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Rotateq Rotavirus Vaccine

RotaTeq Vaccine Clinical Trials, Dosage, Indication, Side Effects

RotaTeq is a live, oral pentavalent vaccine that contains five reassortant viruses. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (serotype P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P), referred to as serotype P1A, from the human rotavirus parent strain and the outer capsid protein of serotype G6 from the bovine rotavirus parent strain. 

On September 10, 2024, an American Academy of Pediatrics study found the effectiveness of a single dose of the rotavirus vaccine against emergency department visits or hospitalizations for inflammation of the gastrointestinal tract was 78% in children younger than five years and 53% in older children.

RotaTeq was extensively tested and was approved by the U.S. Food and Drug Administration (FDA) in February 2006. The FDA's BL 125122 was issued to New Jersey-based Merck Sharp & Dohme Corp.

RotaTeq Indication

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the Following Types: G1, G2, G3, G4, and G9. It is approved for use in infants aged six to 32 weeks.

RotaTeq Dosage

The vaccination series is administered as an oral 3-dose series to infants between 6 and 32 weeks of age. The first dose of RotaTeq should be administered between 6 and 12 weeks of age, and the third dose should not be given after 32 weeks of age.

RotaTeq Vaccine News

February 22, 2025 - Over 13 years post-rotavirus vaccine introduction, we document significant sustained declines in hospitalizations coded as rotavirus and other AGE in age groups <20 years, with no change in intussusception hospitalization rates in infants. Despite slight increases in AGE hospitalizations in adults, likely due to increased PCR testing, our findings are consistent with a highly favorable risk-benefit ratio at a whole-of-population level in Australia.

August 9, 2022 - The Lancet published - Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomized, controlled, open-label, parallel, phase 4 clinical trial.

January 20, 2022 - In a Lancet article, researchers reported on a study that showed RV3-BB was well-tolerated and immunogenic when co-administered with Expanded Programme on Immunization vaccines in a neonatal or infant schedule.

May 10, 2021 - A study published in JAMA Pediatrics found high protection and a low risk of serious adverse events for fully vaccinated children against rotavirus, emphasizing the importance of worldwide rotavirus vaccinations. The findings of a meta-analysis in this study revealed that RotaTeq vaccinations reduced the incidence of rotavirus gastroenteritis in children under five years of age by 63.6%.

April 29, 2021 - Merck reported RotaTeq vaccine sales decreased 29% last year. 

RotaTeq Clinical Trials

RotaTeq was FDA-approved in 2006. However, this rotavirus vaccine continues to be evaluated in clinical trials

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Availability: 
US, EU, WHO prequalified
Generic: 
Rotavirus Vaccine, live, oral
Drug Class: 
Oral Vaccine
Condition: 
Last Reviewed: 
Tuesday, July 1, 2025 - 07:30
Brand: 
RotaTeq
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Rotarix Rotavirus Vaccine

Rotarix Vaccine 2023

GSK's Rotarix (Rotavirus Vaccine, Live, Oral) is a live, attenuated rotavirus vaccine derived from the human 89-12 strain belonging to the G1P type. This rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The Rotarix vaccine is used to help prevent disease in children. Rotarix works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. However, this vaccine will not treat an active infection already set in the body. The global clinical development program spanned five continents and demonstrates that Rotarix protects against the most common circulating strains (G1 and non-G1 rotavirus strains), including the emerging G9 strain.

On November 7, 2022, the U.S. Food and Drug Administration (FDA) approved an oral-dosing applicator-only presentation (liquid formulation) of ROTARIX, which prevents rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants. This new presentation formulation aims to make it more convenient for healthcare providers to prepare ROTARIX by removing the need to reconstitute the vaccine dose at the point of use.

ROTARIX was first approved by the FDA in 2008. The U.S. FDA's package insert is available at this link. DrugBank: Rotavirus vaccine (DB10276).

UK-based GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical and healthcare companies.

Rotarix Indication

Rotarix is a vaccine indicated for preventing rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants six weeks to 24 weeks. Rotavirus spreads quickly among infants and young children. The virus can cause severe watery diarrhea, vomiting, fever, and abdominal pain. Children who get rotavirus disease can become dehydrated and may need to be hospitalized. The U.S. CDC recommends that infants get the rotavirus vaccine to protect against rotavirus disease. Rotarix can also reduce hospitalizations for all gastroenteritis, regardless of cause. On September 5, 2022, BMJ Global Health wrote rotavirus was the leading cause of diarrhea requiring hospitalization among young children in 28 low- and middle-income countries despite the introduction of the rotavirus vaccine.

Rotarix Dosage

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants at six weeks. There should be at least four weeks between the first and second dose, and the 2-dose series should be completed by 24 weeks of age.

Rotarix Vaccine News

July 26, 2023 - GSK plc announced that established vaccine growth in Q223 was driven by Rotarix, benefitting from the favorable impacts of a US CDC stockpile borrow in 2022 and replenishment in the current quarter.

October 18, 2022 - The JAMA Network published: Rotavirus Leads Global Diarrhea Hospitalizations Among Young Children.

August 22, 2022 - Nigeria has the second-highest number of deaths from rotavirus, accounting for 14 percent of all childhood rotavirus deaths worldwide. The agency said approximately 50,000 children under five die before their fifth birthday due to rotavirus infection.

June 9, 2022 - A peer-reviewed study - Association Between Rotavirus Vaccination and Antibiotic Prescribing among Commercially Insured U.S. Children, 2007-2018 - These results demonstrate that rotavirus vaccines reduce antibiotic prescribing for acute gastroenteritis, which could help reduce the growth of antibiotic resistance.

February 9, 2022 - GSK reported Rotarix sales were down 3% AER but up 1% CER to £541 million, reflecting global demand recovery.

