GAITHERSBURG, Md., Sept. 13,
2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq:
NVAX), a biotechnology company dedicated to developing and
commercializing next-generation vaccines for serious infectious
diseases and Serum Institute of India Pvt. Ltd. (SII), the world's
largest vaccine manufacturer by volume, today announced that the
South African Health Products Regulatory Authority has granted full
product registration with conditions for Novavax' protein-based
vaccine, NVX-CoV2373, as a two-dose primary series for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused
by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in
adults aged 18 and older. The Novavax vaccine is marketed in
South Africa under the brand name
Covovax™.
"We are pleased to work with the Serum Institute to offer our
protein-based vaccine to the people of South Africa and to support expanded access to
an area of the world where vaccination rates are well below public
health targets," said Stanley C.
Erck, President and Chief Executive Officer, Novavax. "As
COVID-19 continues to evolve, having a choice of vaccines is
critical to improving vaccination rates."
The product registration was based on the totality of
preclinical, manufacturing, and clinical trial data submitted for
review. This includes two pivotal Phase 3 clinical trials:
PREVENT-19, which enrolled 29,960 participants aged 18 years and
older in the U.S. and Mexico and was published in the New
England Journal of Medicine (NEJM); and a UK-based trial
with almost 15,000 adult participants, also published
in NEJM.
In both trials, the vaccine demonstrated efficacy with a
reassuring safety and tolerability profile. Serious and severe
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 ≥1/10) were
headache, nausea or vomiting, myalgia, arthralgia, injection site
tenderness/pain, fatigue, and malaise.
NVX-CoV2373 has received authorization for use in adults
aged 18 and older from more than 43 countries, including the U.S.,
and from the World Health Organization (WHO).
Important Safety Information
- NVX-CoV2373 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. Close observation for at least
15 minutes is recommended and a second dose of the vaccine should
not be given to those who have experienced anaphylaxis to the first
dose of NVX-CoV2373.
- Anxiety-related reactions, including vasovagal reactions
(syncope), hyperventilation, or stress‐related 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. The presence of
a minor infection and/or low-grade fever should not delay
vaccination.
- NVX-CoV2373 should be given with caution in individuals
receiving anticoagulant therapy or those with thrombocytopenia or
any coagulation disorder (such as haemophilia) because bleeding or
bruising may occur following an intramuscular administration in
these individuals.
- The efficacy of NVX-CoV2373 may be lower in immunosuppressed
individuals.
- Administration of NVX-CoV2373 in pregnancy should only be
considered when the potential benefits outweigh any potential risks
for the mother and foetus.
- The effects with NVX-CoV2373 may temporarily affect the ability
to drive or use machines.
- Individuals may not be fully protected until seven days after
their second dose. As with all vaccines, vaccination with
NVX-CoV2373 may not protect all vaccine recipients.
- The most common adverse reactions observed during clinical
studies were headache, nausea or vomiting, myalgia, arthralgia,
injection site tenderness/pain, fatigue, and malaise.
For more information on NVX-CoV2373 please visit the following
website:
- Novavax global authorization website
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. The vaccine 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™ 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.
NVX-CoV2373 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°- 8°
Celsius, enabling the use of existing vaccine supply and cold chain
channels. 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 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 NVX-CoV2373 Phase 3 Trials
NVX-CoV2373
continues being evaluated in two pivotal Phase 3 trials.
PREVENT-19 (the PRE-fusion protein
subunit Vaccine Efficacy Novavax Trial
| COVID-19) is a 2:1 randomized, placebo-controlled,
observer-blinded trial to evaluate the efficacy, safety, and
immunogenicity of NVX-CoV2373 with Matrix-M adjuvant in 29,960
participants 18 years of age and over in 119 locations in the
U.S. and Mexico. The primary endpoint for PREVENT-19 was
the first occurrence of PCR-confirmed symptomatic (mild, moderate,
or severe) COVID-19 with onset at least seven 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%. A secondary endpoint was 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. In the trial, NVX-CoV2373 achieved 90.4% efficacy
overall. 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
NEJM.
