Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)
October 11 2022 - 6:06AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of October 2022
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate
by check mark if the registrant is submitting the Form 6-K in paper
as permitted by Regulation S-T Rule 101(b)(7): ____
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 life2.
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.
GSK enquiries
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Media:
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Tim Foley
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+44 (0) 20 8047 5502
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(London)
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Dan Smith
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+44 (0) 20 8047 5502
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(London)
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Kathleen Quinn
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+1 202 603 5003
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(Washington DC)
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Lyndsay Meyer
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+1 202 302 4595
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(Washington DC)
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Investor Relations:
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Nick Stone
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+44 (0) 7717 618834
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(London)
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James Dodwell
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+44 (0) 20 8047 2406
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(London)
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Mick Readey
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+44 (0) 7990 339653
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(London)
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Josh Williams
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+44 (0) 7385 415719
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(London)
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Jeff McLaughlin
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+1 215 751 7002
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(Philadelphia)
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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.
Registered
in England & Wales:
No. 3888792
Registered
Office:
980 Great West
Road
Brentford,
Middlesex
TW8 9GS
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.
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.
Accessed October 2022.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: October
10, 2022
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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