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How Does a Vaccine Get Approved?

Vaccine Production

The vaccines that are used to prevent some of the world’s deadliest diseases go through extensive testing and trials in order to ensure the safety of the general public. The stages of vaccine production, according to historyofvaccines.com are the exploratory stage, the preclinical stage, and then the three stages of clinical development.

The Stages of Development

Exploratory Stage

In the exploratory stage, a 2-4 year study takes place in identifying specific antigens and how they cause disease as well as how they would bee useful in vaccine production.

Pre-clinical Stage

In the preclinical stage, cell and animal testing is used to study the effectiveness of thee vaccine in question. They determine a safe starting dose as well as how the vaccine could be improved upon in the future. Challenge studies are also used, as animals are vaccinated and then infected with the pathogen to see the response and effectiveness of the vaccine.

Clinical Stage

There are three phase of the clinical stage of vaccine development. This is to ensure the safety of the recipients as well as how effective the vaccines is in preventing disease. Phase one includes a small number of adults that are given the vaccine, usually non-blinded, and thee researchers will assess the response of the immune system to the vaccine. Sometimes there will be a challenge study involved to test the effectiveness against a pathogen. Phase two involves hundreds of people as well as a placebo drug. Dose, frequency of immunizations, as well as method of delivery is established in phase two. Phase three involves thousands of people in aa double blind test. Thee large group is to identify any side effects that may occur with the vaccine as well as to study the immune response. After success with all three phases, a vaccine may get approved for use in the general public.

HIV Vaccine Development

Scientists and researchers have been trying for years to create a vaccine against the HIV virus that causes AIDS. So far, the virus has been extremely well equipped in blocking any vaccine attempt, but researchers at the Fred Hutchinson Cancer Research Center in Seattle have developed a way that may avoid the many factors that make HIV impossible to prevent. It involves a five step process in order for our B cells to more efficiently produce antibodies against the virus. There would be a precursor injection that would prompt the B cells to make the specific antibodies followed by four to five more injections that allow the body to recognize the different aspects of HIV that make it so virulent.

Pregnancy, Childbirth, and Allergies

Can What a Mother Eats During Pregnancy Have an Effect on Allergies in Children?

There have been studies taking place that are linking a mother’s diet to the development of allergies, eczema, and asthma. It is largely speculated that the microbiome of a pregnant woman can affect the health of her child. According to the article by Healthline, a study was done involving over one thousand pregnant women, tracking what they at throughout their pregnancy and then the health of their children following birth. According to the results “33 percent of children developed allergies by the age of 2 if their mothers had poor diet diversity and a history of allergic disease.” These statistics suggest a relationship between the microbiome of a mother and the development of immune related issues such as allergies, though scientists are not sure which members of the microbiome have the greatest benefits towards unborn fetuses.

Babies Born Vaginally Show Lower Instances of Immune Issues

An article in Newsweek suggests that there is evidence that not only a mother’s diet has an impact on allergies and other immune related issues, but how the baby is brought into the world. Babies that are born vaginally have a less of a chance of developing immune related issues like eczema and asthma than those born via c-section. This is likely a result of all of the good bacteria present in the birth canal that is transmitted to the fetus during childbirth. These bacterium are extremely beneficial to the development of a baby’s immune system as they rely on passive immunity for a short time following birth. The immune system is not fully developed for a year, so natural birth practices as well as breast feeding are extremely beneficial in protecting a baby from deadly diseases as well as preventing development of autoimmune related issues like allergies.

Breastfeeding Plays a Huge Role in Immunity

Sometimes a mother has no choice in how their baby is born like in instances where an emergency c-section is needed. In these cases, the article in Newsweek represents the medical opinion of Dr. David Hill; “He explained that while choosing between a vaginal birth or c-section isn’t always an option, breastfeeding “even small amounts” could protect children from allergies.” Breastmilk contains important antibodies and immunoglobulin that protect the baby from harmful diseases that they are too young to get vaccinated against. Formulas are not sufficient as a complete breastmilk substitute, as scientists are not even certain of all of the microbiome benefits from breastmilk. Practices like consuming a varied diet while pregnant, having a vaginal birth if possible, and incorporating breastmilk into a baby’s diet as much as possible are very beneficial to proper development of the immune system and decreasing odds of developing autoimmune issues.