July 28, 2021 - GSK announced its financial results. Rotarix sales were up 3% AER and 9% CER to £132 million, reflecting increased channel stocking on wholesaler purchasing patterns in the USA.

May 10, 2021 - A new study's findings from a meta-analysis revealed that Rotarix vaccinations reduced rotavirus gastroenteritis in children younger than five years by 68.4%.

March 4, 2021 - GSK makes landmark pricing agreement for rotavirus vaccine, Rotarix, for use with children living in humanitarian crises. In a press release, Thomas Breuer, Chief Medical Officer of GSK Vaccines, said, "We are delighted to become the first company to offer a rotavirus vaccine through the Humanitarian Mechanism for use with some children most vulnerable to severe diarrhoeal disease."

March 4, 2021 - Médecins Sans Frontières, Save the Children, UNICEF, and the World Health Organization welcome the opportunity to make the rotavirus vaccine available to more children living in humanitarian crises thanks to a landmark pricing agreement with the manufacturer, GSK. The rotavirus vaccine is the second vaccine to be accessed through the scheme. It depends on manufacturers making their vaccines available at their lowest price for use in emergencies - across countries of all income levels. The first to be made public was the pneumococcal vaccine.

June 5, 2009 - The World Health Organisation (WHO) has awarded global prequalification to GlaxoSmithKline Biologicals' vaccine against rotavirus, Rotarix™. The WHO's Strategic Advisory Group of Experts (SAGE) recommended that rotavirus vaccination be included in all national immunization programs. These WHO decisions open the door to making rotavirus vaccines available to children worldwide. The WHO prequalification will accelerate access to the vaccine in Asia and Africa and expand on the WHO decision taken in 2007 to prequalify the vaccine for Europe and the Americas. In addition, the WHO prequalification is necessary for U.N. agencies and the GAVI Alliance to purchase rotavirus vaccines for developing countries.

Rotarix Vaccine Clinical Trials

GSK's Rotarix has completed over 40 clinical trials.

 

 

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Drug Class: 
Oral Live Vaccine
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Last Reviewed: 
Friday, July 28, 2023 - 05:30
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Rotarix
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Yes
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Recombivax HB Hepatitis B Vaccine

Recombivax HB Vaccine

Recombivax HB is a recombinant vaccine that contains synthetic Hepatitis B surface antigen (HBsAg). The HBsAg is produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

Recombinant vaccines contain non-infectious parts of the virus, rather than a live virus or an attenuated (weakened) virus.

MerckVaccines offers full product information.

Recombivax HB Vaccine Indication

RECOMBIVAX HB is indicated to prevent infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for adult predialysis and dialysis patients 18 years of age and older.

Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast.

The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

Recombivax HB Vaccine Dosage

Recombivax HB is administered as an intramuscular injection.

Recombivax HB is approved for use in individuals of all ages. Recombivax HB is available in 3 formulations: Pediatric/Adolescent Formulation, Adult Formulation, Dialysis Formulation.

Recombivax HB Vaccine Adverse Reactions

The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In a study that compared the 3-dose regimen (5 mcg) with the 2-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

Tell your health care provider promptly about any unusual or severe symptoms that develop after you receive this vaccine or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

Recombivax HB Vaccine Clinical Trials

Recombivax HB Vaccine has been tested in over 15 clinical trials. These trials can be found here.

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Generic: 
Hepatitis B Vaccine
Drug Class: 
Recombinant Vaccine
Condition: 
Last Reviewed: 
Wednesday, June 19, 2024 - 06:40
Brand: 
Recombivax HB
Status: 

RabAvert Rabies Vaccine 2026

Rabipur® RabAvert® Rabies Vaccine Clinical Trials, Indication, Side Effects

Bavarian Nordic's Rabipur®/RabAvert® vaccine contains an inactivated rabies antigen. It is indicated for pre-exposure vaccination in both primary series and booster doses, as well as for protection against rabies in all age groups. RabAvert is a sterile, freeze-dried rabies vaccine obtained by growing the fixed-virus strain Flury Low Egg Passage (LEP) in primary cultures of chicken fibroblasts. The growth medium for propagating the virus is a synthetic cell culture medium supplemented with human albumin, polygeline (processed bovine gelatin), and antibiotics. The virus is inactivated with β-propiolactone and processed by zonal centrifugation in a sucrose density gradient. Finally, the vaccine is lyophilized after being added to a stabilizer solution containing buffered polygeline and potassium glutamate.

RabAvert, in combination with passive immunization with Human Rabies Immune Globulin [HRIG] and local wound treatment in postexposure treatment against rabies, has been shown to protect patients of all age groups from rabies when the vaccine is administered as soon as possible after rabid animal contact according to the guidelines of the U.S. CDC's Advisory Committee on Immunization Practices or the World Health Organization (WHO).

On August 5, 2020, Bavarian Nordic announced the launch of its commercial operations in the USA following the acquisition of the manufacturing and global rights to Rabipur/RabAvert from GSK. As of November 15, 2024, the regulators approved the bulk manufacturing process for Rabipur/RabAvert in October, thereby completing the entire technology transfer for the product to Bavarian Nordic, as the fill-and-finish process had already been established and approved. In May 2025, Bavaria Nordic announced that revenue from Rabipur/RabAvert sales in the first quarter increased to DKK 359 million (DKK 235 million). 

Bavarian Nordic is a fully integrated biotechnology company that develops, manufactures, and commercializes life-saving vaccines. On November 14, 2025, BN announced Rabipur/RabAvert vaccine revenues had increased 20% in 2025. The vaccine is market-leading in Western markets, and more than 80% of its revenue comes from the U.S. and Germany.

