Thursday, September 29, 2022

Is There A New Pneumonia Vaccine

And Then There Were Three

There’s a new pneumonia vaccine for adults

Two other pneumococcal vaccines for kids are currently WHO prequalified and are effective at preventing disease caused by the serotypes of pneumococcus they are designed to protect against. Achieving the landmark of WHO prequalification for a new PCV, however, is not easy. Since the initial licensure of the first PCV decades ago, only one other vaccine manufacturer has managed to achieve this goal. To become WHO prequalified, a vaccine must meet international standards for manufacturing quality and perform well in a series of rigorous preclinical and clinical evaluations designed to demonstrate safety and acceptable immune responses.

Accordingly, PNEUMOSIL® has undergone the required clinical development programs sponsored by Serum Institute in India and by PATH in The Gambiawith Phase 3 Gambian study results supporting the vaccines safety and ability to elicit comparable infant immune responses to a prequalified vaccine. In short, this means that the vaccine is expected to perform on par with other vaccines in its class, expanding the suite of options from which countries can choose.

Since WHO prequalification, PNEUMOSIL® also received in 2020 allowing the vaccine to be sold in the country. Soon after, it joined predecessor pneumococcal vaccines in being offered via the pneumococcal Advance Market Commitmentan innovative financing mechanism that supports vaccine manufacturers to produce and supply suitable and affordable vaccines for Gavi-eligible low-income economies.

How Much Does It Cost

For adults over age 65 who have Medicare Part B, both pneumococcal vaccines are completely covered at no cost, as long as they are given a year apart.

If you have private insurance or Medicaid, you should check with your individual plan to find out if the vaccines are covered. Usually, routinely recommended vaccinations, like the pneumococcal vaccines, are covered by insurance companies without any copays or coinsurance. This means you can often get the vaccines at little or no cost.

If you need to pay out of pocket for the vaccines, you can review prices for PCV13 and PPSV23.

Who Should Not Get These Vaccines

Because of age or health conditions, some people should not get certain vaccines or should wait before getting them. Read the guidelines below specific to pneumococcal vaccines and ask your or your childs doctor for more information.

Children younger than 2 years old should not get PPSV23. In addition, tell the person who is giving you or your child a pneumococcal conjugate vaccine if:

You or your child have had a life-threatening allergic reaction or have a severe allergy.

  • Anyone who has had a life-threatening allergic reaction to any of the following should not get PCV13:
  • A shot of this vaccine
  • An earlier pneumococcal conjugate vaccine called PCV7
  • Any vaccine containing diphtheria toxoid
  • Anyone who has had a life-threatening allergic reaction to PPSV23 should not get another shot.
  • Anyone with a severe allergy to any part of either of these vaccines should not get that vaccine. Your or your childs doctor can tell you about the vaccines ingredients.
  • You or your child are not feeling well.

    • People who have a mild illness, such as a cold, can probably get vaccinated. People who have a more serious illness should probably wait until they recover. Your or your childs doctor can advise you.

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    Persons New To Canada

    Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals, as necessary. Review of pneumococcal vaccination status is particularly important for persons from areas of the world where sickle cell disease is present, as persons with sickle cell disease are at risk of serious pneumococcal infections. In many countries outside of Canada, pneumococcal conjugate vaccine is in limited use. Refer to Immunization of Persons New to Canada in Part 3 for additional information about vaccination of people who are new to Canada.

    How Does It Compare To Other Pneumococcal Vaccines

    There Is A Shortage Of The Pneumonia Vaccine In The UK ...

    Like Prevnar 20, Prevnar 13 is a conjugate vaccine that works in a similar way to protect you against pneumococcal disease. Pneumovax 23, on the other hand, is a polyvalent vaccine that works by producing antibodies against pneumococcal bacteria.

    No vaccine is 100% effective at preventing disease, but all three pneumococcal vaccines Prevnar 13, Prevnar 20, and Pneumovax 23 are considered safe and effective for helping protect against pneumococcal disease. And this latest FDA approval demonstrates ongoing pneumococcal vaccine development, with more candidates currently in the pipeline.

