Traveling across the country in a small van

Governor Hogan Announces Vaccine Eligibility Timeline for All Marylanders, and Primary Care, Hospital Equity, and Mobile Clinic Initiatives Phase 2A for Marylanders 60 and Older Will Begin on Tuesday, March 23 All Marylanders 16 and Older Will Be Eligible By April 27 Primary Care Practices Join State’s Vaccination Effort State Launches Hospital Community Vaccination Grant Program Vaccine Equity Task Force to Launch Mobile Clinics in Hard-to-Reach Areas ANNAPOLIS, MD — Governor Larry Hogan today announced that, based on the state’s accelerating vaccination rate and an anticipated increase in supply from the federal government, the State of Maryland will enter Phase 2 of its vaccine distribution plan early next week.

1. The governor also announced a series of unique initiatives to ensure vaccine equity and expand the state’s distribution network, utilizing hospitals, primary care providers, and mobile clinics.
2. We continue to leverage every possible resource we can to get shots into arms as efficiently and equitably as possible,” said Governor Hogan.

“We have built the infrastructure capacity and we are being promised the supply to be able to vaccinate every Marylander in the next couple months. I can assure you that our entire team will not rest until every single Marylander who wants a vaccine has received a vaccine.”,

VACCINE ELIGIBILITY TIMELINE FOR ALL MARYLANDERS 16 AND OLDER Beginning on Tuesday, March 23, the state will make groups in Phase 2 eligible in waves based on risk factors, including age, essential occupations, and underlying health conditions, before opening it up to the general population in Phase 3.

All Marylanders 16 and older will be eligible for vaccines by Tuesday, April 27, Phase 2A : Tuesday, March 23, Eligibility opens for all Marylanders 60 and older. According to Maryland Department of Health data, nearly 90% of the state’s COVID-19 deaths are in the 60+ age range. Pre-registration at mass vaccination sites is now open for Marylanders 60 and older at,

1. Phase 2B : Tuesday, March 30,
2. Eligibility opens for all Marylanders 16 and older with underlying medical conditions that increase the risk for severe COVID-19 illness.
3. According to CDC data, nearly 90% of individuals hospitalized for COVID-19 have an underlying medical condition.
4. Phase 2C : Tuesday, April 13.

Eligibility opens for all Marylanders 55 and older, as well as essential workers in critical industries, including food services (i.e. restaurant workers), utilities, construction workers, transportation, financial services, IT, and other infrastructure.

Individuals will continue to be prioritized at the state’s mass vaccination sites.In addition, the governor announced a series of new initiatives to ensure vaccine equity and expand the state’s distribution network: PRIMARY CARE PRACTICES JOIN STATE’S VACCINATION EFFORT

Beginning this week, primary care practices throughout Maryland are joining the state’s vaccination effort, administering vaccines directly to vulnerable populations they serve. To help achieve more equitable vaccine distribution, the first 37 practices were chosen for the program based on their connection to largely African American and Hispanic communities and areas with less geographic access to vaccination sites.

Throughout Phase 2, primary care practices will focus on vaccinating those with underlying medical conditions that increase the risk for severe COVID-19 illness. Maryland is fortunate to have many of their primary care providers organized under the innovative Maryland Model and the Maryland Primary Care Program.

The is a statewide advanced primary care program with 562 practices. MARYLAND LAUNCHES FIRST-IN-THE-NATION HOSPITAL COMMUNITY VACCINATION GRANT PROGRAM The Maryland Health Services Cost Review Commission has established a Community Vaccination Grant Program to support hospital efforts to engage in community-based vaccination efforts.

1. The program, made possible by the one-of-a-kind “Maryland Model” healthcare finance system, will provide $12 million for community-based vaccination initiatives led by hospitals.
2. Through this unique grant program, hospitals will work with trusted community partners—including local health departments, non-profits, faith-based organizations, and others—to increase Marylanders’ access to the COVID-19 vaccine especially in vulnerable, underserved, and hard-to-reach areas.

VACCINE EQUITY TASK FORCE TO LAUNCH MOBILE CLINICS The Maryland Vaccine Equity Task Force, led by Brigadier General Janeen Birckhead, will launch mobile clinics in hard-to-reach areas utilizing mobile units provided by the University of Maryland School of Nursing.

