Pneumococcal

21 Serotype Pneumococcal Vaccine Approved for Adults

Karen McClorey Hackett — Tue, 18 Jun 2024 12:17:43 +0000

Reviewer:

Merck announced today that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine).

CAPVAXIVE (V116) is specifically designed to help protect adults against the serotypes that cause most invasive pneumococcal disease (IPD) cases. CAPVAXIVE includes eight unique serotypes not covered by other currently approved pneumococcal vaccines.

This innovative vaccine is for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.

And active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in June 2024 to discuss and make recommendations for the use of CAPVAXIVE in adults.

The ACIP met on February 29, 2024, when Heather Platt, M.D., presented Key Results from the Phase 3 Clinical Development Program. Based on CDC data, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults than PCV20 (pneumococcal 20-valent conjugate vaccine).

“Today’s approval is a testament to our population-specific strategy behind CAPVAXIVE, which demonstrated robust immunogenicity in a range of adult populations and is driven by a deep understanding of pneumococcal disease,” said Dr. Dean Y. Li, president of Merck Research Laboratories, in a press release on June 17, 2024.

“We are proud to provide CAPVAXIVE as a new option specifically designed to help protect against the majority of invasive pneumococcal disease-causing serotypes in adults.”

CAPVAXIVE is administered as a single dose, and is the sixth FDA-approved product to utilize the Pfenex Expression Technology® platform.

Current ACIP vaccine recommendations are posted at this CDC link.

Sub Title:

Capvaxive V116 designed to prevent pneumococcal disease in adults

References:

U.S. FDA Approves CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine)

Ligand Collaborator Merck Receives FDA Approval for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for Adults

Image:

Age Groups:

60 64 years

Google News Keywords:

health, vaccines, vaccinations

Featured:

Fact checked:

Tuesday, June 18, 2024 - 12:45

Image Caption:

by Mircea Lancu

Innovative Pneumococcal Conjugate Vaccine for Adults Approaches Approval

Karen McClorey Hackett — Tue, 19 Mar 2024 22:20:58 +0000

Reviewer:

Robert Carlson, MD

Since its discovery by Louis Pasteur in the 1880s, S. pneumoniae has become the leading global cause of morbidity and mortality across all age groups, with seniors being particularly vulnerable.

Over the years, vaccines have prevented significant diseases, with innovative pneumococcal vaccines on the horizon.

At the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases (ISPPD) in Cape Town, South Africa, Merck announced positive data from multiple Phase 3 studies evaluating V116, the company's investigational, adult-specific 21-valent pneumococcal conjugate vaccine.

Across the studies presented, V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, such as those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve), those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus (HIV).

In all STRIDE studies presented at the meeting, V116 elicited higher immune responses than the studied comparators for the serotypes unique to V116.

Several of the studies presented at ISPPD were included in Merck's recent filing submission to the U.S. Food and Drug Administration (FDA).

The FDA granted V116 priority review with a Prescription Drug User Fee Act of June 17, 2024. V116 would be the first pneumococcal conjugate vaccine designed for adults if approved.

"The extensive data presented this week reaffirm our confidence in the potential clinical value V116 could provide to a range of adult populations," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, in a press release on March 19, 2024.

"We are encouraged by the results of these studies showing that V116 has generated immune responses to the serotypes responsible for most adult invasive pneumococcal disease."

In addition to Phase 3 clinical data on V116, Merck also presented preliminary data from the real-world evidence study in the U.S., Pneumococcal Pneumonia Epidemiology, Urine Serotyping, and Mental Outcomes (PNEUMO), which found that among 2,065 adults 50 years of age and older hospitalized with community-acquired pneumonia between 2018 and 2022, 242 pneumococcal serotypes were detected.

Of these serotypes, approximately 84% were covered by V116.

Approximately 25% of the detected serotypes were covered only by V116, not PCV15 or PCV20.

Results from the PNEUMO study support that the serotypes in V116 account for most pneumococcal disease, including invasive and non-invasive, in adults 50 and older, says Merck.

An overview of the V116 late-stage development program is available at this Merck link.

According to the U.S. CDC, pneumococcal disease is an infection caused by Streptococcus pneumoniae. There are more than 100 different serotypes of pneumococcal bacteria, which can affect adults differently than children.

While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include older adults and those with certain chronic or immunocompromising health conditions, such as heart disease, lung disease, and liver disease. Mortality from invasive pneumococcal disease is highest among adults 50 years of age and older.

During the CDC's vaccine committee meeting on February 2024, Ryan Gierke, MPH, presented: Current Epidemiology of Pneumococcal Disease among Adults. The presentation's conclusion included PCV21 has greater coverage of the serotypes causing IPD in adults compared to PCV20, which covers 54–58% of adult IPD, while PCV21 covers 81–84% of adult IPD.

As of March 2024, the U.S. Food and Drug Administration, the European Medicines Agency, and the U.K.'s NHS have approved various vaccines to prevent pneumococcal disease.

Sub Title:

Merck V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development

References:

Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrat

US CDC Pneumococcal Disease

Image:

Age Groups:

60 64 years

Google News Keywords:

vaccinations

Featured:

Fact checked:

Wednesday, March 20, 2024 - 05:15

Image Caption:

US CDC ACIP presentation Feb. 29, 2024

Pneumococcal Vaccination Also Reduces Viral Respiratory Infections

Karen McClorey Hackett — Wed, 13 Mar 2024 21:42:04 +0000

Reviewer:

Robert Carlson, MD

According to emerging evidence, pneumococcal conjugate vaccines (PCVs) not only prevent pneumococcal disease but also have the potential to indirectly reduce viral respiratory tract infections (RTIs) by affecting pneumococcal-viral interactions.

Researchers recently performed a systematic review of interventional and observational studies published between 2000 and 2022 on vaccine efficacy/adjusted effectiveness (VE) and the overall effect of PCV7, PCV9, PCV10, or PCV13 against viral RTI.

This Major Article, funded by Pfizer Inc., was published in the Journal of Infectious Diseases on March 11, 2024, and concluded the strongest evidence was for influenza in children.

