NEW BRUNSWICK, N.J.,
Jan. 6, 2022 /PRNewswire/ -- Johnson
& Johnson (NYSE: JNJ) (the Company) today announced new results
from the largest study to date on the durability of COVID-19
vaccines in the United States
(U.S.), showing that a single shot of the Johnson & Johnson
COVID-19 vaccine resulted in long-lasting protection for up to six
months against COVID-19 breakthrough infections, hospitalizations,
and intensive care unit (ICU) admissions. The study was sponsored
by the Janssen Pharmaceutical Companies of Johnson & Johnson
and conducted in partnership with the Department of Science-Aetion,
Inc, and the Division of Pharmacoepidemiology, Department of
Medicine at Brigham and Women's Hospital and Harvard Medical School.
"We continue to undertake extensive efforts to study the
durability of protection offered by the Johnson & Johnson
vaccine amidst the ever-changing COVID-19 pandemic," said
Mathai Mammen, M.D., Ph.D.,
Executive Vice President, Pharmaceuticals, Janssen Research &
Development LLC, Johnson & Johnson. "While these are rapidly
evolving data, we are seeing vaccine effectiveness against
COVID-19-related hospitalization of approximately 80 percent from a
single shot of the Johnson & Johnson vaccine, and this level of
protection holds steady across the length of time studied thus far
– up to six months. The robust and sustained durability of our
COVID-19 vaccine reflects its unique underlying immunology. We
previously reported that our vaccine induces a strong antibody
response as well as an especially strong increase in T-cells that
is consistent across variants, including Omicron."
The new study posted on medRxiv comprehensively
looked at the durability profiles for all three vaccines authorized
or approved in the U.S. using the same methodology across three
outcomes of interest: COVID-19 breakthrough infections,
hospitalizations, and ICU admissions.
The study showed that the effectiveness of the Johnson &
Johnson COVID-19 vaccine against breakthrough infections and
hospitalizations remained durable. The mRNA vaccines (two-doses)
showed waning effectiveness for hospitalizations and breakthrough
infections. All three vaccines showed no evidence of waning
protection against COVID-19-related ICU admissions at any point,
showing strong sustained protection against critically severe
disease. The study was not designed to compare the durability of
vaccines.
New Real World Evidence Study Details
Comprehensive
studies to date on the durability of all vaccines authorized or
approved for use in the U.S. have been limited, with many focusing
on high-risk populations1,2,3,4,5,6,7 or specific
geographic regions or states.8,9,10 This is the largest
COVID-19 real-world effectiveness durability study to date in the
U.S., and the first to analyze the durability of baseline
protection up to six months for all three U.S. authorized or
approved vaccines, and for three COVID-19 outcomes of interest
(breakthrough infections, hospitalizations, and ICU admissions).
Researchers utilized national claims, laboratory, and hospital data
covering 168 million individuals to conduct a matched case-control
study between January 1 and September 7,
2021 for 17 million fully vaccinated individuals matched on
calendar time, 3-digit zip code, age, sex, and comorbidity
scores.
The study assessed durability by measuring the Odds Ratio (OR),
which represents the odds of a fully vaccinated individual having
an outcome (breakthrough infection, hospitalization, or ICU
admission) in each month relative to the odds of having an outcome
in the first month after full vaccination. An OR greater than one
indicates waning of the vaccine protection over time for that
outcome. The study authors acknowledged that direct comparisons of
OR between vaccines should not be made as there may remain baseline
differences including initial effectiveness between the three
vaccine cohorts.
Johnson & Johnson COVID-19 vaccine
(single-shot)
The Johnson & Johnson COVID-19 vaccine
demonstrated a profile that showed durability of effectiveness up
to 6 months for hospitalizations and ICU admissions across the
study period, with a modest increase in breakthrough infections
starting in month 4.
- The initial level of effectiveness at month 1 after full
vaccination was found to be 81% (95% CI: 76%-82%) for
hospitalizations and 74% (95% CI: 72%-75%) for breakthrough
infections.
- Durability:
-
- There was no evidence of waning protection against
COVID-19-related hospitalization during the study period (OR =
1.25, 95% CI [0.86, 1.80] in month 5+).
- There was no evidence of waning protection against breakthrough
infection in the first three months of follow-up, with modest
waning of protection against breakthrough infection observed in
month 4 (OR = 1.16, 95% CI [1.04, 1.29]) and in month 5+ (OR =
1.31, 95% CI [1.18, 1.47]).
