Penbraya

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Penbraya is a pentavalent conjugate vaccine developed by Pfizer for the prevention of invasive meningococcal disease in people 10 through 25 years of age. [1] Invasive meningococcal disease, caused by the bacterium Neisseria meningitidis , can lead to serious conditions such as meningitis (inflammation of the brain and spinal cord lining) and septicemia (bloodstream infection). [2] Penbraya is approved for use by the US Food and Drug Administration (FDA). [3] Penbraya is the first and only pentavalent vaccine that provides coverage against the five most common serogroups causing meningococcal disease in adolescents and young adults. [4]

Contents

Composition

Penbraya is a vaccine that combines components of two previously licensed meningococcal vaccines:

Mechanism of action

Penbraya works by stimulating the body's immune system to produce antibodies that specifically target the Neisseria meningitidis bacteria. [7] Antibodies against fHbp specifically block this protein's function, preventing the bacteria from evading immune defenses (serogroup B). [8]

Clinical Studies

Penbraya's efficacy was established through a randomized, active-controlled, observer-blinded multicenter phase III study that assessed Penbraya's immunogenicity. [9] The trial compared Penbraya, administered at 0 and 6 months, with Trumenba, another meningococcal serogroup B vaccine, and MenACWY-CRM, a meningococcal conjugate vaccine. The primary measure of effectiveness was the increase in serum bactericidal activity using human complement (hSBA) against various strains of Neisseria meningitidis. The results demonstrated that Penbraya's seroresponse rates for serogroups A, C, W, and Y were non-inferior to those following a single dose of MenACWY-CRM. Moreover, the seroresponse to serogroup B primary strains among participants who received two doses of Penbraya was shown to be non-inferior to those following two doses of Trumenba. [10]

Related Research Articles

<i>Neisseria</i> Genus of bacteria

Neisseria is a large genus of bacteria that colonize the mucosal surfaces of many animals. Of the 11 species that colonize humans, only two are pathogens, N. meningitidis and N. gonorrhoeae.

MeNZB was a vaccine against a specific strain of group B meningococcus, used to control an epidemic of meningococcal disease in New Zealand. Most people are able to carry the meningococcus bacteria safely with no ill effects. However, meningococcal disease can cause meningitis and sepsis, resulting in brain damage, failure of various organs, severe skin and soft-tissue damage, and death.

<span class="mw-page-title-main">Conjugate vaccine</span> Type of vaccine

A conjugate vaccine is a type of subunit vaccine which combines a weak antigen with a strong antigen as a carrier so that the immune system has a stronger response to the weak antigen.

<span class="mw-page-title-main">Rino Rappuoli</span> Italian immunologist (born 1952)

Rino Rappuoli is an Italian immunologist. He is the head of vaccine research and development (R&D) at GlaxoSmithKline (GSK) Vaccines. Previously, he has served as visiting scientist at Rockefeller University and Harvard Medical School and held roles at Sclavo, Vaccine Research and CSO, Chiron Corporation, and Novartis Vaccines.

<i>Neisseria meningitidis</i> Species of bacterium that can cause meningitis

Neisseria meningitidis, often referred to as the meningococcus, is a Gram-negative bacterium that can cause meningitis and other forms of meningococcal disease such as meningococcemia, a life-threatening sepsis. The bacterium is referred to as a coccus because it is round, and more specifically a diplococcus because of its tendency to form pairs.

<span class="mw-page-title-main">Meningococcal disease</span> Often life-threatening bacterial infection

Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis. It has a high mortality rate if untreated but is vaccine-preventable. While best known as a cause of meningitis, it can also result in sepsis, which is an even more damaging and dangerous condition. Meningitis and meningococcemia are major causes of illness, death, and disability in both developed and under-developed countries.

<span class="mw-page-title-main">Pneumococcal conjugate vaccine</span> Vaccine against Strep pneumoniae

Pneumococcal conjugate vaccine is a pneumococcal vaccine made with the conjugate vaccine method and used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children.

<span class="mw-page-title-main">Pneumococcal vaccine</span> Vaccine to prevent infection by the bacteria Stretococcus pneumoniae

Pneumococcal vaccines are vaccines against the bacterium Streptococcus pneumoniae. Their use can prevent some cases of pneumonia, meningitis, and sepsis. There are two types of pneumococcal vaccines: conjugate vaccines and polysaccharide vaccines. They are given by injection either into a muscle or just under the skin.

<span class="mw-page-title-main">Hepatitis B vaccine</span> Vaccine against hepatitis B

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people, routine immunization results in more than 95% of people being protected.

<span class="mw-page-title-main">Hib vaccine</span> Haemophilus influenzae type B vaccine

The Haemophilus influenzae type B vaccine, also known as Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

<span class="mw-page-title-main">JN-International Medical Corporation</span> Pharmaceutical company in Nebraska, United States

JN-International Medical Corporation (JNIMC) is a U.S.-based biopharmaceutical corporation which since 1998 has been focused on developing vaccines and diagnostics for infectious disease for developing countries. This private corporation was founded in 1998 by Dr. Jeeri R. Reddy with the help of Dr. Kelly F. Lechtenberg in a small rural town, Oakland, Nebraska. From there it grew and expanded until in the year 2000 the corporation moved to Omaha, Nebraska.