Rabipur/RabAvert Availability March 2026

The Rabipur/RabAvert vaccine is marketed in 20 countries worldwide, including the USA and Canada. As of May 2025, the U.S. market grew 3% (Jan-Feb) compared to the prior year. RabAvert's market share was 77%. The German market grew by 118% in the first quarter compared to the same period in the previous year. Rabipur's market share was 97%, significantly higher than the last year (82%), during which a temporary stock-out impacted sales and was in line with year-end levels for 2024.

Rabipur/RabAvert Indication

Rabies is present in more than 150 countries and territories worldwide, except Antarctica. Tens of thousands of people die each year from rabies, mainly in Asia and Africa, with 40% being children under 15 years of age.

RabAvert is indicated for pre-exposure vaccination, in both primary series and booster doses, as well as for post-exposure prophylaxis against rabies in all age groups. Pre-exposure vaccination does not eliminate the need for post-exposure treatment in the event of a potential rabies exposure; it simply reduces the dose of post-exposure therapy required.

Patients at risk of a severe hypersensitivity reaction (e.g., anaphylaxis) to RabAvert or any of its components should receive an alternative rabies vaccine if a suitable product is available. However, given the almost invariably fatal outcome of rabies, there is no contraindication to post-exposure prophylaxis, including pregnancy.

RabAvert Dosage

According to the U.S. FDA-approved prescribing information, RabAvert is administered intramuscularly in three doses on Days 0, 7, and 21 or 28. RabAvert is intended for intramuscular (IM) injection. In adults, vaccines are typically administered by IM injection into the deltoid muscle. In small children and infants, vaccines are administered into the anterolateral zone of the thigh. An unintentional intravascular injection may result in systemic reactions, including shock. In addition, syncope (fainting) can occur during the administration of injectable vaccines, including RabAvert. Therefore, procedures should be in place to prevent falls and to restore cerebral perfusion following syncope.

One dose of reconstituted vaccine contains ≤12 mg polygeline (processed bovine gelatin), ≤0.3 mg human serum albumin, 1 mg potassium glutamate, and 0.3 mg sodium EDTA. Small quantities of bovine serum are used in the cell culture process. Bovine components originate only from the United States, Australia, and New Zealand. Minimal amounts of chicken protein may be present in the final product; ovalbumen content is ≤3 Ng/dose (1 mL), based on ELISA.

RabAvert should be stored protected from light at 2°C to 8°C (36°F to 46°F). After reconstitution, the vaccine should be used immediately. It may not be used after the expiration date given on the package and container.

RabAvert Vaccine News

November 14, 2025 - Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: "Our travel health portfolio has shown continued strength, contributing to our best quarter for this business to date. Driven by higher demand and strong performance by our rabies and TBE vaccines in key markets."

May 9, 2025 - Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said: "A robust first quarter for our Travel Health business, demonstrating a 52% growth year-over-year and puts us ahead of our strategic goal of an average annual growth rate of 10-12% for this part of the business until 2027."

February 3, 2025 - "We delivered strong results in 2024 after an extraordinary performance in our Travel Health business, demonstrating a 22% growth year-over-year, combined with additional mpox vaccine orders, as we made significant strides in strengthening the public health response in Africa and other regions during the current outbreak. Thus, we exceeded our base projections for the Public Preparedness business, which will continue into 2025," said Paul Chaplin, President and CEO of Bavarian Nordic.

January 23, 2025 - Health Canada has received additional units of the rabies vaccine. It expects them to be distributed by the end of the month, as Toronto continues to ration its doses amid a shortage.

August 5, 2020 - Bavarian Nordic announced the initiation of its entire commercial operations in the U.S., just eight months after acquiring the manufacturing and global rights to Rabipur/RabAvert from GSK.

October 21, 2019 - Bavarian Nordic announced that it had entered an agreement with GlaxoSmithKline to acquire the manufacturing and global rights to Rabipur®/RabAvert® and Encepur®. 

RabAvert Clinical Trials

The RabAvert vaccine has been tested in several clinical trials.

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Availability: 
20 countries as of 2025
Generic: 
Rabies vaccine
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Saturday, March 21, 2026 - 06:50
Brand: 
RabAvert
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Quadracel Vaccine

Quadracel Description 2022

Quadracel vaccine contains diphtheria toxoid, tetanus toxoid, acellular pertussis [pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), fimbriae types 2 and 3 (FIM)], inactivated poliomyelitis vaccine (IPV) type 1 (Mahoney), type 2 (MEF-1) and type 3 (Saukett)].

Quadracel Indication

Quadracel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis.

Quadracel Dosage

A single dose of Quadracel vaccine is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel vaccine and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed).

Quadracel News 2015 - 2022

August 5, 2022 - New York state health officials have found indications of additional cases of poliovirus in wastewater samples from two different counties.

September 21, 2020 - Sanofi Pasteur Ends Use of Aborted Fetal Tissue for Polio Vaccines, a move recently approved by the U.S. Food and Drug Administration.

September 4, 2020 - Catholic leaders in the U.S. have welcomed the news that one of the world’s biggest vaccine producers has decided to discontinue a polio vaccine derived from an abortion fetal cell line. Sanofi-Pasteur will instead use an ethical animal cell line in the production of its polio vaccine. 

March 26, 2015 - Sanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine for children aged 4 to 6

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Generic: 
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Drug Class: 
Combination Vaccine
Last Reviewed: 
Monday, August 8, 2022 - 06:40
Brand: 
Quadracel
Abbreviation: 
DTaP-IPV
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Proquad Vaccine

Proquad® Vaccine Clinical Trials, Dosage, Efficacy, Side Effects

Merck's ProQuad® (Measles, Mumps, Rubella, and Varicella Virus Vaccine Live (MMRV)) is a combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses. According to the U.S. Centers for Disease Control and Prevention (CDC), combined vaccines combine equivalent component vaccines into single products to prevent more than one disease or protect against multiple strains of infectious agents that cause the same disease. ProQuad is indicated for active immunization to prevent MMRV in children 12 months through 12 years of age.

