Attempts to develop the next generation of Covid vaccines are facing bureaucratic hassles and regulatory uncertainty, scientists say, obstacles that could make it more difficult to contain the spread of the coronavirus and arm the United States against future pandemics.

The Biden administration has now at least addressed a shortfall in funding after months of delays and is rushing to provide the first major grants from a $5 billion program to accelerate a new class of more potent and sustainable inoculations .

But the program faces the blunt reality that vaccine development, after kicking into high gear early in the pandemic, has returned to its slower and more usual pace.

Experiments on a promising nasal vaccine licensed from Yale University have been delayed as researchers spent nearly a year trying to obtain older injections from Pfizer-BioNTech and Moderna for use in the studies. The federal government’s original purchase agreements for those injections prevent doses from being used for research purposes without the companies’ approval, despite the fact that tens of millions of unused injections have been wasted in recent months.

In Pennsylvania, a company developing an inhaled vaccine related to one already in widespread use in India said it unsuccessfully sought clarification on whether it qualified for funding from the US government. The vaccine, the company said, may not have been tested advanced enough to qualify for the new pot of US funding.

And in academic labs and start-up agencies across the country, vaccine makers are groping in the dark about whether clinical trials funded by the Biden administration will be large and sophisticated enough to convince regulators who are still figuring out what to do. need for clearance.

Federal officials, some of whom are concerned about the leadership of the next-generation vaccine program, acknowledged that important questions remain about how the program will work and how quickly it can be delivered. While some officials in the Biden administration hope to roll out new vaccine technology by fall 2024, many scientists believe the doses are at least several years away.

“There’s no money, there’s no infrastructure, there’s no support,” said John Moore, a virologist at Weill Cornell Medicine, of the push for improved vaccines. “So I don’t expect big things from the next generation in the near future.”

Pfizer and Moderna vaccines are powerful preventers of serious disease. But they’ve failed to stop variants like Omicron, which have left more Americans than usual out of work and some sickened by long-term covid. And they have failed to extinguish the danger to some vaccinated Americans, especially older people, adding to the weekly national Covid death toll in the hundreds.

While vaccine technology will dominate the US market as of 2020, major countries such as India and China have rolled out newer inoculations. If those vaccines perform better, they could fortify the United States against deadly future waves, just as a second generation of polio injections helped eliminate that disease from the country decades ago.

But newer Covid vaccines, which rely on less certain technology, are not a certainty. Some are sprayed into the nose or mouth to boost the immune system where the virus first enters, potentially preventing people from becoming infected. Others are designed to protect not only against variants of this virus, but also against other types of coronaviruses, making them a critical tool in a future pandemic.

With large pharmaceutical companies mostly on the sidelines and private investors wary of the market for next-generation vaccines, small biotechnology companies are struggling to advance inoculations due to the laborious and expensive clinical testing process.

“Covid is still here, and the scientific part of me thinks this is important and we should do it,” said Biao He, the CEO of CyanVac, referring to the company’s nasal Covid vaccine, one of the few who has completed enough advanced testing to qualify for extensive government funding. But when he met with investors about his company’s various products, he said, “The capitalist part of me says, ‘Maybe we shouldn’t talk about it.'”

Given the difficulties, vaccine makers have rushed to line up for the new federal money: More than 70 companies responded to the government’s recent call for candidates to apply, a spokesman for the Ministry of Health and Human Resources said services.

Federal health officials aim to finalize a handful of vaccine-related awards this summer and a dozen or more by early 2024, an official said.

But the key features of the initiative known as Project NextGen, including who will lead it, have led to divisions within the administration.

White House officials, hoping for a leader in the form of the former pharmaceutical director who oversaw a program in 2020 to accelerate vaccine development, vetted candidates from outside the administration and identified three finalists: Dr. Larry Corey, an immunologist at the Fred Hutchinson Cancer Center; Dr. Michelle McMurry-Heath, the former CEO of the Biotechnology Innovation Organization; and dr. David A. Kessler, the former chief science officer for the Biden administration’s Covid response, according to people familiar with the search.

But the health department has resisted an outside hire. “HHS is the one to execute and deliver,” said Xavier Becerra, the agency’s director, said this month at a Politico event. Some senior federal officials are concerned about whether the agency can operate with enough urgency, two federal officials said.