These units will be deployed and staffed by the Maryland National Guard. Learn more about the task force at, Each mobile vaccine bus has the versatility to be used as a walk-in clinic or a drive-up site to administer between 60 to 160 vaccines per mission. Individuals will have the option of receiving the vaccine inside the wellness bus or staying in their car and vaccinators administering the vaccine there.

The technology capabilities of the buses allow for registering and scheduling follow up appointments, making this a one-stop shop to getting shots in arms at otherwise hard-to-reach locations across Maryland. ADDITIONAL MASS VACCINATION SITES TO BE ANNOUNCED NEXT WEEK With today’s opening of the mass vaccination site at Wicomico Youth & Civic Center in Salisbury, the state has now opened five statewide.

What is the wait between 1st and 2nd vaccine?

How long to wait between your 1st and 2nd dose – Once you’ve had your 1st dose you need to wait several weeks before getting your 2nd dose of the COVID-19 vaccination. You need to wait:

8 weeks (56 days) if you’re aged 18 or over12 weeks (84 days) if you or your child are aged 5 to 178 weeks (56 days) if you or your child are aged 5 to 17 and at high risk from COVID-19

Find out more about the COVID-19 vaccine for children aged 5 to 15

Which vaccine is in Phase 3?

Recombinant Protein. This vaccine has reached Phase 3 trials.

When must I go for my second vaccine?

Had your first Pfizer vaccine dose? Your second is due 42 days later – Since the start of phase 2 of South Africa’s national vaccine rollout on 17 May, thousands of people have received a first dose of their two-dose mRNA Pfizer-BioNTech vaccine. On 19 May, the National Department of Health announced that for people who have had a first dose of the Pfizer-BioNTech vaccine, the second dose or “booster shot” will now be given six weeks or 42 days later.

Want to better understand why there is a need for a second dose – also called a COVID-19 vaccine booster shot? Find out more about this and current expectations about future COVID-19 vaccine booster shots.

Dr Noluthando Nematswerani is Head of the Discovery Health Centre for Clinical Excellence. She explains: “After you have received your first Pfizer-BioNTech vaccine dose, you will receive an SMS with a notification of the date of your appointment for the second vaccine dose.

Can 1st and 2nd vaccine be different?

Which vaccine will I get? – You cannot usually choose which vaccine you have. If you book online, you’ll only be offered appointments for vaccines that are suitable for you. Most people can have any of the COVID-19 vaccines, but some people are only offered certain vaccines. For example:

if you’re pregnant or under 40 you’ll usually be offered appointments for the Pfizer/BioNTech or Moderna vaccinesif you’re under 18, you’ll only be offered the Pfizer/BioNTech vaccine

You should have the same vaccine for both your 1st and 2nd doses, unless you had serious side effects (such as a serious allergic reaction) after your 1st dose. Most people will be offered a booster dose of the Pfizer/BioNTech vaccine or Moderna vaccine. This means your booster dose may be different from the vaccine you had for your first 2 doses.

Should 1st and 2nd vaccine the same?

COVID-19 Frequently Asked Questions: There is no difference between the 1st and 2nd dose.

What is Phase 4 of vaccine trial?

A type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time.

What phase is Johnson and Johnson vaccine?

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S. Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

Innovation NEW BRUNSWICK, N.J., September 21, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. New data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered.

The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster. “Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations.

Additionally, our Phase 3 trial data further confirm protection against COVID-19-related death,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases.” “It is critical to prioritize protecting as many people as possible against hospitalization and death given the continued spread of COVID-19.

A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

• At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.” The Company has provided available data to the U.S.
• Food and Drug Administration (FDA) and plans to submit the data to other 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.

The data are summarized below: Johnson & Johnson single-shot vaccine showed strong and long-lasting protection in the real world The largest for a COVID-19 vaccine reported to date in the U.S. demonstrated stable vaccine effectiveness of 79 percent (CI, 77%-80%) for COVID-19-related infections and 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations.

There was no evidence of reduced effectiveness over the study duration, including when the Delta variant became dominant in the U.S. Sequencing data were not available for analysis. The study included 390,000 people who received the Johnson & Johnson COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity conducted from March to late July 2021.

