Health
GSK Obtains FDA Approval for MMR Vaccine Priorix
Priorix opposes Merck’s MMRII vaccine in the United States. “we ..Priorix.. First available in the United States, it adds provider options to protect patients from these highly contagious diseases and further enhance their pediatric vaccine portfolio offerings. “Judith Stewart, Senior Vice President and Head of Vaccines, GSK, said.
Priorix was first registered in Germany in 1997 and is currently licensed in more than 100 countries around the world, including Europe, Canada, Australia and New Zealand. So far, more than 800 million doses have been distributed.
MMR vaccination rate
Measles, mumps and rubella are acute and highly contagious viral diseases. In recent years, measles outbreaks have occurred in the United States and around the world, with more than 400,000 cases confirmed in 2019 (decades of progress towards eradicating measles in many countries). It is reversed).
The CDC recommends that children receive the MMR vaccine twice. The first vaccination is 12 to 15 months old and the second vaccination is 4 to 6 years old. Teens and adults also need to be up-to-date on MMR vaccination.
However, a recent Centers for Disease Control and Prevention (CDC) report has reduced vaccines ordered through the Federal CDC Children’s Vaccine Program by more than 10% (about half of US children are vaccinated through this program). I have received it). The report also noted that there are 400,000 fewer children enrolled in kindergarten in grades 2020-2021 than expected nationwide. That is, these children may not be up to date on pediatric immunity such as the MMR vaccination.
GSK states that the safety of Priorix for approval in the United States was evaluated in six clinical trials, with a total of 12,151 participants (6,391 in the United States) receiving at least one dose of Priorix: 8,780. Children (4,148 in the US) of age; 2,917 children (1,950 in the US) 4 to 6 years old. 454 adults and children (293 in the US) 7 years and older.
The most commonly reported side effects were pain, redness, swelling, loss of appetite, irritability, drowsiness and fever.
The efficacy of Priorix has been demonstrated based on immunogenicity data and MMR-II.
With FDA approval, Priorix can be given as a double-dose vaccine regimen or as a second vaccination after another MMR vaccine.
Priorix will be on the agenda of the June CDC Immunization Implementation Advisory Committee (ACIP) meeting to consider formal inclusion in vaccine schedules and recommendations.
GSK’s vaccine portfolio in the United States includes Boostrix, Cervarix, Fluarix, Menveo, Rotaix and Shingrix.
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