One year after a single dose of Proquad, antibody persistence rates were 98.9% against measles, 96.7% against mumps, 99.6% against rubella, and 97.5% against chickenpox. These persistence rates are similar to those observed at one year with the M-M-R II vaccine. However, because a limited proportion (5%-20%) of individuals who receive the measles, mumps, and rubella (MMR) or varicella vaccine fail to respond to the first dose, a second dose is recommended to provide an additional opportunity to develop immunity, of those who do not respond to the first dose of the measles component of MMR or varicella vaccine, 97%-99% respond to a second dose.

The intramuscular route of administration for Proquad was approved by the U.S. Food and Drug Administration (FDA) (STN: 125108) and the European Medicines Agency (EMA) on March 6, 2023. The FDA approved the draft package insert labeling submitted under amendment #2, dated September 15, 2020. Supplemental Update on April 13, 2021. It was updated on April 16, 2021. The Initial U.S. Approval was in 2005. STN: 125108; BL 125108/1010; EMA EMEA/H/C/000622NDC 0006-4171 PROQUAD. On August 21, 2023, the FDA approved a supplemental BLA submitted under section 351(a) of the Public Health Service Act for Measles, Mumps, Rubella, and Varicella Virus Vaccine Live (ProQuad) to include the use of Sterile Diluent prefilled syringes.

On November 14, 2023, the UK's Joint Committee on Vaccination and Immunisation recommended that a vaccine against varicella, commonly known as chickenpox, be added to the UK's routine childhood immunisation programme.

Merck & Co., Inc. (Merck Sharpe & Dohme LLC) is a global research-driven pharmaceutical company dedicated to putting patients first, established in 1891.

Proquad Indications

Merck's ProQuad is a vaccine indicated for active immunization to prevent measles, mumps, rubella, and varicella in children aged 12 months through 12 years. Proquad should not be administered to individuals with certain medical conditions, including blood dyscrasias, leukemia, lymphomas of any type, other malignant neoplasms affecting the bone marrow or lymphatic system, or individuals with any immunodeficient condition or receiving immunosuppressive therapy. Proquad also should not be used in individuals with active, untreated tuberculosis or active febrile illness with a fever (> 101.3 degrees F) or pregnant women

Pregnancy: ProQuad is contraindicated for use in pregnant women. Do not administer ProQuad to women planning to become pregnant in the next three months. Because of the importance of rubella and varicella immunity among women of childbearing age, the postpartum vaccination of women without evidence of immunity to rubella or varicella with MMR, varicella, or MMRV vaccines should not be delayed because of receipt of anti-Rho(D) globulin or any other blood product during the last trimester of pregnancy or at delivery, says the CDC.

AU TGA pregnancy category B2: Drugs that have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or lacking, but available data show no evidence of increased fetal damage.

Proquad Dosage

The CDC published updated vaccination schedules for 2022 on Feb. 17, 2022. Each 0.5-mL dose of ProQuad is administered subcutaneously. The first dose is usually administered between 12 and 15 months of age, but can be given at any time through 12 years of age. If the second dose of measles, mumps, rubella, and varicella vaccine is needed, ProQuad may be used. This dose is typically administered between 4 and 6 years of age. At least one month should elapse between a dose of a measles-containing vaccine, such as M-M-R II. The third dose of MMR may be recommended in certain situations involving mumps outbreaks. However, at least three months should elapse between a dose of varicella-containing vaccine and ProQuad.

Proquad Side effects

The following cautions have been reported for ProQuad: fever, injection-site reactions (including pain, tenderness, soreness, erythema, and swelling), irritability, and rash on the body or at the injection site. In addition, systemic vaccine-related adverse events were reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly, including fever and a measles-like rash.

Hypersensitivity: ProQuad is contraindicated in patients with a history of anaphylactic reaction or hypersensitivity to any vaccine component (including gelatin or neomycin) or an initial dose of measles, mumps, rubella, or varicella-containing vaccine. Use caution when administering ProQuad to individuals with anaphylaxis or immediate hypersensitivity to eggs.

Proquad Vaccine News

March 6, 2023 - The U.S. FDA approved the inclusion of intramuscular (IM) administration to the U.S. package insert for Merck’s measles-mumps-rubella-varicella (MMRV) family of vaccines, increasing the options for administering routinely recommended injectable pediatric vaccinations Merck announced, "As a pediatrician who routinely vaccinates children, I am excited to have now the option to administer these vaccines intramuscularly," said Dr. Todd Wolynn, co-founding pediatrician of Kids Plus Pediatrics. "This approval provides our practice with an additional route of administration."

April 13, 2021 - The US FDA issued a letter saying: 'We have approved your request submitted and received on October 21, 2020, to supplement your Biologics License Application (BLA) under section 351(a) of the Public Health Service Act for Measles, Mumps, Rubella and Varicella Virus Vaccine Live (ProQuad) manufactured at the West Point, PA facility to include newly developed U.S. Patient Package Inserts (PPIs) for the refrigerator-stable and frozen formulations of ProQuad and updated U.S. Package Inserts for the refrigerator-stable and frozen formulations of ProQuad that reference the new PPIs.'

April 16, 2021 - The U.S. FDA updated its Proquad (MMRV) disclosure page.

September 15, 2020 - The US FDA issued a SUPPLEMENT APPROVAL: We have approved your request submitted and received on March 16, 2020, to supplement your Biologics License Application (BLA) under section 351(a) of the Public Health Service Act for Measles, Mumps, Rubella and Varicella Virus Vaccine Live (ProQuad) to update the package insert labeling for the refrigerator-stable and frozen formulations to include revisions to Section 5, Warnings and Precautions to state that secondary transmission of varicella vaccine virus (Oka/Merck) can occur between vaccine recipients and contacts susceptible to varicella, including healthy as well as high-risk individuals, leading to disseminated disease.

