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V114 Pneumococcal Vaccine Safe And Well Tolerated Among Healthy Infants
Streptococcus pneumoniae, commonly known as pneumococcus, can cause severe illness and even death in children. To combat this, pneumococcal conjugate vaccines (PCVs) have been developed and proven effective in reducing pneumococcal disease caused by vaccine serotypes.
A recent phase 3 study published in the journal American Academy Of Pediatrics evaluated the safety and tolerability of VAXNEUVANCE (V114), a 15-valent PCV, in infants. It was found that V114 pneumococcal vaccine safe and well tolerated among healthy infants.
The study conducted by Natalie Banniettis and a team of researchers involved 2,409 infants who were randomly assigned to receive either V114 or Prevnar 13 (PCV13) at ages 2, 4, 6, and 12 to 15 months. The primary objective was to assess the proportion of participants experiencing adverse events (AEs) related to the vaccine. Both solicited and unsolicited injection-site and systemic AEs were recorded for 14 days following each vaccination, and serious AEs were monitored for up to 6 months after the final dose of PCV.
● This study enrolled a total of 2,409 participants who were randomly assigned in a 5:1 ratio to receive either VAXNEUVANCE (V114) or Prevnar 13 (PCV13) in a 3 + 1 dosing regimen. The majority of participants completed the study, with 99.8% receiving the first vaccination.
● Comparable demographic characteristics were observed between the two vaccination groups, including sex, age at enrollment, race, and ethnicity. The reported medical history conditions were also similar, with jaundice and gastroesophageal reflux disease being the most common conditions.
● Regarding safety, both vaccination groups had a similar proportion of participants experiencing adverse events (AEs) after any dose of the pneumococcal conjugate vaccine (PCV). The occurrence of injection-site, systemic, vaccine-related, and serious AEs was generally comparable between the two groups.
● The most frequently reported AEs were those solicited in the trial, and over 86% of participants in both groups experienced one or more solicited AEs after any PCV dose.
● Irritability and somnolence were the most commonly reported solicited AEs.Body temperature measurements collected for seven days after any PCV dose showed no significant differences between the two vaccination groups, with the majority of participants having a maximum body temperature below 38.5°C.
● The occurrence of unsolicited AEs, such as pyrexia, was similar between the V114 and PCV13 groups. Febrile convulsions were rare and not determined to be vaccine-related by the investigator.
● The incidence of serious AEs was comparable between the two vaccination groups, with the majority of serious AEs being infections. In the V114 group, two participants had vaccine-related serious AEs of pyrexia, both of which were considered mild or moderate and resolved within three days.
● Two deaths occurred during the study, one in each treatment group, but neither death was related to the study vaccines according to the investigator's assessment. Importantly, no participants discontinued the study due to AEs.
Based on these findings, it can be concluded that V114 is well tolerated and exhibits a safety profile comparable to that of PCV13 in infants. These results provide strong support for the
routine use of V114 in this population. Pneumococcal vaccines have consistently demonstrated their efficacy in protecting children from pneumococcal disease, and V114 offers an expanded coverage against emerging serotypes while maintaining coverage against the serotypes included in Prevnar 13.
This study adds valuable evidence to the growing body of research on V114, affirming its safety and tolerability in infants. The availability of a 15-valent PCV like V114 is a significant advancement in preventing pneumococcal disease and its associated morbidity and mortality in children. By including additional serotypes, V114 addresses the evolving landscape of pneumococcal strains and strengthens the protective potential of PCVs. The study results provide reassurance to healthcare professionals and parents alike, supporting the adoption of V114 as a standard vaccine for infants to safeguard them against pneumococcal infections.
Reference:
Banniettis, N., Horn, M., Sadarangani, M., Patel, S. M., Greenberg, D., Oberdorfer, P., Klein, N. P., Rupp, R., Dagan, R., Richmond, P., Lumley, J., Zhou, W., Shi, Y., Tamms, G., Feemster, K., Lupinacci, R., Musey, L., Bickham, K., & V114-031 (PNEU-LINK) study group. (2023). Safety and tolerability of V114 pneumococcal vaccine in infants: A phase 3 study. Pediatrics, e2022060428. Https://doi.Org/10.1542/peds.2022-060428.
Pneumococcal Vaccine Market Size And Share Analysis By Top Companies 2028
The MarketWatch News Department was not involved in the creation of this content.
Jun 21, 2023 (AmericaNewsHour) -- Recent report published by research nester titled "Pneumococcal Vaccine Market: Global Demand Analysis & Opportunity Outlook 2028"delivers detailed overview of the global pneumococcal vaccine market in terms of market segmentation by vaccine type, sector type, product type, distribution channel type and region.
Further, for the in-depth analysis, the report encompasses the industry growth drivers, restraints, supply and demand risk, market attractiveness, BPS analysis and Porter's five force model.
With global increase in the pneumococcal disease cases and increasing awareness among the people about the disease, the global pneumococcal vaccine marketis anticipated to record a CAGR of 6.22% during the forecast period i.E. 2019-2028. The vaccines are predominantly used for children and old people or for people who are suffering from chronic disease and are available in different conjugations, depending upon the infections and the age groups to be treated. The rise in child birth rate and geriatric population are expected to positively impact the growth of the market over the forecast period.
The market is segmented into vaccine type, sector type, product type and distribution channel type. Geographically, the global pneumococcal vaccine market is segmented into five regions that include North America, Europe, Asia-Pacific, Latin America and Middle East & Africa. The market in North America is anticipated to witness significant market growth, owing to presence of key market players and high awareness about the vaccines in the region. The market in Europe is anticipated to hold the leading market share, on the back of high adoption of vaccines and proper implementation of regular immunization program. The market in Asia-Pacific region is expected to record a CAGR of around 7% over the forecast period, owing to increased private sector investment in healthcare sector and increased awareness in the region. The market in Middle East and Africa region is anticipated to record an increase in the market share, on account of increasing awareness and rise in government and non-governmental initiatives.
