REG - GSK PLC - US FDA approval of Priorix

GSKAnnouncement

06/06/2022 07:00

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RNS Number : 6884N  GSK PLC  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 older

 

·   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 and older.

 

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 date.

 

"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. 1 
(#_edn1) (, 2  (#_edn2) ) 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. 3  (#_edn3)

 

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. 4  (#_edn4) 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.(4)

 

"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 vaccine.

 

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. 5  (#_edn5)

 

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 recommendations.

 

The US Prescribing Information is available at:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Priorix/pdf/PRIORIX.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Priorix/pdf/PRIORIX.PDF)
.

 

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.

 

 

About GSK

GSK is a science-led global healthcare company. For further information please
visit

www.gsk.com/about-us.

 

 

 

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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.

 

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 1  (#_ednref1) 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
(https://www.cdc.gov/globalhealth/measles/about/index.html) . Accessed May
2022.

 2  (#_ednref2) 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.

 3  (#_ednref3) World Health Organization. Immunization Analysis and Insights.
Available at:
https://www.who.int/teams/immunization-vaccines-and-biologicals/immunization-analysis-and-insights/surveillance/surveillance-for-vpds
(https://www.who.int/teams/immunization-vaccines-and-biologicals/immunization-analysis-and-insights/surveillance/surveillance-for-vpds)
. Accessed May 2022.

 4  (#_ednref4) 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 (http://dx.doi.org/10.15585/mmwr.mm7116a1) . Accessed May 2022.

 5  (#_ednref5) 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
(https://www.cdc.gov/vaccines/vpd/mmr/public/index.html) . Accessed May 2022.

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