Lack of Education Results in STD Outbreaks

Children in Pakistan are Testing Positive For HIV

According to an article in the New York Times, Parents of HIV positive children are panicking at the possibility that their pediatrician is at fault for hundreds of new cases of the virus in the past couple of months. These people live in lower income areas and rely on affordable means of healthcare. This unfortunately has resulted in pediatricians reusing needles in order to save money. HIV is a virus that is passed through blood and bodily fluids and it causes Acquired Immunodeficiency Syndrome, or AIDS. This unfortunate diagnosis leads to a lifetime of medical visits and many cases of early death. These children are also shunned by their family and friends because of the lack of education around the way the disease is spread.

STD Outbreaks in American Universities

According to Baker University’s campus newspaper, there was an outbreak of highly infectious Chlamydia due to unsafe sex. Chlamydia is a sexually transmitted disease that can cause long term reproductive issues, especially in women. One statistic states, “According to the Centers for Disease Control and Prevention (CDC), there were 1,069,111 reported chlamydia cases in 15-24-year-old individuals in 2017.” This is a concerning number that continues to rise, resulting in increased concern regarding STDs in college age people. A lot of the sex education that these people are receiving in their high schools as well as from their parents is not sufficiently teaching them about how to avoid not only pregnancy but STDs as well.

What Can be Done?

In both cases, lack of proper education contributes to the problem. Concerning the tragedy in Pakistan, the parents who are taking their children to see the pediatrician are being taken advantage of by the health care providers. They think that their children are in safe hands because we are taught to trust those that care for our health. Better education for the Pakistani public on how diseases like HIV are transmitted and treated may allow parents to see the warning signs of a possible transmitter like dirty needles. Better education would also allow for peace of mind for the frieends and family of tthe iinfecteed persoon, so theey do not feel like an outcast in theeir own community.

Better sex education for Americans would also improve the situation. Many people are taught that abstinence is the only way to avoid STDs and pregnancy and are not aware of protection measures, as well as warning signs of certain sexually transmitted diseases. This leads to higher instances of unprotected sex and disease transmission.

Humira for Treating Rheumatoid Arthritis

What is a Monoclonal Antibody and what is Humira?

Humira is a monoclonal antibody medication that is used to treat and relieve the symptoms of Rheumatoid Arthritis. Antibodies are the human body’s natural way of defending itself from infectious disease. When a aspects of a disease are detected, also called antigens, the body produces specialized antibodies to fight it off. In some cases the body tries to fight off itself, this is known as an autoimmune disease. Rheumatoid arthritis is an autoimmune disease that affects the joints, causing pain and inflammation. According to MedNet, An effort to treat these diseases is known as monoclonal antibodies. These are laboratory made antibodies that target specific receptors or another action of the immune response that is causing the disease.

How Does Humira Treat RA?

In the immune response, certain receptors trigger the release of Tumor Necrosis Factor, or TNF, which results in inflammation, the body’s way of healing and destroying microbial invasion. In the case of Rheumatoid Arthritis, TNF is released due to a self immune response, where there is no evidence of microbes or signs of tissue damage, instead the cells of the immune system respond to the body’s own cells. According to the manufacturing site, Humira binds to TNF which results in the blocking of its effects, therefore reducing swelling and inflammation of the joints. This medication is also used to treat many other autoimmune diseases that have to do with chronic inflammation, such as Chron’s Disease.

Unfortunately, Humira comes with a wide array of side effects; infections such as TB, hepatitis b in those who carry it, allergic reactions, nervous system problems, blood problems, heart failure, other immune related issues, liver problems and psoriasis. Patients have a bigger risk of developing tuberculosis because the tumor necrosis factor is extremely important for the inflammatory response that rids the body of the disease. this drug affects the innate immune response because Tumor Necrosis Factor is a mediator of the acute inflammatory response and is secreted by a variety of innate immune cells such as macrophages.

Recent Outbreaks

Think Again About Owning a Pet Turtle

Reptiles and chickens are common reservoir for species of Salmonella. According to an article in Forbes, a recent outbreak of Salmonella oranienburg, resulted in the sickening of over 20 people. The source of the illnesses were pet turtles, a common carrier of the bacteria that are not susceptible to the signs and symptoms of the disease which include; cramping, diarrhea, fever, headache, nausea, and vomiting. According to the article,”After noticing that Salmonella outbreaks seemed to be associated with smaller turtles, the U.S. Food and Drug Administration (FDA) earlier this year banned the sales and distribution of turtles with shells less than four inches long.” It would be advisable to keep reptiles away from young children and the elderly, as well as those with compromised immunity, as they are more susceptible to death from the disease. It seems as though outbreaks of these diseases are extremely present in our society, it would be wise to practice good hygiene, such as washing hands after handling reptiles and raw poultry and to cook food all the way through to reduce the chances of contacting Salmonella.