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Rise in Financial Funding and Expansion Projects to Boost the Pneumococcal Vaccine Market Growth
The rise in financial funding and programs such as GAVI has contributed in Advanced Market Commitment to provide pneumococcal vaccines to 60 countries as a regular immunization program and for ongoing trials for developing advanced medication by key players such as Merck & Co. And Pfizer Inc. Which are expected to drive the growth of the market over the forecast period (2019-2027).
Growing Awareness and Rise in Government Initiatives - The growing awareness about the disease and vaccination, coupled with government initiatives and investments in the healthcare sector is expected to increase the growth of the market over the forecast period. GAVI and USAID have been funding the companies that provide vaccines and healthcare facilities to make them available for low income economies.
Industry Players are Progressing towards Minimizing the Barriers faced by the Global Pneumococcal Vaccine Market
The high cost associated with the development of these vaccines, coupled with longer production timelines and vaccine limitations such as in cases where they can only provide prevention from disease caused by streptococcus pneumoniae bacterium, while it is ineffective in case of pneumonia caused by other bacteria is mainly expected to hinder the growth of the market over the forecast period.
This report also provides the existing competitive scenario of some of the key players of the global pneumococcal vaccine market which includes company profiling of Glaxosmithkline PLC, Merck & Co., Pfizer Inc, Panacea Biotec Limited, Pnuvax Incorporated, Serum Institute of India Pvt. Ltd, Shenzhen Kangtai Biological Products Co., Ltd., Walvax Biotechnology and Lanzhou Institute of Biological Products Co., Ltd
The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials and recent news and developments. On the whole, the report depicts detailed overview of the global pneumococcal vaccine market that will help industry consultants, equipment manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market centric strategies according to the ongoing and expected trends in the future.
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Research Nester is a one-stop service provider, leading in strategic market research and consulting with an unbiased and unparalleled approach towards helping global industrial players, conglomerates and executives to make wise decisions for their future investment and expansion by providing them qualitative market insights and strategies while avoiding future uncertainties. We believe in honesty and sheer hard work that we trust is reflected in our work ethics. Our vision is not just limited to gain the trust of our clients but also to be equally respected by our employees and being appreciated by the competitors.
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Determining The Best Time To Vaccinate Against Invasive Pneumococcal Disease
In the U.S., the Centers for Disease Control and Prevention (CDC) recommends routine pneumococcal vaccination for all adults ≥65 years old. Vaccination is also recommended for adults ages 19 through 64 years if they have specific chronic conditions or other risk factors. For both age groups, the CDC suggests regimens based on previous pneumococcal vaccines received, including cases in which the person's vaccination status is unknown.1
The Bottom LineThose are the recommendations for patients in the U.S. However, the optimal age at which a single dose of pneumococcal vaccination may prevent most cases of invasive pneumococcal disease (IPD) in older adults may vary from country to country, according to a modeling study recently reported in Nature Communications.2
Lessening the burden of IPD
A multinational team of investigators found that vaccination at ≥55 years of age was the "most effective strategy" to reduce the burden of IPD in the low- and middle-income countries they studied, whereas vaccination at age 70 was a preferable strategy in their high-income model.2
The group's analysis revealed that a country's overall age demographic, age-related incidence of IPD, and efficacy of the vaccine used impacted the optimal age for pneumococcal vaccination.
But first, let's back up a bit.
Creating a 4-country cohort model
The investigators looked at 4 countries with "long-standing adult pneumococcal surveillance programs."2 These included England (high income), Brazil (middle income), South Africa (middle income), and Malawi (low income), a country in southeast Africa.
The team found that the proportion of older adults between the ages of 55 and 65 was considerably higher in Brazil, Malawi, and South Africa than in England, as was the share of IPD.
For each country, here's the proportion of adults in the 55-to-65 age group, followed by the percentage of annual cases of IPD:
Considering this population data, it's not surprising that the authors' model identified a much younger optimal age for vaccination in the 3 lower- and middle-income countries (Brazil, Malawi, and South Africa) than in the 1 high-income country (England).
Vaccine versus no vaccine
The international team of investigators also looked at the age at which the greatest proportion of IPD cases could be prevented, based on a scenario in which a 23-valent pneumococcal polysaccharide vaccine (PPV23) wanes rapidly, compared to a no-vaccine scenario. Here's what they found:
Of particular note: While PPV23 was used in the above scenario, the cohort model predicted more preventable cases with 20-valent pneumococcal conjugate vaccine (PCV20).
Take the findings with a grain of salt
The authors urge "cautious" interpretation of their findings, pointing to variations in the sensitivity of IPD surveillance. "Reported IPD case data in LMICs [low- and middle-income countries]," they wrote, "are usually incomplete or under-ascertained due to limited resources—e.G., only 19 IPD cases were reported in Malawi and even less so when stratified by age and serotype."2
Other possible limitations were cited, including the multiplicity of factors that can impact vaccine efficacy and the fact that the authors didn't model sequential dosing of vaccine regimens.
Finally, the investigators predict that changes in infant vaccination schedules may reduce the benefit of adult vaccination targeting the same serotypes. "With the likely upcoming use of PCV15 and PCV20 in infants in the near future, the vaccine preventable fraction of adult disease is likely to diminish correspondingly because of the indirect effects of such infant program."2
Published: June 09, 2023
Candy Gulko, a freelance medical writer, has been writing for MedPage Today since 2014. She is the author of a chapter on medical writing ethics and of 2 career books.
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