    Lets review some key differences between the vaccines.

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    Babies And The Pneumococcal Vaccine

    Babies are routinely vaccinated with a type of pneumococcal vaccine known as the pneumococcal conjugate vaccine as part of their childhood vaccination programme.

    Babies born on or after 1 January 2020 have 2 injections, which are usually given at:

    • 12 weeks old
    • 1 year old

    Babies born before this date will continue to be offered 3 doses, at 8 and 16 weeks and a booster at 1 year.

    Which Pneumonia Vaccine Is Best

    There is no best pneumonia vaccine. The two available pneumonia vaccines are different, and which one is best for you depends on how old you are and whether or not you have certain medical conditions.

    The main difference between Prevnar 13 and Pneumovax 23 is the number of pneumococcus strains the vaccine protects against.

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    Signs Of Pneumonia Vaccine Side Effects

    As with any vaccination, there are potential side effects of the pneumonia vaccination. Common side effects include:

    Injection site soreness

    As with most shots and vaccinations, you may experience pain, swelling, or redness at the injection site .

    Less than 1% of people who receive a pneumonia vaccine develop a fever. If your temperature is above 100.4 F , you have a fever.

    Irritability

    Irritability is a feeling of agitation. When you’re feeling irritable, you’re more likely to become frustrated or upset. In children, this may present as fussiness.

    The Flu Pneumonia And Inflammation Create A Deadly Threat

    ASK UNMC What is the new recommendation on pneumonia vaccines for older adults?

    Pneumococcal pneumonia can follow other viral infections, particularly influenza, says William Schaffner, M.D., an infectious disease specialist at the Vanderbilt University School of Medicine. The biology behind it:The flu virus attaches to, and infects, the cells lining the mucous membranes in the back of the throat, nose and bronchial tubes. Normally, the cells eject infectious agents out of the body via the nose or mouth, or they’re simply swallowed. But when impaired by the flu, the cells lining these membranes allow the bacteria to slip down into the bronchial tubes and trigger a secondary infection, in the lungs. The infection inflames the air sacs in the lungs, causing them to fill with pus and fluid. That not only makes it hard to breathe but can allow bacteria to escape into the bloodstream, causing an infection called sepsis, an aggressive inflammatory response that can, ultimately, lead to organ failure.

    Pneumococcal pneumonia, of course, is also likely be a complication of respiratory syncytial virus , a common and highly contagious winter lung infection, whichuncharacteristicallyspread this summer, and SARS-CoV-2, the virus that causes COVID-19. However, the pneumococcal vaccine wont shield you from pneumonia that results from either of them. As Schaffner puts it, Pneumonia from Covid is a different sort of pneumonia.

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    Age Recommendations And Dosing

    Prevnar 13 is approved for use in children 6 weeks and older, and the CDC recommends it for children younger than 2 years old and people 2 years or older with certain medical conditions. Its given into the muscle, and its a 4-dose series for children between 2 and 15 months of age. For children who dont receive the vaccine at this time, a catch-up schedule is available.

    Prevnar 20 is currently approved for use in adults at least 18 years old, but official CDC recommendations havent been established yet. Its given as a single-dose injection into the muscle.

    Pneumovax 23 is approved for use in children 2 years and older at higher risk of infection and adults at least 50 years old. However, the CDC recommends it for all adults 65 years or older, people 2 through 64 years with certain medical conditions, and adults 19 through 64 years who smoke cigarettes. Its a single-dose injection given into the muscle or skin, but additional doses may be recommended for some people.

