Regulatory GSK receives FDA approval for its Measles Vaccine

GSK receives FDA approval for its Measles Vaccine


Measles prevention vaccine; Priorix, developed by British Pharmaceutical company GSK has received U.S. Food and Drug Administration (FDA) approval for the use in individuals 1 year and over. Priorix is MMR-based and is to be administered in two doses. 

The GSK Priorix FDA approval is not only for the prevention of measles but also mumps and rubella (MMR). 

GSK U.S. Head expressed pride in bringing the Priorix to the U.S. market in a bid to protect against the spread of highly-contagious infection diseases in the country. As FDA approved GSK measles vaccine, a government study revealed that vaccination rates for children had fallen overall during the COVID-19 pandemic. This was attributed to a number of factors such as lowered vaccination requirements during remote learning to skipped doctor’s visits.

Measles, rubella, and mumps are all highly infectious diseases with global victims. The mortality rates for the diseases is sizeable. A recent trend of increased cases of measles both in the U.S. and worldwide has ensued.

U.S. Centers for Disease Control and Prevention (CDC) reportedly found a drop of above 10% in immunizations under the federal program. Close to 50% of the children population is immunized under this program and the decline shows that a smaller number of vaccinations are now taking place. CDC also reports lesser children enrolled in kindergarten in the last year’s school term, which means that possibly lesser children have received MMR vaccinations as well. 

The CDC recommends the first dose of the MMR vaccine be administered to children between 12 and 15 months, with the second one to follow between the ages of 4 years to 6 years.

In the last few years, measles has been on the rise in some countries, and worldwide over 400,000 cases were reported in 2019. This is a setback for the progress made in measles eradication. 

“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization. Missed vaccinations during the pandemic make children even more vulnerable to vaccine-preventable diseases like measles. GSK head stated further that “Making Priorix available 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.”

Priorix has been licensed globally to over 100 countries by GSK and almost 800M doses of the measles vaccine have been administered. These licensed countries include Canada, New Zealand, Australia, and all of Europe. 

Clinical studies establishing the safety of Priorix found that the most common reported adverse effects were swelling, irritability, drowsiness, fever, pain, etc. Over 12,000 participants were included in the study who received at least one dose of the vaccine. Half of the participants were from the U.S. with children ranging from 12 months to 7 years and older becoming part of the studies.

GSK was able to generate over $300M from its Priorix MMR vaccine and Priorix Tetra Chickenpox vaccine in the preceding year.

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