These data were consistent with the Phase 3 ENSEMBLE trial, where strong protection against severe/critical disease and death was observed at least 28 days post-final vaccination:

75 percent overall efficacy (CI, 65%-82%) against severe/critical COVID-19, across all age cohorts and all countries included in the study.74 percent efficacy in the U.S. against severe/critical COVID-19 (CI, 39%-91%); 89 percent against hospitalization (CI, 24%-100%); 83 percent against COVID-19-related death (CI, 41%-97%).

Booster shot at two months provided 94 percent protection against COVID-19 in the U.S. The Phase 3 ENSEMBLE 2 study showed that another shot of the Johnson & Johnson COVID-19 vaccine given 56 days after the first provided:

100 percent protection (CI, 33%-100%) against severe/critical COVID-19 – at least 14 days post-final vaccination.75 percent protection against symptomatic (moderate to severe/critical) COVID-19 globally (CI, 55%-87%).94 percent protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%).

When a booster of the Johnson & Johnson COVID-19 vaccine was given two months after the first shot, antibody levels rose to four to six times higher than observed after the single shot. Booster shot at six months provided 12-fold increase in antibodies When a of the Johnson & Johnson COVID-19 vaccine was given six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.

All rises were irrespective of age. The Johnson & Johnson single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received an on February 27, 2021 and (CMA) by the European Commission on March 11. The World Health Organization (WHO) issued on March 12, and the Company received an by the Strategic Advisory Group of Experts (SAGE) on Immunization for the WHO on March 17.

Many more authorizations have been granted in countries worldwide, and regulatory submissions are ongoing. – Additional Notes – Real-World Evidence Study In the largest Vaccine Effectiveness (VE) study of participants receiving the Johnson & Johnson single-shot COVID-19 vaccine in the U.S.

To date, the Janssen R&D Data Science team, Harvard University and Aetion utilized the HealthVerity database, which consisted of longitudinal de-identified patient-level information representative of the U.S. population. This study compared approximately 390,000 people who received the Company’s single-shot COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity.

This study is a longitudinal cohort design, using robust propensity matching methods to create a comparator cohort to assess real-world VE. All analyses were performed using the Aetion Evidence Platform, which is a scientifically validated software that is also used by regulators, payers, and health technology assessment bodies to assess the safety, effectiveness, and value of medical technologies.

1. All transformations of the raw data are preserved for full reproducibility and audit trails are available, including a quality check of the data ingestion process.
2. In the real-world U.S.
3. The Johnson & Johnson single-shot COVID-19 vaccine showed VE of 81 percent (CI, 79%-84%) for COVID-19-related hospitalizations and effectiveness of 79 percent (CI, 77%-80%) for COVID-19-related infections (VE was corrected to compensate for vaccination status misclassification due to under-recording of true vaccination status in health care claims data).

Uncorrected VE was 69 percent (CI, 67%-71%) for COVID-19-related infections; VE of 73 percent (CI, 69%-76%) for COVID-19 hospitalizations. The Johnson & Johnson single-shot COVID-19 vaccine showed VE against COVID-19-related hospitalizations at 86 percent (CI, 83%-89%) for participants younger than 60 years, and 78 percent (CI, 74%-81%) for those 60 years and older.

VE against COVID-19 infections was 81 percent (CI, 79%-82%) for people younger than 60 years, and 75 percent (CI, 73%-78%) for those 60 years and older. These results are consistent with what was observed in the ENSEMBLE study. ENSEMBLE 1 Study The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older.

The ENSEMBLE study was designed to evaluate the safety and efficacy of the Johnson & Johnson vaccine candidate in protecting against moderate to severe/critical COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

In the Phase 3 ENSEMBLE study, a single dose of the Johnson & Johnson COVID-19 vaccine offered strong and durable overall efficacy (75%; CI, 65%-82%; n=46 cases vaccine arm, n=176 cases placebo arm) against severe/critical COVID-19, across all age cohorts and all countries included in the study, after at least 28 days post-vaccination.

While efficacy against severe/critical COVID-19 caused by the initial circulating SARS-COV-2 reference strain (Wuhan) remained high (93%; CI, 54%-99%; n=1 case vaccine arm, n=14 cases placebo arm), there was somewhat lower vaccine efficacy (72%; CI, 56%-82%; n=27 cases vaccine arm, n=93 cases placebo arm) against severe/critical disease caused by variants.

