example, FDA’s biologics division wants to improve the manufacturing of “vaccines against influenza and other emerging diseases.”

CALIFORNIA GETS BOOST IN COVID SHOTS — California could get roughly two million coronavirus vaccines next week thanks in part to the authorization of the Johnson & Johnson vaccine, POLITICO’s Jeremy White reported.

California’s total will be bolstered by about 380,000 doses of the single-shot Johnson & Johnson vaccine, which was FDA authorized for emergency use authorization over the weekend. The additional doses will alleviate the continuing issue of limited vaccines available, which Gov. Gavin Newsom labeled “the only constraint in terms of our capacity to do more and better."

N.J. EXPANDS VACCINE ELIGIBILITY — Gov. Phil Murphy announced that the state is expanding Covid-19 eligibility to more essential workers, including pre-K to 12 educators and support staff, child care workers, transportation workers and additional public safety workers, POLITICO’s Katherine Landergan reported.

Murphy said he expects to start relaxing more restrictions in the “next number of weeks,” especially after the state will receive 73,600 doses of the newly FDA-approved Johnson & Johnson vaccine.

ENGLAND STUDY SAYS TEACHERS NOT AT GREAT RISK — A new U.K. study found that schools with controls to prevent the spread of the coronavirus show similar levels of infection among staff compared with the wider community, POLITICO EU reported.

The study comes as students and teachers are slated to return to classrooms next week in England — and in the U.S., states debate broad moves to send children back to school.

Shamez Ladhani, chief investigator, cautioned that the study covered a short period of time and had a small sample size. Still, he concluded one of the "most likeliest reasons that we don't see the large and widespread infections in schools must be because of all the mitigation processes that are in place.”

Those precautions include enhanced cleaning, limiting gatherings and social distancing among adults.

The Biden administration announced a slew of new health appointments this morning, including tapping Andi Fristedt to be FDA Deputy Commissioner for Policy and naming Rachel Pryor as the counselor for health policy in the HHS Secretary’s office.

BRIAN HARRISON LAUNCHES HOUSE CAMPAIGN — Brian Harrison, the former chief of staff to Trump HHS Secretary Alex Azar, on Monday announced his candidacy to succeed the late Rep. Ron Wright (R-Texas), who died of Covid-19 in February.

Harrison repeatedly clashed with top government officials at the FDA and other agencies during his tenure at HHS. His campaign website touts his efforts to “reign in the Deep State bureaucrats” by pushing to create “term limits” for top health officials across the government. He also claims credit for an HHS policy that exempted distilleries making hand sanitizer from over-the-counter user fees.

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.

— The White House will begin charging journalists for coronavirus tests required to enter the grounds and report from the briefing room, alarming the White House Correspondents’ Association on what could amount to thousands of dollars per newsroom costs, The Washington Post reported.

— AstraZeneca sold its stocks in rival Covid-19 vaccine maker Moderna for roughly $1 billion over the course of last year, Reuters reported.

— Several factories globally that have the capacity to produce hundreds of millions more doses of Covid-19 vaccines are waiting on blueprints and approval from pharmaceutical companies that claim intellectual property, AP reported.

— A study published by Clinical Trials Arena found that human studies on a range of medicines continue to be interrupted by the pandemic, with research for gastrointestinal and hematological disorders most affected.

Hospitals used some Medicare Part B drugs more when the drugs were eligible for pass-through payments, the Government Accountability Office found after reviewing seven medicines.

The FDA announced a public meeting on March 5 to recognize Rare Disease Day, in addition to publishing a request for applications for its Orphan Products Grant Program.

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