- There was no evidence of waning protection against
COVID-19-related ICU admissions at any point (OR = 1.40, 95% CI
[0.43, 4.55] in month 4).
- There was not sufficient follow-up to include a category for 6+
months for breakthrough infections and hospitalizations.
BNT162b2 vaccine effectiveness (two doses 21-42
days apart)
BNT162b2 demonstrated a profile that showed an
increase in hospitalizations and breakthrough infections starting
in month 2, with no waning of effectiveness for ICU admissions over
the study period.
- The initial level of effectiveness at month 1 after full
vaccination was found to be 89% (95% CI: 88%-90%) for
hospitalizations and 88% (95% CI: 87%-88%) for breakthrough
infections.
- Durability:
-
- There was evidence that protection waned against
COVID-19-related hospitalization over time as compared to the first
month of follow-up from vaccination (OR = 3.97, 95% CI [3.26, 4.83]
in month 6+).
- There was evidence that protection waned against breakthrough
infection, where the waning was successively higher for each month
of follow-up (OR = 2.93, 95% CI [2.72, 3.15] for BNT162b2 in month
6+).
- There was no evidence of waning protection against
COVID-19-related ICU admissions at any point (OR = 1.36, 95% CI
[0.80, 2.30] in month 4).
mRNA-1273 vaccine effectiveness (two doses 28-42 days
apart)
mRNA-1273 demonstrated a profile that showed an
increase in hospitalizations in month 3 and breakthrough infections
in month 2, with no waning of effectiveness for ICU admissions over
the study period.
- The initial level of effectiveness at month 1 after full
vaccination was found to be 94% (95% CI: 93%-95%) for
hospitalizations and 92% (95% CI: 91%-92%) for breakthrough
infections.
- Durability:
-
- There was evidence of modest waning in protection against
COVID-19-related hospitalization over time as compared to the first
month of follow-up from vaccination (OR = 1.66, 95% CI [1.26, 2.19]
in month 6+).
- There was evidence that protection waned against breakthrough
infection, where the waning was successively higher for each month
of follow-up (OR = 2.76, 95% CI [2.51, 3.04] in month 6+).
- There was no evidence of waning protection against
COVID-19-related ICU admissions at any point (OR = 1.17, 95% CI
[0.64, 2.13] in month 4).
Other Recent Data for the Johnson & Johnson COVID-19
Vaccine
These results add to the body of evidence showing
that the Johnson & Johnson COVID-19 vaccine elicits protection
against variants of concern. Recently, preliminary data from the
Phase 3b Sisonke study, conducted in
November and December of 2021, demonstrated 85 percent
effectiveness for the homologous (same vaccine) booster shot of the
Johnson & Johnson vaccine, against COVID-19-related
hospitalization in South Africa
when Omicron was dominant.11
The Company also recently announced that a heterologous booster
(different vaccine) of the Johnson & Johnson vaccine in
individuals who initially received the BNT162b2 mRNA vaccine
generated a 41-fold increase in neutralizing antibody responses by
four weeks following the boost and a 5-fold increase in CD8+
T-cells to Omicron by two weeks. A homologous boost with BNT162b2
generated a 17-fold increase in neutralizing antibodies by four
weeks following the boost and a 1.4-fold increase in CD8+ T-cells
by two weeks.12 The increase in CD8+ T-cells
generated by the Johnson & Johnson vaccine may be key to
explaining the high levels of effectiveness against severe COVID-19
disease and hospitalization.
Additional Information
The Johnson & Johnson
COVID-19 vaccine has been authorized as a booster by multiple
regulators and healthcare bodies around the world. Johnson &
Johnson continues to submit relevant data to healthcare regulators,
the World Health Organization (WHO) and National Immunization
Technical Advisory Groups (NITAGs) worldwide to inform
decision-making on local vaccine administration strategies, as
needed.
On December 16, 2021, the U.S.
Centers for Disease Control and Prevention (CDC) endorsed updated
recommendations made by the Advisory Committee on Immunization
Practices (ACIP) for the prevention of COVID-19, expressing a
clinical preference for individuals to receive an mRNA COVID-19
vaccine over the Johnson & Johnson COVID-19 vaccine.