While data from adults were more limited, they were generally consistent with results in children, adding confidence that reported findings represent a true biological effect.

VE against influenza ranged between 41% and 86% (n=4), except for the 2010-2011 influenza season.

In a randomized controlled trial, PCV9 displayed efficacy against viral RTI, human seasonal coronavirus, parainfluenza, and human metapneumovirus. Data in adults were limited (n=3).

PCV13 VE ranged between 4-25% against viral lower RTI, 32-35% against COVID-19 outcomes, 24-51% against human seasonal coronavirus, and 13-36% against influenza A lower RTI, with some 95%CI spanning zero.

This study found PCVs did not offer protection against adenovirus or rhinovirus in children or adults.

These researchers wrote that if the study's results are corroborated, PCV protection against RTIs beyond those due to pneumococci might better capture the full spectrum of PCVs' public health benefits, thereby informing vaccine policymaking and economic evaluations.

As of March 2024, the U.S. Food and Drug Administration, the European Medicines Agency, and the U.K.'s NHS have approved various vaccines to prevent pneumococcal disease.

Sub Title:

Pneumococcal conjugate vaccines offer public health benefits

Reference:

Effect of pneumococcal conjugate vaccines on viral respiratory infections

Image:

Google News Keywords:

vaccines, vaccinations

Featured:

Fact checked:

Thursday, March 14, 2024 - 06:00

Image Caption:

from Pixabay

Vaccines Extraordinarily Reduce Pneumococcus Impact

Karen McClorey Hackett — Mon, 22 May 2023 19:26:51 +0000

Reviewer:

Robert Carlson, MD

At the beginning of the 20th Century, South African miners often were in poor health, and infections such as influenza and pneumonia quickly spread, killing up to one in ten miners yearly.

The biggest killer was pneumococcal pneumonia, wrote GAVI on May 16, 2023.

Within the first four months of working in the mines, 1–2% of men had been infected with it, and among men proven to be infected, 25–56% later died.

They weren't alone. A century later, pneumococcus bacteria continues to be the leading cause of severe pneumonia and bacterial meningitis worldwide.

Pneumonia kills some 740,000 children under five each year, making it the single most significant infectious cause of death in children.

Case fatality rates for children with severe and invasive pneumococcal infections, such as bacteremia or meningitis, range from 20–50% in low- and middle-income countries.

However, pneumococcal pneumonia is deadly no matter who is affected or where a person lives.

Introducing pneumococcal conjugate vaccines (PCVs) has substantially reduced the burden of death and disease, but millions of children remain unvaccinated.

And existing vaccines don't protect against all 90 pneumococcus strains.

Efforts to create a vaccine against pneumococcus began in 1911 when South African mining representatives approached a British doctor called Almroth Wright.

Wright adopted an approach against pneumococcus: injecting whole heat-killed bacteria into thousands of migrant laborers working in gold mines near Johannesburg.

The results of these initial vaccine trials were encouraging – suggesting a substantial reduction in pneumonia cases and deaths after vaccination.

However, it soon became apparent that pneumococcus wasn't a single enemy but that there were multiple 'serotypes' – groups within a species of microorganism that share distinctive surface structures.

Once researchers had figured out how to identify them, they combined these whole killed bacteria into multivalent vaccines to protect against more than one pneumococcus serotype.

During the 1930s and '40s, researchers began to test polysaccharide-based pneumococcal vaccines (PPVs) derived from the polysaccharide "capsule" that pneumococcus wears as a kind of coat. This capsule varies between serotypes, and researchers discovered it was a vital part of the bacterium that people's immune systems responded to following inoculation.

However, with the discovery of penicillin, interest in pneumococcal vaccines waned, and their development stalled.

In 1977, Merck licensed a PPV vaccine containing capsular polysaccharides from 14 pneumococcus strains, followed in 1983 by one containing 23 capsular polysaccharides – Pneumovax – still in use today.

According to a meta-analysis published in 2008, which combined the results of multiple trials, PPVs reduced the incidence of all invasive pneumococcal disease in adults worldwide by 82%.

However, PPV vaccines are largely ineffective in children younger than two years old, presumably due to their immature immune systems.

To overcome this problem, scientists needed to find a way to boost the immune response.

So, they began chemically attaching these capsular polysaccharides to an inactivated form of the diphtheria toxin, called a toxoid, which the immune system easily recognizes.

A pivotal moment came in 2000, with the publication of a clinical trial that evaluated the first of these pneumococcal conjugate vaccines (PCVs) – which was designed to protect against the seven most common pneumococcal strains – in 37,868 infants in Northern California.

It found that the incidence of pneumococcal meningitis was reduced by more than 95% in fully vaccinated infants.

And the efficacy against all invasive pneumococcal disease was greater than 97%.

This vaccine, known as PCV7 or Prevnar7, was licensed in 2000.

However, pneumococcus was not so easily defeated.

Effective as PCV7 was against the strains it covered, its routine use began to be associated with an increased incidence of disease caused by a different strain, called serotype 19A – a phenomenon known as "serotype replacement."

This highlighted the value of vaccinating against a broader range of strains.

PCVs covering 10, 13, and 15 strains have since followed; in some cases, the polysaccharides are conjugated to diphtheria toxoid; in others, to tetanus toxoid or protein D.

In 2021, PCVs protecting against 15 and 20 pneumococcal strains were approved for adult use in the U.S., followed by European authorization in late 2021/early 2022.

PCVs covering more than 20 strains are also in development.

Three PCVs are currently prequalified by the World Health Organization (WHO) for use in infants and children: PCV13, manufactured by Pfizer; and two PCV10 vaccines, manufactured by GSK and the Serum Institute of India.

WHO recommends the inclusion of PCVs in childhood immunization programs worldwide, and as of the end of 2020, 148 out of 194 WHO member states had introduced it – including 63 Gavi-eligible lower-income countries.

These childhood vaccination programs have had an extraordinary impact on rates of pneumococcal disease in those countries that have introduced them.

