PCV - Pneumococcus

In children, acute otitis media (middle ear infection) is the most common form of pneumococcal disease and S. pneumoniae can be found in up to 55 percent of ear aspirates. Before the age of one, over 60 percent of children will have at least one middle ear infection. Otitis media results in more medical office visits than any other childhood illness. Symptoms of pneumococcal otitis media (middle ear infection) in children include fussiness, tugging at ears, sleeplessness, hearing difficulties, and balance issues. In some children, ear infections can become chronic, resulting in recurrent antibiotic use or surgery to place tubes in the ears. Source: (3) 

Common sense practices are key to preventing the spread of contagious respiratory infections. This includes:

• Washing hands thoroughly or using hand sanitizer when hand washing is not available
• Staying home when ill. Staying home when you have been exposed to illness and may be contagious.
• Using a tissue when sneezing or coughing

BREASTFEEDING

Breastfeeding is an incredible way to reduce the risk of your baby catching Pc infections. Breast milk has antibodies that coat the lining of the nose, lungs, and intestines, so most germs that get inhaled or swallowed are killed. Planning to breastfeed your infant for the first six months of their life exclusively, as well as for at least two years if possible, is a great way to boost their immune system and prevent serious illnesses. The following links have more information about the benefits of breast milk:

• Breast milk provides protections against many respiratory diseases, including influenza (flu) 
• “Studies have found that the benefits of breast milk protect against a wide variety of other diseases. Here’s a partial list: Haemophilus influenzae type B, Pneumonia caused by Streptococcus pneumoniae, Meningitis, Infant botulism, Urinary tract infections, Cholera, Salmonella, E. coli infections, Respiratory syncytial virus.”  Source: (4) 
• According to Dr. JP Sears, ”The benefits of human breast milk and its association with healthier babies have been intermittently noted over the past few thousand years,” 
• In addition to providing optimal nutrition to infants, human breast milk has an abundance of bioactive factors that act as a part of the innate immune system of the gastrointestinal tract. Some factors have intrinsic properties that act as part of the defense system, whereas others enhance the ability of the gastrointestinal tract to defend the host.Source: (5) 
• Colostrum, which is what comes in the first few days before the milk comes in, is filled with antibodies and white blood cells that carry the mother’s immunity and literally coat the baby’s intestine and keep bad bacteria out of her body. (And, if your baby gets a cold, ask your doctor about pumping out a drop or two of your milk—into a dropper—and putting it right into your baby’s nose to help fight off a cold. Breast milk is packed with antibodies, white blood cells, enzymes and all sorts of other factors that boost a baby’s immune system. And finally, to make a long story short, breast milk essentially gives your baby probiotics, the good bacteria that helps keep us healthy!  Source: (6)

CHILDCARE SETTINGS

Furthermore, placing a young baby in a group daycare setting significantly increases a baby’s risk of exposure to many illnesses, including Hib, Pc, pertussis, rotavirus, and flu (to name a few). Planning to avoid large childcare settings, including church nurseries or gym childcare services, in the first year would be prudent if possible.

• Rates of illness were higher in children in child care than for children reared exclusively at home during the first 2 years of life, but the differences were non-significant by age 3 years. Source: (7) 
• Infectious Diseases in Childcare Settings Source: (8)
• "Day care centers cluster infants and young children, who are all especially susceptible to disease because their immune systems are inexperienced," Dr. Ellen Fitzpatrick from Sunrise Children's Hospital said. “They basically contract every virus they encounter. This, coupled with close quarters, sharing toys and any lapse in hand hygiene or diaper duty, creates the perfect environment for viruses and other microorganisms to breed. Source: (9) 
• Breast-fed babies who are not in a large group daycare setting have a lower than average risk of catching this disease.

WHEN IS IT GIVEN?

 The CDC recommends four doses of pneumococcal conjugate vaccine (PCV13) for infants and children, with a dose given at 2, 4, 6 and between 12 and 18 months of age.

IS IT SAFE?

The clinical trials relied upon to assess safety prior to licensing its use in children did not use a placebo-control group. Rather, Prevnar 13 was tested against the previous Prevnar vaccine. This vaccine, PCV7, was tested against an experimental meningitis C vaccine. There has never been a true safety study dependent on an inert saline placebo control group.

