Efforts to develop the next-generation COVID-19 vaccine face bureaucratic complexities, regulatory uncertainties and other obstacles that limit the spread of the coronavirus, scientists say. Arming the U.S. against future pandemics could be difficult, he said.
After months of delays, the Biden administration is rushing to issue the first major subsidy from its $5 billion program to at least address the funding shortfall and promote a new class of vaccines that is stronger and more durable. .
But the plan faces the blunt reality that vaccine development ramped up early in the pandemic before returning to a slower, normal pace.
Experiments with a promising nasal vaccine licensed from Yale University have been delayed after nearly a year of attempts to obtain older vaccines from Pfizer Biotech and Moderna for use in the study. Despite the tens of millions of unused shots being wasted in recent months, the federal government’s original purchase agreements for these shots prevented doses from being used for research purposes without company approval. It is
Pennsylvania said a company developing an inhaled vaccine related to one already widely used in India tried in vain to clarify whether it would be eligible for US government funding. . The company said the vaccine may not have undergone sufficiently advanced testing to qualify for new US funding.
And academic research institutes and start-up offices across the country are questioning whether clinical trials funded by the Biden administration will be large and sophisticated enough to win the support of regulators who are still weighing what they need. , vaccine makers are in the dark. clearance.
While some federal officials have concerns about the next-generation vaccine program’s leadership, key questions remain about how the program will operate and how quickly vaccines can be delivered. admitted that While some Biden administration officials hope to have the new vaccine technology deployed by the fall of 2024, many scientists believe the dosage is at least a few years away.
John Moore, a virologist at Weill Cornell Medicine, said there was “no funding, no infrastructure, no support” for promoting an improved vaccine. “So I don’t expect anything big next-gen to happen in the near future.”
Pfizer and Moderna vaccines reliably prevent serious illness. But the spread of variants like Omicron has not been stopped, leaving more Americans out of work than usual and making some sicker from the long-lasting COVID-19 pandemic. And the dangers to some vaccinated Americans, especially the elderly, haven’t gone away, contributing to hundreds of new coronavirus deaths rising every week across the country. ing.
While 2020 vaccine technology dominates the US market, big powers such as India and China are rolling out newer vaccines. Better performance of these vaccines could prevent future waves of deadly infections, just as second-generation polio immunizations helped eradicate polio from the country decades ago. It could strengthen the United States.
But the new coronavirus vaccine, which relies on less certain technology, is far from certain. Some are sprayed into the nose and mouth to stimulate the immune defenses that the virus first enters, potentially preventing people from getting infected. Others are designed to protect against not only variants of this virus, but also other types of coronaviruses, making them important tools in future pandemics.
With big pharma mostly on the sidelines and private investors wary of the next-generation vaccine market, small biotech companies struggle to push vaccines through a difficult and costly clinical trial process. .
“The novel coronavirus still exists, and the scientist part of me thinks this is important and should be done,” said Cyanback CEO Biao He. , mentioned the company’s intranasal COVID-19 vaccine, which is one of the few vaccines available in sufficient quantities. An advanced test for large government funding. But when he meets with investors about the company’s various products, “the capitalist part of me is saying, ‘Maybe we shouldn’t talk about that,'” he says.
Given the difficulties, vaccine makers are queuing for new federal funding. More than 70 companies have responded to the government’s recent call for applicants, a spokesman for the Ministry of Health and Human Services said.
Federal health officials are aiming to decide on a few vaccine-related awards this summer and more than a dozen by early 2024, one official said.
But key features of the initiative, known as Project NextGen, such as who will run it, have created divisions within the administration.
White House officials vetted candidates from outside government, identified three finalists, hoping for a leader in the mold of former drug executive who oversaw 2020 program to accelerate vaccine development bottom. Dr. Larry Corey, an immunologist at Fred Hutchinson Cancer Center. Dr. Michelle McMurray Heath, former Chief Executive of the Biotechnology Innovation Organization. That includes Dr. David A. Kessler, the former chief science officer for the Biden administration’s coronavirus response, according to people familiar with the investigation.