Routine childhood immunization against pneumococcus has also reduced the burden of pneumococcal disease in older children and adults who haven't been vaccinated against it – presumably because there's less community transmission of strains covered by the vaccines.

Four vaccines are currently available for preventing adult pneumococcal disease: PCV13, PCV15, PCV20, and the polysaccharide-based pneumococcal vaccine, PPV23.

If PCV13 or 15 are used, this is usually followed by a dose of PPV23, typically a year later.

Adults who receive PV23 or PCV20 usually only need one dose.

The U.S. CDC updated its recommendation in February 2023.

The road to defeating pneumococcus has been a long one, and there's still a way to go, but through sustained efforts to increase vaccine uptake and future innovations, many more lives could be saved, wrote GAVI.

The unedited GAVI article is posted at this link.

Precision Vaccinations publishes pneumococcal vaccine news.

Sub Title:

Pneumococcal vaccines reduce pneumonia and meningitis related fatalities

References:

GAVI - Routine vaccines, extraordinary impact: Pneumococcus

CDC - Pneumococcal Vaccine Timing for Adults

Triumph of Pneumococcal Conjugate Vaccines

Image:

Google News Keywords:

vaccinations

Featured:

Fact checked:

Tuesday, May 23, 2023 - 05:45

Image Caption:

by Trương Kháng

$30 Million Supports Developing Vaccines in Africa

Don Hackett — Mon, 12 Dec 2022 13:15:51 +0000

Reviewer:

Robert Carlson, MD

A global multinational specialty pharmaceutical company announced today that it would receive USD30 million from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) to support its capabilities to manufacture vaccines for Africa.

This is important news since 99% of all vaccines administered in Africa are currently imported.

The new funding from CEPI and the Gates Foundation will support a ten-year agreement between Aspen Pharmacare Holdings Limited and Serum Institute of India Pvt Ltd. (SII) that aims to expand the sourcing of affordable vaccines manufactured in Africa.

SII is the world's largest vaccine manufacturer by the number of doses produced and sold globally (1.5 billion doses).

Through the partnership with SII, Aspen will manufacture and distribute four routine vaccines in Africa Pneumococcal, Rotavirus, Polyvalent Meningococcal, and Hexavalent.

The technology transfer activities will initiate in early 2023.

In addition, the funding from CEPI and the Gates Foundation will help sustain regional vaccine manufacturing capacity at Aspen for potential future outbreak response to secure early access to African-produced vaccines in a future public health emergency.

Over the past two decades, the increased globalization of vaccine manufacturing has generated more reliable vaccine supplies at a lower cost, helping many countries reach more people with lifesaving vaccines.

Because lifesaving vaccines and treatments are not available or affordable everywhere, vaccine-preventable diseases continue to devastate Africa.

In 2021r, African leaders, civil society, the private sector, and organizations such as the African Union and the Africa Centres for Disease Control laid out a vision to expand regional manufacturing capacity, including an ambitious plan to produce 60% of the continent's vaccines locally by 2040.

And the launch of the Partnership for African Vaccine Manufacturing, as well as a call for supranational funders and procurement agencies to source at least 30% of their requirements from African manufacturers.

Previously, Bill Gates, co-chair of the Bill & Melinda Gates Foundation, reaffirmed the foundation's long-term commitment to Africa and to working directly with countries to support breakthrough solutions in health, agriculture, gender equality, and other critical areas.

"The big global challenges we face are persistent. But we have to remember, so are the people solving them," said Mr. Gates in a press release issued on November 17, 2022.

"Our foundation will continue to support solutions in health, agriculture, and other critical areas—and the systems to get them out of the labs and to the people who need them."

PrecisionVaccinations publishes fact-checked, research-based vaccine information manually curated for mobile readers.

Sub Title:

Gates Foundation and CEPI support Africa based vaccine manufacturing

References:

Commitments to improve access to vaccines in Africa

Serum Institute of India Pvt. Ltd.

Gates Foundation

Image:

Age Groups:

Childhood

Google News Keywords:

Africa, vaccines

Featured:

Fact checked:

Tuesday, December 13, 2022 - 06:15

Image Caption:

by Gerd Altmann

Pneumonia Remains the Forgotten Vaccine-Preventible Disease

Don Hackett — Sat, 18 Jun 2022 11:54:12 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

The U.S. Centers for Disease Control and Prevention (CDC) reported today the number of pneumonia-related fatalities continues to outpace both COVID-19 and Influenza.

The CDC's National Center for Health Statistics (NCHS) Mortality Surveillance includes data evaluating pneumonia, influenza, and COVID-19 (PIC) fatalities.

As of June 17, 2022, data collected (82%) for week #19 indicates there were 2,074 pneumonia fatalities in the USA, far surpassing COVID-19 (1,103) and influenza (57).

And the CDC reported the current 7-day moving average of new COVID-19-related fatalities (306) had increased 18.6% compared with last week. So as of June 8, 2022, a total of 1,005,823 COVID-19 deaths have been reported in the United States.

Historically, pneumonia and influenza cases produced significantly fewer fatalities. For example, in 2020, pneumonia-related deaths were 47,601, while influenza deaths were 5,943.

Pneumonia is an infection of the lungs that can cause mild to severe illness in people of all ages. Viruses, bacteria, and fungi can all cause pneumonia. And these bacteria can cause a wide range of infections—like pneumonia—known as pneumococcal disease.

In the USA, common causes of viral pneumonia are influenza, respiratory syncytial virus, and SARS-CoV-2 viruses. A common cause of bacterial pneumonia is Streptococcus pneumoniae.

The good news is pneumonia is a vaccine-preventable disease, and the U.S. FDA has approved two types of pneumococcal vaccines, PCV13, and PPSV23.

However, neither vaccine can prevent every kind of community-acquired pneumonia, but they work against the 30 most common bacteria types.