Dawn O’Connell, the health department’s assistant secretary for preparedness and response, defended plans to run the program internally through a health agency known as the Biomedical Advanced Research and Development Authority, or BARDA. “Within BARDA, we have the expertise to take these products to the finish line,” she said.

Scientists and health officials acknowledge that Project NextGen will struggle to measure up to its 2020 predecessor, Operation Warp Speed. That $18 billion federal effort, which came amid an onslaught of Covid deaths, accelerated vaccine development by helping companies test and produce injections at the same time. It also removed regulatory hurdles and ensured that the government bought the resulting vaccines.

Project NextGen, coined with Covid deaths at its lowest level, has nor the huge money of Warp Speed nor the mandate to buy shots in bulk.

Still, some experts have questioned whether the new initiative draws valuable lessons from Warp Speed.

Dr. For example, Corey noted that the 2020 program gave budding vaccine makers access to a publicly funded network of academic medical centers experienced in HIV vaccine testing, which helped recruit a more diverse group of tens of thousands of volunteers.

But that expertise won’t be available for next-generation inoculations. Instead, vaccine makers will have to pay private companies to conduct their trials.

“The devil is in the details,” said Dr. Corey, who leads the clinical trials network. “To make it happen, the HIV infrastructure we created and used in Warp Speed, and the studies I planned and conducted, need to be brought back into the system.”

Last month, the Biden administration asked vaccine makers to propose 10,000-person trials that would compare new inoculations to currently available booster injections. If the new vaccines are effective, they could attract the private funding needed for additional testing and production.

With strong results from that type of study, “the calculus is changing for you and your program,” said Marty Moore, chief science officer for Meissa Vaccines, whose nasal spray is a likely candidate for federal funding.

Still, it’s not clear how these proposed trials align with what the Food and Drug Administration might require to approve new vaccines.

The agency relied on larger investigations to clear the first coronavirus recordings in 2020. In early conversations about NextGen with the Biden administration, regulators suggested they might look for a similar level of data from the newer vaccines, two federal health officials said. But the details of their position are still being worked out, and regulatory agencies are considering approaching candidates in the program on a case-by-case basis, a health official said.

Regulators plan to publish guidelines for their standards in the coming months, officials said. “The agency is committed to remaining flexible in its approach to the data,” said Michael Felberbaum, an FDA spokesperson.

Regulatory uncertainty has hindered next-generation vaccine development for years, says Neil King, a biochemist at the University of Washington. To protect against new variants, or even other coronaviruses, his team has updated its previous Covid vaccine, which has been approved in South Korea and Britain.

But despite repeatedly asking the government for advice, he said, he has not received answers about what US regulators will look for in advanced studies of the new vaccine.

“Everyone is screaming for clarity,” he said.

The difference between smaller or larger studies could be hundreds of millions of dollars, said Dr. Bruce Turner, CEO of Xanadu Bio, which is developing Yale’s nasal vaccine.

“For a small business,” he said, “it’s really life and death.”

Most of the NextGen funding is only available to researchers whose vaccines have data from phase 1 trials and are ready for advanced studies within six months — a hurdle many groups have failed to overcome. The program will also fund early stage studies at the National Institutes of Health to compare lesser-tested vaccines and figure out how to measure immune responses, said Dr. John Beigel, an associate director for clinical research at the NIH.

But companies with early-stage vaccines expressed confusion about eligibility.

“A lot of companies don’t even qualify,” said Shankar Musunuri, the CEO of Ocugen, the Pennsylvania company with the inhaled vaccine. “They could have handled this in a more structured way.”

Bureaucratic issues have tripped up vaccine developers like Xanadu Bio, who can’t use Pfizer or Moderna vaccines for their experiments. The restriction stems from a provision in federal purchase agreements that is generally designed to protect companies from the risk of a poorly executed experiment harming their product, though it can also help protect companies from unflattering results.

Health officials said companies could get those doses as soon as the injections become available on the commercial market, a change not expected until late summer or fall.

South Carolina Senator Tim Scott will announce his candidacy for president on Monday and will enter the race with about $22 million in cash, making him one of the most serious contenders for the frontrunner, Donald J. Trump, even if Mr. Scott has fluctuated around 2 percent in Republican primaries.