Individuals who are unable or unwilling to receive an mRNA vaccine
will continue to have access to the Johnson & Johnson COVID-19
vaccine.
The Johnson & Johnson COVID-19 vaccine is an important
choice in the U.S. for people who can't or won't return for
multiple vaccinations or who would remain unvaccinated without an
alternative to the mRNA vaccines. The Johnson & Johnson
COVID-19 vaccine aligns with the WHO's recommendations for medical
interventions in a pandemic setting, which emphasize ease of
distribution, administration and compliance.
For more information on the Company's multi-pronged approach to
helping combat the pandemic, visit: www.jnj.com/covid-19.
Authorized Use
The Janssen COVID-19 Vaccine also known
as the Johnson & Johnson COVID-19 vaccine, is authorized
for use under an Emergency Use Authorization (EUA) for active
immunization to prevent Coronavirus Disease 2019 (COVID-19) caused
by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2).
- Primary vaccination regimen for the Janssen COVID-19 Vaccine is
a single-dose (0.5 mL) administered to individuals 18 years of age
and older.
- A single Janssen COVID-19 Vaccine booster dose (0.5 mL) may be
administered at least 2 months after the primary vaccination to
individuals 18 years of age and older.
- A single booster dose of the Janssen COVID-19 Vaccine (0.5 mL)
may be administered to individuals 18 years of age and older
as a heterologous booster dose following completion of primary
vaccination with another authorized or approved COVID-19 vaccine.
The dosing interval for the heterologous booster dose is the same
as that authorized for a booster dose of the vaccine used for
primary vaccination.
IMPORTANT SAFETY INFORMATION
WHAT SHOULD YOU MENTION TO YOUR VACCINATION PROVIDER BEFORE
YOU GET THE JANSSEN COVID-19 VACCINE?
Tell the vaccination
provider about all of your medical conditions, including if
you:
- have any allergies
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your
immune system
- are pregnant or plan to become pregnant
- are breastfeeding
- have received another COVID-19 vaccine
- have ever fainted in association with an injection
WHO SHOULD NOT GET THE JANSSEN COVID-19
VACCINE?
You should not get the Janssen COVID-19 Vaccine if
you:
- had a severe allergic reaction after a previous dose of this
vaccine
- had a severe allergic reaction to any ingredient of this
vaccine.
HOW IS THE JANSSEN COVID-19 VACCINE GIVEN?
The Janssen
COVID-19 Vaccine will be given to you as an injection into the
muscle.
Primary Vaccination: The Janssen COVID-19 Vaccine is
administered as a single dose.
Booster Dose:
- A single booster dose of the Janssen COVID-19 Vaccine may be
administered at least two months after primary vaccination with the
Janssen COVID-19 Vaccine.
- A single booster dose of the Janssen COVID-19 Vaccine may be
administered to individuals 18 years of age and older who have
completed primary vaccination with a different authorized or
approved COVID-19 vaccine. Please check with your health care
provider regarding and timing of the booster dose.
WHAT ARE THE RISKS OF THE JANSSEN COVID-19
VACCINE?
Side effects that have been reported with the
Janssen COVID-19 Vaccine include:
- Injection site reactions: pain, redness of the skin, and
swelling.
- General side effects: headache, feeling very tired, muscle
aches, nausea, fever.
- Swollen lymph nodes.
- Blood clots.
- Unusual feeling in the skin (such as tingling or a crawling
feeling) (paresthesia), decreased feeling or sensitivity,
especially in the skin (hypoesthesia).
- Persistent ringing in the ears (tinnitus).
- Diarrhea, vomiting.
Severe Allergic Reactions
There is a remote chance that the Janssen COVID-19 Vaccine could
cause a severe allergic reaction. A severe allergic reaction would
usually occur within a few minutes to one hour after getting a dose
of the Janssen COVID-19 Vaccine. For this reason, your vaccination
provider may ask you to stay at the place where you received your
vaccine for monitoring after vaccination. Signs of a severe
allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
Blood Clots with Low Levels of Platelets
Blood clots involving blood vessels in the brain, lungs, abdomen,
and legs along with low levels of platelets (blood cells that help
your body stop bleeding), have occurred in some people who have
received the Janssen COVID-19 Vaccine. In people who developed
these blood clots and low levels of platelets, symptoms began
approximately one to two-weeks after vaccination. Reporting of
these blood clots and low levels of platelets has been highest in
females ages 18 through 49 years. The chance of having this occur
is remote. You should seek medical attention right away if you have
any of the following symptoms after receiving Janssen COVID-19
Vaccine:
- Shortness of breath,
- Chest pain,
- Leg swelling,
- Persistent abdominal pain,
- Severe or persistent headaches or blurred vision,
- Easy bruising or tiny blood spots under the skin beyond the
site of the injection.