Outbreak of Shigella in California

According to an article by the Food Poison Journal, there has been a recent outbreak of Shigellosis, a disease caused by the group of bacteria Shigella. This disease includes, cramps, diarrhea, and a fever and may cause severe dehydration in children and elderly people and those with compromised immune systems. This disease is transmitted through the fecal-oral route and can be prevented with simple hand-washing and good hygiene practice. Humans are the only reservoir of the disease and it is commonly passed as a result of serving food with contaminated hands. The disease can also be transmitted via fomites, so it is very important to decontaminate surfaces that will be used for food prep and eating.

How Can We Prevent Dangerous Outbreaks?

Outbreaks of Salmonella and Shigella can be extremely dangerous in communities that have very young and very old populations. Children can succumb to diarrheal diseases very quickly from dehydration so it is very important to practice rehydration quickly and effectively. But how can these outbreaks occur less and affect less people? It is very important to practice good hygiene and effective cooking techniques in order to eliminate the bacteria from fomites and food. Making sure that young children understand the consequences of interacting with reptile as well as not washing their hands after using the bathroom is another effective way of preventing diseases in daycare and schools.

Antibiotics and the Microbiome

In-Patient Care

According to an article in New Scientist, patients who are treated with intravenous, as well as oral antibiotics are more susceptible to harmful pathogens, such as Clostridioides dificile, due to the decrease of healthy bacteria in the gut microbiome. This is called dysbiosis. According to the article, “In the hospital People treated for several days in an intensive care unit had their stomachs quickly colonized by harmful pathogens, tests show. Healthier gut microbes were pushed out – a shift that may have long-term effects after someone is discharged.” Broad spectrum antibiotics (those that target a wide range of gram-positive and gram-negative bacterium) are most likely the culprit of the loss of a healthy microbiome. It may be beneficial for healthcare providers to search for the direct cause of an infection and provide narrow-spectrum antibiotics to treat it. There is also a great overuse of antibiotics, resulting in increased antibiotic resistance, that has been on an upward trend since the discovery of Penicillin in the 1940s. If physicians become more conscious of the dosage, toxicity, and duration of antibiotic treatment, there may be less of an effect on the gut microbiome.

Out-Patient Care

In contrast to in-patient care, physicians are much more likely to prescribe medication that is not needed, for example the use “amoxicillin” for viral infections like the common cold. According to an article by Infection Control Today, the overuse of antibiotics is a major contributor to bacteria obtaining resistance to them, “Improper use of antibiotics has been associated with increased morbidity, costs, and the proliferation of resistant bacteria. According to the CDC, antibiotic resistance occurs when bacteria develop the ability to defeat the drugs designed to kill them.” There is also an increased risk of developing secondary infections due to reduction in the natural microbiome, as well as from the surviving resistant bacteria that result from over as well as misuse of antibiotics.

What are the Consequences of Dysbiosis?

Dysbiosis is the changing of the microbiome, sometimes as a result of antibiotic use. The rise in over prescriptions of antibiotics in hospital and out-patient settings, as well as the misuse of them by consumers has resulted in an alarming amount of antibiotic resistant bacteria, as well as infections that colonize due to the inevitable reduction of the body’s natural microbiota. According to past blog research, the lessening of the body’s microbiome may actually lead to conditions like Alzheimer’s and Parkinson’s disease as well as other infections like C. diff. It is extremely important for consumers to use their antibiotics fully and correctly, as well as for physicians in an out-patient settings to try to avoid prescribing antibiotics unless absolutely necessary. Physicians in an in-patient setting may be able to become more conscious of which antibiotic they are choosing to use as well as how high the dose is and the duration of treatment.

Superbugs are Super Bad

What are Superbugs?

Antibiotics are known historically as changing the face of medicine, millions of lives have been saved due to the manufacturing and use of these drugs but according to a commentary piece on ResearchGate, superbugs are an increasing issue in today’s society due to the overuse of antibiotics to treat infections. Superbugs are defined as bacteria that are resistant to antibiotics. Most infections do not call for the prescription of antibiotics as they are eliminated sufficiently with the body’s natural defense system. According to the commentary piece, “The severity of the situation can be measured by the findings of Centers for Disease Control and Prevention (CDC), USA, which declared the use of two-third of the antibiotics as inappropriate or unnecessary.” The use of antibiotics in general leads to the development of antibiotic resistant bacteria through natural selection as well as mutations with horizontal gene transfer, a common known one being Methicillin-Resistant Staphylococcus aureus or MRSA which is an extremely dangerous microorganism. One of the most concerning aspects of this process, though it is inevitable, it is being sped up by the unnecessary use of antibiotics.

How Exactly is This Occurring?