    Pneumococcal Conjugate Vaccine: A Newer Vaccine Available In India

    Streptococcus pneumoniae, or pneumococcus, causes pneumonia and infections of the brain and blood that is responsible for mortality in children under five years. Pneumococcal diseases are a major public health problem worldwide.S. pneumoniae is a Gram-positive encapsulated cocci. Based on differences in the composition of the polysaccharide capsule, about 90 serotypes have been identified. The capsule is an essential virulence factor. The majority of cases of pneumococcal diseases in infants is associated with a small number of these serotypes, which vary by region. Pneumococci are transmitted by direct contact with respiratory secretions from patients and healthy carriers. Although transient nasopharyngeal colonization rather than disease is the normal outcome of exposure to pneumococci, bacterial spread to the sinuses or the middle ear, or bacteremia following penetration of the mucosal layer, may occur in persons susceptible to the involved serotype. Pneumococcal resistance to essential antimicrobials such as penicillins, cephalosporins and macrolides is a serious and rapidly increasing problem worldwide. Facilities for laboratory diagnosis of S. pneumoniae, based on growth in traditional culture media, are available in laboratories for routine clinical microbiology, whereas serotyping is performed only in reference laboratories.

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    Summary Of Information Contained In This Naci Statement

    The following highlights key information for immunization providers. Please refer to the remainder of the Statement for details.

    1. What

    Streptococcus pneumoniae is a bacterium that can cause many types of diseases including invasive pneumococcal disease , and community-acquired pneumonia .

    For the prevention of diseases caused by S. pneumoniae in adults, two types of vaccines are available in Canada: pneumococcal 23-valent polysaccharide vaccine containing 23 pneumococcal serotypes and pneumococcal 13-valent conjugate vaccine containing 13 pneumococcal serotypes.

    NACI has been tasked with providing a recommendation from a public health perspective on the use of pneumococcal vaccines in adults who are 65 years of age and older, following the implementation of routine childhood pneumococcal vaccine programs in Canada.

    2. Who

    Information in this statement is intended for provinces and territories making decisions for publicly funded, routine, immunization programs for adults who are 65 years of age and older without risk factors increasing their risk of IPD. These recommendations supplement the recent NACI recommendations on this topic that were issued for individual-level decision making in 2016.

    3. How

    4. Why

    Food And Drug Administration

    Pneumonia: Symptoms, causes, and treatments

    FDA Drug Enforcement Administration

    Food and Drug Administration

    June 30, 1906 115 years ago
    Preceding agencies
    • Food, Drug, and Insecticide Administration
    • Bureau of Chemistry, USDA
    • Division of Chemistry, USDA
    Jurisdiction
    • Amy Abernethy, Principal Deputy Commissioner
    Parent agency

    The United StatesFood and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counterpharmaceutical drugs , vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices , cosmetics, animal foods & feed and veterinary products.

    The FDA’s primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act , but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction.

    FDA headquarters facilities are currently located in Montgomery County and Prince George’s County, Maryland.

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    Persons With Chronic Diseases

    Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional information about vaccination of people with chronic diseases.

    Asplenia or hyposplenia

    Hyposplenic or asplenic individuals should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine, followed by a booster dose of Pneu-P-23 vaccine. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

    Chronic kidney disease and patients on dialysis

    Individuals with chronic kidney disease should receive age appropriate pneumococcal vaccines. Children less than 18 years of age with chronic kidney failure or nephrotic syndrome, should receive Pneu-C-13 vaccine and Pneu-P-23 vaccine. Adults with chronic kidney failure should receive Pneu-P-23 vaccine. Adults with nephrotic syndrome should receive Pneu-C-13 and Pneu-P-23 vaccine. Due to the decreased immunogenicity and efficacy of Pneu-P-23 vaccine in children and adults with chronic kidney failure, 1 booster dose of Pneu-P-23 vaccine is recommended. Refer to Table 3, Table 4 and Booster doses and re-immunization for additional information.

    Neurologic disorders

    Chronic lung disease, including asthma

    Chronic heart disease

    Chronic liver disease

    Endocrine and metabolic diseases

    Non-malignant hematologic disorders

    Cochlear implants

    Where Can You Get The Pneumonia Vaccine

    Once you know one of the pneumonia vaccines is right for you or your family, you may wonder where to get it. These vaccines are commonly available at medical offices and hospitals, so you might be able to get one where you see your healthcare provider. If they do not have it, many pharmacies, including CVS and Walgreens locations, have the vaccine. Your local health department is also a good resource and often gives vaccinations.

