Medicines and Healthcare Products Regulatory Agency Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine in Great Britain*
PR94392
GAITHERSBURG, Md., Feb. 3, 2022 /PRNewswire=KYODO JBN/ --
-- Nuvaxovid(TM) COVID-19 Vaccine (recombinant, adjuvanted)(+) is the first
protein-based COVID-19 vaccine authorized in Great Britain
-- Novavax and the U.K. Vaccines Taskforce previously announced an
agreement for up to 60 million doses
-- Authorization based on data including an ongoing pivotal Phase 3 trial
conducted in the U.K. with almost 15,000 participants
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing
and commercializing next-generation vaccines for serious infectious diseases,
today announced that the Medicines and Healthcare products Regulatory Agency
(MHRA) has granted conditional marketing authorization (CMA) for Nuvaxovid(TM)
COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent
COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older in Great
Britain. The vaccine, also known as NVX-CoV2373, is the first protein-based
vaccine to be authorized for use in Great Britain.
"We are proud that Nuvaxovid will be the first protein-based vaccine option
authorized by MHRA as the United Kingdom tackles this next phase of the
pandemic," said Stanley C. Erck, President and Chief Executive Officer,
Novavax. "We thank the agency for its thorough review process and are
tremendously grateful to the clinical trial participants and trial sites in the
U.K., as well as the Vaccines Taskforce, for their ongoing support and vital
contributions to this program."
The MHRA decision was based on the totality of preclinical, clinical, and
chemistry, manufacturing and controls (CMC) data reviewed by the agency. This
includes two pivotal ongoing Phase 3 clinical trials: PREVENT-19 which enrolled
approximately 30,000 participants in the U.S. and Mexico, the results of which
were published in the New England Journal of Medicine (NEJM(i) (
; and a trial with almost 15,000 participants in the U.K., the results of which
were also published in NEJM(ii) (
) . In both trials, the vaccine demonstrated efficacy with a reassuring safety
profile. Serious and severe adverse (
https://c212.net/c/link/?t=0&l=en&o=3433069-1&h=473920425&u=https%3A%2F%2Fprndl2-irisxe1.prnewswire.local%2FPrimaryContent.aspx%3Fdn%3D3433069-1-1+(ID-B19B8F80AE92).docx%26dt%3Dh%26ro%3DFalse%26fl%3D0%26lf%3Depc%26tid%3D5453419%26oldXEFileName%3DTask%2F2-2-2022%2F10%2F3433069-1-1+(ID-B19B8F80AE92)_XHTMLEditor.html%26isPrimContentChanged%3DTrue%26remObj%3DFalse%26userId%3D1519241%23adverse&a=adverse
) events were low in number and balanced between vaccine and placebo groups.
The most common adverse reactions observed during clinical studies (frequency
category of very common greater than or equal to 1/10) were headache, nausea or
vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and
malaise. Novavax will continue to collect and analyze real-world data,
including the monitoring of safety and the evaluation of variants, as the
vaccine is distributed. The vaccine is stored at 2 degrees - 8 degrees Celsius
and has a current assigned shelf life in Great Britain of 9 months.
Novavax previously announced (
) an agreement with the U.K. Vaccines Taskforce for up to 60 million doses of
Novavax' COVID-19 vaccine.
For more information on Nuvaxovid, including a full listing of where it has
been authorized for use, please visit the following websites:
-- MHRA Regulatory approval of COVID-19 vaccine Nuvaxovid (
)
-- Novavax global authorization website (
)
The brand name Nuvaxovid(TM) has not yet been authorized for use in the U.S. by
the FDA.
Conditional Marketing Authorization of Nuvaxovid(TM) in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted
conditional marketing authorization for Nuvaxovid(TM) COVID-19 Vaccine
(recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by
SARS-CoV-2 in individuals 18 years of age and older.
Important Safety Information
-- Nuvaxovid is contraindicated in persons who have a hypersensitivity to
the active substance, or to any of the excipients.
-- Events of anaphylaxis have been reported with administration of COVID-19
vaccines. Appropriate medical treatment and supervision should be
available in case of an anaphylactic reaction following the
administration of the vaccine. A second dose of the vaccine should not
be given to those who have experienced anaphylaxis to the first dose of
Nuvaxovid.
-- Anxiety-related reactions, including vasovagal reactions (syncope),
hyperventilation, or stress¨Crelated reactions may occur in association
with vaccination as a psychogenic response to the needle injection. It
is important that precautions are in place to avoid injury from
fainting.
-- Vaccination should be postponed in individuals suffering from an acute
severe febrile illness or acute infection. Minor infection and/or low-
grade fever should not delay vaccination.
-- Nuvaxovid should be given with caution in individuals receiving
anticoagulant therapy or those with thrombocytopenia or any coagulation
disorder (such as hemophilia) because bleeding or bruising may occur
following an intramuscular administration in these individuals.
-- The efficacy of Nuvaxovid may be lower in immunosuppressed individuals.
-- The effects with Nuvaxovid may temporarily affect the ability to drive
or use machines.
-- Individuals may not be fully protected until 7 days after their second
dose. As with all vaccines, vaccination with Nuvaxovid may not protect
all vaccine recipients.
-- The most common adverse reactions observed during clinical studies
(frequency category of very common greater than or equal to 1/10) were
headache, nausea or vomiting, myalgia, arthralgia, injection site
tenderness/pain, fatigue, and malaise.
