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Second MMR Vaccine Seeks FDA Approval

August 2, 2021 • 4:28 pm CDT
(Precision Vaccinations News)

Pennsylvania-based GlaxoSmithKline (GSK) today announced it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its Priorix vaccine and is seeking Approval for use in active immunization against infection by measles, mumps, and rubella (MMR).

If approved, the Priorrix vaccine would offer US-based healthcare providers an alternative MMR vaccine. Merck, Inc.'s M-M-R®II is the leading vaccine.

GSK stated in its press release it is also seeking approval for Priorix administration as a second dose to individuals who received another MMR vaccine.

The Priorix MMR vaccine developed by GSK was first registered in Germany in 1997 and is currently licensed in more than 100 countries worldwide, with more than 400 million doses distributed to date.

"If approved (the BLA), Priorix will increase the number of vaccine offerings from GSK against childhood diseases in the US market and strengthen GSK's long-term commitment to prioritizing public health in the US," commented Judy Stewart, SVP and Head of US Vaccines at GSK, in the press statement issued on August 2, 2021.

Priorix is a lyophilized mixed preparation of the attenuated Schwarz measles, RIT 4385 mumps (derived from Jeryl Lynn strain), and Wistar RA 27/3 rubella strains of viruses. The measles and mumps components of the vaccine are produced in chick embryo cell culture and may contain traces of egg protein.

The safety of PRIORIX was evaluated in six clinical studies, in which a total of 17,393 subjects received at least one dose of either Priorix or Merck's M-M-R®II. The efficacy of Priorix was demonstrated based on comparative immunogenicity data with M-M-R®II.

The most commonly reported adverse reactions were pain, redness, swelling, loss of appetite, irritability, drowsiness, and fever.

The U.S. CDC recommends children should get two doses of MMR vaccine, starting with the first dose at 12 to 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.

Measles, mumps, and rubella are acute and highly contagious viral diseases responsible for considerable morbidity and mortality throughout the world. In recent years, measles outbreaks have occurred in the USA and globally, with more than 400,000 cases confirmed in 2019, reports the CDC.

The majority of measles cases during 2019 were related to under-vaccinated international travelers.

Moreover, in May 2020, about 80 million children globally were estimated to be under-vaccinated against measles and other diseases.

Recently, the CDC reported good news. As of July 9, 2021, only two measles cases were confirmed in the USA during 2021.

And studies published in October 2019 showed definitive evidence that a measles virus infection can destroy important immune cells that ‘remember’ previous encounters with specific bacteria. This means an immune system reduction can leave about 40% of children who recover from measles infection are vulnerable to other pathogens that they might have been protected from before their bout with measles.

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information, please visit www.gsk.com/about-us.

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