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AN OVERVIEW OF VACCINE DEVELOPMENT

According to an article by the College of Physicians of Philadelphia, vaccine development is a lengthy, complex, and tiresome process that often lasts up to 15 years. By the end of the 19th century, a plethora of vaccines for humans had been previously developed, including smallpox, rabies, cholera, and typhoid vaccines. Although this was beneficial, there was no vaccine production regulation available at the public and private level. By 1902, the first federal legislation passed in order to control the quality, regulation, and oversight of drugs as they make their way through the 3-step production process. The first step is the exploratory stage, a period of 2-4 years that is burdened by laboratory research. Typically during this time, federally-funded scientists identify natural or artificial antigens (which may be weakened viruses, weakened bacterial toxins, virus-like particles, etc.) that may help prevent or treat a targeted disease. Many pre-clinical studies are conducted in order to test the new product’s ability to provoke an immune response in an organism. Animal models are also used in this stage to give researchers an expectation of the response in humans. Many, many candidate vaccines sadly do not move on beyond this stage because they fail to produce the immune response.

MORE STAGES IN VACCINE PRODUCTION

Next up, the pre-clinical stage involves an application for an Investigational New Drug (IND) to the United States Food and Drug Administration. This application includes a summary of their laboratory results, manufacturing, testing processes, and a proposed study in order to move forward. Once this thorough application has been approved, there are three further sub-phases of testing. According to the CDC, small groups of people (around 20-80 individuals) receive the trial vaccine during Phase I of testing. The goal of this phase is to assess the safety of the trial vaccine and determine the extent of its immune response. During Phase II, the candidate vaccine is given to people who have similar characteristics to the desired population (i.e., people at risk for developing the targeted disease). The goals of this phase are to determine the proposed dosage, schedule of immunizations, method of delivery, and further assess the vaccine’s safety and immunogenicity. If the vaccine successfully passes Phase II, then Phase III uses trials and placebos involving tens of thousands of people. This is a vital stage as certain rare side effects may not be presented in smaller samples, but may surface in a large group of participants. After this long and complex process of approval, the FDA will continue to monitor the authorized vaccine’s production for safety and efficacy. There is also a more specialized vaccine surveillance program – the Vaccine Adverse Event Reporting System (VAERS) that is co-sponsored by both the FDA and CDC – that analyzes reports of side effects that occur after administration.

THE HIV VACCINE DEVELOPMENT PROCESS

According to the World Health Organization, the development of vaccine against HIV is just as complicated as it sounds. The first attempts at producing a vaccine against HIV occurred in the late 1980s, and these endeavors were based on eliciting an antibody response. However, because HIV is a strong pathogen that mutates rapidly in its host organism, their strong outer spike proteins conceal itself from the immune system. This hiding mechanism is super beneficial for the bug but has enormous adverse effects against its host, putting a halt to this antibody-mediated vaccine attempt. However, reports from a positive HIV vaccine trial were released in 2009. The vaccine (named RV 144) was tested in Thailand and employed a combination of two vaccines in order to boost each other’s effects. Fortunately, analysis of this trial proved that the experimental group receiving the vaccine had an infection rate of 31.2% less than the placebo group – great news for this important public health campaign! After this successful investigation, scientists realized that a vaccine against HIV will provide stronger protection if it mounts an adaptive immune response, including both cell-mediated and antibody-based fights.

THE ALLERGY EPIDEMIC

According to a 2019 article, an estimated 32 million people in the United States alone have food allergies. This totals to nearly 10% of the population, a whopping 10 time increase since the prevalence reported 35 years ago. Not only does the prevalence seem to be increasing, but so does the severity of patients’ symptoms. According to a January 2019 study by the Food Allergy Research and Education (FARE), insurance claims for an anaphylactic reaction to food rose approximately 377% in the span of 2017 to 2016. Moreover, the amount of emergency room visits for anaphylaxis in young children more than doubled in the span of 2010 and 2016. These scarily increasing statistics are backed by the notion that our eating habits (that lack necessary dietary fiber) have thrown our normal gut microbiota out of wack. Additionally, due to our expanded exposure to antibiotics, infants are inherited a less diverse microbiota from their mother as they pass through the birth canal and enter the world.

