FDA Approves GSK’s MMR Vaccine Amidst Rise in Missed Vaccinations Among Children

GSK announced that the FDA approved its measles, mumps, and rubella (MMR) vaccine, Priorix, for children 12 months and older, providing healthcare professionals in the United States with the first alternative in several years. Priorix is the first MMR vaccine to contest Merck and Co.’s long-standing vaccines since the early 1970s. The approval comes at a crucial time when children worldwide are missing essential vaccinations.

The Implications of Missed Vaccinations

According to UNICEF, over 20 million children worldwide missed essential vaccines in 2020. That marks an increase of 4 million over 2019. The World Health Organization corroborated these numbers, emphasizing that the most recent rise results from COVID-19 and countries’ efforts to acquire COVID vaccines while letting other vaccines fall to the wayside. 

While COVID-19 is noticeably pushing missed vaccination numbers up, the trend has existed in the US for several years. UNICEF also said that the US ranks number one in high-income countries where children do not have the first dose of an MMR vaccine. Between 2010 and 2017, over 2.5 million children in the US were recorded as not receiving their first dose of MMR vaccine. 

More recent numbers from the CDC show that fewer kindergartners were vaccinated in the 2020-2021 school year as a result of COVID-19. The goal MMR vaccination rate is 95% but the report shows only 93.9% of kindergartners are up to date on their MMR vaccines. 

The growing lackadaisical approach to MMR vaccines concerns many professionals who fear that serious measles outbreaks are growing more likely with decreasing vaccination rates. 

In GSK’s press release, Vice President and Vaccines Therapeutic Area Head, US Medical Affairs at GSK, Temi Folaranmi, MD, said, “Outbreaks 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.” 

Measles is not serious for all those who contract it. According to the CDC, 1 in 4 children who contract measles is hospitalized. 1 to 3 in 1,000 will die from complications due to the disease. The most common complications leading to death are pneumonia and encephalitis, or swelling of the brain. Still, thanks to modern vaccination technology, measles is a preventable disease that could be eradicated, keeping all children safe from the disease. 

The CDC publishes ongoing measles outbreak information, and the most concerning statistic came from 2019 when there were 1,282 confirmed measles cases across 31 states. Since then, there have been 13 cases in 2020, 49 cases in 2021, and so far, only 2 cases in 2022. 

Worldwide though, experts are more concerned. In a warning published by UNICEF, the organization said that measles cases increased by 79% in the first two months of 2022 compared to the same time period in 2021. UNICEF warned that decreasing vaccination rates could reverse decades of progress in eliminating measles. 

Henrietta Fore, UNICEF Executive Director, said, “Measles is far too contagious. It is critical not only to increase coverage but also to sustain vaccination rates at the right doses to create an umbrella of immunity for everyone.” 

Related Article: Link Between Ethnic Discrimination and Slow Vaccination Rate? New Study Shows

Breaking the Monopoly of American MMR Vaccines

Before Priorix’s FDA approval, only two other MMR vaccines were available to Americans, both of which were developed and distributed by Merck and Co. The FDA approved the first, M-M-R II, in 1971, and it remained the standard for children 12 months and above for decades. Merck and Co.’s second option, ProQuad, was FDA approved in 2005 and includes protection for measles, mumps, rubella, and the additional varicella virus. 

For over 50 years, Merck and Co. provided the only regulated MMR vaccine available to Americans, but the approval of Priorix puts an end to that domination. Priorix has proven its worth in the years leading up to its FDA approval. Originally approved in Germany, it is now available in over 100 countries, including all European countries, and over 800 million doses have been administered. 

Last year, GSK reported that its pediatric trifecta of vaccines including Priorix, Varilrix (chickenpox vaccine), and Priorix Tetra (MMR and chickenpox combination vaccine) brought in £260 million. Priorix’s expansion into the US could boost those numbers even higher in the coming years. 

GSK designed Priorix to directly compete with Merck and Co.’s vaccines making it available to children 12 months and older. GSK also assures users that Priorix can be used as a first dose and second dose or as a second dose following the administration of a different manufacturer’s MMR vaccine. 

Priorix is scheduled to be on the agenda for the CDC’s June Advisory Committee Immunization Practices meeting to discuss the formal inclusion of the vaccine into the CDC’s vaccine schedule and recommendations. The inclusion would boost Priorix’s position in competing with the currently available and recommended vaccines from Merck and Co.

The FDA approval of Priorix comes at a potentially crucial time for America due to its increasing number of missed vaccinations among children. A new competitor in the MMR vaccine arena could provide the impetus for children to receive vaccinations to decrease the risk of serious measles outbreaks. 

Author

Reed Slater