September 15, 2020 - The U.S. CDC issued a Travel Alert regarding various African measles outbreaks.

February 9, 2020 – The Los Angeles County Department of Public Health (Public Health) confirmed a measles outbreak among five persons. According to an L.A. Public Health press release, this measles outbreak began when an international infectious measles virus visited the greater Los Angeles area.

January 16, 2020 – Austin Public Health announced an investigation of a confirmed rubella case, the 1st since 1999.

January 7, 2020 - A Pew survey found an overwhelming majority of U.S. adults (88%) say the benefits of the MMR vaccine outweigh the risks, which is about the same share as when Pew measured in 2016.

August 8, 2019 – The US Centers for Disease Control and Prevention (CDC) affirmed its Level 2 Travel Alert regarding Japan's ongoing Rubella virus outbreak.

September 6, 2005 - Merck & Co., Inc. announced that the U.S. FDA had approved the Company's combination vaccine PROQUAD(R) (Measles, Mumps, Rubella, and Varicella (Oka/Merck) Virus Vaccine Live) for simultaneous vaccination against measles, mumps, rubella (German measles) and varicella (chickenpox) in children 12 months to 12 years of age. PROQUAD is the first and only vaccine approved in the United States to help protect against these four diseases in a single shot. PROQUAD is also approved for use in children aged 12 months to 12 years if a second dose of the measles, mumps, and rubella vaccine is administered.

Proquad Vaccine Clinical Trials

Proquad vaccine has been involved in over 35 clinical trials.

In 4 randomized trials in which 5,446 healthy children aged 12 to 23 months received PROQUAD, vaccine response rates for PROQUAD were similar to those induced by the concomitant administration of single doses of M-M-R II and VARIVAX at separate injection sites in 2,038 children. Results showed that following a single dose of PROQUAD, the immune response rates were 97.4 percent for measles, 95.8% to 98.8% for mumps, 98.5% for rubella, and 91.2% for chickenpox. The duration of protection from measles, mumps, rubella, and chickenpox infections after vaccination with PROQUAD is unknown.

0 min read
Vaccine: 
Availability: 
Clinics, hospitals, pharmacy
Generic: 
MMRV
Clinical Trial: 
https://www.merck.com/research-and-products/clinical-trials/
Drug Class: 
Vaccine
Last Reviewed: 
Saturday, July 5, 2025 - 06:45
Brand: 
Proquad
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Manufacturer Country ID: 
FDA First In Class: 
Yes
Kosher: 
Yes
Halal: 
Yes
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Priorix Vaccine

Priorix MMR Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage

GlaxoSmithKline (GSK) Priorix is a trivalent measles, mumps, and rubella (MMR) vaccine, a lyophilized mixed preparation of the attenuated Schwarz measles virus, the mumps virus derived from the Jeryl-Lynn strain, and the rubella virus Wistar RA 27/3. The measles and mumps components of the vaccine are produced in chick embryo cell culture and may contain traces of egg protein. Priorix has demonstrated noninferiority of the immune response compared to the M-M-R II® vaccine. Immune response to any antigens in Priorix or the coadministered vaccines was similar to the immune responses obtained when M-M-R II was coadministered with the same routine U.S. pediatric vaccines.

On June 23, 2022, Elisabeth Krow-Lucal, Ph.D. MPH Measles, Mumps, Rubella Vaccines Work Group, U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), presented: Priorix for Prevention of MMR. Then, on November 18, 2022, the CDC's MMWR: Priorix Recommendations of the ACIP - United States, 2022, confirmed that Priorix and the M-M-R II vaccine are considered fully interchangeable, including for all off-label recommended uses—the ACIP Evidence to Recommendations Framework for the Use of Priorix to Prevent MMR in October 2022. The CDC says Priorix may be used in accordance with the existing MMR recommendations, both on- and off-label. On February 9, 2023, the American Academy of Pediatrics supported the CDC's recommendation on offering Priorix in the U.S. 

The U.S. FDA approved (STN:125748) Priorix, which became available in the U.S. in 2022. Priorix contains 9 mg of sorbitol, 6.5 nanograms of para-aminobenzoic acid per dose, and 334 micrograms of phenylalanine per dose. In addition, this vaccine has a trace amount of neomycin. Codes: CVX Code: 03, MVX Code: SKB, CPT Code: 90707, ICD-10-CM Code: Z23.

As of 2025, more than 800 million Priorix doses have been distributed. It is currently licensed in over 100 countries, including Canada, EnglandEurope, Ireland, Switzerland, New Zealand, and the United States. 

London-based GlaxoSmithKline plc (GSK) is a global healthcare company with a special purpose: to help people do more, feel better, and live longer. For further information, please get in touch with GSK.

Priorix Vaccine Availability 2025

Priorix was first registered in Germany in 1997. In March 2012, the European Medicines Agency (EMA) completed a review of Priorix. In June 2022, the U.S. Food and Drug Administration (FDA) approved Priorix (STN:125748) to prevent MMR in individuals 12 months of age and older. Priorix TETRA has been approved in Canada. In the U.S., PRIORIX was added to the CDC Vaccines for Children program.

Priorix Vaccine Indication

Priorix is indicated to protect against MMR. It works by helping the body make antibodies that protect your child against these diseases.

Priorix Vaccine Dosage

Globally, Priorix is recommended for use in individuals aged ≥9 months, according to a 1- or 2-dose schedule, depending on the country. Priorix is administered as a subcutaneous or Intramuscular injection in the deltoid region or the anterolateral area of the thigh. A single 0.5 mL dose of the reconstituted vaccine is recommended. A second dose of MMR is recommended at least one month after the first dose for better measles protection. There is no difference between the first and second vaccine doses concerning the frequency category for the adverse reactions, except for pain at the injection site, which was "Common" after the first and "Very common" after the second vaccine dose.

