New virus variants threaten Biden pandemic plans — Merck abandons vaccine plans — States claw back unused shots from nursing homes

By Sarah Owermohle

Presented by The AIDS Institute

With David Lim, Brianna Ehley, Maura Turcotte and Emily Martin

— New virus variants threaten Biden pandemic plans as government collaborates on potential boosters.

— Merck abandons vaccine plans in the first major failure among Warp Speed projects.

— States claw back unused shots from nursing homes amid pressure to vaccinate more.

It’s Tuesday, welcome back to Prescription Pulse. To learn this today, after snow in D.C., is upsetting. As always, send tips to Sarah Owermohle at sowermohle@politico.com or @owermohle. Loop in David Lim (dlim@politico.com or @davidalim) and Brianna Ehley (behley@politico.com or @briannaehley).

A message from The AIDS Institute:

People with HIV can’t afford another health crisis. In the midst of a global pandemic, there’s another public health crisis looming for people with HIV. A new Trump Administration rule threatens to drastically increase out-of-pocket costs for life-saving HIV medicines. Help fight this rule. Call the White House and demand they leave copay assistance alone. TheAidsInstitute.org/action

NEW VIRUS VARIANTS THREATEN BIDEN PANDEMIC PLANS — The Biden administration is rushing to prevent the spread of new strains of the coronavirus that scientists worry could be more transmissible or render vaccines less effective.

The government is collaborating with Moderna to develop vaccine booster shots aimed at strains first identified in South Africa and the United Kingdom. Preliminary research on Moderna’s Covid-19 vaccine suggest the shot is less potent, but still effective, against a strain first found in South Africa — leading the company to develop a booster shot “out of an abundance of caution,” said CEO Stéphane Bancel.

“We’re trying to stay a step ahead of the game, rather than waiting for something to happen and reacting,” Anthony Fauci, director of the National Institutes of Allergy and Infectious Disease, which is working with Moderna, told POLITICO.

The U.S. has detected 195 cases of the U.K. variant and one case, first reported on Monday in Minnesota, of a variant originating in Brazil. There have been no confirmed cases of the South African variant in the United States so far.

Biden campaigned on quickly reining in the virus, but since taking office has emphasized the difficulties that his team faces — warning it is contending with a series of pressing health and logistical challenges, Adam Cancryn and I write.

In the meantime, it’s unclear how quickly Moderna’s booster shots — if effective — could move through the regulatory chain. Chief Medical Officer Tal Zaks said on an investor call Monday that the company has not had that conversation with FDA just yet, but that slightly varied annual flu shots could provide a precedent.

FDA says it has “already given thought to developing a potential pathway, should changes need to be made to authorized COVID-19 vaccines or other products based on information on emerging variants.”

MERCK ABANDONS COVID VACCINES — Drug giant Merck is ending work on potential Covid-19 vaccines after weak results from early trials, it said Monday.

The company will stop development of two potential shots because the immune responses they produced in Phase I studies were weaker than those elicited by other Covid-19 vaccines and those seen in people infected with the virus, Lauren Morello writes.

It’s the first major fail for a manufacturer that has received significant U.S. funding: The Biomedical Advanced Research and Development Authority gave Merck $38 million to develop its shots. Merck was one of the later entrants in the vaccine race after it announced the two candidates in May.

Although Merck is walking away from Covid-19 vaccines, the company said it will continue to work on a pair of treatments for the virus. The company inked a $356 million deal with Warp Speed last year to provide the U.S. with up to 100,000 doses.

PFIZER FINISHES TEEN VAX ENROLLMENT — Pfizer has enrolled more than 2,000 children ages 12-15 in a study of its Covid-19 vaccine, a company spokesperson said last Friday. On its heels is Moderna, also trying to enroll adolescents but lagging after slow enrollment during the holidays, Maura Turcotte reports.

More than 2.8 million children and young adults between 0 to 24 years old had confirmed cases of Covid-19 last year, according to CDC reports.

It has big implications. Data from both the Pfizer and Moderna trials could determine when children and teens may finally get the jab. On Wednesday, the CDC's Advisory Committee on Immunization Practices will meet to discuss Covid-19 clinical trials in children.

BD TOUTS ANTIGEN-TEST STUDY — Diagnostics manufacturer BD is the latest to argue rapid antigen tests are highly accurate at catching people who are capable of spreading virus that can grow in cell culture, pointing to a recent study published in the journal Clinical Infectious Diseases. The study examined 251 people within seven days of the onset of Covid-19 symptoms.

“By providing a more relevant test to identify individuals that are likely to be shedding infectious virus and therefore transmit SARS-CoV-2, we will be in a better position to contain its spread,” BD vice president of medical affairs Charles Cooper said in a press release.