The pediatric expansion of PREVENT-19 is a 2:1 randomized,
placebo-controlled, observer-blinded trial to evaluate the safety,
effectiveness, and efficacy of NVX-CoV2373 with Matrix-M
adjuvant in 2,247 adolescent participants 12 to 17 years of age in
73 locations in the U.S., compared with placebo. In the pediatric
trial, the vaccine achieved its primary effectiveness endpoint
(non-inferiority of the neutralizing antibody response compared to
young adult participants 18 through 25 years of age from
PREVENT-19) and demonstrated 80% efficacy overall at a time when
the Delta variant of concern was the predominant circulating strain
in the U.S. Additionally, immune responses were about
two-to-three-fold higher in adolescents than in adults against all
variants studied.
Additionally, a trial conducted in the U.K. with 14,039
participants aged 18 years and over 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 seven 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.
About Matrix-M™ Adjuvant
Novavax'
patented saponin-based Matrix-M adjuvant has
demonstrated a potent and 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. The Novavax COVID-19 vaccine, has
received authorization from multiple regulatory authorities
globally, including the U.S. Food and Drug Administration, the
European Commission, and the WHO. The vaccine is currently under
review by multiple regulatory agencies worldwide, including for
additional indications and populations such as adolescents and as a
booster. In addition to its COVID-19 vaccine, Novavax
is also currently evaluating its COVID-19-Influenza
Combination vaccine candidate in a Phase 1/2 clinical trial,
its quadrivalent influenza investigational vaccine
candidate, and an Omicron strain-based vaccine (NVX-CoV2515) as
well as a bivalent format Omicron-based / original strain-based
vaccine. These vaccine candidates incorporate Novavax'
proprietary saponin-based Matrix-M adjuvant to enhance
the immune response and stimulate high levels of neutralizing
antibodies.
For more information, visit www.novavax.com and
connect with us on LinkedIn.
About Serum Institute of India
Driven by the philanthropic
philosophy of affordable vaccines, Serum Institute of India Pvt, Ltd. is the world's
largest vaccine manufacturer by number of doses produced and sold
globally (more than 1.5 billion doses), supplying the world's least
expensive and WHO-accredited vaccines to as many as 170 countries.
It was founded in 1966 with the aim of manufacturing
lifesaving immunobiological drugs including vaccines
worldwide. With a strong commitment towards global health, the
institute's objective has been proliferated by bringing down the
prices of newer vaccines such as such as Diphtheria,
Tetanus, Pertussis, Hib,
BCG, r-Hepatitis B, Measles, Mumps and Rubella
vaccines. SII is credited with bringing world-class
technology to India, through its
state-of-the-art equipped multifunctional production facility
in Manjari, Pune and government agencies to
transform emergency medicine and critical care along with
spearheading the race of vaccine development against the COVID-19
pandemic. Serum Life Sciences Ltd is a subsidiary company of Serum
Institute of India, with a global
sales office in London to market
COVID-19 vaccines manufactured by Serum Institute of India.
Forward-Looking Statements
Statements herein
relating to the future of Novavax, its operating plans
and prospects, its partnerships, the timing of clinical trial
results, the ongoing development of NVX-CoV2373, NVX-CoV2515 and
bivalent Omicron-based / original strain based vaccine, a
COVID-seasonal influenza combination investigational vaccine
candidate, 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,
additional worldwide authorizations of NVX-CoV2373 for use in
adults and adolescents, and as a booster, the evolving COVID-19
pandemic, the potential impact and reach of Novavax
and NVX-CoV2373 in addressing vaccine access, controlling the
pandemic and protecting populations, the efficacy, safety intended
utilization, and the expected administration of NVX-CoV2373 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, without limitation, 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; unanticipated
challenges or delays in conducting clinical trials; 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,
2021 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
Erika Schultz |
240-268-2022
ir@novavax.com
Media
Ali Chartan or Giovanna Chandler | 202-709-5563
media@novavax.com
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