Priorix-TETRA MMRV Vaccine

PRIORIX-TETRA is a sterile lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus, the Wistar RA 27/3 rubella virus strain, and the OKA strain of the varicella-zoster virus. Each virus strain is produced separately in either chick embryo cells (mumps and measles) or MRC-5 human diploid cells (rubella and varicella).

Priorix Immunocompromised

There is limited data on using Prioeix in immunocompromised subjects; therefore, vaccination should be considered cautiously, and only when, in the physician's opinion, the benefits outweigh the risks (e.g., asymptomatic HIV subjects).

Priorix Contraindications

Contraindications for Priorix are severe allergic reaction (e.g., anaphylaxis) to any component of Priorix or after a previous dose of any measles, mumps, and rubella-containing vaccine; severe immunodeficiency; and pregnancy or planning to become pregnant within the next month.

Priorix Women

Pregnant women must not be vaccinated with Priorix, says GSK. However, fetal damage has not been documented when MMR vaccines have been given to pregnant women. Therefore, inadvertent vaccination of unknowingly pregnant women with MMR-containing vaccines should not be a reason for the termination of pregnancy. Nevertheless, women of childbearing potential should be advised to avoid pregnancy for one month following vaccination. Furthermore, there is no human data regarding use in breastfeeding women. Nursing mothers may be vaccinated where the benefit outweighs the risk in the health professional's judgment.

Priorix Administration

Reconstitute the Lyophilized Antigen Component, Live only with the accompanying Sterile Water Diluent Component to form PRIORIX. The reconstituted vaccine should be a clear peach-to-fuchsia-pink suspension. Parenteral drug products should be visually inspected for particulate matter and discoloration before administration, whenever the solution and container permit. If either of these conditions exists, do not administer the vaccine. Instead, administer PRIORIX immediately after reconstitution. If not used immediately, store refrigerated at 36° to 46° F (2° to 8°C) and administer within 8 hours. Discard the reconstituted vaccine if it is not used within 8 hours.

Priorix Side Effects

Side effect information is available in the public domain via the Oxford Vaccine Knowledge Project. There is a risk of febrile seizures following immunization with Priorix, and thrombocytopenia and thrombocytopenic purpura have been reported following Priorix vaccination. A summary of studies involving MMR studies can be found on their website: https://vk.ovg.ox.ac.uk/vk/mmr-vaccine.

Priorix-TETRA Vaccine

PRIORIX-TETRA is a sterile lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain), the Wistar RA 27/3 rubella virus strain, and the OKA strain of the varicella-zoster virus. Each virus strain is produced separately in either chick embryo cells (mumps and measles) or MRC-5 human diploid cells (rubella and varicella). Although PRIORIX-TETRA contains live viruses, they are too weak to cause severe disease in healthy people. However, some spots, blisters, and fever may occasionally appear in the first two weeks after vaccination.

Priorix Vaccine News

November 23, 2023 - Switzerland's Federal Office for National Economic Supply confirmed a shortage of Priorix vaccines.

February 10, 2023 - The AAFP and several other organizations co-released the 2023 adult and childhood/adolescent immunization schedules.

November 23, 2022 - The U.S. CDC and the WHO announced nearly 40 million children are susceptible to the growing measles threat.

November 18, 2022 - U.S. CDC ACIP Recommendation: Priorix is recommended according to the existing MMR vaccination schedules and is an off-label option for preventing measles, mumps, and rubella.

June 6, 2022 - GSK announced the U.S. FDA approved the Priorix vaccine for most people over the age of one year.

February 23, 2022 - Remon Abu-Elyazeed, MD, Ph.D., presented 'Overview of GSK's MMR Vaccine' during the CDC's ACIP vaccine committee meeting.

August 2, 2021 - GSK submitted a Biologics License Application to the U.S. FDA for PRIORIX and is seeking approval for active immunization against MMR infection.

March 24, 2021 - Vaccine manufacturers across the globe have been partnering with organizations such as the WHO, UNICEF, and GAVI Alliance to improve their vaccination programs and reach the maximum number of people to offer vaccines. Despite several governmental initiatives, measles is a leading cause of death among young children. 

April 30, 2020 - Study: Immunogenicity and Safety of an MMR Vaccine Administered as the First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. Conclusions: If licensed, the MMR-RIT could provide a valid option for preventing measles, mumps, and rubella in children in the United States and help reduce the risk of a vaccine shortage.

January 12, 2020 - A study published in the Pediatric Infectious Disease Society concluded that, if licensed, the Priorix / MMR-RIT vaccine could provide a valid option for preventing MMR in children 12 to 15 months old in the U.S.

March 22, 2019 - A phase 3 study published in the Pediatric Infectious Diseases Society Journal found that GlaxoSmithKline's MMR vaccine was safe and effective in healthy children.

Priorix Vaccine Clinical Trials

GSK continues to test the safety and efficacy of Priorix in clinical trials.

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Vaccine: 
Availability: 
100 countries
Generic: 
MMR Vaccine
Clinical Trial: 
https://www.clinicaltrials.gov/
Drug Class: 
Vaccine, live
Last Reviewed: 
Tuesday, November 18, 2025 - 05:40
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Priorix
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Prevnar 13 Pneumococcal Vaccine

Prevnar 13 Pneumococcal Vaccine Description For 2022

Pfizer Inc.'s Prevnar 13 is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM197 protein. 

PCV13 (pneumococcal conjugate vaccine) protects against 13 of the approximately 90 types of pneumococcal bacteria that can cause the most serious types of pneumococcal disease, including pneumonia, meningitis, and bacteremia. However, Prevnar 13 does not protect against diseases caused by S. pneumoniae serotypes that are not in the vaccine.

