Where will J&J produce millions of vaccines? — More over-the-counter Covid tests — FDA lets Moderna fill vials with more vaccine

By Sarah Owermohle and David Lim

Presented by Coalition for Affordable Prescription Drugs

With Emily Martin

— Where will J&J produce millions of vaccines after manufacturing problems with partners?

— There are more over-the-counter Covid tests after new FDA greenlights.

— FDA allows Moderna to fill vials with more coronavirus vaccine.

It’s Friday, welcome back to Prescription Pulse. The news is out: I'm moving to the Pulse newsletter next week after two and a half wonderful years with Prescription Pulse. From drug approvals to drug pricing bills, 80-page Medicare rules to 8-hour advisory committees, it's been a joy. You're in very good hands with David Lim and some exceptional talent joining the ranks (and I'll be around.) Keep in touch (sowermohle@politico.com or @owermohle) and send David your tips at ( dlim@politico.com or @davidalim).

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The Trump Administration’s prescription drug “Rebate Rule” will raise seniors’ premiums by up to 25%, skyrocket government spending, and will not deliver the lower drug costs that patients need. It should be eliminated to protect seniors and taxpayers. Learn more.

WHERE WILL J&J PRODUCE MILLIONS OF VACCINES? Multiple Johnson & Johnson partners chipping in on the coronavirus vaccine are mired in questions about their factories’ processes this week, stoking fears that J&J could miss its ambitious vaccine goals — a worry that the company strongly dismisses.

J&J still aims to deliver 100 million doses by the end of May, it said in a statement where it promised to take a more direct role in supervising production at contract plants.

What happened: First, concerns about hygiene at a Merck plant broke open in a whistleblower complaint about FDA inspections that alleged unsanitary work conditions at the Durham, N.C. facility that is slated to help produce J&J vaccine substance.

“We produce our medicines and vaccines to the highest standards, in full compliance with regulations and good manufacturing practices,” Merck said in a statement.

Within hours there was another hit — J&J’s Maryland partner to produce the vaccine, Emergent BioSolutions, had mixed up ingredients with another vaccine, ruining millions of shots. Senior administration officials knew about potential Emergent problems for more than a week but the batch problem came to light late last week, Erin Banco, Rachel Roubein and Sarah reported.

Emergent said it has isolated the batch and will dispose of it. “Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process,” it said.

What’s next: A senior administration official tells us it could take a matter of days or weeks to get Emergent back on track — and eventually authorized by the FDA — to produce and release J&J doses. In the meantime, the company has help to fill and finish vaccine vials, but no one cleared to help with the key ingredients themselves.

Plus, AstraZeneca — at the center of its own troubles about vaccine confidence — has also partnered with Emergent to produce millions of shots. The company said it is “are aware of the reports regarding the facility and we understand Emergent is investigating the matter."

FDA: MODERNA CAN FILL VIALS WITH MORE VACCINE — FDA announced late Thursday that Moderna is now allowed to put up to 15 doses of vaccine in each vial, a 50 percent increase, and that vaccinators can, when possible, extract an extra 11th dose from existing 10-dose vials.

The agency also said Moderna's vaccine can be kept at room temperature for 24 hours, up from 12 hours, and that once a vial is opened, vaccine can now be administered for 12 hours, up from six hours.

All those changes "will help provide more vaccine doses to communities and allow shots to get into arms more quickly,” FDA vaccine regulator Peter Marks said in a statement.

NIH LAUNCHES TRIAL OF MODERNA VARIANT VACCINE — The National Institutes of Health said Wednesday it is enrolling adults in an early-phase clinical trial to evaluate a Moderna vaccine targeting a more contagious coronavirus variant first found in South Africa.

The study aims to enroll about 210 adults without a known history of a Covid-19 infection in Atlanta, Cincinnati, Nashville and Seattle by the end of April.

FDA AUTHORIZES TWO MORE OTC COVID-19 TESTS — The FDA announced late Wednesday it authorized several rapid Covid-19 tests meant to be used to repeatedly screen asymptomatic people, a move that will expand the United States’ arsenal of tools to detect the virus as states reopen schools and workplaces.

The OTC tests, made by Quidel and Abbott, can now be used by people to repeatedly screen themselves for the virus at home. Abbott said it plans to sell the tests to retailers at a per-test cost in the single digits, but it is unclear what price consumers eventually will pay.