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STATES CLAW BACK UNUSED SHOTS FROM NURSING HOMES -- A number of states are reclaiming unused Covid-19 vaccine doses from CVS and Walgreens, originally intended for long term care facilities, as they face mounting pressure to get shots into arms faster, Brianna Ehley writes,

The states — including Maine, Michigan, Minnesota, Oklahoma and Utah — say tens of thousands of shots designated for nursing homes and other long-term care facilities participating in a federal program are going unused, while health officials are speeding through the weekly supply of vaccines for other priority groups.

Some of the states are also refusing to allot more doses to the pharmacy programs for long term care facilities until they use up more of their supply. They say that revising allocations to the pharmacy program won’t hinder vaccinations at long-term care facilities. But the moves highlight just how strapped many states are for doses.

THE NFL’S COVID SCREENING PLAYBOOK — The National Football League used a whopping 623,000 PCR tests from Aug. 9 to Nov. 21 to screen approximately 11,400 players and staff for the coronavirus, David Lim reports.

The league discovered that transmission of the virus occurred between individuals who had less than 15 consecutive minutes of exposure within six feet of a confirmed case based on data collected from devices people wore, according to a study published Monday in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

NFL chief medical officer Allen Sills told reporters the league consulted with the White House, CDC and FDA about the use of the tests, which were performed by BioReference Laboratories on primarily Roche Cobas, Hologic Panther and ThermoFisher QuantStudio machines.

“We essentially have a real world look at 32 different communities that have been followed over a six to seven month period of time,” Sills said. “That data simply doesn't exist anywhere else.”

A message from The AIDS Institute:

PHRMA CHALLENGES NEW HHS 340B MOVE — The drug lobby on Friday asked a federal court to throw out HHS’ new process to resolve big-money disputes between manufacturers and hospitals over drug discounts for poor patients, Susannah Luthi writes.

PhrMA argued in its lawsuit that the unexpected final rule — issued in the last weeks of the Trump administration — was “not the product of reasoned decision-making” and is a breach of executive power. The complaint also alleges the program’s supervising agency is too lax.

The dispute comes as Xavier Becerra, Biden’s nominee for HHS secretary, is preparing for his confirmation hearing — and he may not sympathize with PhRMA’s stance. Last month, in a letter to Trump HHS Secretary Alex Azar, he sided with providers in the standoff, bluntly criticizing drug companies for holding back on some of their discounts.

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UK: WE’LL HELP WITH NEW VARIANTS — The United Kingdom is launching a platform to help other countries identify news coronavirus variants, the country’s health department announced this morning.

Countries can analyze potential variants through samples submitted to the “New Variant Assessment Platform,” the government said. It could also include training, resources, personnel and equipment, the Department of Health and Social Care said.

Countries will be able to apply for assistance by contacting the World Health Organization where an existing channel does not already exist with the UK, it said.

Pfizer appointed Joyce Rogers as Vice President of U.S. Policy & Public Affairs. Rogers previously worked for Advocate Aurora Health and AARP on government relations.

A message from The AIDS Institute:

In the midst of a global pandemic, there’s another public health crisis looming for people living with HIV. A recently imposed Trump administration rule threatens to take away much-needed copay assistance for patients relying on HIV medicines. And that would mean drastic increases in out-of-pocket costs. For too many, these life-saving medicines could become too expensive to afford. And let’s face it — HIV is treatable only if the medicines patients rely on are affordable. Putting them out of reach financially is cruel, unsafe and unnecessary. Please help us right this wrong. Call the White House and demand they leave copay assistance for HIV medicines alone. TheAidsInstitute.org/action

-- European Council President Charles Michel said the bloc will use “legal means,” if necessary, make pharmaceutical companies respect any contracts they have signed to supply Covid-19 vaccines, Reuters reported. A few days prior, AstraZeneca blamed a manufacturing issue in Europe when it said it expected to deliver tens of millions fewer doses than planned, The Wall Street Journal reported.

-- Italian officials also promised to take legal action and step up pressure in Brussels against Pfizer and AstraZeneca after learning of the shortages and delays in deliveries, Reuters reported.

-- Beximco Pharmaceuticals, a Bangladeshi drugmaker, acquired a majority stake in Sanofi’s subsidiary in the country for more than $48 million, AP reported.

HHS published a notification that the agency is delaying implementation of Trump’s rule requiring health centers participating in the 340B program to make insulin and epinephrine available to low-income patients, after Biden’s Jan. 20 executive order called for agencies to pause or revoke directives from Trump that would hinder any pandemic efforts.

A study commissioned by the International Chamber of Commerce suggests that monopolization of the global Covid-19 vaccine supply could hit wealthy countries’ economies just as hard as those in the developing world, with losses totaling up to $9.2 trillion.

FDA is holding a virtual workshop with the Critical Path Institute from Feb. 9-11 to discuss a framework for the System of Hospitals for Innovation in Pediatrics — Medical Devices.

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