THE IMMUNE RESPONSE

Because an allergic person’s immune system has been thrown out of wack, their body overreacts to harmless proteins (from eggs or peanuts, from example). A food allergy stems from a series of “biochemical misunderstandings.” According to a 2019 ScienceDaily article, the body naturally produces an antibody called Immunoglobin E (also known as IgE). Once this IgE encounters an intruder on the skin or within the body, it will release histamine to flag it for attack and cause an allergic reaction. Those with a food allergy will have an increased and overreactive IgE response against peanuts, eggs, milk, or whatever they are allergic to. The next time a person is exposed to the same allergen, the IgE antibodies will once again signal fighter cells to blast the intruder with histamines and other weapons in order to create an inflammatory response. Sometimes this allergic reaction can be just a sneeze, while other times it can be fatal when left unchecked.

WHAT’S NEXT?

After much researching into the allergy epidemic, the American Academy of Pediatrics advised that children that are risk for allergies (as revealed by family history, a personal history of eczema, etc.) should be fed that certain allergen around 4 months of age. Although it sounds backwards, early exposure may actually help in preventing the allergy itself. There have been several approaches to this ever-spreading phenomenon, one being oral immunotherapy (OIT). This treatment option presents patients with gradually increasing amounts of an allergy in order to reduce their sensitivity. Sublingual immunotherapy (SLIT) has also been tested, in which an allergen dissolving tablet is placed beneath the tongue. Moreover, epicutaneous immunotherapy (EPIT) uses technology similar to a nicotine patch in order to deliver allergens through the skin. According to a July 2019 Physician’s Weekly article, Dr. Ruchi S. Gupta stresses the fact that there needs to be greater patient education and awareness in order for adults and children alike to receive a proper diagnosis to undergo appropriate treatment.

Some Scary Statistics

According to an August 2019 ScienceDaily article, the bacterium that causes gonorrhea has relentlessly beat all of the medicinal world. Just in between the years of 2013 and 2017, gonorrhea diagnoses have markedly increased by 67%, yet the antibiotics that used to stop it have proved helpless. The once-reliable drugs used to include penicillin, tetracycline, and ciprofloxacin, yet Neisseria gonorrhoeae has successfully developed resistance to these. In 2010, once Neisseria gonorrhoeae had developed resistance to the last remaining class of antibiotics, the Centers for Disease Control and Prevention began recommending “dual therapy” to patients. This means that doctors must now prescribe two drugs at the same time in order to combat this strong bacterium. Although gonorrhea is not fatal, it can cause severe problems that last a lifetime.

A Public Health Concern

According to a recent report by the CDC, we are currently down to one last class of antibiotics that is effective against gonorrhea. This is a huge public health concern for the United States because gonorrhea control relies on our ability to treat the infection. In 1993, ciprofloxacin, a fluoroquinolone, and two cephalosporins (ceftriaxone and cefixime) were required treatments for gonorrhea. By 2006, nearly 14% of samples were resistant to Cipro in all regions of the country and in all homo- and heterosexual populations. By 2007, the cephalosporins were the only remaining recommended treatments for the second most commonly reported disease in the United States. And to put the icing on the cake, up to 30% of new gonorrhea infections that are reported each year are resistant to at least one drug minimum.

Severe Side Effects

If gonorrhea is left untreated, then this strong bacterium can be transmitted to others and produce severe health outcomes. These problems can include infertility, ectopic pregnancy, and increased risk for HIV in the future. There are multiple factors that lead the drive for increased gonorrhea exposure in the world. This includes expansive drug use, poverty, the stigma behind STDs, and unstable housing that can reduce access to STD prevention. Moreover, decreased condom use among vulnerable populations (including gay and bisexual men) can also lead to increased exposure to gonorrhea. At the local and state level, there have been detrimental cuts to STD programs in recent years which reduces patient follow ip and linkage to care management. These factors prove significant when untreated gonorrhea may lead to newborn deaths related to STDs, revealing a marked 22% increase in the time between 2017 and 2018. All of these statistics about gonorrhea’s impact and resistance, although scary, could lead to increased awareness among the population so that those who are worried about their risk for STDs can get tested and treated in the most effective way.

WHAT IS A MONOCLONAL ANTIBODY?