Harvard University epidemiologist Michael Mina — who has advocated for at-home antigen tests — called the authorizations “a major milestone” that he hopes will help slow the spread of Covid-19 and its variants by enabling infected people to quickly isolate themselves.

FDA laid the groundwork for the new authorizations in mid-March when senior regulators announced they would allow some diagnostics manufacturers to market Covid-19 tests for regular at-home use before companies complete studies on how well the tests perform in people without symptoms.

NIH and CDC also announced this week the launch of a study where a month of free Covid-19 antigen tests will be given to up to 160,000 people in Pitt County, N.C., and Chattanooga, Tenn., to explore if three-times-a-week self-testing can cut down on Covid-19 infections.

JOIN THE CONVERSATION, SUBSCRIBE TO “THE RECAST” Power dynamics are shifting in Washington, and more people are demanding a seat at the table, insisting that all politics is personal and not all policy is equitable. “The Recast” is a new twice-weekly newsletter that breaks down how race and identity are recasting politics, policy and power in America. Get fresh insights, scoops and dispatches on this crucial intersection from across the country and hear from new voices that challenge business as usual. Don’t miss out on our latest newsletter, SUBSCRIBE NOW. Thank you to our sponsor, Intel.

FDA INVESTIGATING REPROCESSED UROLOGICAL ENDOSCOPES — The FDA announced Thursday it is investigating numerous reports of patient infections associated with reporcessed urological endoscopes. The devices, which are used to view a patient’s urinary tract, have been the subject of more than 450 medical device reports since 2017.

“We are very concerned about the three reported deaths — outside of the United States — associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” chief medical device regulator Jeff Shuren said.

The decision to scrutinize urological endoscopes comes after the agency grappled with contamination challenges related to duodenoscopes over the past several years.

FDA UPDATES LIST OF COVID TESTS AFFECTED BY VARIANTS — The FDA updated its list of Covid-19 tests that may be affected by virus variants on Tuesday. Much of the information is similar to what was published in January, but a few tests made by Cepheid have been added. The agency says the impact on the performance of Cepheid’s test “does not appear to be significant.”

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MEDTRONIC ASKS FOR FDA PERMISSION TO STUDY HUGO ROBOT — Medtronic announced Wednesday it filed for an investigational device exemption for its Hugo soft-tissue robotic system.

FTC CHALLENGES ILLUMINA-GRAIL VERTICAL MERGER — The Federal Trade Commission said Tuesday it voted 4-0 to challenge gene-sequencing company Illumina’s $7.1 billion proposed acquisition of cancer detection test developer Grail.

Illumina said it is offering clinical oncology customers contracts guaranteeing “equal and fair access” to its sequencing offerings and a commitment to decrease prices by more than 40 percent by 2025. But that doesn’t appear to be alleviating the FTC’s concerns about the merger.

Illumina will challenge the FTC complaint in court, according to Illumina Chief Medical Officer Phil Febbo.

NEWSOM'S MASSIVE DRUG PURCHASING OVERHAUL ON HOLD — California Gov. Gavin Newsom’s plan to overhaul the way the state buys drugs is on indefinite hold after being delayed by the pandemic and a proposed $2.2 billion merger that has triggered antitrust concerns, POLITICO Pro’s Victoria Colliver reports.

Newsom announced the Medi-Cal Rx plan on his first day in office in January 2019, issuing an executive order that called for streamlining the state’s Medicaid prescription drug program and creating a single state bulk purchasing system.

It was slated for Jan. 2021 but that was punted to April 1 due to the pandemic. Now, it's unclear when it will start since the proposed acquisition of a key vendor has triggered a state antitrust review.

TUNE IN TO GLOBAL TRANSLATIONS: Our Global Translations podcast, presented by Citi, examines the long-term costs of the short-term thinking that drives many political and business decisions. The world has long been beset by big problems that defy political boundaries, and these issues have exploded over the past year amid a global pandemic. This podcast helps to identify and understand the impediments to smart policymaking. Subscribe and start listening today.

AN ANTI-PARASITIC FRENZY — In just 12 months, an affordable anti-parasitic has made its way from a humble head-lice treatment to being touted as a "miracle cure" for coronavirus — getting an audience before the U.S. Senate and making its way into official government guidelines, POLITICO EU’s Ashleigh Furlong reports.

