Action Represents Another Milestone for the
Global Partnership Against Ebola
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has approved ERVEBO® (Ebola Zaire Vaccine, Live) (pronounced
er-VEE-boh) for the prevention of disease caused by Zaire
ebolavirus in individuals 18 years of age and older. The duration
of protection conferred by ERVEBO is unknown. ERVEBO does not
protect against other species of Ebolavirus or Marburgvirus.
Effectiveness of the vaccine when administered concurrently with
antiviral medication, immune globulin (IG), and/or blood or plasma
transfusions is unknown. Do not administer ERVEBO to individuals
with a history of a severe allergic reaction (e.g., anaphylaxis) to
any component of the vaccine, including rice protein.
“Approval of this vaccine by the FDA represents another
important milestone in the global response to Ebola Virus Disease
and stands as a tremendous accomplishment by a unique global
partnership,” said Dr. Roger M. Perlmutter president, Merck
Research Laboratories. “In acknowledging this event, I wish in
particular to recognize the heroic efforts being made by frontline
responders to the ongoing outbreak in the Democratic Republic of
the Congo. We are proud and honored to play a role in supporting
their vital activities, and we remain focused on the important work
ahead.”
“Having an Ebola vaccine approved by the FDA is a significant
milestone in Ebola preparedness and prevention efforts,” said Rick
Bright, Ph.D., deputy assistant secretary for preparedness and
response and director of the Biomedical Advanced Research and
Development Authority (BARDA). “At BARDA, we are tremendously proud
to have been a part of this unprecedented collaboration between
private and public sectors in multiple countries that has led to
this important moment in public health history.”
As previously announced, Merck is working to initiate
manufacturing of licensed doses and expects these doses to start
becoming available in approximately the third quarter of 2020.
Merck is working closely with the U.S. government, WHO, UNICEF, and
Gavi (the Vaccine Alliance) to plan for how eventual, licensed
doses will support future public health preparedness and response
efforts against Zaire ebolavirus disease.
During this transition period, Merck continues to work urgently
with its partners to ensure uninterrupted access to the
investigational Ebola Zaire vaccine (V920) in support of ongoing
international response efforts in the Democratic Republic of the
Congo and neighboring countries. Merck has, to date, shipped more
than 275,000 1.0mL doses of V920 based on requests by the WHO.
Merck has also made submissions to African country national
regulatory authorities in collaboration with the African Vaccine
Regulatory Forum (AVAREF), that will allow the vaccine to be
registered in African countries considered to be at-risk for Ebola
outbreaks by the WHO.
Selected Safety Information for ERVEBO
CONTRAINDICATIONS
Do not administer ERVEBO to individuals with a history of a
severe allergic reaction (e.g., anaphylaxis) to any component of
the vaccine, including rice protein.
WARNINGS AND PRECAUTIONS
Management of Acute Allergic Reactions
Among 15,399 subjects vaccinated with ERVEBO, there were two
reports of anaphylaxis. Monitor individuals for signs and symptoms
of hypersensitivity reactions following vaccination with ERVEBO.
Appropriate medical treatment and supervision must be available in
case of an anaphylactic event following the administration of
ERVEBO.
Limitations of Vaccine Effectiveness
Vaccination with ERVEBO may not protect all individuals.
Vaccinated individuals should continue to adhere to infection
control practices to prevent Zaire ebolavirus infection and
transmission.
Immunocompromised Individuals
The safety and effectiveness of ERVEBO have not been assessed in
immunocompromised individuals. The effectiveness of ERVEBO in
immunocompromised individuals may be diminished. The risk of
vaccination with ERVEBO, a live virus vaccine, in immunocompromised
individuals should be weighed against the risk of disease due to
Zaire ebolavirus.
Transmission
Vaccine virus RNA has been detected by RT-PCR in blood, saliva,
urine, and fluid from skin vesicles of vaccinated adults.
Transmission of vaccine virus is a theoretical possibility.
ADVERSE REACTIONS
The clinical development program for ERVEBO included clinical
studies conducted in North America, Europe and Africa, in which a
total of 15,399 adults received a dose of ERVEBO. The total number
of subjects vaccinated with ERVEBO in double-blind,
placebo-controlled trials was 1,712 and in open label trials was
13,687.
The most common injection-site adverse reactions reported by
subjects taking ERVEBO in Study 1 (N=500) were injection-site pain
(34.0%) and redness/swelling (2%). The most common injection-site
adverse reactions reported by subjects taking ERVEBO in Study 2
(N=1051) were injection-site pain (70.0%), swelling (17%), and
redness (12%).
The most common systemic adverse reactions reported following
vaccination with ERVEBO in Study 1 (N=498) were headache (37%),
feverishness (34%), muscle pain (33%), fatigue (19%), nausea (8%),
joint pain/tenderness (7%), rash (4%), and abnormal sweating (3%).
