PCV13 Tied to Fewer Pneumonia Hospitalizations in Older Adults

ACIP Endorses 20-Valent Pneumococcal Vaccine For Kids

The CDC's Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. Children.

All 14 members voted in favor of the following four proposals:

Routine use in children ages 2-23 months: ACIP recommended either the 15-valent PCV (PCV15; Vaxneuvance) or PCV20, according to currently recommended dosing and schedules.

Children with an incomplete vaccination status: PCV15 or PCV20 was recommended according to the current dosing and schedule as catch-up vaccination for healthy children ages 24 to 59 months and for kids 24 to 71 months with certain underlying medical conditions that increase the risk of pneumococcal disease.

Children ages 2 to 18 years with a risk condition: For kids in this age group who are already up to date on all PCV doses before 6 years of age, no more doses were recommended if the children received at least one dose of PCV20. However, if these kids received the 13-valent PCV (PCV13; Prevnar 13) or PCV15, the recommendation is for one dose of PCV20 or the 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23).

Children ages 6-18 years with a risk condition who have not received PCV13, PCV15, or PCV20: For this group, a single dose of PCV15 or PCV20 was recommended at least 8 weeks after the most recent dose. If PCV15 is used, a follow-up dose of PPSV23 was recommended at least 8 weeks later.

ACIP also added new underlying conditions to the list of risk conditions: chronic kidney disease (excluding dialysis patients, as those are listed under immunologic conditions), chronic liver disease, moderate persistent or severe persistent asthma (under chronic lung disease), and those with renal failure on maintenance dialysis.

"Pneumococcal vaccines at the moment are messy, and we're trying to make them a little bit coordinated with what's already out there," ACIP member Sarah Long, MD, of St. Christopher's Hospital for Children in Philadelphia, explained prior to the voting.

During the meeting, the CDC presented data showing rates of invasive pneumococcal disease in winter 2022 exceeding 1.20 per 100,000 children under the age of 5 years, while rates for 2018 to 2021 were all well below 1 per 100,000.

"We never know when we will have a severe season as we did this season," said Katherine Poehling, MD, MPH, of Wake Forest School of Medicine in Winston-Salem, North Carolina, and chair of ACIP's work group on pneumococcal vaccines. "This winter we saw more cases of mastoiditis -- which is a serious complication of the ear infections and pneumonia requiring chest tubes -- than I have seen for the last 20 years."

PCV20 offers the broadest serotype coverage of any PCV, adding serotypes 8, 10A, 11A, 12F, and 15B to the PCV15 vaccine. The FDA approved PCV20 for infants and children in April, with data supporting the approval in children ages 2 to 23 months based on randomized phase II and phase III data comparing the vaccine to PCV13.

In these kids, PCV20 showed numerically lower immunoglobulin G geometric mean concentrations for the 13 shared serotypes with PCV13. After the third dose, noninferiority for PCV20 versus PCV13 was not achieved for serotypes 1, 3, 4, 9V, 23F, and 12F for one of the outcomes. After the fourth dose, noninferiority was achieved for all 13 shared serotypes. The results also showed noninferiority to PCV13 for the seven additional non-shared serotypes.

For kids ages 2 to 18 years with risk conditions, a single-arm phase III trial (involving healthy children who had received three doses of PCV13) supported the approval, demonstrating that a single dose of PCV20 was immunogenic for all 20 serotypes a month following vaccination.

Poehling expressed concern over the lack of clinical data for the new vaccines: "I think it's very important to remind everybody that all we have is immunogenicity data," she said. "We have no effectiveness and no efficacy data on either PCV15 or PCV20."

Notably, she said, PCV15 has increased immunogenicity to serotype 3, "which is an important cause of pneumococcal disease today."

ACIP chair Grace Lee, MD, MPH, of Stanford University School of Medicine in California, said the multiple vaccine options were important, given the lack of data available on efficacy, particularly in children.

"I don't believe we have enough data to make a preferential recommendation [between PCV15 or PCV20] at this time," said Lee.

All recommendations from ACIP are not considered final until published in the CDC's Morbidity and Mortality Weekly Report.

Ingrid Hein is a staff writer for MedPage Today covering infectious disease. She has been a medical reporter for more than a decade. Follow

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Guidelines For Vaccinating Pregnant Women

1Hepatitis A Vaccine: Weigh risk vs. Benefit in pregnant women at high risk for exposure.

2Hepatitis B Vaccine: Vaccination is recommended for all previously unvaccinated pregnant adults. Heplisav-B and PreHevbrio are not recommended in pregnancy due to lack of safety data.

