Biden Administration to Back Lifting of COVID Vaccine Patents

THURSDAY, May 6, 2021 (HealthDay News) -- The Biden administration announced on Wednesday that it will support a controversial proposal to waive patent protections for coronavirus vaccines, while the drug industry warned such a move would actually dampen the development of vaccines.

The United States had been a holdout at the World Trade Organization over the proposal, which could give drugmakers around the world a look at the trade secrets of how the viable COVID-19 vaccines have been made, The New York Times reported. But President Joe Biden has come under pressure to throw his support behind the proposal, the newspaper reported.

Katherine Tai, the United States trade representative, announced the administration's support for the proposal on Wednesday afternoon.

"This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures," she said in a statement. "The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines."

Tai said the United States would participate in negotiations over the matter, but that those talks would "take time, given the consensus-based nature of the institution and the complexity of the issues involved."

The announcement is only one step toward a potential international agreement on suspending intellectual property rights, the Times reported. Negotiating an agreement that satisfies all member countries will be challenging, and it is far from clear what would happen if such an agreement was reached, the Times said.

Shortly after the decision was announced, the pharmaceutical industry issued a statement that assailed the extraordinary decision. Stephen Ubl, president and chief executive of the Pharmaceutical Research and Manufacturers of America, called the announcement "an unprecedented step that will undermine our global response to the pandemic and compromise safety."

"This decision will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines," he said, adding that the move would have the effect of "handing over American innovations to countries looking to undermine our leadership in biomedical discovery."

But global health activists praised the administration's decision. It is "a truly historic step, which shows that President Biden is committed to being not just an American leader, but a global one," said Priti Krishtel, an executive director of the Initiative for Medicines, Access & Knowledge.

Still, the activists said a waiver alone would not increase the world's vaccine supply. It must be accompanied by a process known as "tech transfer," in which patent holders supply technical know-how and personnel.

"Handing needy countries a recipe book without the ingredients, safeguards and sizable work force needed will not help people waiting for the vaccine," Dr. Michelle McMurry-Heath, president and chief executive of the Biotechnology Innovation Organization, told the Times. "Handing them the blueprint to construct a kitchen that — in optimal conditions — can take a year to build will not help us stop the emergence of dangerous new COVID variants."

Craig Garthwaite, a professor of strategy at the Kellogg School of Management at Northwestern University, also noted that, unlike many drugs, the coronavirus vaccines are complex technologies that will be difficult to copy without the help of the companies that developed them.

"People think you're going to pick up this patent and read it like a cheesecake recipe, and make this awesome cheesecake," he told the Times. "You really want Moderna and Pfizer helping you."

Biden sets new goal as vaccination rates drop

As coronavirus vaccination rates start to slow in the United States, President Joe Biden on Tuesday set a new goal to deliver at least one shot to 70% of adult Americans by July 4 while he tries to convince the hesitant to get inoculated.

Some states are leaving more than half of their available doses unordered, so Biden also announced that his administration will now shift doses from states with less need to states with greater demand for shots, the Associated Press reported. He also called for states to make vaccines available on a walk-in basis, and he will tell pharmacies to do the same.

"You do need to get vaccinated," Biden said from the White House Tuesday. "Even if your chance of getting seriously ill is low, why take the risk? It could save your life or the lives of somebody you love."

Dr. Eric Topol, a professor of molecular medicine at Scripps Research in California, told The New York Times he was "overjoyed" by the announcement. He had pushed for loosening vaccine allocation limits last month, when Michigan was struggling with a virus surge and could not get desperately needed extra vaccine doses.

The federal government's new flexibility will allow for states to respond rapidly when they see "the temperatures rising on the heat map of the country," Topol told the Times.

So far, more than 107 million Americans are fully vaccinated, according to the U.S. Centers for Disease Control and Prevention. The United States is now administering first doses at a rate of about 965,000 per day — half the rate of three weeks ago, but almost twice as fast as needed to meet Biden's new target, the AP reported.

"I'd like to get it to 100%, but I think realistically we can get to that place between now and July Fourth," Biden said of his new goal.

His administration will target three areas as it tries to hasten the pace of vaccinations:

• Adults who need more convincing to take the vaccine.
• Those who have struggled or are in no hurry to obtain a shot.
• Adolescents aged 12-15, once federal authorities approve vaccination for that age group.

Ahead of the U.S. Food and Drug Administration's expected authorization of the Pfizer vaccine for kids aged 12 to 15, the White House is also developing plans to speed vaccinations for that age group. Biden urged states to administer at least one dose to their adolescents by July 4 and to deliver doses to pediatricians' offices and other trusted locations, with the aim of getting many young people fully vaccinated by the start of the next school year, the AP reported.

Though White House officials privately acknowledge the steep challenge, Biden sounded an optimistic note on Tuesday.

"The light at the end of the tunnel is actually growing brighter and brighter," Biden said.

FDA set to approve Pfizer vaccine for 12 and older

The FDA plans to expand emergency use of Pfizer's coronavirus vaccine by next week so that children as young as 12 can be immunized.

After Pfizer's trial in adolescents showed its vaccine worked as well in teens as it does in adults, the FDA started preparing to add an amendment covering that age group to the vaccine's emergency use authorization, the Times reported. Federal officials familiar with the agency's plans who were not authorized to speak publicly relayed the information, the Times said.

Medical experts welcomed the news, calling it a major step forward in the U.S. vaccination campaign.

Vaccinating children is key to raising the level of immunity in the population, experts told the Times, and it could put school administrators, teachers and parents at ease if millions of students become eligible for vaccinations before schools open in September.

Dr. Ashish Jha, dean of the Brown University School of Public Health and the father of two teenage daughters, said the approval would be a big moment for families like his.

"It just ends all concerns about being able to have a pretty normal fall for high schoolers," he told the Times. "It's great for them, it's great for schools, for families who have kids in this age range."

Still, with demand for vaccines falling among adult Americans -- and much of the world clamoring for the surplus of American-made vaccines -- some experts said the United States should donate excess shots to India and other countries that have had severe outbreaks.

"From an ethical perspective, we should not be prioritizing people like them [adolescents] over people in countries like India," Dr. Rupali Limaye, a Johns Hopkins University researcher who studies vaccine use, told the Times.

But Jha said that the United States now has enough vaccine supply to both give shots to young Americans and to help the rest of the world. More than 107 million adults in the United States have been fully vaccinated, but at least 44 percent of American adults still have not yet received even one shot.

While most adolescents seem to be spared from severe COVID-19, Dr. Anthony Fauci, the Biden administration's top COVID-19 adviser, has stressed the importance of expanding vaccination efforts to include them and even younger children.

As of Thursday, the U.S. coronavirus case count passed 32.5 million, while the death toll topped 579,000, according to a tally from Johns Hopkins University. Worldwide, over 155.3 million cases had been reported by Thursday, with more than 3.2 million people dead from COVID-19.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.

SOURCES: Associated Press; The New York Times