These may not be all the possible side effects of the Janssen
COVID-19 Vaccine. Serious and unexpected effects may occur. The
Janssen COVID-19 Vaccine is still being studied in clinical
trials.
Guillain Barré Syndrome
Guillain Barré syndrome (a neurological disorder in which the
body's immune system damages nerve cells, causing muscle weakness
and sometimes paralysis) has occurred in some people who have
received the Janssen COVID-19 Vaccine. In most of these people,
symptoms began within 42 days following receipt of the Janssen
COVID-19 Vaccine. The chance of having this occur is very low. You
should seek medical attention right away if you develop any of the
following symptoms after receiving the Janssen COVID-19
Vaccine:
- Weakness or tingling sensations, especially in the legs or
arms, that's worsening and spreading to other parts of the
body.
- Difficulty walking.
- Difficulty with facial movements, including speaking, chewing,
or swallowing.
- Double vision or inability to move eyes.
- Difficulty with bladder control or bowel function.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience
a severe allergic reaction, call 9-1-1, or go to the nearest
hospital.
Call the vaccination provider or your healthcare provider if you
have any side effects that bother you or do not go away.
Report vaccine side effects to FDA/CDC Vaccine Adverse
Event Reporting System (VAERS). The VAERS toll-free number
is 1-800-822-7967 or report online to
https://vaers.hhs.gov/reportevent.html. Please include "Janssen
COVID-19 Vaccine EUA" in the first line of box #18 of the report
form. In addition, you can report side effects to Janssen Biotech
Inc. at 1-800-565-4008.
CAN I RECEIVE THE JANSSEN COVID-19 VACCINE AT THE SAME TIME
AS OTHER VACCINES?
Data have not yet been submitted to FDA
on administration of the Janssen COVID-19 Vaccine at the same time
as other vaccines. If you are considering receiving the Janssen
COVID-19 Vaccine with other vaccines, discuss your options with
your healthcare provider.
Please read Emergency Use Authorization (EUA) Fact Sheet for
Healthcare Providers Administering Vaccine (Vaccination Providers)
including full EUA Prescribing Information available
at: www.JanssenCOVID19Vaccine.com/EUA-factsheet.
About Johnson & Johnson
At Johnson & Johnson,
we believe good health is the foundation of vibrant lives, thriving
communities and forward progress. That's why for more than 130
years, we have aimed to keep people well at every age and every
stage of life. Today, as the world's largest and most broadly-based
healthcare company, we are committed to using our reach and size
for good. We strive to improve access and affordability, create
healthier communities, and put a healthy mind, body and environment
within reach of everyone, everywhere. We are blending our heart,
science and ingenuity to profoundly change the trajectory of health
for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies of Johnson &
Johnson
At Janssen, we're creating a future where disease is
a thing of the past. We're the Pharmaceutical Companies of Johnson
& Johnson, working tirelessly to make that future a reality for
patients everywhere by fighting sickness with science, improving
access with ingenuity, and healing hopelessness with heart. We
focus on areas of medicine where we can make the biggest
difference: Cardiovascular & Metabolism, Immunology, Infectious
Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary
Hypertension. Learn more at www.janssen.com. Follow us at
@JanssenGlobal.
Cautions Concerning Forward-Looking
Statements
This press release contains "forward-looking
statements" as defined in the Private Securities Litigation Reform
Act of 1995 regarding development, manufacture and distribution of
the Johnson & Johnson COVID-19 vaccine. The reader is cautioned
not to rely on these forward-looking statements. These statements
are based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or
uncertainties materialize, actual results could vary materially
from the expectations and projections of the Janssen Pharmaceutical
Companies, and/or Johnson & Johnson. Risks and uncertainties
include, but are not limited to: challenges and uncertainties
inherent in product research and development, including the
uncertainty of clinical success and of obtaining regulatory
approvals; uncertainty of commercial success; manufacturing
difficulties and delays; competition, including technological
advances, new products and patents attained by competitors;
challenges to patents; product efficacy or safety concerns
resulting in product recalls or regulatory action; changes in
behavior and spending patterns of purchasers of health care
products and services; changes to applicable laws and regulations,
including global health care reforms; and trends toward health care
cost containment. A further list and descriptions of these risks,
uncertainties and other factors can be found in Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended
January 3, 2021, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in the company's most
recently filed Quarterly Report on Form 10-Q, and the company's
subsequent filings with the Securities and Exchange Commission.