According to a MedicineNet article, adalimumab (otherwise known by its brand name, Humira) is a drug prescribed to reduce the symptoms of rheumatoid arthritis, Crohn’s disease, psoriatic arthritis, and other similar diseases. While looking at that long name, notice that the last three letters spell “mab”, which suggests the main component of the drug is a monoclonal antibody. What is a monoclonal antibody, you ask? According to a Mayo Clinic article, monoclonal antibodies are molecules that are engineered in a laboratory in order to substitute for other antibodies. They can enhance or mimic the natural immune system, which can become really handy in its fight against foreign cells. They do this by flagging foreign cells for the immune system, blocking foreign cells’ growth, triggering cell membrane destruction, or blocking immune system inhibitors.

WHAT IS ADALIMUMAB?

Adalimumab is a synthetic, injectable antibody that binds and blocks the effects of Tumor Necrosis Factor alpha (TNF-alpha) in rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and psoriatic arthritis. TNF-alpha is a cytokine that creates an inflammatory response throughout the body in response to injury. In the case of arthritis, TNF-alpha is notorious for sparking pain, tenderness, and the swelling of joints. Unchecked arthritis can ultimately lead to the destruction of a person’s joints, so treatment is quite important to prevent extreme discomfort. Because adalimumab (or Humira) binds and blocks TNF-alpha, its consequence of inflammation is greatly reduced, and arthritis’s gradual joint destruction is either slowed or prevented – yay!

SIDE EFFECTS OF HUMIRA

As always, there could be side effects in response to taking Humira. The most common side effects include headache, rash, nausea, and vomiting. It may also cause swelling, pain, and itching at the site of injection. Because Humira suppresses the innate immune system for its effects to take over, taking this drug can make the patient susceptible to other diseases, and may be accompanied by minor infections of the urinary or respiratory tracts. It is also important to note, like many other drugs that block the effects of TNF-alpha, Humira may also be associated with more severe complications like tuberculosis, aplastic anemia, anaphylaxis, sepsis, and fungal infections. It is important that one should not take Humira if there is a chance they could be pregnant … wow, now I really sound like I’m dictating a Humira commercial.

WHAT IS SHIGELLA?

When I think about Shigella, I think about gross water, improperly handled food, and the lack of hygiene. According to the FDA, this is all somewhat true. Shigella is a bacterium that spreads from contaminated feces or pollute water in which an infected person has been. Food can also become contaminated when it is handled by an infected person who did not wash their hands after using the bathroom (tsk tsk) or if unclean water was used in the preparation of said food. Symptoms of shigellosis (dysentery, vomiting, cramping, fever – all the fun stuff) usually develop within a period of 8 hours-2 days after infection and typically subside by itself in a week or less. However, symptoms can become quite serious in some cases for which they are treated with antibiotics. And this was just the case with a few recent outbreaks within the last 6 months alone. (!!!)

FIRST SHIGELLA SCARE

According to a June 2019 article by the CDC, public health officials have been investigating a multistate outbreak of gastrointestinal illnesses that were linked to raw oysters from Estero El Cardon estuary in Baja California Sur, Mexico. As of June 21, 2019, 16 people reported being ill from five different states. Using interviews, the 15 people who consented answered questions about food exposures in the week before they came ill. All 15 reported eating raw oysters. These people were found to be infected with multiple pathogens including Vibrio parahaemolyticus, Shigella flexneri, STEC non-O157, Vibrio albensis, Campylobacter lari, and norovirus genogroup 1. Among the 15 people who provided information, 2 people (or 13%) were hospitalized for antibiotic therapy (which, by the way, don’t use Ampicillin – Shigella has already developed resistance). As of June 21, 2019, the outbreak seemed to have cleared and there were thankfully no deaths.

ONE MORE SCARE FOR GOOD MEASURE

According to a May 2019 article, there was another outbreak of shigellosis at a wedding party in Oregon, this time sickening 112 people. The outbreak was caused by Shigella flexneri type 3a, which accounts for less than 3% of S. flexneri accounts. According to Steven Rekant, an officer with the CDC’s Epidemic Intelligence Service, “This was one of the largest foodborne outbreaks of shigellosis in U.S. history.” And what was the cause? Contaminated asparagus … yum. This investigation defined shigellosis cases as having diarrhea that lasted 5 days, and further confirmed this when they isolated S. flexneri from patients’ stools. Of the 95 patients that provided information, 97% reported they developed illness within 12-72 hours after the wedding. 57 patients presented to a healthcare facility and 10 were unfortunately hospitalized. Thankfully, there were no deaths reported! At the end of the day, researchers pointed to poor hygiene by the food-handler as the “likely cause of contamination.” So, please people – wash! your! hands!