And other FDA-approved vaccines can help prevent pneumonia available as of June 17, 2022, including:

COVID-19
Haemophilus influenzae type b (Hib)
Influenza
Measles
Pertussis
Varicella

Unfortunately, the CDC's data shows that in 2020, the percentage of adults who received a pneumococcal vaccination was just 25.5%.

In an editorial written by AMIT A. SHAH, MD, AGSF, Mayo Clinic College of Medicine and Science, and published by the American Academy of Family Physicians, current real-world data was highlighted, which is excerpted below:

"With the 2021 approval of PCV15 (Vaxneuvance) and PCV20 (Prevnar 20), the ACIP has greatly simplified pneumococcal vaccination recommendations."

PCV15 and PCV20 are conjugate vaccines that provide durable protection because of a T cell-dependent mechanism of action and resulting memory B cell formation that provide mucosal immunity.

In contrast, PPSV23, a capsular polysaccharide vaccine that induces an immune response via the release of immunoglobulin from B cells, does not result in mucosal immunity, and protection wanes over five to six years.

Compared with the PCV13 vaccine, the PCV15 and PCV20 vaccines cover additional strains that cause about 15% and 27% of invasive pneumococcal disease in patients 65 years or older and 13% and 28% of disease in patients 19 to 64 years of age with underlying conditions, respectively.

'Studies have shown that the overall immunogenicity of PCV20 alone or PCV15 plus PPSV23 is similar to PCV13 plus PPSV23. Therefore, PCV15 and PCV20 are expected to be safe and well-tolerated, with no serious adverse events noted in clinical trials,' wrote Dr. Shah.

The CDC published an updated vaccination schedule in February 2022, highlighting recommendations from CDC's Advisory Committee on Immunization Practices.

PrecisionVaccinations publishes fact-checked, research-based vaccine news curated for mobile readership.

Sub Title:

Pneumonia is a vaccine-preventable disease

References:

CDC: FluView

CDC: Pneumococcal Vaccine Recommendations

CDC: Influenza

Simplifying Pneumococcal Immunizations for Adults

CDC: Immunization Schedules

Pneumococcal Vaccines 2022

Image:

Google News Keywords:

health, vaccines, vaccinations, flu, influenza, covid, covid-19, pneumonia, pneumococcal

Featured:

Fact checked:

Saturday, June 18, 2022 - 05:45

Image Caption:

U.S. CDC

U.S. FDA Accepts for Priority Review the Biologics License Application for Investigational 15-valent Pneumococcal Vaccine

Don Hackett — Tue, 12 Jan 2021 18:11:27 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for V114, Merck’s investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 years of age and older.

Merck announced the FDA set a Prescription Drug User Fee Act, or target action date, of July 18, 2021.

Furthermore, Merck stated the European Medicines Agency is also reviewing an application for licensure of V114 in adults. Merck is also developing V114 for use in children.

“Invasive pneumococcal disease in adults is on the rise in many countries, driven by highly-invasive serotypes including serotype 3, which is included in the currently licensed pneumococcal conjugate vaccine, as well as serotypes not included, such as serotypes 22F and 33F,” said Dr. Roy Baynes, SVP and head of global clinical development, CMO, Merck Research Laboratories, in a press release issued on January 12, 2021.

“We look forward to working with the FDA during the review of this application.”

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease in adults. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease in older adults worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.

V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.

The BLA and priority review designation is supported by results from Phase 2 and Phase 3 clinical studies in a variety of adult populations, including healthy adults and those at increased risk, such as adults with chronic medical conditions, adults with HIV, and those 65 years of age and older.

Additional studies in the BLA support the potential use of V114 in various real-world clinical settings, including in co-administration with the quadrivalent influenza vaccine and as part of a sequential administration with PNEUMOVAX 23, and demonstrate equivalent performance among consecutive lots of V114.

The FDA grants priority review to medicines and vaccines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment or prevention of a serious condition.

Visit Merck.com to learn more about Merck’s infectious diseases pipeline.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

Merck investigational 15-valent pneumococcal conjugate vaccine prevents disease

References:

U.S. FDA Accepts for Priority Review the Biologics License Application for V114, Merck’s Investigational 15-valent Pneumococcal

Pneumovax 23 Pneumococcal Vaccine

V114 Pneumococcal Disease Vaccine

Image:

Google News Keywords:

health, vaccines, vaccinations, Pneumococcal, merck, 15 valent vaccine, v114

Featured:

15-Valent Pneumococcal Conjugate Vaccine Reports Positive Phase 3 Results

Don Hackett — Tue, 20 Oct 2020 21:25:07 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

Two additional Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, a Merck investigational 15-valent pneumococcal conjugate vaccine were announced.

Merck’s press release on October 20, 2020, stated ‘V114 was generally well-tolerated in both studies, with a safety profile consistent with that observed for V114 in previously reported studies.’

V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine in development for the prevention of pneumococcal disease in adults and children. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with the invasive pneumococcal disease worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.

Dr. Roy Baynes, senior VP and head of global clinical development, CMO, Merck Research Laboratories, stated: “These data provide important information about the potential for V114 followed by PNEUMOVAX 23, a polysaccharide vaccine included in more than 90 percent of age-based adult pneumococcal immunization programs globally, to help protect healthy adults and adults who are at increased risk for pneumococcal disease.”

In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13, followed by PNEUMOVAX® 23, one year later. This study found the immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114.

Results also showed that at 30 days post-vaccination with either V114 or PCV13, immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F, the two serotypes not included in PCV13.

In the PNEU-DAY (V114-017) Phase 3 study, immunocompetent adults 18 to 49 years of age with underlying medical conditions associated with increased risk for pneumococcal disease, V114 generated immune responses generally comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post-vaccination.

These findings from the V114 Phase 3 clinical program in adults, including PNEU-PATH and PNEU-DAY, will be presented at a future scientific congress. Plans for global regulatory licensure applications, beginning with the U.S. Food and Drug Administration (FDA) before the end of 2020, remain on track.

Results from both studies are based on opsonophagocytic activity (OPA) responses – a measure of vaccine-induced functional antibodies.

Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the U.S., among adults 65 years of age or older.