According to the commentary piece, this phenomenon is occurring at an alarming rate mainly due to self medication as a means to treat viral infections, which are not susceptible to the use of antibiotics. There is also a large consumption of these drugs in the livestock industry allowing potentially lethal diseases to mutate in a way that could possibly infect humans as a result of food consumption. There is a large mindset of “if I get sick, then I will just be prescribed medicine to treat it,” however, many of the diseases that are over treated with antibiotics are preventable with simple hygiene practices like washing hands and preparing food correctly. If people are more mindful of the way diseases spread, there would be less of a need for antibiotics and therefore would lessen the probability of superbug development.

Can Superfoods Help Control Superbugs?

Due to antimicrobial resistance being an increasing issue in today’s society it is very important to find solutions to this sooner than later, many researchers are taking an interest in the properties of superfoods, which may be beneficial in the treatment of otherwise incurable diseases. According to an article by the Telegraph UK, the solution to drug resistant bacteria may reside in the properties of green tea, this was tested by combining a drug that is becoming useless in treating serious infections with a chemical in the tea, “Researchers at the University of Surrey combined epigallocatechin (EGCG) with the antibiotic, finding the combination was up to 31 per cent more effective at killing off harmful bacteria compared to the drug antibiotic alone.” This may be the secret to treating serious infections that would otherwise kill the patient.

New Developments in Vaccine Research

Wouldn’t it be Great to Avoid the Annual Influenza Vaccine?

According to an article in the Baltimore Sun, the University of Maryland has been granted a 200 million dollar grant to improve the effectiveness of the Influenza vaccine. Influenza is a highly infectious disease that causes millions of infections and thousands of deaths each year. Every Fall, millions of Americans receive their annual flu vaccine, which is chosen based on mutation patterns of the virus. These mutations are a result of antigenic drift, which are minor changes in the virus, causing it to be unrecognizable to our immune system. People commonly refuse to get the vaccine as they find it to be ineffective or are ignorant to how serious the disease actually is. In order to combat this, the federal government has initiated action in flu vaccine funding and research to potentially create a vaccine that is effective for more than a year at a time. The researchers at the University of Maryland are hopeful that the vaccine will improve within seven years. I believe this would be an extremely beneficial result of the grant as it would ensure immunity for multiple years (like the MMRV vaccine) as well as provide peace of mind to those who are immunocompromised or too young to be vaccinated, which make up a large number of the deaths from the flu each year.

Is Immunity from HSV-2 (Genital Herpes) a Possibility?

According to an article by EurekAlert, the University of Pennsylvania School of Medicine has been conducting research on a potentially effective vaccine for Herpes Simplex Type 2, more commonly known as Genital Herpes. They tested their vaccine on mice and guinea pigs with a surprising amount of success. According to the researchers, “This vaccine stimulates three types of antibodies: one that blocks the herpes virus from entering cells, and two others that ensure the virus doesn’t “turn off” innate immune system protective functions.” This would be extremely beneficial for humans, as herpes is an extremely common sexually transmitted disease with no cure, as the virus lies latent in the body until the immune system weakens. It can infect anybody and raises the risk of being infected by HIV. Mothers can spread it to their babies by vertical transmission. Millions of people would be able to prevent this infection with a course of action other than remaining abstinent.

Why is Vaccine Research so Important?

The federal government is choosing to fund research like the flu vaccine effort in order to provide safety to those who rely on herd immunity as well as healthy individuals who succumb to the disease due to not being vaccinated every year. In an age of “anti-vaccination movements,” information being spread over social media has a lot of influence on the views of the general population regarding the safely of vaccines. Creating a more effective flu vaccine would be extremely beneficial as it would only need to be administered a certain amount of times rather than yearly and would allow millions of people to avoid sick days from work or school each year. This would also protect thousands of people who rely on others to be immune to deadly diseases like influenza. A vaccine for a less common disease like Herpes Simplex Type 2, would reduce the amount of population that exists with the latent virus within them. It could help reduce the susceptibility of HIV as well as herpes cases in newborn babies.

Anti-Vaccination Jokes Will Never Get Old…

Facebook’s Issue With The Anti-Vax Movement

Facebook has been a popular social media website since its inception in 2004 by Mark Zuckerberg . In the past few years however, members of the anti-vaccination movement have been using the platform to spread discredited and incorrect information about vaccines, especially the MMRV vaccine that was falsely attributed to developmental disabilities. This has gripped many members of the Facebook community and caused them to fight against mandatory vaccinations by claiming bodily autonomy, and that their children will suffer from vaccine injuries. According to The National Public Radio, Facebook has recently addressed this matter by insisting they will be removing advertisements and posts that spread misinformation about vaccines. They are partnering with large organizations such as the World Health Organization and Centers for Disease Control and Prevention, in order to obtain factual information regarding vaccine education in hopes that it will educate parents on the harmful effects of not receiving deadly disease prevention.

