Earlier this month, the Trump administration said it was finishing $ 500 million in RNM vaccine investigation and changing its focus on other approaches, including a “virus virus vaccinates” “denounced” generation Gold Standard “.
“Generation Gold Standard is a paradigm shift,” said Dr. Jay Bhattacharya, director of the National Health Institutes, in a press release in May promoting the next investigation initiative. “It extends the protection of vaccines beyond the limits and prepares for viral flu threats, not only today, but also tomorrow, using traditional vaccine technology that takes the 21st century.”
However, experts in vaccines and infectious diseases say the approach is wrong.
“It’s a step back,” said Dr. James Campbell, vice president of the Infectious Diseases Committee of the American Academy of Pediatrics. “We have inactivated full virus vaccines for a long time, a long time.”
Louis Pasteur developed the first full virus vaccine at the end of the 19th century, who made an early version of the rage vaccine.
“It is not innovative at all,” said Angela Rasmussen, virologist at the University of Saskatchewan. “It is actually old, more or less, according to vaccine standards.”
While other vaccines activate the immune system using specific virus proteins, integral virus vaccines generally preserve most virus components.
“Take the virus, you grow it, you purify it and kill it with an inactivating agent. That is a complete viral vaccine,” said Dr. Paul offit, director of the Vaccine Education Center of the Children’s Hospital of Philadelphia. Other integral virus vaccines use live but weakened virus versions.
Campbell said that for many years of vaccine research, scientists have been able to identify the parts of a virus that are more likely to activate the immune system and train it to fight an invading pathogen. These parts are known as “antigens.”
If the immune system is like the hound of the body of the body, tracking the invaders, then many newer vaccine technologies that are directed to specific antigens present the hound with only the pieces of the invader’s clothing that are more useful for it. A full virus vaccine, on the other hand, would be like presenting a blood with all the wardrobe of an invader.
Campbell said it may sound better at first glance to use the entire virus instead of key pieces, but that additional virus pieces could actually do nothing to improve the immune response.
“For example, the hepatitis B vaccine is an antigen, the surface antigen of hepatitis B, and is almost 100% protection against hepatitis B. It does not need the entire hepatitis B virus,” he said.
Offit agreement. “The hepatitis B vaccine has practically eliminated hepatitis B infections in young children,” he said. “So that’s good enough.”
Campbell offered COVID-19 vaccines as another example. “There were virus covid vaccines around the world, but they were not used in the United States, they were used elsewhere, and if you look at their general protection, it is not so good,” he said.
A Singapore study, for example, found that the people who obtained a vaccine against Covid of Whole-Virus virus had more than 1.5 times twice as probabilities of being infected than those that had been immunized with an RNM vaccine that only went to the spike protein of the virus.
“If it was thought that whole virus vaccines for Covid were the best technology to move forward with the back when the pandemic began, we would have done it,” Campbell said.
Implementing inappropriate vaccines against complete virus when they are not needed is not only unnecessary; In some cases, it can be harmful.
Campbell pointed out the development of the RSV vaccine as a case in question.
“When we use the virus vaccine for the full virus many years ago, instead of protecting the children of the RSV, it led to what we call ‘antibody dependent improvement,” he said. “The children had a RSV worse than if they had not been vaccinated, and that was because they had a complete virus inactivated by formalin.”
That Vaccine against the RSV trial was in the 1960s, and delayed decades investigation.
Since then, said Campbell, RSV vaccination has been directed only against the F protein, a piece of the virus, or has used a monoclonal antibody, which is like a preformed immune response. The first RSV vaccine was approved in 2023.
“Those protect really well,” he said. “We do not want to use the vaccine killed against the virus throughout the RSV. It will harm people.”
Some vaccines against the virus around the world are still used. Hepatitis A vaccines and rage are killed by vaccines against the entire virus, which means that they include the constituent pieces of the virus that have been inactivated. Seasonal flu vaccines also use full virus technology.
Campbell said it is possible that a full virus vaccine can be an optimal choice for some pathogens in the future.
In search of a universal flu vaccine
But as for whether the entire virus platform will unlock a new innovation in the search for a universal flu vaccine, as suggested by the Department of Health and Human Services, Campbell said it would be possible to use vaccines against the entire virus if they could be genetically designed to express multiple flu tension antigens, but that it does not have much to do with the entire virus platform.
“If it’s just a complete virus, and it’s a tension, that’s what we do now,” said Campbell.
Emily Hilliard, HHS press secretary, said in a statement: “The Golden Standard of the generation marks a critical step to restore the strategic approach and radical transparency to the pandemic preparation of the United States.”
“Developed completely by government scientists, free from the influence of the industry, the BPL vaccine platform could provide broad and lasting protection against all viral influenza pathogens, including influenza and coronavirus, with the additional potential to block transmission and stop outbreaks at the source,” said Hilliard. BPL, or beta-propioactone, is a chemical that has been used for decades to kill the viruses used in vaccines.
A universal flu vaccine has been an objective of scientists for a long time, since it would ideally offer years against the flu. Due to the speed with the muta virus, annual flu vaccines are needed to protect against the most current strains.
“There are many different ways in which people are working, and if we choose only one of them, especially one that is a very old technology that people have tried so many times before and could not make a universal flu vaccine, I think it is putting all our eggs in a basket and that the field does not really advance,” said Campbell.
Offit said that withdrawing research funds for RNM vaccines could be particularly detrimental in the case of a pandemic.
“If something bad happens, as if there were an aviar flu pandemic, for example, we will be less prepared,” he said, added that RNM technology has a shorter production cycle than totally killing virus vaccines, which means that a Vaccine against MNR would be available much earlier.
Rasmussen said: “We would probably need a year to climb to the manufacture of complete national scale” using a full virus vaccine, adding: “Actually, you have to grow a ton of virus and then inactivate it and then make sure it is inactivated.”
With other vaccine technologies, such as protein subunit or RNAs, “basically you make protein or RNAm, which can be done synthetically, without requiring any viruses or anything for it to grow it,” he said. “They are much easier to change and adapt as necessary, since new strains can arise.”
Offit said: “One of the studies among the 22 studies that were eliminated in that retirement of $ 500 million was considering to what extent the RNM technology would be valuable for avian flu.”
Ultimately, Campbell said, science should lead the way, not from top to bottom to link the hands of scientists.
“The devil is in the details, not only in radical statements on which platform is an appropriate platform and what is not,” he said.
There are multiple platforms available for vaccine development, which are tested for their respective properties.
“Eventually, one or two, perhaps, rise to look better, and those are the ones that people continue to chase,” he said. “That is what we do in vaccination, is trying to discover what works and what does not work, both for basic science, by immunology, for disease models, before entering humans, and then real human studies to compare and contrast immune responses, safety and protection, not only sweeping statements on the platform.”