The U.S. FDA issued its approval for Prevnar 13 in 2010. In July 2016, the FDA expanded the age indication to include adults 18 through 49 years of age, in addition to the already approved indication for adults 50 years and older.

Prevnar 13 Pneumococcal Vaccine Indication

Pneumococcal disease refers to any illness caused by pneumococcal bacteria. These bacteria can cause many types of illnesses, including pneumonia, an infection of the lungs.  Pneumococcal bacteria are one of the most common causes of pneumonia, says the U.S. CDC.

Prevnar 13 is a vaccine indicated in children 6 weeks through 17 years (before 18th birthday) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. In addition, for children 6 weeks through 5 years of age (before the 6th birthday) to prevent otitis media caused by 7 of the 13 serotypes in the 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.

Additionally, on February 18, 2022, ACIP voted to remove PCV13 from the list of recommended vaccines for adults. The new recommendation now states that adults ≥65 years and adults 18-64 with certain medical conditions who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive 1 dose of PCV15 or 1 dose of PCV20. If PCV15 is used, this should be followed by a dose of PPSV23.

Prevnar 13 Pneumococcal Vaccine Dosage

Prevnar 13 is administered as an intramuscular injection only. Visit Pfizer Prevnar 13 for detailed prescribing information.

Prevnar 13 Pneumococcal Vaccine News For 2019 - 2022

July 28, 2022 - Pfizer reported the Prevnar family of vaccines was up 41% operationally in the second quarter of 2022 compared to the second quarter of 2021.

February 21, 2022 - The UK Health Agency published the 2022 complete immunization schedule. This schedule recommends children at 12 weeks receive Prevnar 13.

February 18, 2022 - The U.S. CDC published new immunizations schedules for both Children and Adults.

February 8, 2022 - Pfizer Inc. reported Prevnar / Prevenar 13 & 20 global sales decreased 25% operationally, driven by a 27% decline in the U.S. primarily due to unfavorable timing of government purchases for the pediatric indication and disruptions to healthcare activity related to COVID-19, and a 24% operational decline outside the U.S. primarily due to the impact of increased adult uptake in the prior-year period from greater vaccine awareness for respiratory illnesses.

November 11, 2021 - World Pneumonia Day, November 12, 2021, will address the future of pneumonia prevention.

July 28, 2021 - Pfizer reported financial results. Prevnar 13 was up 34% in the USA, driven by 35% growth in the pediatric indication primarily due to higher levels of healthcare activity and wellness visits compared to the prior-year quarter, which was heavily impacted by COVID-19-related mobility restrictions and limitations, and favorable timing of government purchases, partially offset by a lower year-over-year birth rate, and 24% growth in the adult indication, which was primarily driven by higher levels of healthcare activity compared to the prior-year quarter, partially offset by the impact of a lower remaining eligible unvaccinated population.

March 10, 2021 - Pneumonia vaccine may affect the course of COVID-19. "Kaiser Permanente members who received the PCV13 vaccine appeared to be diagnosed with COVID-19 less often, and when they were, they seemed to have less severe outcomes, overall," said the senior author, Sara Y. Tartof, Ph.D., MPH, a scientist with the Kaiser Permanente Southern California Department of Research & Evaluation. 

November 27, 2019 – Pneumococcal vaccination recommendations have undergone several changes in recent years, confusing those who need to select a preventive vaccine.

October 15, 2019 – A new study has found a bacterial infection that can lead to pneumonia or meningitis is linked to weakened immune systems in children.

September 9, 2019 – Pfizer announced positive preliminary results of a Proof-of-Concept Phase 2 clinical study assessing its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077.

Prevnar 13 Pneumococcal Vaccine Clinical Trials

Prevnar 13 has been involved in hundreds of clinical trials.

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Generic: 
PCV13
Drug Class: 
Vaccine
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Prevnar 13
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Pneumovax 23 Pneumococcal Vaccine

Pneumovax®23 Vaccine 2022

Merck's PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) is a vaccine that can help protect against infection by 23 types of pneumococcal bacteria, common and often cause serious illnesses. Pneumovax 23 vaccine contains 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.

On October 23, 2020, a study published by PLOS concluded 'That PPV23 vaccination provides moderate long-term protection against hospitalization with PPV23 serotype pneumonia. And, PPV23 vaccination may continue to have an important role in national pneumococcal immunization policies, including the possibility of revaccination of older adults.' In a group of 2,357 patients (717 PPV23 cases, 1,640 controls) with an average time of 10 years since PPV23 vaccination, we estimated the VE of PPV23 against PPV23 serotype pneumonia to be 24% after adjustment for patient factors (95% CI 5%–40%, p = 0.02).

The U.S. Centers for Disease Control and Prevention published on January 28, 2022, newly simplified recommendations for pneumococcal vaccination in the elderly and immunocompromised. The changes were published in the Morbidity and Mortality Weekly Report. Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Merck Sharp & Dohme Corp. is an American multinational pharmaceutical company and one of the world's largest pharmaceutical companies.

Pneumovax 23 Indication

The global prevalence of pneumococcal disease, an infection caused by Streptococcus pneumoniae, is evolving, says the U.S. CDC. Highly aggressive strains, or serotypes, threaten to put more people at risk for non-invasive pneumococcal illnesses such as pneumonia (when it is confined to the lungs), sinusitis, and otitis media (middle ear infection); and invasive pneumococcal illnesses such as bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia) and meningitis. 