3Human Papillomavirus (HPV) Vaccine: HPV vaccines are not recommended for use in pregnant women. If a woman is found to be pregnant after initiating the vaccination series, the remainder of the 3‑dose series should be delayed until completion of pregnancy. Pregnancy testing is not needed before vaccination. If a vaccine dose has been administered during pregnancy, no intervention is needed.

4Inactivated Influenza Vaccine (IIV): Women who are or will be pregnant during influenza season should receive IIV. Age appropriate vaccine formulation must be given.

5Meningococcal (MenACWY) Vaccine and Meningococcal B Vaccines: Pregnancy should not preclude vaccination with MenACWY, if indicated. Defer vaccination with MenB vaccine unless benefits outweigh risks.

6Pneumococcal Conjugate Vaccine (PCV13, PCV15, PCV20): ACIP currently has no recommendation for PCV vaccination but ACOG recommends vaccination in pregnant patients at high risk for severe pneumococcal disease.

7Pneumococcal Polysaccharide Vaccine (PPSV23): The safety of PPV23 during the first trimester of pregnancy has not been evaluated, although no adverse consequences have been reported among newborns whose mothers were inadvertently vaccinated during pregnancy.

8Inactivated Polio Vaccine (IPV): Vaccination of pregnant women should be avoided on theoretical grounds. However, if a pregnant woman is at increased risk for infection and requires immediate protection, IPV can be administered in accordance with the recommended schedules for adults.

9Tetanus, Diphtheria, acellular Pertussis (Tdap) Vaccine: One dose of Tdap should be administered during each pregnancy irrespective of the patient's prior history of receiving Tdap. To maximize the maternal antibody response and passive antibody transfer to the infant, optimal timing for Tdap administration is between 27 and 36 weeks of gestation although Tdap may be given at any time during pregnancy. For women not previously vaccinated with Tdap, if Tdap is not administered during pregnancy, Tdap should be administered immediately postpartum. Wound Management: If a Td booster is indicated for a pregnant woman, Tdap should be administered. Unknown or Incomplete Tetanus Vaccination: Pregnant women who never have been vaccinated against tetanus should receive three doses containing tetanus and reduced diphtheria toxoids. The recommended schedule is 0, 4 weeks and 6 through 12 months. Tdap should replace 1 dose of Td, preferably between 27 and 36 weeks gestation.

10Anthrax Vaccine: In a pre-event setting with low risk for exposure to aerosolized B. Anthracis spores, vaccination of pregnant women is not recommended and should be deferred until after pregnancy. In a post-event setting with a high risk of exposure, pregnancy is neither a precaution nor a contraindication to PEP. Pregnant women at risk for inhalation anthrax should receive AVA and 60 days of antimicrobial therapy as described.

11Japanese Encephalitis (JE) Vaccine: No controlled studies have assessed the safety, immunogenicity, or efficacy of Ixiaro in pregnant women. Vaccination during pregnancy may be considered if travel to an area with endemic infection is unavoidable and risk of disease outweighs risk of adverse effects in pregnancy.

12Rabies Vaccine: Because of the potential consequences of inadequately managed rabies exposure, pregnancy is not considered a contraindication to post-exposure prophylaxis. If risk of exposure to rabies is substantial, pre-exposure prophylaxis might be indicated during pregnancy.

13Typhoid Vaccine: No data have been reported on the use of any of the typhoid vaccines in pregnancy. Vi polysaccharide vaccine should be given to pregnant women if clearly needed.

14Vaccinia (smallpox) Vaccine: Should not be administered in a pre-event setting to pregnant women or to women who are trying to become pregnant. If a pregnant woman is inadvertently vaccinated or if she becomes pregnant within 4 weeks after smallpox vaccination, she should be counseled regarding concern for the fetus. Smallpox vaccination during pregnancy should not be a reason to terminate pregnancy. Pregnant women who have had a definite exposure to smallpox virus (ie, face-to-face, household, or close-proximity contact with a smallpox patient) and are, therefore, at high risk for contracting the disease, should be vaccinated. When the level of exposure risk is undetermined, the decision to vaccinate should be made after assessment by the clinician and the patient of the potential risks versus the benefits of smallpox vaccination.

15Yellow Fever Vaccine: Pregnancy is a precaution for YF vaccine administration. If travel is unavoidable, and the risks for YFV exposure outweigh the vaccination risks, a pregnant woman should be vaccinated. If the risks for vaccination outweigh the risks for YFV exposure, pregnant women should be issued a medical waiver to fulfill health regulations. Although no specific data are available, a woman should wait 4 weeks after receiving YF vaccine before conceiving.

16COVID-19 Vaccine:Vaccination is recommended for all pregnant patients, those who might become pregnant, recently pregnant or breastfeeding. A growing body of evidence on safety and efficacy of vaccination indicates that benefits outweigh any potential risks. Those unvaccinated prior to pregnancy or previously received only monovalent vaccine are recommended to receive bivalent mRNA vaccine.