• INCREASED RISK OF FEBRILE SEIZURES: “A CDC study of children aged 6 months to 2 years has shown a small increased risk for febrile seizures during the 24 hours after a child receives the inactivated influenza vaccine (flu shot) at the same time as the pneumococcal 13-valent conjugate (PCV13) vaccine or the diphtheria, tetanus, acellular pertussis (DTaP) vaccine. The flu shot was not associated with an increased risk of febrile seizures when it was given on a different day from the other two vaccines. Studies have not shown an increased risk for febrile seizures after the DTaP vaccine, except when it is given at the same time as the flu shot. There may be a small increase in the risk of febrile seizure when PCV13 (pneumococcal) vaccine is given by itself.” Source: (10) 
• Prevnar 13 (PCV13) adverse reactions reported in infants and young children during pre-licensing clinical trials: injection site pain, swelling, redness, fever, decreased appetite, increased and decreased sleep, irritability, diarrhea, vomiting, rash, hives, hypersensitivity reaction including bronchospasm, facial swelling, and shortness of breath, seizures, pneumonia, gastroenteritis, bronchiolitis, and death (reported as SIDS.). Source: (11) 

Concerning ingredients: aluminum (125 micrograms), polysorbate 80 (100 micrograms)

•  ALUMINUM: there is a growing body of evidence that aluminum accumulates at potentially toxic levels (to the central nervous system and bones). The FDA made the recommendation that for preterm infants, aluminum should never exceed 5 micrograms per kilogram of the baby’s weight per day. J.B. Handley’s book The Autism Epidemic cites aluminum toxicity as a main contributor to the rise in autism diagnoses.
• POLYSORBATE 80: this is commonly added to vaccines and food as an emulsifier. The FDA generally considers it safe in small doses, but there is very little information regarding the safety of injecting this chemical. There has been recent research (a study in mice) that indicates polysorbate 80 causes metabolic dysfunction and may be a contributing factor to chronic inflammatory diseases and metabolic disorders. A study in rodents found that ingesting polysorbate 80 disrupted the composition of bacteria in the gut, causing low-grade inflammation and obesity. A 2005 case study found that injected polysorbate 80 can trigger anaphylactic shock.

IS IT EFFECTIVE?

Before the vaccine (2001), there was an estimate of around 17,000 cases of severe pneumococcal disease in children younger than 5 years old each year, and the CDC believes the annual number of Pc cases (both children and adults) has decreases by about 75% since the vaccine came into use. The reported number of severe cases in children under 5 each year over the past few years has been around 2,000, with experts estimating that the number is probably closer to 4,600. Source: (12) Dr. Bob Sear’s The Vaccine Book

About 1/3 of severe Pc cases are due to strains not covered by the current vaccine. Due to the history of strain replacement prevalent with the Pc bacterium, these uncovered strains will likely continue to increase, necessitating an even more expanded vaccine.

In the United States, two post-licensing trials on the effectiveness of the original 14-valent pneumococcal polysaccharide vaccine in the elderly or persons with chronic medical conditions found the vaccine to be ineffective against bronchitis and pneumonia in this particular population. Source: (13) Simberkoff MS, Cross AP, Al-Ibrahim M et al. Efficacy of pneumococcal vaccine in high-risk patients. Results of a Veterans Administration Cooperative Study. N Engl J Med. 1986 Nov 20; 315(21):1318-27

In addition to the vaccine’s ineffectiveness in eliminating pneumococcal disease from all strains contained within the vaccine, non-vaccine type strains have also emerged in the United States, most notably strains 33F, 22F, 12, 15B, 15C, and 23 A.31 Other countries have experienced a similar situation, including Taiwan, which noted a decrease in vaccine-type strain invasive disease and confirmed pneumococcal disease but an increase in non-vaccine type strain invasive disease, most notably caused by strains 23A, 15A and 15B. Sources: (15) Lee LH, Gu XX, Nahm MH Towards New Broader Spectrum Pneumococcal Vaccines: The Future of Pneumococcal Disease Prevention; (16)Vaccines (Basel). 2014 Mar; 2(1): 112–128, and Su LH,  Kuo AJ, Chia JH et al; (17) Evolving pneumococcal serotypes and sequence types in relation to high antibiotic stress and conditional pneumococcal immunization Sci Rep. 2015; 5: 15843

