with Paige Winfield Cunningham

The United States is under heavy pressure to help suspend intellectual property rights for coronavirus vaccines.

It'll be a hot topic as the World Trade Organization holds its general meeting this Wednesday.

A temporary patent waiver on the vaccines would let more companies produce them.

The U.S. has joined several other wealthy countries in blocking a proposal spearheaded by South Africa and India for a temporary patent waiver on the vaccines. The waiver would allow companies around the world to produce generic versions of coronavirus vaccines and therapeutics for a temporary time without having to worry about being sued for intellectual property violations.

The pharmaceutical industry strongly opposes the waiver. But global health advocates and progressive lawmakers are urging the Biden administration to back the waiver — and there are some indications Biden officials are listening.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, supports sharing technologies from companies that hold vaccine patents. And Katherine Tai, the U.S. trade representative, told colleagues she’s considering advocating to lift some patent protections, although she’s still gathering information, our colleagues Dan Diamond and Jeff Stein report

White House press secretary Jen Psaki confirmed last week the administration was considering the waiver but said no decision had been made. 

U.S. support for a waiver could be crucial.

The WTO generally operates by consensus among its 164 member nations. While more than 100 countries have expressed support for the waiver, Britain, Switzerland and Canada have joined the U.S. in opposing it.

But experts say that other countries are likely to come around if the United States supports the waiver.

“I think we would see things change very rapidly if we saw a change in the U.S. position,” said Amy Kapczynski, a professor at Yale Law School and an expert in intellectual property law and global health.

Advocates for the waiver note stark disparities in vaccine access.

Nearly half of the vaccine doses administered so far have gone to wealthy countries, which account for just 16 percent of the world population. Even as coronavirus cases are declining in the U.S., a surge of cases in India is driving world records. 

More than 170 former heads of states and Nobel laureates have called on the Biden administration to back the waiver, which they say will ramp up global vaccine production and make it more equitable. 

Pressure is also growing on the Hill.

On Friday, a group of eight House members, including Reps. Earl Blumenauer (D-Ore.) and Rosa DeLauro (D-Conn.) met with Tai and White House coronavirus coordinator Jeff Zients to urge action on a waiver. And a group of ten senators, including Bernie Sanders (I-Vt.) and Elizabeth Warren (D-Mass.), sent a letter last month urging the administration to “prioritize people over pharmaceutical profits” by backing it.

“Our government has invested enormous sums of money into the production of these technologies. All people should benefit from that investment. It should not just go to a handful of wealthy companies,” Sanders told reporters. “It’s one thing when a person dies and there is nothing you can do about it. It’s another thing if you have the tool to save them.”

The pharmaceutical industry has pushed back. In a March 5 letter to President Biden, the Pharmaceutical Research and Manufacturers of America, an industry lobbying group, argued that a waiver would undermine innovation, sow confusion in supply chains and create a barrier to information-sharing.

Supporters say they’ve heard those arguments before.

Starting around two decades ago, countries including Mozambique, Zambia, Zimbabwe, Indonesia, Malaysia and Brazil issued licenses allowing companies in their countries to produce and import generic HIV drugs, despite fierce resistance from the pharmaceutical industry. The moves were credited with driving down prices and saving lives.

And although pharmaceutical companies have projected they can produce 12 billion doses this year, supporters of the waiver are skeptical. 

They worry any additional doses will be hoarded by rich countries for booster shots and childhood vaccinations and that the pharmaceutical industry will fall short of its pledges. If that happens, it could be years before developing countries get vaccines.

There are some companies that say they are ready to ramp up production but are unable to do so because of intellectual property restrictions or lack of partnership from large vaccine-makers. The Canadian biotech company Biolyse, for instance, is seeking a special license from the Canadian government to produce Johnson & Johnson vaccines this year. 

“There’s a bottleneck right now. Everyone knows the current supplies aren’t adequate, but nobody has taken up a plan to get scale,” Kapczynski said. “Should international law be stopping countries from doing everything in their power from scaling up production? The answer to that is no.” 

But a waiver on its own is unlikely to be a silver bullet.

The waiver wouldn’t force companies to give up trade secrets. And, unlike in the case of anti-retrovirals to combat the AIDS epidemic, vaccines are more complex and harder to reverse engineer. 

“You need the know-how,” says Jayashree Watal, an expert on intellectual property who has represented India before the WTO. “Companies are not going to reveal their trade secrets, even if you waive all the rights. You need the active transfer of knowledge.”

Rachel Silverman, a policy expert at the Center for Global Development, suggests that governments would be better off pressuring companies to do more voluntary licensing arrangements, in which they share technical trade secrets. 

Without knowledge transfers, the vaccines would need to be tested again in clinical trials, taking up crucial months, she argues. By that point, the world may have sufficient supply and severe vaccine shortages may be over. 

Both Watal and Silverman worry that the emphasis on intellectual property rights is distracting from an immediate need for countries such as the United States to free up export of raw materials and share more of the vaccines that have been produced. 

Once the patent issue is out of the way, knowledge-sharing may follow. 

Companies worried about protecting their brands and gaining royalties may be more likely to enter into licensing agreements, argues Lori Wallach, the director of Public Citizen’s Global Trade Watch. 

The U.S. government also has some leverage to push the vaccine-maker Moderna to share knowledge, given that the company's mRNA vaccine was developed in partnership with the National Institutes of Health, which owns a key patent behind the technology.

“The strongest, most powerful thing about this waiver is it changes the power dynamic,” said Wallach. “The option of the vaccine not getting made is off the table.”

