Writing the variant playbook

With David Lim, Brianna Ehley and Emily Martin

On Tap

— Writing the variant playbook involves leaning on flu lessons and guidance in the coming weeks.

— J&J files for emergency use setting the stage for a third option.

— FDA limits plasma to early use after new data.

It’s Friday, welcome back to Prescription Pulse. Let’s hear it for “beer-reviewed” research, up there with vaccine sh--s and pubic health. As always, send tips (and, I guess, typos) to Sarah Owermohle at [email protected] or@owermohle. Loop in David Lim ([email protected] or@davidalim) and Brianna Ehley ([email protected] or @briannaehley)

Eye on FDA

WRITING THE VARIANT PLAYBOOK — The Food and Drug Administration is preparing to release new standards for Covid-19 vaccine booster shots, tests and drugs in the coming weeks — all aimed at preparing the country to beat back fast-spreading virus variants that are less susceptible to existing shots, David Lim and I report.

It’ll take two to three weeks to issue guidance according to four people familiar with the discussion. In the meantime, federal and state officials are scrambling to track how widely the coronavirus variants first found in South Africa, Brazil and the United Kingdom are spreading in the United States.

And it could be a cornerstone of future Covid-19 battle plans. Health experts say there are key lessons for FDA in the global, long-held approach to influenza. Shots made yearly to battle the flu rely on a foundational vaccine that is then altered to fight the particular variants that pop up each season.

The agency seems to agree on a shortened timeline. “We do not believe there will be the need to start at square one with any of these products—we recognize we are in a pandemic and we need to arm health care providers with the most appropriate tools to fight this pandemic on the frontlines,” said acting commissioner Janet Woodcock.

But in the meantime... Until booster or new vaccines are ready, tracking the variants’ movements through precise genetic sequencing of patient samples and diagnostic testing will be vital to staving off a surge in infections from the new strains. And the U.S. is far from painting an accurate picture just yet, writes David.

The country is sequencing less than a half a percent of all positive samples from Covid-19 testing. Sequencing more than 5 to 10 percent would provide an early warning that new variants are becoming more prevalent and allow researchers to evaluate if they are breaking through with vaccines, said Phil Febbo, chief medical officer of genomic sequencing company Illumina.

FUTURE OF VACCINES — Speaking of nimble moves in vaccine development, FDA acting chief of staff Julie Tierney told the Food and Drug Law Institute Thursday the U.S. does not yet have a “plug and play” vaccine platform for emerging infectious diseases, but praised the speed at which Covid-19 vaccines have been developed.

“We have learned a lot from each time we are dealing with an emerging infectious disease, whether it’s Ebola or Zika, or of course Covid-19, that we can then leverage a lot of that learned knowledge to be prepared for the next pandemic,” Tierney said.

J&J FILES FOR EMERGENCY USE — The U.S. manufacturer announced late Thursday that it had filed an application with FDA for emergency use authorizationfor a single-dose shot, potentially adding a critical third option to the country’s supply within weeks.

The good: The single dose is appealing to public health officials who say it will be critical to vaccinating vulnerable, hard-to-reach and even skeptical people. It also can be stored in regular refrigerators unlike other options that require ultra-cold freezers.

Plus, it’s very effective at protecting people from hospitalization and death, which J&J (and many public health officials) argue is the most important part. Rendering the coronavirus mild curbs the scariest parts of this pandemic, Mathai Mammen, global research and development head for J&J’s pharmaceutical arm Janssen, said last week.

The maybe bad: But the J&J shot also proved less effective against a virulent Covid-19 strain first found in South Africa, falling to just 57 percent efficacy in a trial run in that country. Cases of the strain, dubbed B.1.351, have already popped up in the U.S. while scientists meanwhile warn that other variants, like the one first found in the United Kingdom, could soon adopt the strain’s hardiness against vaccines.

Mark your calendars: FDA has already scheduled an advisory committee meeting to discuss the vaccine on Feb. 26.

AND NOVAVAX ON THE WAY — A fourth manufacturer could enter the review arena soon. Maryland-based Novavax also announced Thursday that they are in “rolling review” with multiple health agencies around the globe, including the FDA.

But that doesn’t mean the company is filing for emergency use just yet. The FDA has said before that it wants to see complete data from vaccine makers in a formal application. Novavax’s shot is currently in phase 3 trials in both the U.S. and the U.K. but started its U.S. leg in late December, meaning it is in for another three weeks minimum of safety follow-up before it can apply under the current standards.

FDA PARES DOWN PLASMA EUA — The agency revised its emergency authorization for convalescent plasma late Thursday, saying that based on new data it would advise use of plasma with potent coronavirus antibodies —drawn from volunteers who have recovered from Covid-19 infection — to only be used in hospitalized patients who are early in the disease course.

Remember: FDA issued emergency use authorization for convalescent plasma in August after President Donald Trump urged action and researchers said it carried little risk. The then-president called it a “historic” achievement and a very “safe and very effective” method against the virus, even as some scientists raised objections over sparse data.

But now low-titer plasma is out. The agency says that plasma without strong antibodies are no longer authorized under emergency use because the weaker plasma was not effective in randomized clinical trials reviewed since the August decision.

FDA also stated that there is no clear benefit to using plasma for people who are severely ill with respiratory failure that requires intubation or mechanical ventilation.

FAUCI: WE NEED MORE COVID DRUGS — There should be a concerted effort for the targeted development of anti coronavirus drugs to address the lack of outpatient therapies for Covid-19 patients, the government’s top infectious disease expert, Anthony Fauci, said this week.