NmVac4-A/C/Y/W-135 is the commercial name of the polysaccharide vaccine against the bacterium that causes meningococcal meningitis. The product, by JN-International Medical Corporation, is designed and formulated to be used in developing countries for protecting populations during meningitis disease epidemics.

<span class="mw-page-title-main">Jeeri R. Reddy</span>

Jeeri Reddy an American biologist who became an entrepreneur, developing new generation preventive and therapeutic vaccines. He has been an active leader in the field of the biopharmaceutical industry, commercializing diagnostics and vaccines through JN-International Medical Corporation. He is the scientific director and president of the corporation that created the world's first serological rapid tests for Tuberculosis to facilitate acid-fast bacilli microscopy for the identification of smear-positive and negative cases. Prevention of mother-to-child transmission of HIV was achieved in South East Asia by the use of rapid tests developed by Reddy in 1999. Reddy through his Corporation donated $173,050 worth of Rapid Diagnostic Tests (RDTs) for malaria in Zambia and actively participated in the prevention of child deaths due to Malaria infections. Reddy was personally invited by the president, George W. Bush, and First Lady Laura Bush to the White House for Malaria Awareness Day sponsored by US President Malaria Initiative (PMI) on Wednesday, April 25, 2007.

<span class="mw-page-title-main">Meningitis</span> Inflammation of the membranes around the brain and spinal cord

Meningitis is acute or chronic inflammation of the protective membranes covering the brain and spinal cord, collectively called the meninges. The most common symptoms are fever, intense headache, vomiting and neck stiffness and occasionally photophobia.

Meningococcal vaccine refers to any vaccine used to prevent infection by Neisseria meningitidis. Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. The vaccines are between 85 and 100% effective for at least two years. They result in a decrease in meningitis and sepsis among populations where they are widely used. They are given either by injection into a muscle or just under the skin.

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The African meningitis belt is a region in sub-Saharan Africa where the rate of incidence of meningitis is very high. It extends from Senegal to Ethiopia, and the primary cause of meningitis in the belt is Neisseria meningitidis.

MenAfriVac is a vaccine developed for use in sub-Saharan Africa for children and adults between 9 months and 29 years of age against meningococcal bacterium Neisseria meningitidis group A. The vaccine costs less than US$0.50 per dose.

CRM197 is a non-toxic mutant of diphtheria toxin, currently used as a carrier protein for polysaccharides and haptens to make them immunogenic. There is some dispute about the toxicity of CRM197, with evidence that it is toxic to yeast cells and some mammalian cell lines.

A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year.

<span class="mw-page-title-main">Diana Martin (scientist)</span> New Zealand microbiologist (1942–2019)

Diana Rae Martin was a New Zealand microbiologist. She was a Fellow of the Royal Society Te Apārangi from 2000, and was made an Officer of the New Zealand Order of Merit for services to microbiology in 2008.

References

  1. ↑ "FDA Approves Pentavalent Meningococcal Vaccine from Pfizer for Ages 10 to 25 years". Patient Care Online. 24 October 2023. Retrieved 25 February 2024.
  2. ↑ "Meningococcal Disease". U.S. Centers for Disease Control and Prevention (CDC). 1 September 2023. Retrieved 25 February 2024.
  3. ↑ "Penbraya". U.S. Food and Drug Administration (FDA). 27 November 2023.
  4. ↑ "Approval-first for meningococcal vaccine". European Pharmaceutical Review. Retrieved 26 February 2024.
  5. ↑ "Trumenba". U.S. Food and Drug Administration (FDA). 9 March 2023.
  6. ↑ Dhillon S, Pace D (1 November 2017). "Meningococcal Quadrivalent Tetanus Toxoid Conjugate Vaccine (MenACWY-TT; Nimenrix): A Review". Drugs. 77 (17): 1881–1896. doi:10.1007/s40265-017-0828-8. ISSN   1179-1950. PMID   29094312. S2CID   24522214.
  7. ↑ "Penbraya: Uses, Dosage, Side Effects, Warnings". Drugs.com. Retrieved 25 February 2024.
  8. ↑ Beernink PT (22 October 2019). "Effect of complement Factor H on antibody repertoire and protection elicited by meningococcal capsular group B vaccines containing Factor H binding protein". Human Vaccines & Immunotherapeutics. 16 (3): 703–712. doi:10.1080/21645515.2019.1664241. ISSN   2164-5515. PMC   7227650 . PMID   31526219.
  9. ↑ "Penbraya (meningococcal groups A, B, C, W, and Y vaccine) FDA Approval History". Drugs.com. Retrieved 25 February 2024.
  10. ↑ "Penbraya (meningococcal groups A, B, C, W, and Y vaccine) – New vaccine approval". professionals.optumrx.com. Retrieved 26 February 2024.
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