Pneumococcal conjugate vaccine

ACIP Recommends Routine PCV13 Immunization for Adults 65 and Older

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The CDC’s Advisory Committee on Immunization Practices (ACIP) held aspecial meeting(www.cdc.gov) Aug. 13 to discuss and vote on the use of pneumococcal vaccines in older adults. The meeting concluded with the committee recommending routine immunization with 13-valent pneumococcal conjugate vaccine (PCV13) for adults 65 or older.

The special session was convened prior to the regularly scheduled meeting in October to ensure any such recommendation was made as quickly as possible, said AAFP liaison to the ACIP Jamie Loehr, M.D., of Ithaca, N.Y. Doing so will allow physicians to discuss PCV13 vaccination with patients who are already visiting the office to receive the annual influenza vaccine, he said.

Recommendation Specifics

The recommendation addressed specifics of who and when to vaccinate, as well as about initiating a discussion with patients regarding additional vaccination steps.

First, the recommendation calls for offering a dose of the PCV13 vaccination, marketed by Pfizer Inc. as Prevnar 13, to adults age 65 or older who have not previously received a pneumococcal vaccine or whose previous vaccination history is unknown. The recommendation then notes that physicians should recommend a dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23), marketed by Merck and Co. as Pneumovax, for these patients six to 12 months after PCV13 vaccination.

STORY HIGHLIGHTS
  • The CDC’s Advisory Committee on Immunization Practices (ACIP) held a special meeting Aug. 13 that culminated in a vote to recommend routine immunization with 13-valent pneumococcal conjugate vaccine (PCV13) for adults 65 or older.
  • The ACIP also recommended that a dose of 23-valent pneumococcal polysaccharide vaccine be administered to these patients six to 12 months after PCV13 vaccination.
  • Currently, Medicare only pays for one dose of pneumococcal vaccine for patients older than 65.

Secondly, the recommendation states that if a patient 65 or older has not previously received the PCV13 vaccine but has received one or more doses of PPSV23, that patient should receive a dose of PCV13 at least one year after administration of the most recent dose of PPSV23.

If an additional dose of PPSV23 is indicated, that dose should be given six to 12 months after PCV13 vaccination and at least five years after the most recent dose of PPSV23.

The ACIP recommendation becomes valid only after it is approved by the CDC director and subsequently published in the CDC’s Morbidity and Mortality Weekly Report, Loehr explained.

Supporting Evidence

The decision to recommend PCV13 vaccination was supported by evidence from the Pfizer-sponsored Community-acquired Pneumonia Immunization Trial in Adults (CAPiTA) study(www.pfizer.com) that was conducted in the Netherlands.

The CAPiTA study involved almost 85,000 participants 65 or older, half of whom received the PCV13 vaccine and the other half of whom received a placebo. In the vaccine group, about 45 percent fewer first episodes of vaccine-type community-acquired pneumonia were seen compared to the placebo group. Also, a 75 percent reduction in vaccine-type invasive pneumococcal disease was seen in the vaccine group compared with controls.

“So it was pretty clear (from the evidence) that for vaccine-naïve people who had not received Pneumovax, getting this vaccine significantly decreased their risk of serious illness,” Loehr said.

Limitations of the study included that it was industry-sponsored and no participants had previously received the PPSV23 vaccine, he said.

“So there is no evidence, explanation or understanding of what happens to people who have had PPSV23 (regarding) how much PCV13 helps in addition,” Loehr said.

Medicare Coverage

Ideally, physicians would give both the PCV13 and PPSV23 vaccines separated by six months to a year to retain the initial vaccine’s efficacy. But currently, Medicare only pays for one dose of pneumococcal vaccine for patients older than 65.

According to Loehr, Jan. 1, 2016, is the earliest the Medicare representative at the ACIP meeting thought Medicare might be able to take the ACIP recommendation into account and approve coverage for two pneumococcal vaccines for those 65 or older.

“So someone walks in who just turned 65 last month — it’s very easy — you give them PCV13,” Loehr said, “or if someone has never had a pneumococcal vaccine, they could be 72, and the decision is straightforward to give them the PCV13 vaccine.”