But the health department is resisting hiring from outside. “HHS has to do and deliver,” said the agency’s director, Xavier Becerra. said this month At a Politico event. Two federal officials said some senior federal officials are concerned about whether the agency can operate with sufficient urgency.
Dawn O’Connell, the Department of Health’s assistant secretary for preparedness and response, defended plans to implement the program internally through a health agency known as the Biomedical Advanced Research and Development Authority (BARDA). “We have the expertise within BARDA to bring these products to the end line,” she said.
Scientists and health officials agree that Project NextGen will have a hard time matching its 2020 predecessor, Operation Warp Speed. Amid a skyrocketing death toll from COVID-19, the $18 billion federal effort sped up vaccine development by helping companies test and manufacture vaccines simultaneously. It also cleared regulatory hurdles and ensured governments could buy the resulting vaccine.
Project NextGen is considered to have the lowest number of deaths from COVID-19, It’s not Warpspeed’s huge bankroll There is no obligation to purchase shots in bulk.
Still, some experts question whether the new effort is learning valuable lessons from Warp Speed.
For example, Dr. Corey says the 2020 program will give emerging vaccine makers access to a network of government-funded academic medical centers with experience testing HIV vaccines, helping to attract a more diverse group of tens of thousands of volunteers. He said it helped him get hired.
But that expertise is not available for next-generation vaccination. Instead, vaccine makers will have to pay private companies for the trials.
“The devil is in the details,” says Dr. Corey, who directs the Clinical Trials Network. “For that to succeed, the HIV infrastructure that was created and used at Warp Speed and the trials that I planned and conducted must be put back into the system.”
Last month, the Biden administration asked vaccine makers to propose a 10,000-person trial comparing the new shot with currently available boosters. If the new vaccine is effective, it could attract private funding for additional testing and manufacturing.
Strong results from this kind of trial “change the math for you and your program,” said Marty Moore, Meisa Vaccine’s chief scientific officer. The company’s 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 may require to license new vaccines.
The agency relied on large trials to clear the first coronavirus vaccination in 2020. Two federal health officials said early conversations about NextGen with the Biden administration suggested that regulators might look for similar levels of data from new vaccines. However, the details of their position are still under review, and regulators are considering approaching program candidates on a case-by-case basis, one health official said.
Officials said regulators plan to issue guidance on standards in the coming months. “FDA is committed to maintaining a flexible approach to data,” said FDA spokesman Michael Felberbaum.
University of Washington biochemist Neil King said regulatory uncertainty has hampered the development of next-generation vaccines for years. To protect against new variants, as well as other coronaviruses, his team has updated previous COVID-19 vaccines licensed in South Korea and the UK.
But he said despite repeated calls for guidance from the government, he had no answer as to what U.S. regulators would want from advanced research into new vaccines.
“Everybody wants clarity,” he said.
Bruce Turner, Ph.D., chief executive of Xanadu Bio, which is developing nasal vaccines at Yale University, said the difference between small and large studies could be up to hundreds of millions of dollars. said.
“For a small company, it’s really a matter of life and death,” he said.
Most of NextGen’s funding is only available to researchers whose vaccine has Phase 1 data and is ready for advanced research within six months, a hurdle many groups have cleared. not. According to John Begel, M.D., associate director of clinical research at the NIH, the program is an early-stage study at the National Institutes of Health to compare less-tested vaccines and figure out how to measure immune responses. It will also fund trials.
However, companies with early-stage vaccines have expressed confusion over whether their vaccines will be covered.
“Many companies will not even be eligible,” said Shankar Musnuri, chief executive of Pennsylvania-based inhaler vaccine developer OcuGen. “They could have had a more structured approach to this.”
Vaccine developers such as Xanadu Bio are stumbling on bureaucratic issues that prevent them from using vaccines from Pfizer and Moderna for testing. This restriction stems from a clause in federal purchase agreements, which is generally intended to protect companies against the risk of product damage due to poorly conducted experiments, but also to protect companies from unwanted consequences. It may also help protect against
Health officials said companies could get these doses once the vaccine was available on the commercial market, but the change wasn’t expected until late summer or fall.