17Zoster Vaccine (RZV): Consider delaying vaccination until after pregnancy due to insufficient data. The live attenuated vaccine (ZVL) is no longer available.

Adult Immunizations: What You Need

Becoming an adult means leaving behind the trappings of our youth, but immunizations are not necessarily one of them. Many of the vaccinations we had as children need to be repeated as adults to maintain proper immunity. And just as adulthood brings a new set of responsibilities, being an adult can also require a new set of immunizations.

Many of the vaccines we received as children to create immunities to infectious diseases last a lifetime, but not all of them. For example, tetanus and diphtheria vaccines need to be updated with a new vaccine and then with booster shots every 10 years to maintain immunity. There are other reasons why adult immunizations may be necessary:

Some adults never received immunizations as children.

Vaccine recommendations and vaccines change over the years. Certain vaccines may not have been available when some adults were children.

Immunity can fade over time.

As we age, we become more susceptible to serious disease caused by common infections like the flu.

As an adult, we may work in the health care field or other profession that puts us at risk for contact with infectious diseases.

There have been several updates in adult vaccine recommendations since the last set of guidelines were released. One of the most notable: the Advisory Committee on Immunization Practices (ACIP) recommends that the human papillomavirus (HPV) vaccine be given to all amae and females aged 13 to 26.  Vaccination is also recommended for males through age 26 who have sex with men and for those whose immune system may be compromised. Other significant changes include:

The ACIP now suggests that adults without evidence of prior immunity to chickenpox receive the varicella vaccine. Special consideration should be given to:

Those at high risk for infection or transmission, such as health care workers and teachers

Those who are in close contact with people at high risk of infection

Family and others who come in contact with people with compromised immune systems

Shingles can be a very painful and debilitating disease. People 50 and older and people without evidence of immunity who are known to be at risk of exposure should be vaccinated against shingles.

The ACIP also recommends one or more doses of the measles, mumps, rubella vaccine (MMR) be administered to adults in certain age groups and with certain risk factors. Adults born before 1957 can be considered immune to measles and mumps.

Hepatitis B vaccine is recommended for adults seeking protection from hepatitis B exposure. Any adult working in high-risk environments like STD clinics or drug rehab centers, should be vaccinated for hepatitis B. Health care workers, public safety workers, household contacts, and sexual partners of persons with chronic hepatitis B should also receive the hepatitis B vaccine.

Pneumococcal vaccines - there are 2 types of pneumococcal vaccines in the U.S.: Pneumococcal conjugate vaccines (PCV13, PCV15, and PCV20) and Pneumococcal polysaccharide vaccine (PPSV23). Adults aged 19-64 should get a pneumonia vaccine if they have certain medical conditions or if they smoke. All adults 65 years or older should be vaccinated. Your doctor will be able to tell you which vaccine is best for you and what the dosing procedure should be.

The ACIP recommends that everyone aged 6 and older get a COVID-19 vaccination. These may be combined with other routine vaccines in the same doctor's visit. You're not fully vaccinated until 2 weeks after a single-dose shot or the second dose of a two-dose series. Those who are fully vaccinated can go back to activities they did before the pandemic and don't have to wear a mask or practice social distancing unless rules or laws require it.

If you are pregnant or planning to become pregnant, it is important that you make sure your adult immunizations are current. A child's first set of immunities is often passed on from the mother, and more importantly, contracting certain infectious diseases -- such as rubella -- while pregnant greatly increases a child's risk of birth defects.

The benefits of vaccinating pregnant women usually outweighs the risks of the vaccine, says the CDC. Risks to a developing fetus from a vaccine are largely theoretical, while risks to a fetus from an infectious disease contracted by the mother are well documented.

All women who are pregnant need to talk with their doctor about getting a flu shot and about getting the Tdap vaccine. The Tdap vaccine provides protection against tetanus, diphtheria, and pertussis and should be given during the third trimester of each pregnancy.

If you are pregnant or trying to become pregnant, talk to your health care provider before being vaccinated with a live virus vaccine, such as chickenpox, measles, or the LAIV flu vaccine. If possible, avoid live virus vaccinations during pregnancy or right before pregnancy since live virus vaccines can increase the risk of transmitting the disease to the fetus. If you're considering becoming pregnant and need a live virus vaccine, wait at least four weeks after vaccination before trying to get pregnant.

People who are pregnant have a greater chance of getting seriously ill with COVID-19. Having COVID-19 during pregnancy also raises the risk of complications, including preterm birth. So far, research shows that it's safe to get any of the COVID-19 vaccines. The ACIP suggests that people who are pregnant be vaccinated against the virus. 

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