Invasive pneumococcal disease due to serotypes 22F and 33F has been linked to higher case fatality rates and prolonged hospitalization in adults. Overall, adults with certain medical conditions, such as heart disease, diabetes, or chronic obstructive pulmonary disease (COPD), have a higher risk for pneumococcal disease compared to those without these conditions.

The V114 Phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability, and immunogenicity of V114 in a variety of populations who are at increased risk for pneumococcal disease, including healthy older adults and children, as well as people who are immunocompromised or have certain chronic medical conditions.

About Pneumococcal Disease

The global prevalence of pneumococcal disease, an infection caused by bacteria called Streptococcus pneumoniae, is evolving. There are more than 90 different types of pneumococcal bacteria which can affect adults differently than children.

Highly aggressive strains, or serotypes, threaten to put more people at risk for non-invasive pneumococcal illnesses such as pneumococcal pneumonia, sinusitis, and otitis media, and invasive pneumococcal illnesses such as pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord).

While healthy adults and children can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include children under the age of 2, older adults such as those 65 years of age and older, and people with immunosuppressive or certain chronic health conditions.

An updated overview of pneumococcal vaccines is listed on this PrecisionVaccinations webpage.

PrecisionVaccinations publishes research-based vaccine development news.

Sub Title:

Merck V114 pneumococcal conjugate vaccine consists of 15 serotypes

References:

Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-v

V114 Pneumococcal Disease Vaccine

Pneumococcal Vaccines

Image:

Google News Keywords:

health, vaccines, vaccinations, merck, 15-valent Pneumococcal Conjugate, Pneumococcal, PNEUMOVAX 23

Featured:

Late Stage Vaccine Updates Issued by Pfizer

Don Hackett — Mon, 22 Jun 2020 13:05:23 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Pfizer Inc. announced the initiation of four Phase 3 clinical trials within its current pipeline of investigational vaccines.

"The start of four Phase 3 studies across our portfolio of investigational vaccines is a testament to the talented and dedicated colleagues working throughout Pfizer, and the continued commitment to unlocking the potential promise and value that vaccines hold for our world,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc., in a June 22, 2020, press statement.

"If approved, all three vaccine candidates could help prevent serious, possibly deadly infectious diseases that negatively impact millions of people of all ages globally.”

Two studies (NCT04382326 and NCT04379713) of the 20-valent pneumococcal polysaccharide conjugate vaccine candidate, 20vPnC, evaluating a four-dose series in infants starting at 2 months of age. Both studies will expand the data on the safety and tolerability of the investigational vaccine in infants and include a control group of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). Study NCT04382326 has the goal of determining immunologic noninferiority between 20vPnC and Prevnar 13®, a critical requirement for vaccine licensure.

One study (NCT04424316) of the respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in pregnant women to evaluate the safety and efficacy of RSVpreF in infants born to immunized pregnant women as compared to placebo.

One study (NCT04440163) of the pentavalent meningococcal vaccine candidate, MenABCWY, in adolescents and young adults to assess the safety, tolerability, and immunogenicity of the MenABCWY vaccine candidate compared to licensed meningococcal vaccines, with the goal of determining immunologic noninferiority.

Precision Vaccinations publishes investigational vaccine news.

Sub Title:

Pfizer announces pneumococcal, meningococcal and RSV clinical trials

Reference:

Pfizer Announces Start of Four Phase 3 Clinical Trials for Investigational Vaccines

Image:

Google News Keywords:

health, vaccines, vaccinations, pneumococcal vaccine, meningococcal vaccine, rsv vaccine, pregnant women and vaccines

GoodRx Vaccine:

prevnar-13

Featured:

Pfizer Completes Third Phase Three 20vPnC Vaccine Study

Don Hackett — Sun, 24 May 2020 12:51:40 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A 20-valent pneumococcal conjugate vaccine candidate was found to elicit responses across 20 serotypes, meeting the primary immunogenicity objective of an extensive clinical trial.

In this phase 3 study, the 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) safety profile was reported similar to the Prevnar 13® control group.

This clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the U.S. Food and Drug Administration (FDA), and other countries’ regulatory agencies.

New York based Pfizer Inc. announced top-line study results on May 14, 2020, which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20vPnC vaccine candidate, in adults 18 through 49 years of age, not previously vaccinated against pneumococcal disease.

“We are excited by the progress of our adult development program for 20vPnC as this is the second phase 3 trial for this investigational vaccine for which we have positive topline data,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer, in a press statement.

“These new data highlight Pfizer’s strong heritage, expertise, and success in manufacturing highly-complex biological products such as pneumococcal conjugate vaccines. Demonstration of lot consistency is critical to help ensure that vaccine recipients receive the same level of protection irrespective of the manufactured lot used.”

Pfizer will seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed.

Pfizer’s 20vPnC vaccine candidate includes 13 serotypes already included in Prevnar 13.

Pfizer’s Phase 3 adult clinical program for 20vPnC includes 3 clinical trials (NCT03760146, NCT03828617, and NCT03835975) evaluating the vaccine candidate for the prevention of invasive disease and pneumococcal pneumonia in adults 18 years or older.

Combined, these trials have enrolled more than 6,000 adult subjects, including populations of vaccine-naïve adults and adults with prior pneumococcal vaccination. All three trials have been completed.

This new press release refers to NCT03828617: Phase 3 randomized, double-blind trial enrolled 1,700 adults aged 18 through 49 years with no history of pneumococcal vaccination.

Additional trials include NCT03760146: Phase 3 randomized, double-blind trial comparing immune responses in patients ≥60 years old after 20vPnC administration to responses in a control group receiving 13vPnC or PPSV23.

And, NCT03835975: Phase 3 randomized, open-label trial, designed to describe the safety and immune response of 20vPnC in an estimated 875 adults aged 65 years or older with prior pneumococcal vaccination.

The 7 new serotypes included in 20vPnC are global causes of invasive pneumococcal disease and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally, says Pfizer.