However, if a patient is 67 and had the PPSV23 vaccine two years ago, the new ACIP recommendation calls for administration of the PCV13 vaccine, but Medicare won’t currently pay for it. The PCV13 vaccine costs between $135 and $150 and the patient would have to pay for it out-of-pocket. The upshot: There will be patients who turn down the second vaccine because it is expensive, said Loehr.

If a patient who is 65 or older hasn’t enrolled in Medicare and still carries insurance from a traditional insurance provider, a second pneumococcal vaccine should be more easily covered, Loehr said, because these insurers are required to follow ACIP guidance and they have to do so more quickly than Medicare.

Reassessing the Recommendation

During the recent meeting, ACIP members also addressed re-evaluating the PCV13 vaccination recommendation in 2018. At that point, they decided, the recommendation could be revised if needed.

In addition to monitoring the impact of the new recommendation in adults age 65 or older who receive the vaccine, the group also suggested monitoring disease trends among PCV13-naïve adults to evaluate the effects of herd immunity and the long-term utility of routine PCV13 use.

The history of the seven-valent pneumococcal conjugate vaccine that was released in 2000 and was for years recommended for infants and children could foreshadow what’s to come for PCV13, which is the version now recommended for these young patients.

“By (December 2010), those seven strains not only were very rare in children, but they also were very rare in adults, as well,” Loehr said. “So the presumption is, by the end of eight to 10 years after PCV13 has become widely adopted, there won’t be that many of those particular strains of pneumococcal disease still hanging around.

“If that is true, then the cost/benefit analysis of this vaccine changes dramatically. By vaccinating a number of children, you have actually protected most of the adults.”

U.S. Hospitalizations for Pneumonia after a Decade of Pneumococcal Vaccination.

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BACKGROUND

The introduction of 7-valent pneumococcal conjugate vaccine (PCV7) into the U.S. childhood immunization schedule in 2000 has substantially reduced the incidence of vaccine-serotype invasive pneumococcal disease in young children and in unvaccinated older children and adults. By 2004, hospitalizations associated with pneumonia from any cause had also declined markedly among young children. Because of concerns about increases in disease caused by nonvaccine serotypes, we wanted to determine whether the reduction in pneumonia-related hospitalizations among young children had been sustained through 2009 and whether such hospitalizations in older age groups had also declined.

METHODS

We estimated annual rates of hospitalization for pneumonia from any cause using the Nationwide Inpatient Sample database. The reason for hospitalization was classified as pneumonia if pneumonia was the first listed diagnosis or if it was listed after a first diagnosis of sepsis, meningitis, or empyema. Average annual rates of pneumonia-related hospitalizations from 1997 through 1999 (before the introduction of PCV7) and from 2007 through 2009 (well after its introduction) were used to estimate annual declines in hospitalizations due to pneumonia.

RESULTS

The annual rate of hospitalization for pneumonia among children younger than 2 years of age declined by 551.1 per 100,000 children (95% confidence interval [CI], 445.1 to 657.1), which translates to 47,000 fewer hospitalizations annually than expected on the basis of the rates before PCV7 was introduced. The rate for adults 85 years of age or older declined by 1300.8 per 100,000 (95% CI, 984.0 to 1617.6), which translates to 73,000 fewer hospitalizations annually. For the three age groups of 18 to 39 years, 65 to 74 years, and 75 to 84 years, the annual rate of hospitalization for pneumonia declined by 8.4 per 100,000 (95% CI, 0.6 to 16.2), 85.3 per 100,000 (95% CI, 7.0 to 163.6), and 359.8 per 100,000 (95% CI, 199.6 to 520.0), respectively. Overall, we estimated an age-adjusted annual reduction of 54.8 per 100,000 (95% CI, 41.0 to 68.5), or 168,000 fewer hospitalizations for pneumonia annually.

CONCLUSIONS

Declines in hospitalizations for childhood pneumonia were sustained during the decade after the introduction of PCV7. Substantial reductions in hospitalizations for pneumonia among adults were also observed.

Source: NEJM

 

Uganda: Immunization — Parents to Face Arrest.