The most common systemic adverse reactions reported following
vaccination with ERVEBO in Study 2 (N=1051) were joint pain (18%),
arthritis (5%), rash (4%), and vesicular lesions (2%).
Arthralgia was reported to occur in 7% to 40% of vaccine
recipients in blinded, placebo-controlled studies. Severe
arthralgia, defined as preventing daily activity, was reported in
up to 3% of subjects.
Arthritis (including events of arthritis, joint effusion, joint
swelling, osteoarthritis, monoarthritis or polyarthritis) was
reported to occur in 0% to 24% of subjects in blinded,
placebo-controlled studies in which subjects received ERVEBO or a
lower dose formulation, with all but one study reporting arthritis
in <5% of subjects. Most occurrences of arthritis were reported
within the first few weeks following vaccination, were of mild to
moderate intensity, and resolved within several weeks after onset.
In one study conducted in Switzerland (Study 5, NCT02287480), 102
subjects received ERVEBO or a lower dose formulation. In this
study, arthritis was reported to occur in 24% of subjects and
severe arthritis, defined as preventing daily activity, in 12% of
subjects.
Rash was reported to occur after administration of ERVEBO in
blinded, placebo-controlled studies, with all but one study
reporting rash in <9% of subjects. In Study 5, rash was reported
to occur in 25% (n=4) of ERVEBO recipients and 7.7% (n=1) of
placebo recipients.
White blood cell counts were assessed in 697 subjects who
received ERVEBO. Decreases in lymphocytes were reported in up to
85% of subjects and decreases in neutrophils were reported in up to
43% of subjects. No associated infections were reported.
Among 15,399 ERVEBO recipients, two serious adverse reactions of
pyrexia were reported as vaccine-related. In addition, two serious
adverse reactions of anaphylaxis were reported as vaccine-related.
None of these serious adverse reactions were fatal.
DRUG INTERACTIONS
Interference with Laboratory Tests
Following vaccination with ERVEBO, individuals may test positive
for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic
acid or antigens. GP-based testing may have limited diagnostic
value during the period of vaccine viremia, in the presence of
vaccine-derived Ebola GP, and following antibody response to the
vaccine.
USE IN SPECIFIC POPULATIONS
Pregnancy
There are no adequate and well-controlled studies of ERVEBO in
pregnant women, and human data available from clinical trials with
ERVEBO are insufficient to establish the presence or absence of
vaccine-associated risk during pregnancy.
The decision to vaccinate a woman who is pregnant should
consider the woman’s risk of exposure to Zaire ebolavirus.
Lactation
Human data are not available to assess the impact of ERVEBO on
milk production, its presence in breast milk, or its effects on the
breastfed child. The developmental and health benefits of
breastfeeding should be considered along with the mother’s clinical
need for ERVEBO and any potential adverse effects on the breastfed
child from ERVEBO or from the underlying maternal condition. For
preventive vaccines, the underlying condition is susceptibility to
disease prevented by the vaccine.
Geriatric Use
Clinical studies of ERVEBO did not include sufficient numbers of
subjects 65 years of age and older to determine whether they
respond differently from younger subjects.
More About the Development of the Vaccine
ERVEBO, known as V920 in its investigational phase, was
initially engineered by scientists from the Public Health Agency of
Canada’s National Microbiology Laboratory and the technology was
subsequently licensed by a subsidiary of NewLink Genetics
Corporation. In late 2014, when the Ebola outbreak in western
Africa was at its peak, and with the goal of applying its
capabilities in process research, clinical development, and
manufacturing to an important global effort, Merck acquired the
rights to develop V920 from NewLink Genetics. Since that time, the
company has worked closely with a diverse range of external
collaborators to enable a broad clinical development program with
partial funding from the U.S. government, including the Department
of Health and Human Service’s Biomedical Advanced Research
Development Authority (BARDA) and the Department of Defense’s
Defense Threat Reduction Program (DTRA) and Joint Vaccination
Acquisition Program (JVAP). Beginning in 2015 Merck began
manufacturing the emergency-use supplies that have been used to
support outbreak response efforts prior to availability of licensed
doses in collaboration with Gavi. Merck’s ongoing V920 vaccine
supply replenishment activities are supported by partial Federal
funding from BARDA under Contract No. HHSO100201700012C. Merck has
been responsible for the research, development, manufacturing and
regulatory efforts in support of V920. The company has committed to
working closely with other stakeholders to accelerate the continued
development, production and availability of the vaccine.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of pharmaceutical industry regulation and health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; the company’s ability to accurately predict future market
conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of the company’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2018
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Before administering ERVEBO® (Ebola Zaire Vaccine, Live), please
read the Prescribing Information at
https://www.merck.com/product/usa/pi_circulars/e/ervebo/ervebo_pi.pdf
The Patient Information is also
available at
https://www.merck.com/product/usa/pi_circulars/e/ervebo/ervebo_ppi.pdf
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