THE ANTIBIOTIC MISUSE SCARE

Although the vast majority of sinus infections will clear up on their own without antibiotics, most of these infections end up being treated by this therapy according to an article posted by the Harvard Medical School. It is because of this educational gap that have alarmed public health researchers because these unnecessary prescriptions lead to more side effects and higher bacterial resistance rates in the future. However, many patients demand antibiotics for their sinus infections and physicians prescribe them even with these concerning consequences. And it’s not just sinus infections that are causing a scare, it is frankly the majority of infections that are being improperly treated with an excessive amount of antibiotics that will lead to bacteria being resistant to all future treatment. This occurs when the bacteria in your body changes which makes it difficult for the medicine to fight the bacteria after increased exposure. In other words, it means that one day you might we might get an illness that cannot be treated with antibiotics due to its misuse according to an August 2019 article.

WHAT CAN GO WRONG WITH ANTIBIOTIC MISUSE?

According to a June 2019 article, antibiotics not only act on the pathogen that rudely causes your infection, but it also works on the natural, beneficial microbiota that occurs naturally in the body. In 2008, there was research conducted to study three healthy individuals that were treated with Ciprofloxacin. Later, their fecal samples were tested and found to contain about a third of the bacterial taxa. These researchers sadly discovered a decrease in taxonomic richness and diversity of their microbiota as well. Although many bacterial groups recovered after this inappropriate treatment, several bacterial taxa unfortunately did not improve, even after six months. Because there is a such a close link between the microbiota and its host, a disturbance of the natural microbiota by antimicrobial treatment can act as a potential harm to host health, leading to the development of autoimmune, allergic, and inflammatory diseases.

WHAT’S NEXT?

So, where do we go from here? Do we just cease giving antibiotics to infected individuals? When you look at the research, it seems that way. Children who are exposed to antibiotics within their first year of life have shown an empirical increased risk of developing asthma. In fact, their risk increased with the number of antibiotic courses prescribed. However, this evidence shouldn’t completely scare us into never using antibiotic therapy ever again – it is imperative that healthcare professionals prescribe antibiotics at only appropriate times and stress the fact that patients should take their full course of antibiotics even if symptoms subside. Additionally, although the gut microbiome can be permanently disturbed with even short-term or low-dose treatments, this may also open up a different avenue for microbiome modulation as a new therapeutic treatment for infections.

AN INTERNATIONAL PUBLIC HEALTH CONCERN

Although the title of this blog post sounds positive, bacteria that has evolutionary resistance against antibiotics through certain horizontal gene transfer is actually quite alarming. The increasing prevalence of this antimicrobial resistance is a significant phenomenon and concern in the public health field. In order to combat this international issue, researchers have been documenting the rate of drug resistance of specific pathogens to find a better approach to healthcare. According to a March 2019 article, some research groups in Mexico have calculated the drug resistance rate of Escherichia coli, Klebsiella pneumoniae, and Enterococcus faecium to name a few. Their study aimed to create a broader picture of antimicrobial resistance of both Gram-positive and Gram-negative bacteria through the participation of 47 different laboratories and hospitals across Mexico.

SCARY STATISTICS

So, what did this research conclude? These researchers found that K. pneumoniae‘s resistance reached as high as 12.5% for respiratory specimens. They observed that after three or four generations, E. coli resisted up to 50-60% of its specified antibiotics. In Acinetobacter baumannii, the resistance rates for cefepime and ciprofloxacin were higher than 50%. Regarding the Gram-positive Staphylococcus aureus, methicillin resistance was as high as 21.4% for respiratory specimens causing MRSA. I don’t know about you, but these statistics are quite concerning for me when antibiotics are widely thought to be the cure for ridding certain bacteria. There must be steps taken so that antibiotics can be used in its most effective state or so that the healthcare industry can use other forms of successful treatment for patients with these pathogens.