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immunization

Story at-a-glance

  • Ugandan President Museveni issued a warning that parents who choose not to vaccinate their children will be punished severely, and the decision treated as a crime
  • In the US, children have been barred from attending public education institutions and adults have been fired from their jobs for choosing to avoid vaccination
  • The real issue surrounding vaccine mandates is not one of public health; it’s one of money, power and an assault on your freedom
  • You have the right to be fully informed about the benefits and risks of pharmaceutical products – like vaccines – and be allowed to make a fully conscious choice about whether or not you decide to take the risk, without being punished for it – but this right is increasingly under attack in the US and around the globe

Parents who choose not to vaccinate their children will be punished severely, and the decision treated as a crime, according to a warning issued earlier this month by Ugandan President Museveni.

Speaking at a primary school for the launch of the 10-valent pneumococcal vaccine (PCV 10), President Museveni said:1

“I’m going to consult with my people on what penalty should be given to parents who do not bring their children for immunization because some are just reluctant to do so.”

Jail Time for Making an Informed Medical Decision for Your Child?

President Museveni’s warning echoes threats being made around the globe, with the “public health police” coming after those who choose not to vaccinate their children, or make other “non-conventional” medical choices for them.

In Uganda, parents may soon face arrest, fines and jail time if they choose not to have their children vaccinated. In the US, children have been barred from attending public education institutions, and adults have been fired from their jobs, and these are just the latest tactics in a coordinated effort aimed at eliminating all vaccine exemptions.

Make no mistake … what’s happening in Uganda could soon be happening in the US, as vaccine choice is increasingly being targeted by public health officials and other vaccine proponents. All 50 states have enacted vaccine laws that require proof children have received a certain number of vaccinations in order to attend daycare, middle school, high school and college.

However, all 50 states currently allow a medical exemption to vaccination (medical exemptions must be approved by an M.D. or D.O.); 48 states allow a religious exemption to vaccination; and 17 states allow a personal, philosophical or conscientious belief exemption to vaccination for children attending school. But these exemptions are increasingly under attack.

Is Vaccination Necessary for the Greater Good?

Warnings like the one from President Museveni are often given under the pretense that such enforcement is necessary to protect public health. In the Ugandan case, it was referring to the PCV 10 shot, which is intended to protect children from pneumococcal infections, such as pneumonia and meningitis.

But the real issue surrounding vaccine mandates is not one of public health; it’s one of money, power and an assault on your freedom.

In the US, for instance, recent outbreaks of pertussis, measles, and mumps have officially been blamed on those who are unvaccinated, even though the diseases have occurred primarily in people who were vaccinated, and no one seems to be able to fully explain how that is the fault of those who are unvaccinated…

If the vaccine theory was correct, these people should have been protected because they were vaccinated. Published studies into the outbreaks have revealed that a lot of the blame should be placed on ineffective vaccines – not on the unvaccinated minority – yet vaccines continue to be pushed as the best way to protect against infectious disease.

Even President Museveni acknowledged that parents need to be boiling drinking water, using clean latrines and eating properly in order to help curb the spread of pneumococcal infections, yet still threatened parents with severe punishment for choosing not to vaccinate, implying that not doing so would put the entire country at risk.

This concept of “herd immunity,” the idea that when the majority of the community is vaccinated against a contagious disease, it offers protection for everyone in the community because there is little opportunity for an outbreak to occur, is widely promoted in the US as well, even though vaccines do not confer the same kind of immunity as being challenged by and overcoming the natural disease.

The science clearly shows that there’s a big difference between naturally acquired herd immunity and vaccine-induced herd immunity, as natural infection typically gives lifelong immunity, while vaccines only confer temporary (and incomplete) protection. Thus, the idea of vaccine-induced herd immunity is seriously flawed because when the vaccine’s protective period wanes, there is no more herd immunity.

In order to eradicate infectious disease from a nation, you need sanitation facilities, toilets, healthy food and clean water, as well as children and a population with healthy immune systems, yet vaccinations are typically touted as the first and best line of defense, while these important basics are largely overlooked.