After announcing his campaign in his hometown of North Charleston, Mr. Scott going to Iowa and New Hampshire, the first two states in the Republican nominating contest. According to an adviser with direct knowledge of Mr. Scott’s plans, Mr. Scott’s campaign has earmarked approximately $6 million in television and radio advertising in those states. The Scott campaign also plans to spend millions of dollars on digital ads targeting voters in Iowa and New Hampshire that will run through the first Republican primary debate, scheduled for August.

Mr. Scott, the most influential elected black conservative in America, has a compelling life story upon which to build his campaign. He portrays his rise from poverty to become the first black senator from South Carolina and the only black Republican in the senate as an embodiment of the American dream.

Mr. Scott rarely directly criticizes Mr. Trump, but his message couldn’t be more different from the former president’s. While Mr. Trump speaks ominously of “retaliation”—his pledge to undermine the civil service and law enforcement agencies he pejoratively refers to as the “deep state”—Mr. Scott prefers the sunny language of Ronald Reagan.

“Americans are losing one of the most inspiring truths we have, which is hope – hope that things can and will get better, hope that education and hard work can equate to prosperity, hope that we remain a city on a hill, a shining example of what can be when free people decide to join hands in self-government,” said Mr. Scott in one speech last year in the Reagan Library on the Future of the Republican Party.

“America is at a crossroads,” he said, “with the potential for a great reset, a renewal, even a rebirth — where we can choose how we will fulfill today’s potential and tomorrow’s promise.”

There is little evidence to date that Mr. Scott’s message strikes a chord with the populist base of the modern GOP, led in recent years by a former TV star who loves to fight. For years, the Republican base has fed on apocalyptic gossip that often portrays Democrats as enemies bent on destroying America. In a party dominated by Mr Trump’s message:American carnage”, can the speech of Mr. Scott on the importance of “unity,” “hope,” and “redemption” sound like a message from another time.

Mr. Scott’s campaign will have to weigh his inherently optimistic message against the brutal realities of Republican primary politics.

“We will remain true to Mr. Scott’s optimistic view, but we are also not afraid to draw contrasts where necessary,” said the consultant with knowledge of Mr. Scott’s plans.

Mr. Scott will have more than enough money to find out if there’s a bigger market for his ideas than the polls suggest. His support for pro-business policies has made him a favorite of the Republican donor class, and he has billionaires like Oracle founder Larry Ellison — who aligned with Mr. Trump when he was in the White House — who are willing to donate millions. put dollars behind his campaign.

Workers at a rural Georgia factory that builds electric school buses with generous federal grants voted to unionize Friday, marking a surprise victory for organized workers and Democrats in their hopes of turning massive new cash injections from Washington into a union bridge in the Deep South .

The company, Blue Bird in Fort Valley, Georgia, may lack the cachet of Amazon or the ubiquity of Starbucks, two other companies that have drawn union attention. But the 697-to-435 vote by Blue Bird workers to join the United Steelworkers was the first major organizing election at a plant that received major federal funding under legislation signed by President Biden.

“This is just a barometer of the future, especially in the South, where working people have been ignored,” AFL-CIO president Liz Shuler said Friday night after the vote. “We are now in a place where we have the investments in place and a strategy to raise wages and protections for a good high-road future.”

The three bills that make up that investment include a $1 trillion infrastructure package, a $280 billion measure to revive a domestic semiconductor industry, and the Inflation Reduction Act, which included $370 billion for clean energy to combat climate change. to go.

Each of the bills contained language to help unions expand their membership, and Blue Bird management, opposed to the union action, had to contend with the Democrats’ subtle aid to the steelworkers.

Blue Bird will benefit from the new federal funds. Last year, it hailed the $500 million mark which the Biden administration provided through the infrastructure bill for the replacement of diesel-powered school buses with zero- and low-emission buses. Georgia school systems alone are getting $51.1 million to buy new electric buses, but Blue Bird sells its buses nationwide. More money coming through the Inflation Reduction Act, another law praised by the company.