Pneumococcal disease is a name for any infection caused by bacteria called Streptococcus pneumoniae, or pneumococcus, says the US Centers for Disease Control and Prevention (CDC).

Pneumococcal infections can range from ear and sinus infections to pneumonia and bloodstream infections. There are vaccines to help prevent pneumococcal disease.

Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually.

Pneumococcal disease is common in young children, but older adults are at the greatest risk of serious illness and death. Vaccines are the best way to prevent pneumococcal disease.

There are 2 vaccines used in the USA helping to protect people against pneumococcal disease:

Pneumococcal conjugate vaccine (PCV13)
Pneumococcal polysaccharide vaccine (PPSV23)

Most people who get a pneumococcal vaccine do not have any serious problems with it. However, side effects can occur. Most side effects are mild, meaning they do not affect daily activities, says the CDC.

Pneumococcal disease vaccine development news published by Precision Vaccinations.

Sub Title:

PF-06482077 is a 20-Valent pneumococcal conjugate vaccine candidate (20vPnC) helping protect people from invasive pneumococcal disease and pneumonia

References:

PFIZER ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 LOT CONSISTENCY STUDY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

CDC: Pneumococcal Disease

PF-06482077 (20vPnC) 20-Valent Pneumococcal Vaccine

Image:

Google News Keywords:

health, vaccines, vaccinations, 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE, PNEUMOCOCCAL disease, prevnar 13

Featured:

$120 Million Financing to Advance MAPS Vaccines

Don Hackett — Mon, 27 Apr 2020 21:42:36 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A Massachusetts based biotechnology company announced the completion of a $120 million Series B financing round.

Announced on April 23, 2020, Affinivax Inc. said in a press release it is advancing its novel Multiple Antigen Presentation System (“MAPS”) vaccine technology into clinical trials.

Steven B. Brugger, CEO of Affinivax, “We are very excited to look ahead to our next phase of growth, taking our lead pneumococcal vaccine through Phase 3 testing and bringing several additional novel MAPS vaccines and immunotherapies into clinical trials.”

Affinivax’s lead vaccine targeting Streptococcus pneumoniae (ASP3772, partnered with Astellas Pharma) includes 24 pneumococcal serotypes, more than any other vaccine on the market or in clinical testing today.

ASP3772 is currently being studied in pneumococcal infection in elderly adults, its initial indication, in an ongoing Phase 2 study that is nearing completion.

In a previously completed Phase 1 study, ASP3772 was demonstrated to be safe and highly immunogenic in healthy adults. The clinical program for ASP3772 is expected to expand to include an infant indication.

Affinivax recognizes the ongoing need to increase protection against new, emerging pneumococcal serotypes and will continue to focus on developing additional pneumococcal MAPS vaccines designed to prevent against an even greater number of serotypes.

The MAPS technology platform uses proprietary chemistry that capitalizes on the highly specific and durable non-covalent, affinity binding between biotin and rhizavidin, a biotin-binding protein.

The highly stable MAPS complex created by this affinity binding contributes to a simple, modular, and efficient approach to the development of novel vaccines and immunotherapies.

Conventional vaccine conjugation technology seeks to optimize the generation of protective antibody responses mainly to polysaccharide antigens, using the protein antigen as a carrier.

In stark contrast, a MAPS vaccine can present both the polysaccharide and the protein antigens to the host immune system to induce both a B- and T-cell immune response.

This unique capability of the MAPS technology allows for the tailored development of each MAPS vaccine or immunotherapy based on the specific type of immune response that is most desired for each pathogen and disease.

Affinivax is advancing a next-generation technology platform to enable the development of vaccines and immunotherapies.

Pneumococcal vaccine development news published by Precision Vaccinations.

Sub Title:

Affinivax ASP3772 vaccine is currently being studied in pneumococcal infection in seniors

Reference:

Affinivax Announces $120 Million Series B Financing to Advance Pipeline of Novel MAPS Vaccines and Immunotherapies

Image:

Google News Keywords:

health, vaccines, vaccinations, pneumococcal vaccine , elderly and pneumococcal, Affinivax Inc, maps technology

Featured:

Pneumococcal Conjugate Vaccine Candidate Expected to Meet Licensure Criteria

Don Hackett — Wed, 18 Mar 2020 22:26:53 +0000

Reviewer:

Robert Carlson, MD

Pfizer Inc. announced top-line results from a Phase 3 clinical trial which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate.

On March 18, 2020, Pfizer’s press release stated: The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at 1-month after vaccination, were met for all serotypes in common with licensed Prevnar 13, and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23).

However, 1 of the new 7 serotypes missed noninferiority criteria by a small margin.

Secondary immunogenicity objectives for adults 18-59 years old compared to those 60-64 years old met non-inferiority for all 20 serotypes.

The safety objectives were met in adults 18 years of age or older demonstrating that the safety and tolerability of 20vPnC were comparable to licensed pneumococcal vaccines.

Based on prior discussions with regulators, these data are expected to meet licensure criteria.

“We are encouraged by the results from this study and remain on track to file the adult 20vPnC indication with the FDA by the end of 2020,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer.

“20vPnC builds on a well-established and trusted foundation of pneumococcal conjugate experience and science that Pfizer has accumulated for more than 20 years.”

“The results from this pivotal study provide evidence that the 20vPnC vaccine is expected to have a comparable safety profile and likely be as effective as Prevnar 13 in helping prevent invasive pneumococcal disease and pneumonia due to the 13 serotypes in Prevnar 13, and also effective against disease due to the seven additional pneumococcal serotypes in adults 18 years of age or older.”

Pfizer’s 20vPnC vaccine candidate includes 13 serotypes already included in Prevnar 13.

The seven new serotypes included in 20vPnC are global causes of invasive pneumococcal disease (IPD) and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally.

Globally, pneumococcal pneumonia is estimated to cause about 500,000 deaths and 30 million episodes in adults 70 years and older annually, says the World Health Organization.

Pfizer said it ‘will seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed.’

On September 20, 2018, Pfizer announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for 20vPnC for the prevention of invasive disease and pneumonia in adults age 18 years or older.