Copies of these filings are available online
at www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. None of the Janssen Pharmaceutical Companies
nor Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
1 Self WH, Tenforde MW, Rhoads JP, et al.
Comparative effectiveness of Moderna, Pfizer-BioNTech, and Janssen
(Johnson & Johnson) vaccines in preventing COVID-19
hospitalizations among adults without immunocompromising conditions
— United States, March–August
2021. MMWR Morb Mortal Wkly Rep. Published online
September 24, 2021:1337-1343.
https://www.cdc.gov/mmwr
2 Tenforde MW, Self WH, Adams K, et al. Association
Between mRNA Vaccination and COVID-19 Hospitalization and Disease
Severity. JAMA. 2021;326(20):2043-2054.
doi:10.1001/jama.2021.19499
3 Poukka E, Baum U, Palmu A, et al. Cohort study of
covid-19 vaccine effectiveness among healthcare workers in
Finland, December 2020 - October
2021. Vaccine. 2021.
4 Hagan LM, Mccormick DW, Lee C, et al. Outbreak of
SARS-CoV-2 B.1.617.2 (Delta) variant infections among incarcerated
persons in a federal prison-Texas,
July-August 2021. Morbidity and
Mortality Weekly Report. 2021;70(38):1349-1354.
5 Rovida F, Cassaniti I, Paolucci Stefania, et al.
SARS-CoV-2 vaccine breakthrough infections with the alpha variant
are asymptomatic or mildly symptomatic among health care workers.
medRxiv. Posted July 3, 2021.
doi:10.1101/2021.06.29.21259500
6 Nunes B, Rodrigues AP, Kislaya I, et al. mRNA
vaccine effectiveness against COVID-19-related hospitalisations and
deaths in older adults: A cohort study based on data linkage of
national health registries in Portugal, February to August 2021. Eurosurveillance.
2021;26(38). doi:10.2807/1560-7917.ES.2021.26.38.2100833
7 de Gier B, Andeweg S, Backer JA, et al. Vaccine
effectiveness against SARS-CoV-2 transmission to household contacts
during dominance of Delta variant (B.1.617.2), August-September 2021, the
Netherlands. Eurosurveillance. 2021
Nov;26(44):2100977. doi:10.1101/2021.10.14.21264959
8 Liu C, Lee J, Ta C, et al. A retrospective
analysis of COVID-19 mRNA vaccine breakthrough infections-risk
factors and vaccine effectiveness. medRxiv. Posted
October 07, 2021.
doi:10.1101/2021.10.05.21264583
9 Rosenberg ES, Dorabawila V, Easton D, et al.
COVID-19 vaccine effectiveness by product and timing in
New York state. medRxiv.
Posted October 9, 2021.
doi:10.1101/2021.10.08.21264595
10 Robles-Fontán MM, Nieves EG, Cardona-Gerena I,
Irizarry RA. Time-varying effectiveness of the mRNA-1273, BNT162b2
and Ad26.COV2.S vaccines against SARS-CoV-2 infections and COVID-19
hospitalizations and deaths: an analysis based on observational
data from Puerto Rico.
medRxiv. Posted October 18,
2021. doi:10.1101/2021.10.17.21265101
11 Grey GE, et al. Vaccine effectiveness against
hospital admission in South African health care workers who
received a homologous booster of Ad26.COV2 during an Omicron
COVID19 wave: Preliminary Results of the Sisonke 2 Study.
medRxiv. Posted December 29,
2021. doi: 10.1101/2021.12.28.21268436v1
12 Tan CS, et al. Homologous and Heterologous
Vaccine Boost Strategies for Humoral and Cellular Immunologic
Coverage of the SARS-CoV-2 Omicron Variant. medRxiv. Posted
December 30, 2021. doi:
10.1101/2021.12.02.21267198
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