“We need something like a Z-pack for covid,” Fauci said during an interview with JAMA.

The director of the National Institutes of Allergy and Infectious Disease added that monoclonal antibody therapies — several of which are authorized by FDA -- are logistically difficult and need to be administered in the hospital, which is counterproductive and could put others at risk of getting infected. “We need very effective direct antiviral agents against Sars Cov-2...something like a combination antiretroviral therapy for HIV,” he said, adding that there may already be some in the pipeline.

In Congress

PINGREE NAMED VICE CHAIR OF FDA APPROPRIATIONS SUBCOMMITTEE — House Appropriations Committee Chair Rosa DeLauro (D-Conn.) announced Rep. Chellie Pingree (D-Maine) will serve as the vice chair of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies subcommittee.

Industry Intel

BRISTOL MYERS SQUIBB TO DEVELOP ROCKEFELLER’S COVID THERAPY — Bristol Myers Squibb this week announced it will develop Rockefeller University’s novel monoclonal antibody combination to treat Covid-19. The drugmaker secured exclusive rights to manufacture the combination therapy that includes two monoclonal antibodies used to block the SARS-CoV-2 spike protein and neutralize the virus.

Rockefeller University launched clinical trials of the treatment in January. Preclinical data suggests the therapies could be effective against emerging variants, the drugmaker said in a press release.

The FDA last fall granted emergency use authorizations to Eli Lilly and Regeneron for monoclonal antibody therapies to treat COVID-19. The treatments are designed to act as immune cells to help fight infections.However, there is limited supply of already-authorized antibody treatments, and patients in some cases have struggled to get them.

WHAT 23andMe MERGER MEANS FOR PRIVACY — Home DNA test kit company 23andMe is going public via a merger with Richard Branson’s Virgin Group’s acquisition corporation, and bioethicists tell us the move raises the possibility of other potential changes — including to the company’s privacy policy or ethics board, POLITICO’s Mohana Ravindranath reports. (Current 23andMe shareholders will retain an 81 percent ownership stake in the combined new company, which will trade under the ticker symbol “ME”).

For years, federal agencies and lawmakers have warned of the pitfalls of putting sensitive genetic information in the wrong hands, including employment or insurance discrimination.

A 23andMe spokesperson emphasized that users must proactively opt-in to share their genetic data for research and can withdraw their data at any time. They also must offer separate and explicit consent for any individual-level data to be shared, and all research is overseen by an outside Institutional Review Board called Ethical and Independent Review Services, the spokesperson said.

The company’s privacy statement notes that in the event of a merger, customer data “would remain subject to the promises made in any pre-existing privacy statement,” the spokesperson said. That privacy statement also outlines possible changes to its privacy policy, but pledges to “provide customers with notice before the modifications are effective, such as by posting a notice on our website or sending a message to the email address associated with your account.”

Public Health

So far, roughly 13 million Americans have received at least one dose of a Covid-19 vaccine, according to CDC figures this week. Of the vaccine recipients that provided information on sex, age and race or ethnicity, 63 percent have been women, 60.4 percent have been white and 55 percent were 50 years or older. Black Americans and other people of color still lag noticeably behind white people, as Politico’s DataPoint reporter Annette Choi lays out.

Pharma Worldwide

U.K. LAUNCHES ‘MIX AND MATCH’ VACCINE TRIALS — British scientists on Thursday launched an unprecedented trial to see if two doses of different Covid-19 vaccines yield an immune response similar to that of the same vaccine.

Preliminary results are expected by early summer. The approach has worked before against Ebola but is not proven to work for coronavirus. Britain, which is experiencing vaccine shortages, was the first country to approve delayed dosing and is now the first to try mixing shots.

Matthew Snape, chief investigator of the trial, said the reason for the study is to “create a safety net” that can offset any supply disruptions. “It’s good to have that in the back pocket … if there was a problem,” he said.

Pharma Moves

Merck CEO Ken Frazier is retiring after almost 30 years at the pharmaceutical company including a decade as chief executive. The board appointed Robert Davis, currently executive vice president of global services and chief financial officer, to the role starting this summer. Frazier will continue as executive chairman.

3M announced Tuesday that Dow CEO Jim Fitterling will join its board of directors on Feb. 5.

Quick Hits

— Canada is set to receive a large delivery of vaccines over the next months through COVAX, a platform designed to maximize supply to poor countries, the Guardian reported.

— World Trade Organization talks on a proposal by India and South Africa to temporarily suspend intellectual property rules related to Covid-19 vaccines halted after other countries objected, DW News reported.

— An investigation by Consumer Reports found that an illegal dietary supplement named tianeptine, with effects similar to opioids, was being widely bought in bulk and resold, and argued that the FDA’s efforts to stop the manufacturing of such a drug have significant shortcomings.

— Jazz Pharmaceuticals bought GW Pharmaceuticals, the maker of the first cannabidiol-derived drug to be approved in the U.S., in a $7.2 billion cash-and-stock deal, Reuters reported.

— In Forbes, a former Pfizer executive called a recent report on pharma competition from Rep. Katie Porter (D-Calif.) “fraught with errors” and arguedthat innovation was not stifled because of FDA’s track record of drug approvals.

— Drugs’ efficacy in different populations demonstrates the need for diverse clinical trials, the head of the Johns Hopkins Department of Pharmacology wrote in aScience Magazine perspective.

Document Drawer

AARP sent a letter to House Energy and Commerce Committee members asking them to help create a centralized online tool and toll-free phone numbers to make it easier for seniors in the U.S. to make appointments to receive the Covid-19 vaccine.