The FDA previously granted Fast Track designation for 20vPnC in September 2017 for use in adults aged 18 years or older.

Pneumonia vaccine development news published by Precision Vaccinations.

Sub Title:

Adult 20vPnC vaccine candidate indicated for the majority of currently circulating pneumococcal disease

References:

PFIZER ANNOUNCES TOP-LINE RESULTS FROM PHASE 3 STUDY OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE

Trial to Evaluate the Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-naïve Adul

WHO: Pneumococcal disease

3-Doses of 20vPnC Vaccine Reported Safe For Infants

Image:

Age Groups:

Google News Keywords:

health, vaccines, vaccinations, pneumococcal, prevnar13, 20 valent pneumococcal, pfizer

Featured:

$3 Million Vaccine Development Awarded To Combat Pneumococcus

Don Hackett — Sat, 22 Feb 2020 17:09:14 +0000

Reviewer:

Robert Carlson, MD

A St. Louis bioscience startup announced it has received a $3 million federal grant to advance the company’s development of a next-generation vaccine to combat pneumococcus.

Pneumococcus is one of the most common causes of severe pneumonia.

In addition, pneumococcus can cause other types of infections, such as bloodstream infections, pneumonia, meningitis, and middle ear infections, says the Centers for Disease Control and Prevention (CDC).

VaxNewMo said in a press release on February 21, 2020, it has earned a Phase II Small Business Innovation Research (SBIR) grant, which is awarded to companies to conduct research and development that can more quickly lead to private sector commercialization.

And, this award further shows the commitment and support of the National Institutes of Health for VaxNewMo’s bioconjugation technology for vaccine development.

“This coveted SBIR grant will allow VaxNewMo to advance the development of a next-generation, multivalent pneumococcal bioconjugate vaccine that can cover the world’s most frequently-encountered pneumococcal serotypes at a price tag that is affordable for all countries,” said Christian Harding, Ph.D., VaxNewMo CEO, in the press release.

“We will use the Phase II SBIR grant to establish processing capabilities to manufacture the vaccines.”

Previously, the company published a research article, September 2019 that discussed ‘bioconjugate vaccines targeting the capsule of hvKp that can provide immunity and protection against extremely lethal hvKp strains. Additionally, they discussed that bioconjugation is a promising technology for the rapid development of efficacious vaccines against emerging bacterial threats.’

The new funding also will be used to hire three new scientists for VaxNewMo’s lab inside the BioGenerator Labs.

In the USA, there are 2 kinds of pneumococcal vaccines available today. These vaccines protect against many, but not all types of pneumococcal bacteria.

An unrelated study published in Nature during February 2019, said ‘currently licensed pneumococcal conjugate vaccines are synthesized chemically, which is a laborious process plagued with technical challenges, low yields, and batch-to-batch variations, highlighting the need for improved conjugate vaccine synthetic methodologies.’

This means there is still a chance someone can develop the pneumococcal disease after vaccination, says the CDC.

VaxNewMo is an early stage biotechnological company developing next-generation conjugate vaccines against infectious diseases using our proprietary in vivo conjugating technology. Our platform technology supports the generation of polysaccharide-protein conjugate based vaccines against multiple targets.

Vaccine Development news published by Precision Vaccinations.

Sub Title:

VaxNewMo bioconjugation technology for vaccine development gains funding

References:

BioGenerator-supported VaxNewMo Earns $3 Million Grant to Advance Vaccine Development

A promising bioconjugate vaccine against hypervirulent Klebsiella pneumoniae

CDC: Pneumococcal Disease

A platform for glycoengineering a polyvalent pneumococcal bioconjugate vaccine using E. coli as a host

Image:

Google News Keywords:

health, vaccines, vaccinations, vaccine development, VaxNewMo research

GoodRx Vaccine:

prevnar-13

Featured:

Clearing Up Pneumococcal Vaccine Questions

Don Hackett — Sun, 19 Jan 2020 22:48:04 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A new commentary published in JAMA reinforces the changes by the Centers for Disease and Control (CDC)’s vaccine committee in 2019 regarding pneumococcal vaccine recommendations for seniors.

This news article was written by Bridget M. Kuehn, MSJ, on January 14, 2020, saying the CDC’s Advisory Committee on Immunization Practices (ACIP) suggests that adults aged 65 years or older should receive only the 23-valent pneumococcal polysaccharide vaccine (PPSV23) with a few exceptions.

This ACIP announcement was issued on November 22, 2019, because the pneumococcal vaccination recommendations had undergone several changes, causing confusion for those who need to select a preventive vaccine.

In 2014, the ACIP recommended that older adults receive the 13-valent pneumococcal conjugate vaccine (PCV13) first, then the PPSV23 at least 1 year later.

Since then, widespread childhood vaccination with PCV13 and its predecessor the 7-valent pneumococcal conjugate vaccine have “led to sharp declines in pneumococcal disease among unvaccinated children and adults,” according to the ACIP’s review of the evidence.

Based on that review, the ACIP voted to remove the recommendation for routine use of PCV13, followed by PPSV23 in this senior population.

“Incidence of PCV13-type disease has been reduced to historically low levels among adults aged ≥65 years through indirect effects from pediatric PCV13 use,” the authors wrote.

The PPSV23 vaccine contains 12 serotypes in common with PCV13 and an additional 11 serotypes, for which there are no indirect effects from PCV13 use in children.

But, adults aged 19 years or older with an immunocompromising condition, cerebral spinal fluid leak, or cochlear implant should continue to receive both vaccines, the ACIP recommends.

And, some adults aged 65 years or older may have a greater risk of exposure to strains of Streptococcus pneumoniae covered by the PCV13 vaccine, such as those seniors living in nursing homes or long-term care facilities, people living in areas with low rates of pediatric vaccination with PCV13, or those traveling to areas with no childhood PCV13 vaccination program.

Furthermore, the ACIP recommends that healthcare providers engage in shared decision-making with such at-risk patients to decide whether they should continue to receive PCV13 followed by the PPSV23 vaccination.