Korea has also reported high rates of antibiotic-resistant strains not found in PCV13 since the introduction of the vaccine.Non-vaccine type strains continue to appear in many Western European countries, prompting researchers stress the need for new vaccines to cover the antibiotic-resistant strains of S. pneumoniae not found within the current vaccines. Sources: (18) Tin Tin Htar M, Christopoulou D, Schmitt HJ Pneumococcal serotype evolution in Western Europe; (19) BMC Infect Dis. 2015; 15: 419; Büyükcam A, Güdücüoğlu H, Karaman K et al; (20)  Invasive pneumococcal infection due to serotype 15A after the pneumococcal conjugate vaccine implementation in Turkey. Hum Vaccin Immunother. 2017 Aug 3; 13(8):1892-1894. Steens A, Bergsaker MA, Aaberge IS et al; (21) Prompt effect of replacing the 7-valent pneumococcal conjugate vaccine with the 13-valent vaccine on the epidemiology of invasive pneumococcal disease in Norway Vaccine. 2013 Dec 16; 31(52):6232-8

Here are a few notable quotes from the NVIC PCV Safety Page:

• “Information on pneumococcal conjugate vaccine efficacy found in the Prevnar 13(PCV13) product insert reports information pertaining to the original PCV vaccine, Prevnar (PCV7).”
• “The Prevnar 13(PCV13) product insert also states that effectiveness of the vaccine cannot be established in the following population: Infants born prematurely, Persons with HIV-infection, Children with sickle cell disease, Persons who had received an allogeneic hematopoietic stem cell transplant”
• “Researchers in the United States have noted that while invasive pneumococcal disease has decreased since the introduction of pneumococcal conjugate vaccines, S. pneumoniae strains have continued to adapt and this has resulted in the ongoing emergence of antibiotic resistant non-vaccine serotypes. The use of pneumococcal conjugate vaccines has also caused an increase in other serious pathogens such as Haemophilus influenzae and Moraxella catarrhalis. Since the introduction of PCV vaccines, H. influenzae and M. catarrhalis otitis media have increased to replace S.pneumoniae otitis media”
• “While the CDC and other global health organizations have attributed the decrease in invasive pneumococcal disease to vaccination, the introduction of pneumococcal conjugate vaccines has brought changes to clinical practice. Emergency room collection of blood cultures, once a routine practice in the assessment and treatment of children presenting with fever in the emergency room, have decreased since PCV vaccine introduction. This change in clinical treatment protocol may be artificially inflating the rate of decrease of pneumococcal disease in children and reducing the detection of non-vaccine type replacement strains.”

WHAT ARE THE RISKS AND SIDE EFFECTS? 

• Vasovagal Syncope (fainting) 
•  Increased rates of otitis media (ear infections) 
• The PCV Vaccine insert states 8% of severe reactions occurred in initial safety testing

Reported pneumococcal vaccine reactions include fever, severe local reactions (swelling, redness, and pain at site of injection), irritability, drowsiness, restless sleep, vomiting, diarrhea, rash, decreased appetite, bronchiolitis, gastroenteritis, pneumonia, convulsions, and sudden infant death syndrome (SIDS). 

•  If given with the flu vaccine (common at 6 or 12 months), 1 in 1600 chance of febrile seizure
• CDC states that 80% become fussy or irritable. 50% have drowsiness and poor feeding. If given with DTaP and Hep B, it may compound these effects.
• NVIC states, “Using the MedAlerts search engine, as of May 31, 2019, there have been 21,536 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with pneumococcal vaccinations (PCV7, PCV13, PPSV23). Over 60 percent of these reported serious pneumococcal vaccine-related adverse events occurred in children 6 and under. Of these pneumococcal-vaccine related adverse event reports to VAERS, 2,306 were deaths, with nearly 70 percent occurring in children under 6 years of age.” 
• As of November 1, 2023, there have been 372 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following vaccination with pneumococcal conjugate vaccine (PCV), including 25 deaths and 347 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 147 children and adults, who have filed claims for pneumococcal conjugate vaccine injury. (Source: U.S. Department of Health and Human Services.)

STRAIN REPLACEMENT has been observed since Pc vaccines have been on the market. Most of the information below is sourced from the National Vaccine Information Center pages on PCV. 