Vaccinations May Increase Resistant Infection Rates

It’s imperative that your right to informed consent is protected, as the safety and efficacy of taking multiple vaccinations in childhood has never been proven. Instead what we are now seeing is a rise in vaccine-induced diseases.

For instance, certain hard-to-treat bacterial infections in children are on the rise because of the widespread use of antibiotics and the conjugated pneumococcal vaccines2 and a rise in shingles cases in adults has been linked to the chickenpox vaccine.3 The Prevnar pneumococcal vaccine has also been linked to the development of a deadly form of strep bacteria called 19A,4 which has developed super resistance and is spreading.

To put it simply, the widespread use of vaccinations may trigger bacterial adaptations leading to antibiotic-resistant bacterial diseases and vaccine-resistant viral diseases. Cases noted in the literature include:

  • Whooping Cough: In Australia, dangerous new strains of whooping cough bacteria were reported in March 2012.5 The vaccine, researchers said, was responsible. The reason for this is because, while whooping cough is primarily attributed toBordetella pertussis infection, it is also caused by another closely related pathogen called B. parapertussis, which the vaccine does NOT protect against.

Two years earlier, scientists at Penn State had already reported that receiving the pertussis vaccine significantly enhanced nasal colonization of B. parapertussis, thereby promoting vaccine-resistant whooping cough outbreaks.6

  • Hepatitis B: In 2007, immunologists discovered mutated vaccine-resistant viruses were causing disease.7
  • Polio: The oral polio vaccine, which is still used in many third-world countries, is made from live polio viruses, and carries a risk of causing polio. The viruses in the vaccine can also mutate or recombine into a deadlier version, igniting new outbreaks.

The US Centers for Disease Control and Prevention (CDC) admits that 154 cases of polio in the US that occurred between 1980 and 1999 were vaccine-associated, or on average 8 cases per year in the US.8

Your Freedom is Under Attack

Informed consent to medical risk taking is a human right. You have the right to be fully informed about the benefits and risks of pharmaceutical products – like vaccines – and be allowed to make a fully conscious choice about whether or not you decide to take the risk, without being punished for it like Ugandan President Museveni is suggesting. More than $2.5 billion dollars has been awarded to children and adults in America who have been seriously injured by vaccines. Yet those rights are increasingly being taken away.

For example, last year health officials in New Mexico changed their vaccine exemption form so that philosophical objections are no longer an option. In Vermont, the legal right to take a vaccine exemption for philosophical beliefs was also threatened with bills promoted by two Vermont legislators, State Senator Kevin Mullin and State Representative George Till.

They joined with the Vermont Health Commissioner, Dr. Harry Chen, to lead a crusade to take away philosophical exemption to vaccination but the bills went down in defeat after supporters of the National Vaccine Information Center (NVIC) and Vermont Coalition for Vaccine Choice educated legislators and the public about the need to keep the philosophical exemption from being stripped from Vermont public health laws.

Get Informed Before You Vaccinate

All Americans need to know their options for legally opting-out of vaccinations, and you also need to know why it’s so important to protect this legal option, whether you choose to use every federally recommended vaccine for yourself and your children or not. No matter what vaccination choices you make for yourself or your family, there is a basic human right to be fully informed about all risks and have the ability to refuse to allow substances you consider to be harmful, toxic or poisonous to be forced upon you.

Unfortunately, the public-private business partnership between government health and defense agencies and pharmaceutical corporations manufacturing and marketing vaccines in the US is getting closer and closer. There is some serious discrimination against Americans, who want to be free to exercise their human right to informed consent to medical risk-taking when it comes to making voluntary decisions about which vaccines they and their children use. We cannot allow that happen!