• The single-dose regimen had 53 percent (CI, 47%-58%; n=433 cases vaccine arm, n=883 cases placebo arm) efficacy against moderate to severe/critical infection with 58 percent (CI, 35%-74%; n=30 cases vaccine arm, n=69 cases placebo arm) efficacy against the reference strain.
• Efficacy against hospitalizations related to COVID-19 in the ENSEMBLE trial was 76 percent (CI, 54%-88%; n=16 cases vaccine arm, n=64 cases placebo arm), and efficacy against COVID-19-related deaths was 83 percent (CI, 41%-97%; n=3 cases vaccine arm, n=17 cases placebo arm).

In the U.S., the ENSEMBLE trial demonstrated vaccine efficacy against moderate to severe/critical COVID-19 infection of 70 percent 28-days post-vaccination (CI, 61%-77%; n=77 cases vaccine arm, n=239 cases placebo arm), 74 percent against severe/critical infection (CI, 39%-91%; n=7 cases vaccine arm, n=26 cases placebo arm) and 89 percent against hospitalization (CI, 24%-100%; n=1 case vaccine arm, n=9 cases placebo arm).

1. Median follow-up time in the ENSEMBLE study was four months, with 23 percent of the participants with follow-up of greater than six months.
2. The vaccine was generally well-tolerated by all participants, with fewer local and systemic reactions as compared with Phase 1/2 data.
3. ENSEMBLE was initiated in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S.

Department of Health and Human Services (HHS) under Other Transaction Agreement HHSO100201700018C, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. Full data will be submitted for publication in the coming months.

ENSEMBLE 2 Study The Phase 3 ENSEMBLE 2 study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen, given at a 56-day interval, versus placebo in adults 18 years old and older with and without comorbidities associated with an increased risk for severe COVID-19.

The study was designed to assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose. In the ENSEMBLE 2 Phase 3 study solicited and unsolicited adverse events following this second dose are similar to those seen in single-dose studies.

Compared to the single-dose results, ENSEMBLE 2 also demonstrated increased efficacy of a two-dose schedule against moderate to severe/critical COVID-19 of 75 percent (CI, 55%-87%; n=14 cases vaccine arm, n=52 cases placebo arm) and severe/critical COVID-19 of 100 percent (CI, 33%-100%; n=0 cases vaccine arm, n=8 cases placebo arm) at least 14 days following the second vaccination prior to unblinding.

In the U.S., efficacy against moderate to severe/critical COVID-19 was 94 percent (CI, 58%-100%; n=1 case vaccine arm, n=14 cases placebo arm).

Median follow-up time in the ENSEMBLE 2 study was 36 days since second vaccination, with 29 percent of participants having at least two months of follow-up after receipt of their second dose.The vaccine, when given as a second dose or booster, remained generally well-tolerated.Full data will be submitted for publication in the coming months.For more information on the Company’s multi-pronged approach to helping combat the pandemic, visit:,###

Authorized Use The Janssen COVID-19 vaccine is authorized for use in the U.S. 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) in individuals 18 years of age and older.

have any allergieshave a feverhave a bleeding disorder or are on a blood thinnerare immunocompromised or are on a medicine that affects your immune systemare pregnant or plan to become pregnantare breastfeedinghave received another COVID-19 vaccinehave 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 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. The Janssen COVID-19 Vaccine vaccination schedule is a single 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.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.

Difficulty breathingSwelling of your face and throatA fast heartbeatA bad rash all over your bodyDizziness 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.

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.

Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the bodyDifficulty walkingDifficulty with facial movements, including speaking, chewing, or swallowingDouble vision or inability to move eyesDifficulty 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,
• 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.
• Please read Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including full EUA Prescribing Information available at 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 of a potential preventive vaccine for COVID-19.
• 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, 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.

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Media Contacts: Jake Sargent+1 [email protected] Kumar+1 [email protected] Buckley+44 7900-655-261 [email protected] Investor Relations: Jennifer McIntyre +1 732-524-3922

: Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S. Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

Does Pfizer booster cover Omicron?

How do the updated vaccines differ from the original ones? – The FDA has been incredibly deliberate in referring to the vaccines as “updated” rather than “new,” and there’s an important reason for that. They’re different from the original vaccines in just one small, albeit powerful, way.

1. The updated vaccines use the same technology as the existing ones, meaning they work the same way,” says Dr.
2. John Cooke, medical director of the RNA Therapeutics Program at Houston Methodist.
3. They simply now contain two mRNA molecules instead of just one.” Recall that the Pfizer and Moderna COVID-19 vaccines are mRNA vaccines, meaning they use pieces of mRNA to help train your your immune system to recognize viral proteins — the spike protein on the virus’ surface, in particular.