Prior to PCV-13, there was PCV-7 which covered seven pneumococcal strains and was licensed in the US in 2000. The mass use of PCV-7 in America put pressure on 80-something other strains to cause invasive disease, along with being responsible for increasing the rate of otitis media( caused by other serotypes not included in the seven-valent vaccine. Therefore, PCV-13 was created.“Following PCV7 introduction on a global scale, scientists began to report that while the vaccine appeared to be effective in reducing nasopharyngeal carriage of S. pneumoniae strains found within the vaccine, this reduction had resulted in a significant increase in non-vaccine type strains, 43 most notably, strain 19A, a highly virulent and antibiotic-resistant serotype. In Spain, an increase in invasive pneumococcal disease occurred following the introduction of PCV7, with the emergence of several non-vaccine type strains,” NVIC PCV Info.

PCV-13 was introduced in 2010. “Since the introduction of PCV13, pneumococcal strains not covered within the vaccine have continued to emerge. Researchers in the United States have noted that while invasive pneumococcal disease has decreased since the introduction of pneumococcal conjugate vaccines, S. pneumoniae strains have adapted and antibiotic resistant non-vaccine strains have emerged. These non-vaccine type strains include strains 33F, 22F, 12, 15B, 15C, and 23 A.” 

FUTURE VACCINES

• Merck is currently (as of May 2019) in stage 3 clinical trials of a 15-valent pneumococcal conjugate vaccine, which will add strain 22F and 33F to the 13 strains currently found in PCV13.  Source: (21) PubMed https://pubmed.ncbi.nlm.nih.gov/30244873/
• In 2018, Pfizer was awarded Breakthrough Therapy Designation by the FDA for a new 20-valent pneumococcal vaccine. Source: (22) FiercePharma FDA Breakthough https://www.fiercepharma.com/vaccines/racing-merck-pfizer-wins-fda-breakthrough-tag-for-20-valent-pneumococcal-vaccine

SOURCES FOR PCV7 STRAIN REPLACMENT

• (24) Associated Press. Shot may be inadvertently boosting superbugs. NBC NEWS Sep. 17, 2007
• (25) Singleton RJ, Hennessy TW, Bulkow LR, et al Invasive pneumococcal disease caused by nonvaccine serotypes among alaska native children with high levels of 7-valent pneumococcal conjugate vaccine coverage. JAMA.2007 Apr 25;297(16):1784-92.
• (26)Ardanuy C, Tubau F, Pallares R, et al. Epidemiology of invasive pneumococcal disease among adult patients in barcelona before and after pediatric 7-valent pneumococcal conjugate vaccine introduction, 1997-2007. Clin Infect Dis. 2009 Jan 1;48(1):57-64.
• (27) Muñoz-Almagro C, Jordan I, Gene A, et al. Emergence of invasive pneumococcal disease caused by nonvaccine serotypes in the era of 7-valent conjugate vaccine. Clin Infect Dis. 2008 Jan 15;46(2):174-82
• (28) Fenoll A, Granizo JJ, Aguilar L et al. Temporal Trends of Invasive Streptococcus pneumoniae Serotypes and Antimicrobial Resistance Patterns in Spain from 1979 to 2007. J Clin Microbiol. 2009 Apr; 47(4): 1012–1020.

SOURCES FOR PCV7 STRAIN REPLACMENT

• (29) Lee GM, Kleinman K, Pelton S et al. Immunization, Antibiotic Use, and Pneumococcal Colonization Over a 15-Year Period. Pediatrics.2017 Nov;140(5).
• (30) Bender, K Pneumococcal Colonization Adapts to Vaccination, Antibiotics. MD Magazine.Dec. 1, 2017
• (31) Lee LH, Gu XX, Nahm MH Towards New Broader Spectrum Pneumococcal Vaccines: The Future of Pneumococcal Disease Prevention Vaccines (Basel). 2014 Mar; 2(1): 112–128.

Pneumococcal (PCV13- Prevnar13)

• bronchiolitis
• gastroenteritis
• pneumonia
• sudden infant death syndrome (SIDS)
• fever
• decreased appetitte
• irritability
• increased or decreased sleep
• diarrhea
• vomiting
• rash
• inconsolable crying
• hypersensitivity
• seizures
• urticaria
• anaphylactic/ anaphylactoid reaction including shock
• apnea