RNS Number : 6884N
06 June 2022
Issued: 6 June 2022, London UK
GSK announces US FDA approval of Priorix for the prevention of
measles, mumps and rubella in individuals 12 months of age and
-- Priorix becomes an additional source of measles, mumps and rubella vaccine for US patients
GSK plc (LSE/NYSE: GSK) today announced that the US Food and
Drug Administration (FDA) has approved Priorix (Measles, Mumps and
Rubella Vaccine, Live) for active immunisation for the prevention
of measles, mumps and rubella (MMR) in individuals 12 months of age
Priorix is currently licenced in more than 100 countries
worldwide, including all European countries, Canada, Australia and
New Zealand, with more than 800 million doses distributed to
"We're proud to make Priorix available in the US for the first
time, adding a choice for providers to help protect patients
against these highly-contagious diseases and to further strengthen
offerings in our paediatric vaccine portfolio," said Judy Stewart,
Senior Vice President and Head of US Vaccines, GSK.
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 US and globally, with more than 400,000 cases
confirmed in 2019, reversing decades of progress toward measles
elimination in many countries. 
According to a recent 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 through which about half of the children in the country
are immunised, dropped more than 10%, indicating that fewer
vaccinations in children were occurring.  The report also noted
400,000 fewer children entered kindergarten in the 2020-2021 school
year than expected nationally, meaning those children may not be up
to date on childhood immunisations like their MMR vaccination.
"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," said Temi
Folaranmi, MD, Vice President and Vaccines Therapeutic Area Head,
US Medical Affairs, GSK. "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."
The safety of Priorix was evaluated in six clinical studies, in
which a total of 12,151 participants (6,391 in the US) received at
least one dose of Priorix: 8,780 children (4,148 in the US) 12
through 15 months of age; 2,917 children (1,950 in the US) 4
through 6 years of age; and 454 adults and children (293 in the US)
7 years of age and older. The most commonly reported adverse
reactions were pain, redness, swelling, loss of appetite,
irritability, drowsiness and fever. The efficacy of Priorix was
demonstrated based on immunogenicity data versus the comparator
Priorix will provide US healthcare professionals with another
MMR vaccine choice. Priorix may be administered as a first dose,
followed by a second dose of Priorix. Priorix may also be
administered as a second dose to individuals who have previously
received the first dose of another MMR-containing vaccine.
The CDC recommends people get a MMR vaccine to protect against
measles, mumps and rubella. Children should get two doses of MMR
vaccine, starting with the first dose at 12 through 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. 
Priorix is scheduled to be on the agenda for the June CDC
Advisory Committee on Immunization Practices (ACIP) meeting for
consideration of formal inclusion into the vaccine schedule and
The US Prescribing Information is available at:
Important Safety Information
-- The following is based on the US Prescribing Information for
Priorix. Please consult the full Prescribing information for all
the labelled safety information.
-- Contraindications for Priorix are: severe allergic reaction
(e.g., anaphylaxis) to any component of Priorix, or after a
previous dose of any measles-, mumps- and rubella-containing
vaccine; severe immunodeficiency; and pregnancy or planning to
become pregnant within the next month.
-- Appropriate medical treatment and supervision must be
available to manage possible anaphylactic reactions following
administration of Priorix.
-- There is a risk of febrile seizure following immunisation with Priorix.
-- Thrombocytopenia and thrombocytopenic purpura have been
reported following vaccination with Priorix.
-- Syncope (fainting) can occur in association with
administration of injectable vaccines, including Priorix.
Procedures should be in place to avoid injury from fainting.
-- The tip caps of the prefilled syringes contain natural rubber
latex which may cause allergic reactions.
-- Vaccination with Priorix may not protect all susceptible individuals.
-- Most common solicited adverse reactions in clinical trial
participants: 12 through 15 months of age: local reactions were
pain, and redness; systemic reactions were irritability, loss of
appetite, drowsiness and fever; 4 through 6 years of age: local
reactions were pain, redness and swelling; systemic reactions were
loss of appetite, drowsiness and fever; and 7 years of age and
older: local reactions were pain and redness.
GSK is a science-led global healthcare company. For further
information please visit
Media enquiries: Tim Foley +44 (0) 20 8047 (London)
Simon Moore +44 (0) 20 8047 (London)
Kathleen Quinn +1 202 603 5003 (Washington
Sean Clements +1 215 740 3088 (Philadelphia)
Analyst/Investor Nick Stone +44 (0) 7717 (London)
Sonya Ghobrial +44 (0) 7392 (Consumer)
James Dodwell +44 (0) 20 8047 (London)
Mick Readey +44 (0) 7990 (London)
Josh Williams +44 (0) 7385 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described in the Company's
Annual Report on Form 20-F for 2021, GSK's Q1 Results for 2022 and
any impacts of the COVID-19 pandemic.
Registered in England & Wales:
980 Great West Road
 Centers for Disease Control and Prevention. About Global
Measles, Rubella, and Congenital Rubella Syndrome (CRS). Available
at: https://www.cdc.gov/globalhealth/measles/about/index.html .
Accessed May 2022.
 Su, S. B., Chang, H. L., & Chen, A. K. Current Status of
Mumps Virus Infection: Epidemiology, Pathogenesis, and Vaccine.
International Journal of Environmental Research and Public Health
2020, 17(5), 1686. https://doi.org/10.3390/ijerph17051686.
 World Health Organization. Immunization Analysis and
Insights. Available at:
. Accessed May 2022.
 Seither R, Laury J, Mugerwa-Kasujja A, Knighton CL, Black
CL. Vaccination Coverage with Selected Vaccines and Exemption Rates
Among Children in Kindergarten - United States, 2020-21 School
Year. MMWR Morb Mortal Wkly Rep 2022;71:561-568. DOI:
http://dx.doi.org/10.15585/mmwr.mm7116a1external icon . Accessed
 Centers for Disease Control and Prevention. Measles, Mumps,
and Rubella (MMR) Vaccination: What Everyone Should Know. Available
at: https://www.cdc.gov/vaccines/vpd/mmr/public/index.html .
Accessed May 2022.
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