The pneumococcal disease includes pneumococcal infections of the lung, blood, and coverings of the brain and spinal cord. Pneumovax 23 will not prevent disease caused by capsular pneumococcus types other than those contained in the vaccine. PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Additionally, the U.S. CDC recommends for people with certain chronic conditions such as diabetes, heart disease, or COPD and are 19 to 64 years old, 1 dose of PCV15 followed by PNEUMOVAX 23 or 1 dose of PCV20. Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any vaccine component. Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness. Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or greater severity of reactions in some older individuals cannot be ruled out. Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

Pneumovax 23 Dosage

Pneumovax 23 is administered as an intramuscular or subcutaneous injection only. Pneumovax 23 is for people 50 years of age and older and is approved for persons aged ≥2 years who are at increased risk for pneumococcal disease. And if you are 65 years or older, the U.S. CDC recommends either one dose of PCV15 followed by Pneumovax 23 or one dose of Prevnar 20.

Intervals between PCV and PPSV23. Findings from eight immunogenicity studies that evaluated the immune response after a sequence of 7-valent PCV, PCV13, or PCV15 followed by PPSV23 administered at intervals of 2, 6, or 12 months or 3–4 years were reviewed (16–18,25–29). Three studies comparing intervals ranging from 2 to 6 months between administration of PCV and PPSV23 found no significant difference in immunogenicity measured after PPSV23 receipt, although reactogenicity tended to be higher with shorter intervals (25–29). In a study that compared antibody responses to 1 dose of PCV13 with responses to PCV13 followed by PPSV23 1 year apart, the immune responses following PPSV23 were significantly lower compared with the responses after a dose of PCV13 for eight of 12 common serotypes. In another study that compared antibody response to 1 dose of PCV13 with responses to PCV13 followed by PPSV23 approximately 4 years apart, the immune responses following PPSV23 were significantly higher for seven of 12 common serotypes (26). These findings suggested that longer intervals between administration of PCV and PPSV23 might improve immunogenicity in immunocompetent adults, although a direct comparison between a 1- versus 4-year interval was not made.

Pneumovax 23 Sales in 2021

Merck & Co. reported on February 3, 2022, lower sales of PNEUMOVAX 23, which declined 14% to $292 million, primarily driven by lower demand in the U.S.

Pneumovax 23 News 2021 - 2022

November 11, 2021 - This year's World Pneumonia Day theme is Stop Pneumonia/Every Breath Counts.  

June 9, 2021 - As reported by Barron's, the U.S. Food and Drug Administration approved Pfizer's updated pneumococcal vaccine (Prevnar 20) for adults late Tuesday in a development that positions the drug giant for a battle with Merck as both hope to win supremacy in the lucrative market.

April 29, 2021 - Merck confirmed Pneumovax 23 sales decreased by 36% last year.

October 23, 2020 - A case-control test-negative design study: Effectiveness of the 23-valent pneumococcal polysaccharide vaccine against vaccine serotype pneumococcal pneumonia in adults. In establishing an established national childhood PCV13 vaccination program, PPV23 vaccination of clinical at-risk patient groups and adults aged ≥65 years provided moderate long-term protection against hospitalization with PPV23 serotype pneumonia. These findings suggest that PPV23 vaccination may continue to have an important role in adult pneumococcal vaccine policy, including the possibility of revaccination of older adults.

September 25, 2020 - The U.S. FDA approved Merck's request submitted and received November 26, 2019, to supplement your Biologics License Application under section 351(a) of the Public Health Service Act for Pneumococcal Vaccine, Polyvalent, PNEUMOVAX® 23 manufactured at your West Point, Pennsylvania facility to update the package insert to include data on the sequential administration of Prevnar 13® and PNEUMOVAX® 23 in Sections 6.1 Clinical Trials Experience and 14.2 Immunogenicity.

July 20, 2020 - Time for a third-generation pneumococcal conjugate vaccine.

June 22, 2020 - Merck announced results from two initial Phase 3 studies evaluating the safety, tolerability, and immunogenicity of V114, the company's investigational 15-valent pneumococcal conjugate vaccine. These data, in addition to results from V110-029, a study evaluating PNEUMOVAX ® 23 in healthy adults 50 years of age or older, were published via the International Symposium on Pneumococci and Pneumococcal Diseases online digital library.

January 31, 2020 - Updated Pneumococcal Vaccine Recommendations for Older Adults.

November 26, 2019 -  The U.S. FDA stated: 'We have approved your request submitted and received June 4, 2019, to supplement your Biologics License Application under section 351(a) of the Public Health Service Act for Pneumococcal Vaccine Polyvalent (PNEUMOVAX®23) manufactured at West Point, Pennsylvania. We hereby approve the draft package insert labeling submitted under Amendment 5001, dated November 8, 2019.'

Pneumovax 23 Vaccine Clinical Trials

Mercks' Pneumovax 23 has been in numerous clinical trials to test the safety, tolerability, and immunogenicity. 

 

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Availability: 
Worldwide
Generic: 
Pneumococcal Vaccine
Drug Class: 
Vaccine
Condition: 
Last Reviewed: 
Tuesday, June 21, 2022 - 07:40
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Pneumovax 23
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PedvaxHIB Vaccine

PedvaxHIB Description 2022

PedvaxHIB is a sterile product formulated to contain: 7.5 mcg of Haemophilus b PRP, 125 mcg of Neisseria meningitidis OMPC and 225 mcg of aluminum as amorphous aluminum hydroxyphosphate sulfate 

PedvaxHIB Indication

PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age. PedvaxHIB should not be used in infants <6 weeks of age.

PedvaxHIB Dosage

Age (months)      at First DosePrimaryAge (months)      at Booster    DoseDose

2 to 10                   2 doses, 2 months apart                    12 to 15          0.5 mL

11 to 14                 2 doses, 2 months apart                       —                 0.5 mL

15 to 71                 1 dose                                                  —                 0.5 mL

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Generic: 
Haemophilus b Conjugate Vaccine
Drug Class: 
Vaccine
Brand: 
PedvaxHIB
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