Why Get Rid of the Movement?

The Anti-Vax movement was founded on the now discredited journal article linking the MMRV vaccine and Autism. Measles, a potentially deadly disease especially in young children, the elderly, and those with compromised immune systems, has been on the rise in multiple cities in the United States. According to an article by USA Today Measles was declared eliminated from the country in the year 2000, thanks to the introduction of the MMRV vaccine in 1963, and is at risk of losing that status due to a recent outbreak in New York among other states. The MMRV vaccine is 97% effective, leading to the conclusion that most of the infections are a result of not getting vaccinated. It is very unfortunate that anti-vax parents would deliberately put not only their own children, but those who rely on herd immunity due to age or a compromised immune system, at risk due to the false notion that it will give their child autism. These people continue to spread misinformation on social media platforms, resulting in more parents refusing to protect their children. It really has to stop.

Is Facebook Going to Help?

I believe that taking the platform away from the people who are spreading anti-vaccination information will have a positive effect on the effort to contain the Measles outbreaks as well as spreading information regarding the importance of herd immunity. People will believe anything that they read on the internet, especially if there seems to be factual evidence backing it up, such as the discredited journal article in the Lancet. If this information was removed from the site and replaced with factual information from global health organizations, it would encourage parents to vaccinate their children and advocate for others to do so in order to maintain a “Measles free America” as well as keep other dangerous diseases in check.

Can Your Microbiome Make You Sick?

What is a Human Microbiome?

The human body contains billions of microbiota that flourish on our skin and in the vagina, oral cavity, and digestive tract. Those that inhabit our gut are mostly bacteria that thrive in the large intestine, and according to the journal Cells, the gut microbiome are responsible, in part, for a large amount of bodily functions such as; maintaining homeostasis of the intestines, metabolic functions, and strengthening the immune response. There is also evidence to suggest that there is direct communication between gut microbiota and the brain regarding these bodily functions. We are constantly told by our parents, coaches, and teachers to maintain a healthy diet in order to perform best physically and cognitively, this is important in maintaining a healthy microbiome as well. If the gut-brain communication is disrupted, especially during adolescence, it can result in a large number of conditions ranging from allergies and asthma, to serious autoimmune diseases like Rheumatoid Arthritis or Multiple Sclerosis. There is also evidence that disruption of a healthy microbiome can lead to neurodegenerative diseases such as Parkinson’s and Alzheimer’s Disease.

Can Gut Microbiome Alterations Cause Parkinson’s Disease?

The short answer is maybe. According to the article written in the journal Cells, there may be a connection between disruptions in the normal human microbiome and the onset of the neurodegenerative Parkinson’s Disease, that affects the motor system. This discussion was sparked by the notion that Lewy bodies, which are clumps of protein in the brain that contribute to many neurological disorders, are being found in areas outside of the central nervous system, leading researchers to believe that the microbiome is responsible for these abnormalities. The authors suggest through their research that “when comparing the human microbiome samples from healthy controls versus PD patients, significant dysbiosis was observed in PD that correlated to a change in the relative abundance of certain bacterial genus or species, rather than the appearance or disappearance of a particular microbial population.” They found that bacteria that is present in minuscule amounts in healthy individuals are present in larger amounts in those with Parkinson’s Disease. Though no connection has been officially concluded, it makes one wonder if a definite connection is found, this disease may be able to be treated like Clostridium Difficile is. A fecal transplant to reestablish a healthy gut microbiome.

What About Alzheimer’s?

Alzheimer’s Disease is also a neurodegenerative disease common in elderly people, that causes dementia. According to the journal Molecular Neurobiology, in recent years, a new hypothesis on how Alzheimer’s disease develops is becoming increasingly popular, as older studies have become disproven. There is the notion that dysbiosis of the gut microbiome that comes with age as well as unhealthy habits can actually lead the metabolites and LPS of the gut bacteria to penetrate the epithelial barrier between the intestines and the rest of the body, that sparks a systemic inflammatory response that ends up affecting the microglia in the brain and the astrocytes that maintain the tight junctions in the blood brain barrier. It seems as though more definitive research may allow for researchers to potentially treat the debilitating symptoms of Alzheimer’s with therapies involving restoration of a healthy microbiome. There may be a way to stop the disease from occurring through the use of healthy habits and probiotic usage.