It’s vitally important to know your legal rights and understand your options when it comes to using vaccines and prescription drugs. For example, your doctor is legally obligated to provide you with the CDC Vaccine Information Statement (VIS) sheet and discuss the potential symptoms of side effects of the vaccination(s) you or your child receive BEFORE vaccination takes place. If someone giving a vaccine does not do this, it is a violation of federal law. Furthermore, the National Childhood Vaccine Injury Act of 1986 also requires doctors and other vaccine providers to:

  • Keep a permanent record of all vaccines given and the manufacturer’s name and lot number
  • Record serious health problems, hospitalizations, injuries and deaths that occur after vaccination in the patient’s permanent medical record
  • File an official report of all serious health problems, hospitalizations, injuries and deaths following vaccination to the federal Vaccine Adverse Events Reporting System (VAERS)

If a vaccine provider fails to inform, record or report, it is a violation of federal law. It’s important to get all the facts before making your decision about vaccination; and to understand that you have the legal right to opt out of using a vaccine that you do not want you or your child to receive. But as mentioned earlier, vaccine exemptions are under attack in a number of states, and it’s in everyone’s best interest to protect the right to make informed, voluntary vaccination decisions.

What You Can Do to Make a Difference

While it seems “old-fashioned,” the only truly effective actions you can take to protect the right to informed consent to vaccination and expand your rights under the law to make voluntary vaccine choices, is to get personally involved with your state legislators and the leaders in your community.

THINK GLOBALLY, ACT LOCALLY.

Mass vaccination policies are made at the federal level but vaccine laws are made at the state level, and it is at the state level where your action to protect your vaccine choice rights will have the greatest impact.

Signing up to be a user of NVIC’s free online Advocacy Portal at www.NVICAdvocacy.org gives you access to practical, useful information to help you become an effective vaccine choice advocate in your own community. You will get real-time Action Alerts about what you can do if there are threats to vaccine exemptions in your state. With the click of a mouse or one touch on a Smartphone screen you will be put in touch with YOUR elected representatives so you can let them know how you feel and what you want them to do. Plus, when national vaccine issues come up, you will have all the information you need to make sure your voice is heard.

So please, as your first step, sign up for the NVIC Advocacy Portal.

Contact Your Elected Officials

It is so important for you to reach out and make sure your concerns get on the radar of the leaders and opinion makers in your community, especially the politicians you elect who are directly involved in making vaccine laws in your state. These are your elected representatives, so you have a right and a responsibility to let them know what’s really happening in your life and the lives of people you know when it comes to vaccine mandates. Be sure to share the “real life” experiences that you, or people you know, have experienced with vaccination.

Internet Resources

I also encourage you to visit the following web pages on the National Vaccine Information Center (NVIC) website atwww.NVIC.org:

  • NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries and death. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
  • If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
  • Vaccine Freedom Wall: View or post descriptions of harassment by doctors or state officials for making independent vaccine choices.

Find a Doctor Who will Listen to Your Concerns

If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don’t want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to punish patients and parents who become truly educated about health and vaccination and want to make vaccine choices instead of being forced to follow risky one-size-fits-all vaccine policies.

If you are treated with disrespect or are harassed in any way by a doctor (or government official), do not engage in an unproductive argument. You may want to contact an attorney, your elected state representatives or local media if you or your child are threatened.

However, there is hope.

At least 15 percent of young doctors recently polled admit that they’re starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors, who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families, who decline use of one or more vaccines.

So take the time to locate and connect with a doctor, who treats you with compassion and respect and is willing to work with you to do what is right for your child.

Sources and References

 

Source: mercola.com

 

 

 

 

 

 

10-Valent Pneumococcal Vaccine Highly Effective in Infants and Toddlers.

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A 10-valent pneumococcal conjugate vaccine is up to 100% effective in preventing vaccine-type invasive disease in young children, according to an industry-sponsored study in the Lancet. The PHiD-CV10 vaccine, marketed in Europe as Synflorix, contains 10 serotype-specific polysaccharides conjugated to Haemophilus influenzae protein D, tetanus toxoid, and diphtheria toxoid carriers.

Researchers randomized nearly 46,000 Finnish children aged 6 weeks to 18 months to receive the pneumococcal vaccine or a control vaccine. Vaccination schedules depended on the patient’s age and included either two or three primary vaccinations at varying intervals, with or without a booster dose.

During over 2 years’ follow-up, there were 13 cases of vaccine-type invasive pneumococcal disease. The vaccine’s efficacy ranged from 92% to 100%, depending on the schedule followed. No safety concerns emerged.

A commentator says that the results “provide confirmatory, conclusive evidence about the vaccine’s benefits against invasive disease.”

Source: Lancet