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FDA approves GSK’s Priorix vaccine for measles, mumps and rubella

The vaccine has been approved to use in those aged 12 months and above

GSK

GlaxoSmithKline (GSK) has announced that it has received approval from the US Food and Drug Administration (FDA) for Priorix, a live measles, mumps and rubella (MMR) vaccine. The vaccine can be used to immunise those aged 12 months and above to help prevent contracting measles, mumps and rubella.

The treatment is currently licensed in more than 100 countries globally, including all European countries, Australia, New Zealand and Canada, with a roll-out of over 800 million doses to date.

Measles, mumps and rubella are highly-contagious viral diseases and account for significant morbidity and mortality worldwide.

More recently, increasing instances of measles outbreaks have been recorded in the US and globally, with over 400,000 cases confirmed in 2019, which marks a considerable regression in the decades of progress made towards the elimination of measles in many countries.

Temi Folaranmi, vice president and vaccines therapeutic area head of US Medical Affairs at GSK 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.

“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,” he added.

Outlined in a US Centers for Disease Control and Prevention (CDC) report, vaccine ordering in the past two years through the CDC’s Vaccines For Children programme – the federal programme which has facilitated the immunisation of about half of the children in the US – dropped by more than 10%, suggesting that fewer vaccinations in children were occurring.

It was also highlighted that 400,000 fewer children were enrolled in kindergarten in the 2020-2021 school year than expected nationally, which means those children might be behind on childhood immunisations.

The safety of Priorix was evaluated in six clinical studies, in which a total of 12,151 participants, including 6,391 in the US, were given at least one dose of the vaccine. The efficacy of Priorix was demonstrated based on immunogenicity data versus the comparator vaccine.

With this approval, Priorix will offer US healthcare professionals another MMR vaccine choice. It may be administered as a first dose, followed up by a second dose of Priorix. It can also be administered as a second dose to individuals who have previously received the first dose of another MMR-containing vaccine.

Article by
Fleur Jeffries

8th June 2022

From: Research, Regulatory, Healthcare

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