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FDA Greenlights GSK’s MMR Vaccine

07.06.2022 - The US Food and Drug Administration (FDA) has greenlit GSK’s Priorix-branded GSK’s mumps and rubella vaccine (MMR) for people 12 months and older. It is only the second such shot to be licensed for US distribution in more than 50 years. Merck & Co’s MMR-II vaccine was approved by the FDA for the pediatric application in 1971.

Priorix 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, GSK said.

Following the recommendation of the US Centers for Disease Control, (CDC), the first GSK shot will be administered to babies and toddlers aged 12 to 15 months, and the second dose will be given to children aged four to six years. It also can be given as a second dose to those who have already been vaccinated with the Merck product.

The UK drugmaker said it has studied the safety of its MMR vaccine in more than 12,000 people, around three-quarters of whom were children in the 12-to 15-month group. Some 3,000 children aged four to six years were trial participants, with 454 children and adults aged seven or older receiving the shot.

CDC figures show that during the past two years, when Covid-19 dominated the vaccine discussion, orders for the MMR shot through the agency’s Vaccines for Children program, dropped more than 10%, indicating that fewer were being vaccinated against the common childhood diseases.

“Outbreaks of measles in recent years demonstrate how quickly diseases can return without widespread immunization,” ​​said Temi Folaranmi, GSK’s vice president and vaccines therapeutic head for the US.  “Missed vaccinations during the pandemic makes children even more vulnerable to vaccine-preventable diseases like measles.”

Reports point to a spike in US measles cases to 1,282 in 2019 – the most since the early 1990s – with the majority of cases seen among unvaccinated people. According to the World Health Organization, more than 207,000 people died as a result of measles globally in that year, due to low vaccination rates.

For reasons also not fully explained, another of GSK’s vaccines – Shingrix, to prevent infection with shingles, the common name for Herpes Zoster – has been widely administrated to older adults in the US for a number of years but is still not licensed in the EU. The European Medicines Agency (EMA) said some time ago it was reviewing the vaccine. The only shingles vaccine approved in Europe is Zostavax made by Merck & Co.

Author: Dede Williams, Freelance Journalist