REG - GSK PLC - US FDA approves Boostrix maternal immunisation

GSKAnnouncement

10/10/2022 07:01

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RNS Number : 2601C  GSK PLC  10 October 2022

Issued: 10 October 2022, London

For media and investors only

 

US FDA approves Boostrix for immunisation during pregnancy for the prevention
of whooping cough in newborn infants

 

Boostrix is the first vaccine in the US to help protect infants younger than
two months from pertussis (whooping cough)

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Boostrix (tetanus toxoid, reduced diphtheria
toxoid, and acellular pertussis vaccine adsorbed  Tdap ) for immunisation
during the third trimester of pregnancy to help prevent pertussis (whooping
cough) in infants less than two months of age.

 

Since 2010, the Centers for Disease Control and Prevention (CDC) has reported
15,000 to 48,000 pertussis cases among people of all ages in the United States
each year.(1) Infants are at high risk of complications from whooping cough
because their immune systems are still developing.(1)

 

According to the CDC, the Tdap vaccination given during pregnancy provides the
best protection to infants against whooping cough. Vaccination passes
protective antibodies to babies before birth to protect them in their first
months of life(2).

 

Roger Connor, President, Vaccines and Global Health, GSK, said: "We're
immensely proud to have the first-ever Tdap vaccine approved by the FDA
specifically for use during pregnancy. We believe this approval may help
protect more infants from the potentially life-threatening implications of
whooping cough."

 

Boostrix is currently approved in over 80 countries worldwide, including the
US, most European Union countries, Canada, Australia and New Zealand for
immunisation against tetanus, diphtheria and pertussis.

 

About BOOSTRIX

Boostrix is indicated in the US for:

·      Active booster immunisation against tetanus, diphtheria and
pertussis in individuals aged 10 years and older.

·      Immunisation during the third trimester of pregnancy to help
prevent pertussis (whooping cough) in infants less than two months of age.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology
and talent to get ahead of disease together. Find out more at
www.gsk.com/company (http://www.gsk.com/company) .

 

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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 Q2 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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References:

1.     Centers for Disease Control and Prevention. Pertussis Cases by Year
(1922-2019). Available at:
https://www.cdc.gov/pertussis/surv-reporting/cases-by-year.html
(https://www.cdc.gov/pertussis/surv-reporting/cases-by-year.html) . Accessed
October 2022.

2.     Centers for Disease Control and Prevention. Whooping Cough is
Deadly for Babies. Available at:
 https://www.cdc.gov/pertussis/pregnant/mom/deadly-disease-for-baby.html
(https://www.cdc.gov/pertussis/pregnant/mom/deadly-disease-for-baby.html) .
Accessed October 2022.

 

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