W saidWhile the COVID-19 medication is currently committed to protecting people from serious illness, public health professionals face serious questions about the shots and their ability to sustain them. prevention of disease in the years to come. Would a new power of corn be better? How long is the protection? Are boosters the only way to increase that defense? Is there a better and more organized way to provide vaccines and stimulants to increase prevention in the face of an ever -changing disease?
These are the topics discussed by the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee at a long virtual meeting on April 6. the reason for the increased effect of the vaccines on the prevention of COVID-19.
Because health professionals at the Centers for Disease Control and Prevention (CDC) and regulators at the FDA are constantly learning about how the disease works, and how prevention is necessary. and to protect it, the U.S. strategy relied on a game of capture: first following the waves of patients with first -line drugs and then with stimulants to keep those waves from rising. And complement the health care system with patients.
Currently, the medical system is a complex algorithm based on the medication available to people, as well as their age and medical status.
The Pfizer-BioNTech mRNA drug, for example, is approved as a first-line drug, which means two seasons, for 16 or more patients, and is approved under the emergency use control for children five to 15 years of age. It is considered a new booster for people under 12 years of age, but for children 5 to 11, the booster is recommended for people with weak immune systems. The current mRNA therapy is approved for people 18 and older as a two-dose first, and for a third, booster dose for these ages as well. The Johnson & Johnson-Janssen drug is approved as a first and second-line drug for 18 or more patients.
The FDA has also approved a second booster dose (four shots) of the drugs Pfizer-BioNTech and Moderna for people over 50 years of age and those with immune systems.
Tough leaders have led the FDA to call its committee in order to come up with a more efficient training plan moving forward. Currently, 70% of the American population has access to the drug from their first vaccine – two clusters of mRNA vaccines from Pfizer -BioNTech or Moderna, or one vaccine from Johnson & Johnson-Janssen. Only about 50% of this group had a booster disease.
Instead of confusing advice, studies show that the protection provided by cannabis, including stimulants, is reduced. The panel heard from CDC scientists, who reported in studies that combined blood serum from people who were fully treated with their primary sources with Omicron, there was a 25-fold drop in antibodies capable of neutralizing such; among those who were encouraged, there was a 6-fold fall in that neutralization process.
That’s why the booster plan isn’t stable at the moment, so the committee discussed ways to establish a plan designed to study the impact of the crop and make decisions about how to do it. when to change shots or boosters.
One project they discussed was the influenza model: With an age -appropriate flu shot, a panel of scientists invited by the World Health Organization to analyze data on genetics the spread of influenza viruses and the number of established diseases. They then discuss the type of influenza that needs to be included in the year, and health agencies in different countries follow this advice when it comes to prescribing their medications. years old.
This model does not apply to SARS-CoV-2, because researchers are not aware of its genetic mutations and the nature of human disease. The various mutations that have changed from the original disease to the present, including Alpha, Beta, Delta and Omicron, do not show any pattern or progression from a set of mutations to another. It is very different from influenza virus, which usually changes in the general airways.
In addition, while most anti -inflammatory drugs are developed in the same way, by growing the desired influenza viruses in chicken eggs then producing specific flu proteins that included in the shots, there are a variety of tracks used in the COVID-19 kits, depending on the other. mRNA, some in recombinant viral proteins, and others in viral vectors that send viral messages to the immune system.
In addition, with COVID-19, it is not clear what age-appropriate vaccine is as common as influenza, but it is not entirely clear what causes that change. “The problem is how we decide when we need to change the color, and what will be the threshold where we can say there’s a lot of escape from preventing the? cancer needs a change – it’s a difficult question to answer, ”Drs. Cody Meissner, director of pediatric surgery at Tufts Medical Center, and one of the FDA committee members.
Such decisions should be made using information that may or may not be the gold standard that committee members want to know, for good reasons. If new versions of medicines that address different conditions are to be developed, those vaccines must go through safety and testing. Ideally, it would come from a month -long study of those who were detained and then diagnosed with the disease, to see if they had the disease, and if they did, how the disease was.
But, for example, to have enough new shots ready for a wave of cases in the fall, they need to be tried and done by May or June. The committee members therefore discussed the possibility of using the nature of the lab -related studies that have led to permits and approvals to this day, where scientists test blood. from those recorded and measuring the quality of the antibodies produced that can eradicate the disease.
Such studies are being done. The committee’s focus is on COVAIL, released by the National Institute of Allergy and Infectious Diseases. The trial, which investigates the different booster types – and characteristics – of Moderna’s COVID -19 mRNA images, involved about 600 participants in 24 cells across the US. All the volunteers were arrested with two rounds of Modern shooting, as well as one assault. They will be given one of the six stimuli:
- any disease of the early kidneys
- a series of test shots that point to the Beta and Omicron modes
- Two images, given two months apart, of the same trial drug exploring the different Beta and Omicron variants.
- a kind of test shoot that captures Delta and Omicron
- a disease of the experimental drug looking to Omicron
- a sample of the experimental drug that refers to the original filter and Omicron.
“Can we create a design where we’re not looking for different flavors but can create a texture that points to a cocktail of different flavors?” said Dr. Nadine Rouphael, physician of medicine and executive director of the Hope Clinic at the Emory Vaccine Center, and director of the COVAIL research. “The idea behind COVAIL is to take the different medications that are available, just put them together, and try to see what kind of natural responses they compare with the other. [original] kano. “Rouphael expects first results this summer. Other similar studies on Pfizer-BioNTech’s mRNA disease are being worked on together and will provide results within a few months.
The current policy of responding to COVID-19 waves with a new booster disease is “we don’t get what we want, which means a vaccine that lasts longer and is more resistant. -Pale, “said Rouphael. Most of the members of the board agreed that a vaccine that was prescribed to many patients at the same time, could provide longer-lasting protection, which may be the most effective treatment in COVID- disease management. 19.
The committee also stressed that before waiting for the pharmaceutical industry to refer to the images they are developing, as has been the case so far, the FDA needs to take a more aggressive approach. “Now the developers have come to us with ideas for evaluating the composition and nature of the vaccines,” said Jerry Weir, director of viral products at the FDA’s Office of Vaccines. Research. “How about the idea that we have to prioritize the lessons that need to be done to understand the choice?”
The committee appealed to the FDA for giving them too much information about studies such as COVAIL, and the genetic mutations in SARS-CoV-2 that scientists are looking for, in order to to determine the information about the future work on the COVID-19 model. to be published. “What keeps me up at night is the knowledge that we can’t keep growing. We’re going to get cancer, and I’m not talking about immune fatigue but physical fatigue. from those who are not encouraged, “said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. “We want people to continue to have confidence in the safety and well-being of all COVID-19 patients. Our goal is to stay ahead of the various types and diseases of the future to ensure that they are safe. we are doing our best to reduce the number of illnesses and deaths due to COVID-19 in our population. “
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