“ACIP will continue to review relevant data as they become available and update pneumococcal vaccination policy as appropriate,” the CDC’s authors wrote.

This ACIP recommendation is important since about 175,000 cases of the pneumococcal disease occur each year in the USA. And, the fatality rate is between 5-7 percent, says the CDC.

The pneumococcal disease is spread from person to person by droplets in the air. The pneumococci bacteria are common inhabitants of the human respiratory tract.

There are 2 major clinical syndromes of invasive pneumococcal disease: bacteremia, and meningitis. They are both caused by infection with the same bacteria but have different manifestations.

Pneumococcal pneumonia is the most common disease caused by pneumococcal infection and can occur in combination with bacteremia and/or meningitis, or it can occur alone.

Moreover, there are 3,000-6,000 cases of pneumococcal meningitis each year.

Additionally, new research is helping to clarify the benefits of childhood vaccinations.

A study published on October 15, 2019, found a bacterial infection that can lead to pneumonia or meningitis is also linked to weakened immune systems in children. This study found the rate of immune deficiency in healthy children presenting with the pneumococcal disease was up to 26.4 percent.

To address this issue, the CDC continues to say all infants should be given a primary series of PCV13, at ages 2, 4, and 6 months with a booster at age 12 to 15 months.

The CDC’s recommendation of the PCV13 vaccine, (Prevnar 13) and pneumococcal polysaccharide vaccine (PPSV23, Pneumovax) should not be given at the same visit.

Since these vaccination suggestions have changed and could be confusing, the CDC suggests everyone speak with a healthcare provider to learn which vaccine is best for their needs.

Pneumococcal disease and vaccine news published by Precision Vaccinations.

Sub Title:

PPSV23 pneumococcal vaccination recommendations have undergone several changes

References:

Pneumococcal Vaccine Recommendation

CDC: ACIP Grade for PCV13 use among adults 65 years and older

Weak Immune Systems Linked to Bacterial Infections in Children

Image:

Age Groups:

65 and Over

Google News Keywords:

health, vaccines, vaccinations, Pneumococcal disease, prevnar, 65 years and older, PCV13,

GoodRx Vaccine:

prevnar-13

Featured:

Emory University Takes Vaccine Development Leadership Role

Don Hackett — Fri, 20 Dec 2019 18:14:05 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

Emory University announced it will lead a new effort aimed at developing vaccines and other therapies to combat infectious diseases.

Announced by the National Institute of Allergy and Infectious Diseases (NIAID) on December 19, 2019, Emory is leading 7 other academic institutions that will form the new Infectious Diseases (ID) Clinical Research Consortium Leadership Group.

The other institutions represented on the ID leadership group are Baylor College of Medicine; John Hopkins University; University of Alabama Birmingham; the University of Cincinnati (and Cincinnati Children’s); the University of Maryland, Baltimore; the University of Washington; and Vanderbilt University.

This announcement says David S. Stephens, M.D., professor and chair of the Department of Medicine in Emory University School of Medicine and vice president for research of Emory’s Woodruff Health Sciences Center, will serve as the ID leadership group’s principal investigator along with Kathleen Neuzil, M.D., professor of medicine and pediatrics at the University of Maryland.

Additionally, part of the National Institutes of Health (NIH), NIAID intends to provide approximately $29 million per year over 7 years for nine Vaccine and Treatment Evaluation Units (VTEUs) around the country and the companion leadership group.

For more than half a century, NIAID has supported the VTEUs which have performed high-quality clinical research to test new vaccines and therapies for infectious diseases in adults and children.

An important strength of the VTEUs is their ability to enroll large numbers of volunteers into trials rapidly and vaccinate them in a safe, effective and quick manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns says the NIAID website.

The other 8 VTEU sites are Baylor College of Medicine; Cincinnati Children’s Hospital Medical Center; Kaiser Permanente Washington Health Research Institute; Saint Louis University; University of Maryland School of Medicine; University of Rochester; University of Washington; and Vanderbilt University Medical Center.

Moving forward, these VTEUs will work with the new leadership group to enhance integration, efficiency, and collaboration in order to address NIAID priorities.

NIAID Director Anthony S. Fauci, M.D., said in a related press release, “This flagship program aligns with NIAID’s dual mission of conducting robust, wide-ranging biomedical research on existing infectious diseases while maintaining readiness to respond to emergent disease threats with the quick design and launch of clinical trials. We anticipate that the addition of a centralized leadership group will further enhance the effectiveness of this time-tested program.”

One of the primary goals of NIAID research is to develop new vaccines against infectious diseases, such as pneumococcal infections.

The World Health Organization estimates that more than 1.6 million people, including more than 800,000 children under five, die each year from pneumococcal infections.

NIAID has invested more than 30 years of research into developing pneumococcal vaccines.

Early product development support, as well as Phase I and II studies conducted by VTEU sites in infants, were helpful in developing Prevnar, a vaccine to prevent pneumococcal diseases in children younger than 2 years of age.

VTEUs also test new ways to deliver vaccines.

For example, VTEUs enrolled young children in a Phase III trial of FluMist, an influenza vaccine administered by nasal spray. The vaccine was 93 percent effective against the predominant flu strains of the 1996-97 flu season.

In 1998, researchers inoculated the children against three flu strains thought to be circulating that season. The nasal spray vaccine was 86 percent effective against not only the flu strains covered in the vaccine but also against a circulating strain not included in the injected form of the vaccine.

Furthermore, to respond to public health emergencies, the leadership group will have the capacity to rapidly organize and initiate clinical trials at the VTEU sites.

The grant number for the leadership group award is 1 UM1 AI148684-01.

Vaccine Research news published by Precision Vaccinations

Sub Title:

Infectious Diseases Clinical Research Consortium to test new vaccines and therapies

References:

Emory University tapped to lead national infectious disease, vaccine effort

NIH: Network of VTEU Sites

Infectious Diseases Clinical Research Consortium awards announced

Image:

Age Groups:

6 month

9 months