But that money came with strings attached — strings that subtly tilted the playing field toward the union. Just two weeks ago, the Environmental Protection Agency, which manages the Clean School Bus Program, pushed for a requirements for all recipients of federal grants to detail the health insurance, paid time off, retirement and other benefits they offered their employees.

They also required the companies to “commit to remain neutral in any organizing campaign and/or to voluntarily recognize a union on the basis of a vote of majority support”. And under the rules of the infrastructure law, no federal money can be used to thwart union elections.

The Steelworkers union used the rules to its advantage. In late April, it filed multiple unfair labor practices charges against Blue Bird’s management, citing $40 million in rebates the company had received from the EPA, which certain that those funds could not be used for anti-union activities.

“The rules say if workers want to unionize, you can’t use money to hire anti-union law firms or use people to scare workers,” said Daniel Flippo, executive director of the Steelworkers district that covers the Southeast. the mood . “I am convinced that Blue Bird has done that.”

Politicians also got involved. Georgia’s two Democratic senators and Southwest Georgia’s Democratic House member also subtly pushed management of the plant, in a union-hostile but politically crucial state, to at least keep the election fair.

“I have been a longtime supporter of the USW and its efforts to improve working conditions and living standards for workers in Georgia,” Democratic Congressman Representative Sanford Bishop wrote of the United Steelworkers in an open letter to Blue Bird workers. “I want to encourage you to exercise your rights granted by the National Labor Relations Act.”

Blue Bird management minimized such pressure in its public statements, even as it fought hard to hit back union organizers.

“While we respect and support employees’ right to choose, we do not believe Blue Bird is better served by injecting a union into our relationship with employees,” said Julianne Barclay, a spokeswoman for the company. “During the upcoming election campaign, we expressed our view to our employees that a union is not in the best interest of the company or our employees.”

Friday’s union victory makes the labor movement think big as federal money continues to flow, and that could be good for Mr. Biden and other Democrats, especially in the crucial state of Georgia.

“Workers in places like Blue Bird embody the future in many ways,” Mr Flippo said after the vote, adding: “For too long companies have cynically viewed the South as a place where they could suppress wages and working conditions because they believed they prevent workers from joining unions.”

The union shop Blue Bird, with 1,400 employees, is set to become one of the largest in the South, and union leaders said it could be a bridgehead as they keep an eye on new electric vehicle suppliers — and possibly the biggest, toughest targets: foreign electric cars. automakers such as Hyundai, Mercedes-Benz and BMW, who have settled in Georgia, Alabama and South Carolina in part to avoid unions.

“Companies are moving there for a reason — they want the smoothest possible path to crushing unions,” said Steve Smith, a national spokesperson for the AFL-CIO. intrusion like we’ve never had before.”

Rising suddenly from a rural highway lined with peach and pecan orchards, the Blue Bird factory has long made a practice of hiring lower-skilled workers, some of whom have prison records and most of whom start at $16 or $17 an hour, said Alex Perkins, chief organizer of the United Steelworkers in Georgia.

A union was a hard sell for such vulnerable workers against a management that was vehemently opposed, the organizers admitted. When the last shift of the day came out on Thursday, most of the workers refused to speak officially. A group of about a dozen workers stood at the Circle K gas station across the street from the factory in early darkness on Friday, holding pro-union placards as the first workers arrived to vote under the eyes of National Labor Relations observers Board.

But Cynthia Harden, who has worked at the factory for five years and voted for organization, did speak about the pressure that pressured workers to vote against. Slideshows about the voting process, which showed ballots marked “no”, said the company could go out of business if the union won, and there was a sudden appearance of food trucks at lunchtime and banners on the fence reading: ” We love our Employees!”

“They’ve already made some changes, but if the union hadn’t started, nothing would have happened,” she said.

The letter written by Georgia Democratic Senators Raphael Warnock and Jon Ossoff to Matt Stevenson, CEO and president of Blue Bird, was remarkably timid, praising the company for its partnership and its well-paying jobs before “encouraging all involved, regardless of their wishes.” result, to ensure that the letter and spirit of the National Labor Relations Act are followed.”

Mr. Perkins was offended by that tone, given the work the unions had done to help Mr. Warnock win re-election last year. “I won’t forget next time,” he said.

Both senators declined requests for comment on the election.