WHAT’S NEXT?

As much as I am worried about the future of therapy with these alarming statistics, there have been alternatives investigated in order for treatment to remain effective. According to a recent article, the use of antibodies, probiotics, bacteriophages, and antimicrobial peptides are currently undergoing clinical research as alternatives for conventional antibiotics. Regarding antibodies, their specificity and the inability of bacteria to develop resistance against them is highly attractive for treatment, however quite expensive. Probiotics and fecal transplant therapy have already been in practice in order to enhance and balance the human microbiota with great success. Because just designing new antibiotics will lead to inevitable resistance by bacteria, the use of oligonucleotides have also been in the works to silence resistance genes and to re-sensitize already-resistant bacteria. As more and more antibiotics are being rendered ineffective against drug-resistant bacteria, focus must be shifted towards these alternative treatment options because this antimicrobial campaign is a dangerous worldwide concern.

WHAT IS MELANOMA?

Melanoma is a type of cancer that begins in a person’s melanocytes (the cells that create melanin which pigments their skin). According to a recent article from the American Cancer Society, about 96,480 new melanomas will be diagnosed just in the United States in 2019 alone. Of those people, about 7,230 people are expected to die from this cancer as well. Melanoma is 20 times more common in whites than in African Americans, however like any type of cancer, there are a number of risks that blend into your vulnerability for it. To name a few, excessive UV light exposure, having an abundant amount of moles, having a personal or family history of melanoma, being immunocompromised, or just being older and male increase a person’s risk of melanoma. Wouldn’t it be simply incredible to design a vaccine that prevented against this horrible form of cancer so that thousands of people and their families around the world would not have to suffer?

A NEW VACCINE IN THE WORKS

I don’t know about you, but when I think of vaccines, measles and chicken pox and mumps come to my head, not cancer. However, researchers at Tel Aviv University have fortunately thought out of this MMRV box and have successfully created a vaccine to fight against melanoma, the most aggressive of the skin cancers. According to a 2019 Science Daily article, this new vaccine has so far proven effective in preventing melanoma and treating primary tumors in mouse models. The innovative research is focused on a single nanoparticle that Professor Satchi-Fainaro states has shown “for the first time that it is possible to produce an effective nano-vaccine against melanoma and to sensitize the immune system to immunotherapies.” At the molecular level, this vaccine stimulates the immune system and teaches its cells to identify and attack cells containing the melanoma’s detectable two peptide chain. This means that the immune system will attack melanoma cells in vaccinated mice from now on. The researchers also tested the new vaccination on healthy mice and found that the mice did not have a sick response, showing that the vaccine effectively prevented the disease as well.

WHAT’S NEXT FOR THIS VACCINE?

This vaccine has devised a whole new path into the treatment of melanoma, even in the most advanced stages of the disease. Before these Tel Aviv researchers materialized this immunization, the war on cancer (particularly melanoma) was primarily through chemotherapy, radiation, and immunotherapy which are all very invasive processes. Opportunely, this recent treatment has significantly delayed the advancement of melanoma and has extended the lifetime of all immunized mice in a noninvasive and more compassionate way. This new platform is so crucial to cancer treatment research because the nano-vaccine could not only apply to just melanoma but also numerous other types of abnormal cell growth. Just thinking about how a simple shot could significantly improve thousands of people’s lives leaves me astounded at the wonders of scientific research and hopeful for the future.

How Facebook is extending beyond social media

In the aftermath of the retracted 1998 Wakefield et. al article diving into the erroneous cause-and-effect relationship between receiving immunizations and developing autism, there has been a ludicrous wave of people refusing to vaccinate their children. Yes, you heard this right. People are choosing not to protect their kids against the horrors of a multitude of diseases and illnesses although vaccine efficacy has proven to be 80-99%. Although I cannot speak to their decision, I can spill facts about how they try to persuade others into their thinking – one way being through Facebook advertisements and groups. You may think this social media platform would not be compelling, but according to a March 2019 article, 18-year-old Ethan Lindenberger (who notably decided to get vaccinated against his mother’s wishes) testified that his mom did in fact use only Facebook or Facebook-linked sites for all of her information on the anti-vaccination movement. This proves how quickly severely misleading or downright fake information can circulate on the Internet and especially social media platforms.