For additional information, please visit www.NovavaxCovidVaccine.com for the
full Summary of Product Characteristics with Package Leaflet, Prescribing
Information and Important Safety Information, adverse event reporting
instructions, or to request additional information.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of
the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to
generate antigen derived from the coronavirus spike (S) protein and is
formulated with Novavax' patented saponin-based Matrix-M(TM) adjuvant to
enhance the immune response and stimulate high levels of neutralizing
antibodies. NVX-CoV2373 contains purified protein antigen and can neither
replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a
vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses
(5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days
apart. The vaccine is stored at 2 degrees - 8 degrees Celsius, enabling the use
of existing vaccine supply and cold chain channels. The current assigned shelf
life of the vaccine in Great Britain is 9 months. Use of the vaccine should be
in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and
distribution of NVX-CoV2373 worldwide. Existing authorizations leverage
Novavax' manufacturing partnership with Serum Institute of India (SII), the
world's largest vaccine manufacturer by volume. They will later be supplemented
with data from additional manufacturing sites throughout Novavax' global supply
chain.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000
participants, achieved 90.4% efficacy overall. It was designed as a 2:1
randomized, placebo-controlled, observer-blinded study to evaluate the
efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for
PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild,
moderate or severe) COVID-19 with onset at least 7 days after the second dose
in serologically negative (to SARS-CoV-2) adult participants at baseline. The
statistical success criterion included a lower bound of 95% CI >30%. The key
secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or
severe COVID-19. Both endpoints were assessed at least seven days after the
second study vaccination in volunteers who had not been previously infected
with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody
response after the second dose in both studies. Full results of the trial were
published in the New England Journal of Medicine (NEJM)(i) (
).
A trial conducted in the U.K. with 14,039 participants was designed as a
randomized, placebo-controlled, observer-blinded study and achieved overall
efficacy of 89.7%. The primary endpoint was based on the first occurrence of
PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at
least 7 days after the second study vaccination in serologically negative (to
SARS-CoV-2) adult participants at baseline. Full results of the trial were
published in NEJM(ii) (
).
About Matrix-M(TM) Adjuvant
Novavax' patented saponin-based Matrix-M(TM) adjuvant has demonstrated a potent
and generally well-tolerated effect by stimulating the entry of
antigen-presenting cells into the injection site and enhancing antigen
presentation in local lymph nodes, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved
health globally through the discovery, development and commercialization of
innovative vaccines to prevent serious infectious diseases. The company's
proprietary recombinant technology platform harnesses the power and speed of
genetic engineering to efficiently produce highly immunogenic nanoparticles
designed to address urgent global health needs. NVX-CoV2373, the company's
COVID-19 vaccine, has received authorization from multiple regulatory
authorities globally, including Conditional Marketing Authorization from the
European Commission** and Emergency Use Listing from the World Health
Organization. The vaccine is also under review by multiple regulatory agencies
worldwide.
For more information, visit www.novavax.com and connect with us LinkedIn (
).
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and
prospects, its partnerships, the ongoing development of NVX-CoV2373, the scope,
timing and outcome of future regulatory filings and actions, including Novavax'
plans to supplement existing authorizations with data from the additional
manufacturing sites in Novavax' global supply chain, the potential impact of
Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic
and protecting populations, the efficacy, safety and intended utilization of
NVX-CoV2373, and the expected integration of NVX-CoV2373 into the United
Kingdom's broader COVID-19 vaccination program are forward-looking statements.
Novavax cautions that these forward-looking statements are subject to numerous
risks and uncertainties that could cause actual results to differ materially
from those expressed or implied by such statements. These risks and
uncertainties include challenges satisfying, alone or together with partners,
various safety, efficacy, and product characterization requirements, including
those related to process qualification and assay validation, necessary to
satisfy applicable regulatory authorities; difficulty obtaining scarce raw
materials and supplies; resource constraints, including human capital and
manufacturing capacity, on the ability of Novavax to pursue planned regulatory
pathways; challenges meeting contractual requirements under agreements with
multiple commercial, governmental, and other entities; and those other risk
factors identified in the "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections of Novavax'
Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent
Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange
Commission (SEC). We caution investors not to place considerable reliance on
forward-looking statements contained in this press release. You are encouraged
to read our filings with the SEC, available at www.sec.gov and www.novavax.com,
for a discussion of these and other risks and uncertainties. The
forward-looking statements in this press release speak only as of the date of
this document, and we undertake no obligation to update or revise any of the
statements. Our business is subject to substantial risks and uncertainties,
including those referenced above. Investors, potential investors, and others
should give careful consideration to these risks and uncertainties.
Contacts:
Investors
Novavax, Inc.
Erika Schultz | 240-268-2022
ir@novavax.com
Solebury Trout
Alexandra Roy | 617-221-9197
aroy@soleburytrout.com
Media
Ali Chartan | 240-720-7804
Laura Keenan Lindsey | 202-709-7521
media@novavax.com
(i) Dunkle L, Kotloff K, Gay C. Efficacy and Safety of NVX-CoV2373 in Adults in
the United States and Mexico. N Engl J Med. 2021 Dec 15.
(ii) Heath P, Galiza E, Baxter D. Safety and Efficacy of NVX-CoV2373 Covid-19
Vaccine. N Engl J Med. 2021 June 30;385:1172-1183.
(+)This medicine is subject to additional monitoring. This will allow quick
identification of new safety information. If you are concerned about an adverse
event, it should be reported on a Yellow Card. Reporting forms and information
can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA
Yellow Card in the Google Play or Apple App Store. When reporting please
include the vaccine brand and batch/Lot number if available.
*Great Britain conditional marketing authorization includes England, Scotland
and Wales
**European Commission conditional marketing authorization includes Northern
Ireland
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SOURCE Novavax, Inc.
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