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    This Infectious Disease Can Pose A Serious Health Risk For Those Age 65 And Older But Two Vaccines Can Offer Sound Protection

    One of the leading health dangers for older adults is pneumonia. It is the most common cause of hospital admissions after childbirth. In fact, adults age 65 and older have a higher risk of death from pneumonia hospitalization than any other reason.

    Pneumonia is an infection of the lungs by bacteria, viruses, or other microbes. Most cases are caused by the bacteria Streptococcus pneumoniae, Mycoplasma pneumonia, Chlamydia pneumoniae, Chlamydia psittaci, and Legionella pneumophila. A similar inflammation of the lung, called pneumonitis, can be caused by an inhaled chemical and is more common in people who have had strokes and have difficulty swallowing. A physical exam, chest x-ray, and blood test can confirm a diagnosis.

    New Merck Pneumonia Vaccine Ok’d In Us Weeks After Pfizer’s

    Moderna Combining COVID, RSV And Flu Vaccines Into One Shot

    U.S. regulators have approved a new pneumonia vaccine from Merck, more than a month after OK’ing an improved version of rival Pfizers shot

    U.S. regulators have approved a new pneumonia vaccine from Merck, more than a month after OK’ing an improved version of rival Pfizers shot.

    Both new shots offer better protection against bacteria that can cause pneumonia, meningitis and blood infections, as well as garden-variety ear and sinus infections.

    Merck said Friday that the Food and Drug Administration approved its shot, called Vaxneuvance, for people aged 18 and up. It protects against 15 of the roughly 100 pneumococcal strains, including those most responsible for severe disease.

    Merck hasnt disclosed its shots price or when it will be launched.

    Pfizers updated vaccine, Prevnar 20, was approved on June 8 for adults. It has a list price of $232, but Pfizer said insured patients likely can be vaccinated for free or at low cost.

    A panel of U.S. Centers for Disease Control and Prevention vaccine experts is set to review both vaccines in October and recommend who should get them.

    Pfizers new vaccine protects against seven more strains than the decade-old Prevnar 13, long the worlds most-lucrative vaccine with nearly $6 billion in annual revenue. In one large study, the new shot was 75% effective against the most serious disease.

    Merck and Pfizer have been testing their shots in children and infants and plan to seek approval for those age groups.

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    Do The Pneumonia Vaccines Work

    The pneumococcal vaccines are very effective at preventing pneumonia and other pneumococcal diseases in both adults and children. In one large study of over 84,000 adults aged 65 and older, those who received PCV13 were less likely to get pneumococcal pneumonia than were those who received a placebo shot. The vaccine protected about 45% of vaccinated people from getting pneumonia and about 75% from getting an invasive pneumococcal disease. Invasive pneumococcal disease is the most serious type and can be life-threatening.

    PPSV23 is also effective and protects at least 50% of vaccinated, healthy adults from invasive pneumococcal infections.

    In children, PCV13 has decreased the amount of invasive pneumococcal disease. According to the CDC, PCV13 prevented about 30,000 cases of invasive disease in the first 3 years it was available.

    Getting the vaccine not only protects you from getting pneumonia and other types of pneumococcal disease, but also protects vulnerable people around you who cant get vaccinated.

    Where Can I Find These Vaccines

    Your doctors office is usually the best place to receive recommended vaccines for you or your child.

    PCV13 is part of the routine childhood immunization schedule. Therefore, it is regularly available for children at:

    • Pediatric and family practice offices
    • Community health clinics

    If your doctor does not have pneumococcal vaccines for adults, ask for a referral.

    Pneumococcal vaccines may also be available for adults at:

    • Pharmacies
    • Health departments
    • Other community locations, such as schools and religious centers

    Federally funded health centers can also provide services if you do not have a regular source of health care. Locate one near youexternal icon. You can also contact your state health department to learn more about where to get pneumococcal vaccines in your community.

    When receiving any vaccine, ask the provider to record the vaccine in the state or local registry, if available. This helps doctors at future encounters know what vaccines you or your child have already received.

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