{"id":8007,"date":"2022-06-11T09:46:29","date_gmt":"2022-06-11T17:46:29","guid":{"rendered":"https:\/\/store.apotheraspecialtypharmacy.com\/?p=8007"},"modified":"2022-06-12T11:24:06","modified_gmt":"2022-06-12T19:24:06","slug":"priorix-becomes-an-additional-source-of-measles-mumps-and-rubella-vaccine-for-us-patients","status":"publish","type":"post","link":"https:\/\/store.apotheraspecialtypharmacy.com\/?p=8007","title":{"rendered":"Priorix\u00a0becomes an additional source of measles, mumps and rubella vaccine for US patients"},"content":{"rendered":"

GSK announces US FDA approval of Priorix for the prevention of measles, mumps and rubella in individuals 12 months of age and older<\/a><\/h1>\n

GSK plc (LSE\/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved <\/span>Priorix<\/em>\u00a0(Measles, Mumps and Rubella Vaccine, Live) for active <\/span>immunization for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older.<\/span><\/p>\n

Priorix<\/em> is currently licensed in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand, with more than 800 million doses distributed to date.<\/p>\n

\u201cWe\u2019re proud to make\u00a0Priorix<\/em>\u00a0available in the US for the first time, adding a choice for providers to help protect patients against these highly-contagious diseases and to further strengthen offerings in our paediatric vaccine portfolio,\u201d said Judy Stewart, Senior Vice President and Head of US Vaccines, GSK.<\/p>\n

Measles, mumps and rubella are acute and highly-contagious viral diseases responsible for considerable morbidity and mortality throughout the world.[1]<\/a>[2]<\/a><\/sup>\u00a0In recent years, measles outbreaks have occurred in the US and globally, with more than 400,000 cases confirmed in 2019, reversing decades of progress toward measles elimination in many countries.[3]<\/a><\/p>\n

According to a recent US Centers for Disease Control and Prevention (CDC) report, vaccine ordering in the past two years through the CDC\u2019s Vaccines For Children programme, the federal programme through which about half of the children in the country are immunised, dropped more than 10%, indicating that fewer vaccinations in children were occurring.[4]<\/a>\u00a0The report also noted 400,000 fewer children entered kindergarten in the 2020-2021 school year than expected nationally, meaning those children may not be up to date on childhood immunisations like their MMR vaccination.[4]<\/a><\/sup><\/p>\n

\u201cOutbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunisation. Missed vaccinations during the pandemic makes children even more vulnerable to vaccine-preventable diseases like measles,\u201d said Temi Folaranmi, MD, Vice President and Vaccines Therapeutic Area Head, US Medical Affairs, GSK. \u201cMaking\u00a0Priorix<\/em>\u00a0available to patients in the US will ensure health care professionals have more than one option for this critical vaccine as they work to catch their patients up on recommended vaccinations.\u201d<\/p>\n

The safety of\u00a0Priorix<\/em>\u00a0was evaluated in six clinical studies, in which a total of 12,151 participants (6,391 in the US) received at least one dose of\u00a0Priorix<\/em>: 8,780 children (4,148 in the US) 12 through 15 months of age; 2,917 children (1,950 in the US) 4 through 6 years of age; and 454 adults and children (293 in the US) 7 years of age and older. The most commonly reported adverse reactions were pain, redness, swelling, loss of appetite, irritability, drowsiness and fever. The efficacy of\u00a0Priorix<\/em>\u00a0was demonstrated based on immunogenicity data versus the comparator vaccine.<\/p>\n

Priorix<\/em>\u00a0will provide US healthcare professionals with another MMR vaccine choice.\u00a0Priorix\u00a0<\/em>may be administered as a first dose, followed by a second dose of\u00a0Priorix<\/em>.\u00a0Priorix\u00a0<\/em>may also be administered as a second dose to individuals who have previously received the first dose of another MMR-containing vaccine.<\/p>\n

The CDC recommends people get a MMR vaccine to protect against measles, mumps and rubella. Children should get two doses of MMR vaccine, starting with the first dose at 12 through 15 months of age, and the second dose at 4 through 6 years of age. Teens and adults should also be up to date on their MMR vaccination.[5]<\/a><\/p>\n

Priorix<\/em>\u00a0is scheduled to be on the agenda for the June CDC Advisory Committee on Immunization Practices (ACIP) meeting for consideration of formal inclusion into the vaccine schedule and recommendations.<\/p>\n

The US Prescribing Information is available at:\u00a0https:\/\/gskpro.com\/content\/dam\/global\/hcpportal\/en_US\/Prescribing_Information\/Priorix\/pdf\/PRIORIX.PDF<\/a>.<\/p>\n

Important Safety Information<\/strong><\/p>\n