This helps your body mount a quicker and more efficient immune response to the virus should you get infected. (Related: ) “In addition to containing mRNA encoding a piece of the original virus’ spike protein, the updated vaccines include a second piece of mRNA encoding the spike protein of the BA.4/BA.5 omicron variants,” explains Dr.

Cooke. “It’s a small adjustment from a technological standpoint, but a powerful one in terms of how it can help boost immunity to the specific variants currently circulating.” This dual nature is why the updated vaccines are referred to as bivalent. “They are called bivalent vaccines because half of the booster targets the original COVID-19 virus, and the other half works against the omicron variant,” adds Dr.

Maryland to advance to Phase 2A in COVID-19 vaccine distribution

Sostman.

Can you get second vaccine before 21 days?

What happens if someone gets the second shot before the 21-day or 28-day time frame? Second dose given within a grace period of fewer than 4 days from the recommended date for the second shot are considered valid and do not need to be repeated. The second shot should be given as close to the recommended time as possible, but vaccinations given outside of the recommended times do not need to be repeated.

How long can I wait between Pfizer vaccines?

COVID-19 Vaccination Important update: Healthcare facilities CDC has updated select ways to operate healthcare systems effectively in response to COVID-19 vaccination. Stay Up to Date with COVID-19 Vaccines Including Boosters CDC recommends that p eople ages 5 years and older receive one updated (bivalent) booster if it has been at least 2 months since their last COVID-19 vaccine dose, whether that was:

• Their final primary series dose, or
• An original (monovalent) booster

People who have gotten more than one original (monovalent) booster are also recommended to get an updated (bivalent) booster. COVID-19 vaccines available in the United States are effective at protecting people from getting seriously ill, being hospitalized, and dying.

• Pfizer-BioNTech
• Moderna
• Novavax
• Johnson & Johnson’s Janssen (J&J/Janssen) (However, CDC recommends that the J&J/Janssen COVID-19 vaccine only be, due to safety concerns.)

The updated (bivalent) boosters are called “bivalent” because they protect against both the original virus that causes COVID-19 and the Omicron variant BA.4 and BA.5. Previous boosters are called “monovalent” because they were designed to protect against the original virus that causes COVID-19.

1. They also provide some protection against Omicron, but not as much as the updated (bivalent) boosters.
2. The virus that causes COVID-19 has changed over time.
3. The different versions of the virus that have developed over time are called variants.
4. Learn more about,
5. Two COVID-19 vaccine manufacturers, Pfizer and Moderna, have developed updated (bivalent) COVID-19 boosters.

You are up to date with your COVID-19 vaccines if you have completed a COVID-19 vaccine primary series and received the most recent booster dose recommended for you by CDC. COVID-19 vaccine recommendations are based on three things:

1. Your age
2. The vaccine you first received, and
3. The length of time since your last dose

People who are moderately or severely immunocompromised have, You are still up to date if you receive all COVID-19 vaccine doses recommended for you and then become ill with COVID-19. You do not need to be immediately revaccinated or receive an additional booster.

1. If you recently had COVID-19, you may consider delaying your next vaccine dose (whether a primary dose or booster) by 3 months from when your symptoms started or, if you had no symptoms, when you first received a positive test.
2. Reinfection is less likely in the weeks to months after infection.
3. However, certain factors, such as personal risk of severe disease, or risk of disease in a loved one or close contact, local, and the most common currently causing illness, could be reasons to get a vaccine sooner rather than later.

COVID-19 vaccine dosage is based on age on the day of vaccination, not on size or weight. Children get a smaller dose of COVID-19 vaccine than teens and adults based on their age group. Up to Date: 2 weeks after 3rd dose, since a booster is not recommended for this age group at this time More details: At least 2 months after 2nd dose or last booster, children age 5 years can only get a Pfizer-BioNTech booster, and children ages 6–11 years can get a Pfizer-BioNTech or Moderna booster.

Up to Date: Immediately after you have received the most recent booster recommended for you More details: Pfizer-BioNTech or Moderna At least 2 months after 2nd dose or last booster Up to Date: Immediately after you have received the most recent booster recommended for you More details: Up to Date: Children 6 months to 4 years of age are up to date two weeks after completing the 2nd dose of their primary series.