HOW FACEBOOK CAN PUT A STOP TO THIS MOVEMENT

In an effort to put an end to this misinformation flow, Facebook recently announced that it will no longer recommend these anti-vaccination groups and block advertisements that promote their goals. It is important to note that the company itself is attempting to reduce the amount of people who see this content without censoring it completely. I think this move is quite beneficial as The World Health Organization came out with a statement saying that “vaccine hesitancy” is one of the top global threats to healthcare of 2019, and Facebook could be a platform that unintentionally spreads this reluctance to vaccines. Facebook putting a stop to these fraudulent claims is quite honorable if you think about it, as the spread of health misinformation can create real damage in our communities and world today. If Facebook is able to curb the falsified accounts of the anti-vaccination movement, then I believe there would be a huge decrease in the number of people who choose not to immunize their children, leading to healthier discussion about this movement and healthcare as a whole.

ANOTHER PERSPECTIVE ON THE ANTI-VAXXER MOVEMENT

While reading another article into this issue, I was intrigued by another perspective into the anti-vaccination movement. It is a principle of this campaign that the government has no right to force parents to vaccinate their kids before they enter public school. And yes, I believe that everyone has the right to their own body and their own decisions. I acknowledge the fact that the government should not force anyone to do anything against their own will, however we have rules for a reason. There have been decades of authorized research behind the science of vaccinations and its efficacy. It is important that everyone is vaccinated in order to eradicate certain illnesses and to keep our people safe.  And just because the anti-vaccination movement is endorsed by (discredited) theories that vaccines cause autism (which is not the worst thing in the world, by the way) does not make this faction legitimate. So please, for the love of herd immunity, go get your kids vaccinated!!!

The Autism and Microbiota link

According to the Centers for Disease Control and Prevention, one in every 59 children in the United States is diagnosed with autism spectrum disorder (ASD). Due to this increasing phenomenon within our nation, certain researchers have taken steps in order to hopefully aid children with ASD and their families in this significant lifestyle shift. Currently, there are some effective treatments for ASD such as social support and behavioral therapy because autism is largely focused on its associated communication difficulties. However, according to a 2019 ScienceDaily article, there is a new path within autism research headed up by Arizona State University that targets the gut microbiome, which normally helps our bodies to digest food and prevents growth of harmful bacteria. This new research is centered on this specific microbiome because gastrointestinal etiologies have been discovered to have a 30-50% comorbidity with ASD – its chronic pain may cause increased irritability, decreased attention, and adverse behavior. Additionally, this gut microbiome may affect brain health, as revealed when Krajmalnik-Brown, Arizona State University professor, stated “we are finding a very strong connection between the microbes that live in our intestines and signals that travel to the brain.” 

A Look into Microbiota Transfer Therapy

This new, cutting-edge technique is known as Microbiota Transfer Therapy (MTT), which is a fancy name for a type of fecal transplant. According to an Autism Speaks article which delineates MTT, the children received antibiotics for 2 weeks and then had a bowel cleanout to prepare for a colonoscopy. Afterwards, they received a transplant of healthy bacteria by mouth or by enema. Notably, there were remarkable improvements of gut health AND autism symptoms (such as social deficits and behavior difficulties) that persisted at least two years after treatment. These positive results could be largely due to management of these participants’ chronic discomfort, leading to more progressive and effective coping skills for behavioral issues without lingering pain.

FDA Approval

Because this MTT technique has been so effective for a considerable amount of children, the Food and Drug Administration has fast-tracked its certification in order to help families touched by autism. While running their own study delving into the method of MTT, the FDA discovered that this therapy reduced gastrointestinal symptoms by 77% and core ASD symptoms by 24% two months after treatment. It proved long-term effectiveness two years later as well. I completely believe that this fast-track designation is crucial to the well-being of families of children with ASD because there is currently no specific FDA-approved medication to target the core symptoms of autism. Moreover, having this microbiome technique quickly approved provides some relief and hope for their future lifestyle. In summary, the gut microbiome could play an essential role in treating core symptoms of ASD and establishing strong brain health. All I gotta say is … any one got more of that gut microbiome stuff?