What is ivermectin? Veterinarians have seen a rush on doses meant for large animals as people battle to get doses meant for humans, while black markets cash in and a fervent media campaign pushes inconclusive research. But the world’s leading drug regulators have consistently warned against its use for coronavirus.

The European Medicines Agency is the latest issuing warnings. The FDA meanwhile has warned that overdosing on the drug could even lead to death.

EU HEALTH AUTHORITY REASSURES ON ASTRAZENECA — The European Medicines Agency said that there's “no evidence that would support restricting the use of [the AstraZeneca] vaccine in any population” as countries continue to do just that, Furlong writes.

Regulators still haven’t identified specific risk factors like age, gender or medical history that would raise the risk for blood clots after the shot, EMA’s executive director Emer Cooke, said. A further recommendation is expected following a meeting of the EMA’s safety committee next week.

The comments come after Germany Chancellor Angela Merkel and the health minister suspended the shot for those under 60 years old, after originally allowing the shot for only younger people.

AUSTRIA IN TALKS TO PURCHASE RUSSIAN VACCINE AFTER EU DISPUTE — Austria announced it’s in talks with Russia to buy 1 million doses of the Sputnik V vaccine, in the country’s latest move to boost vaccine supplies amidst escalating tension with the EU, POLITICO EU’s Helen Collis reports.

During an EU leaders video summit Thursday, Chancellor Sebastian Kurz threatened to block the European Commission from securing another 100 million Pfizer vaccine doses unless Vienna gets a bigger slice of the delivery. Pfizer announced it can get only 10 million doses out by June 30, which set off a fight among EU countries over the population-based formula for allocating vaccines.

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

— A record start for new drug approvals: The FDA’s Center for Drug Evaluation and Research approved more new drugs during the first quarter of the year than the start of any first quarter in its history, according to an analysis by AgencyIQ. The Center approved 14 new molecular entities in Q1, compared to the previous record of 12 in 2017. While the data don’t necessarily mean 2021 will break overall drug approval records, the approvals do demonstrate FDA’s resilience during the pandemic.

— …but a slow start for regulation: The FDA does not plan to release any new significant regulations that were not already on its agenda toward the end of the Trump administration, according to an updated regulatory agenda released by the Department of Health and Human Services (HHS) earlier this week. While the agenda includes 11 regulations slated for release by the agency, all were previously announced. However, the agenda likely reflects a lack of permanent FDA leadership more than a lack of regulatory ambition. AgencyIQ expects a slate of new regulations to be announced once an FDA commissioner is confirmed.

A message from Coalition for Affordable Prescription Drugs:

Approved in a last-minute push under the Trump Administration, the Rebate Rule would raise seniors’ Medicare Part D premiums by up to 25%, increase federal spending, and threaten the success of Medicare Part D. The Biden Administration has delayed the Rebate Rule and protected seniors temporarily. Seniors can’t afford a 25% spike in their premiums. Now is the time to eliminate the Rebate Rule and protect seniors and taxpayers. Learn more.

Former Trump official John O’Brien is the next CEO and president of the National Pharmaceutical Council, the company announced. O’Brien was previously a senior adviser to HHS Secretary Alex Azar on drug prices, and before that a PhRMA lobbyist.

— Merck is lining up a buyout deal to get a new women’s health portfolio started a year after revealing its original plans, Endpoint News reports.

— WTO Chief Ngozi Okonjo-Iweala said that vaccine manufacturers should make enough doses for everyone in the world or voluntarily hand their technology to developing countries, BBC reports.

— Vaccination campaigns in the European Union have been sluggish, which has prompted some politicians to float the possibility of giving the Russian Sputnik V vaccine the green light, DW reports.

— South African President Cyril Ramaphosa celebrated the news that African countries will be able to access up to 400 million J&J vaccine doses, RFI reports.

The Congressional Research Service published a report on Wednesday examining the impacts of potential drug-pricing and patent bills.

The International Finance Corporation announced a $30 million loan to Neolpharma , a Mexican pharmaceutical group, to satisfy the growing demand for high-specialty medicines for the middle-to-low-income population in the region.

The Government Accountability Office released a report examining patent rights and federal funding that supported preclinical and clinical research involving remdesivir.

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