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 merge equivalent component vaccines into single products to prevent more than one disease or protect against multiple strains of infectious agents causing 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 measles, mumps, and rubella (MMR) or varicella vaccinees fail to respond to one dose, a second dose is recommended to provide another 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 Union 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/000622; NDC 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 U.K.'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 immunization program.
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 12 months through 12 years of age. 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 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 at 12 to 15 months of age but can be given anytime 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 usually administered at 4 to 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 might be recommended in certain mumps outbreak situations. 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 (pain/tenderness/soreness, erythema, and swelling), irritability, and rash on the body or at the injection site. In addition, systemic vaccine-related adverse events reported at a significantly greater rate in recipients of ProQuad than in recipients of the component vaccines administered concomitantly were fever and 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 12 months to 12 years of age if a second dose of 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 percent for mumps, 98.5 percent for rubella, and 91.2 percent for chickenpox. The duration of protection from measles, mumps, rubella, and chickenpox infections after vaccination with PROQUAD is unknown.