Ahh, oof and ouch

AHH: The spring wave of coronavirus cases is subsiding.

Forty-two states and D.C. are reporting lower caseloads over the past week, as a spike in infections starting in March appears to be abating. The daily average of new cases nationwide is at its lowest point since mid-October. Hospitals in Michigan and other Upper Midwest states that were hit hard in April are now discharging more patients than they are admitting, The Post’s Joel Achenbach, Dan Keating and Jacqueline Dupree report.

And despite dire warnings from public health officials about the spring wave, it didn't prompt a corresponding surge in deaths, which have continued to decline, albeit slowly. 

That's like because vaccinations and previous infections have contributed to growing immunity in the population.  Federal health officials announced on Friday that 100 million Americans are fully vaccinated. But vaccination rates have dropped since a peak on April 13, a trend that may reflect the fact that many of the people most eager and able to get shots have already done so.

OOF: A landmark trial over the opioid crisis is set to start today in West Virginia.

“Cabell County and its seat, Huntington, will test a legal claim made by thousands of cities, counties, Native American tribes and other plaintiffs that drug companies ignored red flags and flooded their communities with addictive pain pills, causing a ‘public nuisance’ and fueling an epidemic of substance abuse, overdoses and deaths,” The Post’s Meryl Kornfield reports.

Unsealed documents and unearthed videos reveal the tactics used by drug companies to sell America on opioids, even as the addiction crisis was deepening. (Dalton Bennett/The Washington Post)

“The landmark trial in West Virginia against drug distributors known as the “Big Three” — AmerisourceBergen, Cardinal Health and McKesson — comes after an 11th-hour settlement averted an Ohio trial in October 2019 and coronavirus-related delays stalled opioid cases across the country,” Meryl continues.

Attorneys for Huntington and Cabell county are seeking $500 million from the drug distributors, alleging that they failed to refuse and report suspicious orders even as the county was flooded with opioids. From 2006 to 2014, there were more than 81 million prescription hydrocodone and oxycodone pills distributed in the county, enough for 94 pills per person per year. 

OUCH: A powerful teachers union influenced federal guidance on school reopenings.

Emails exchanged between federal officials and leaders of the American Federation of Teachers show that the union lobbied the CDC on — and suggested language for — the agency's school reopening guidance issued in February, the New York Post reports.

“The documents show a flurry of activity between CDC Director Dr. Rochelle Walensky, her top advisers and union officials — with Biden brass being looped in at the White House — in the days before the highly-anticipated Feb. 12 announcement on school-reopening guidelines,” Jon Levine reports.

“Thank you again for Friday’s rich discussion about forthcoming CDC guidance and for your openness to the suggestions made by our president, Randi Weingarten, and the AFT,” AFT's Kelly Trautner wrote in a Feb 1 email describing the union as the CDC’s “thought partner.”

The AFT praised the guidance, saing the agency “met fear of the pandemic with facts and evidence.” 

“Many others, however, were puzzled and angered by what they saw as the CDC willfully ignoring the science and slow-walking a return to in-person learning even as mounting evidence showed schools were not a primary source of coronavirus infections as long as they followed mitigation strategies,” Jon writes.

Mental health amid the pandemic

Mental health providers struggled to respond to a surge in demand during the pandemic.

Behavioral health providers laid off staff, cut hours and closed programs even as demand for services surged, according to a Government Accountability Office report. CDC surveys found that around 38 percent of Americans reported symptoms of anxiety and depression during the pandemic, compared to 11 percent in 2019. 

“The report on patient access to behavioral health care during the covid-19 crisis also casts doubt on whether insurers are abiding by federal law requiring parity in insurance coverage, which forbids health plans from passing along more of the bill for mental health care to patients than they would for medical or surgical care,” Kaiser Health News’s Emmarie Huetteman reports.

More in coronavirus news

  • Thousands of Indian Americans are struggling to help relatives in India survive a deadly coronavirus surge. Families are strategizing on how to obtain oxygen or find open hospital beds amid a collapsing healthcare system. They are also pressuring officials in the United States to ramp on assistance, Fenit Nirappil and Ambreen Ali report. Over the weekend, White House officials said that they were doing everything they can to help respond to the crisis.
India recorded more than 400,000 new covid-19 cases for the first time on May 1, as the country battles a devastating second wave. (Reuters)
  • The CDC determined that episodes of fainting, dizziness and other short-term adverse reactions at five vaccine sites were driven by anxiety, not a problem with the shots, the Associated Press’s Mike Stobbe reports. All of the cases occurred with the Johnson & Johnson vaccine, and four of the five sites temporarily shut down. The CDC said that people who are nervous about shots may be more likely to opt for Johnson & Johnson because it only requires one shot, and this group may also be more predisposed to “anxiety-related events.”
  • Biden told NBC News’s Craig Melvin that he has not ruled out requiring coronavirus vaccines for the military once they receive final Food and Drug Administration authorization. The Pentagon reported in April that nearly 40 percent of Marines have declined the vaccine.

Who's who at the WHO

Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, plans to run for a second five-year term.

His decision, reported by Stat News's Helen Branswell, sets up a referendum on the WHO’s handling of the Covid-19 pandemic under his leadership.

“It is unclear at this point whether others will emerge to challenge the 56-year-old from Ethiopia, who made history in 2017 when he became the first African elected to the global health agency’s top job,” Helen writes. “WHO director-generals may only serve two five-year terms, and must be elected each time. Publicly, Tedros, as he is known, has sidestepped questions of whether he plans to seek a second term. But the source familiar with his thinking confirmed it is his intention to do so."

Sugar rush