Children 5 years of age who received a Moderna primary series are up to date immediately after they have received the most recent booster recommended for them. More details: Pfizer-BioNTech or Moderna At least 2 months after 2nd primary series dose Up to Date: Immediately after you have received the most recent booster recommended for you More details: Novavax is not authorized as a booster dose at this time.

Pfizer-BioNTech or Moderna At least 2 months after 2nd primary series dose Up to Date: Immediately after you have received the most recent booster recommended for you More details: Pfizer-BioNTech or Moderna At least 2 months after 2nd primary series dose or last booster Up to Date: Immediately after you have received the most recent booster recommended for you More details: Pfizer-BioNTech or Moderna At least 2 months after 2nd primary series dose or last booster Up to Date: Immediately after you have received the most recent booster recommended for you More details: Pfizer-BioNTech or Moderna At least 2 months after 2nd primary series dose A monovalent Novavax booster is available in limited situations More details: Pfizer-BioNTech or Moderna  At least 2 months after 2nd primary series dose A monovalent J&J/Janssen booster is available in limited situations.

More details: Up to Date: Immediately after you have received the most recent booster recommended for you More details: Getting your 2nd dose: Talk to your healthcare or vaccine provider about the timing for the 2nd dose in your primary series.

• People ages 6 months through 64 years, and especially males ages 12 through 39 years, may consider getting the 2nd primary Pfizer-BioNTech, Moderna, or Novavax 8 weeks after the 1st dose.
  • A longer time between the 1st and 2nd primary doses may increase how much protection the vaccines offer, and further minimize the rare risk of,
• Anyone wanting protection due to high levels of community transmission, p eople ages 65 years and older, or people who are more likely to get very sick from COVID-19, should get the second dose of:
  • Pfizer-BioNTech COVID-19 vaccine 3 weeks (or 21 days) after the first dose.
  • Moderna COVID-19 vaccine 4 weeks (or 28 days) after the first dose.
  • Novavax COVID-19 vaccine 3 weeks (or 21 days) after the first dose.

Staying up to date: If you have completed your primary series, but are not yet eligible for a booster, you are also considered up to date. Novavax booster : You may get a monovalent Novavax booster if you are unable or unwilling to receive a Pfizer or Moderna updated (bivalent) COVID-19 booster and you meet the following requirements:

• You are 18 years of age or older
• You completed a COVID-19 vaccine primary series at least 6 months ago
• You have not gotten any other booster dose

CDC does not recommend mixing products for your primary series doses. If you received Pfizer-BioNTech, Moderna, or Novavax for the first dose of your primary series, you should get the same product for all following primary series doses.

Does 2nd vaccine have to be at same place?

No, you are not required to get your second dose at the same location that you received your first dose. However, it’s encouraged that you receive both doses at the same location so your provider can ensure you’re getting the same vaccine type at the correct time.

1. Additionally, second doses are automatically accounted for and sent to the location where your first shot occurred, so you are “guaranteed” your second shot at that location.
2. Switching locations may delay the timing of your second shot appointment.
3. It is a good idea to bring your CDC vaccine card or record from CT WiZ with you for subsequent COVID-19 vaccine appointments.

You can COVID-19-Vaccination-Scheduling-Options,

What is a Stage 3 vaccine trial?

The Oxford Vaccine Centre COVID-19 Phase II/III Clinical Trial Explained – What is the purpose of this research study? The purpose of this study is to test a new vaccine against COVID-19 in healthy volunteers. This study aims to assess how well people across a broad range of ages could be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19.

• It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.
• What is the vaccine being tested? ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans.

Genetic material has been added to the ChAdOx1 construct, that is used to make proteins from the COVID-19 virus (SARS-CoV-2) called Spike glycoprotein (S). This protein is usually found on the surface of SARS-CoV-2 and plays an essential role in the infection pathway of the SARS-CoV-2 virus.

1. The SARS-CoV-2 coronavirus uses its spike protein to bind to ACE2 receptors on human cells to gain entry to the cells and cause an infection.
2. By vaccinating with ChAdOx1 nCoV-19, we are hoping to make the body recognise and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and therefore prevent infection.

Has the vaccine been tested on animals? Our collaborators at Rocky Mountain Laboratories (NIAID/NIH) have conducted a rapid yet thorough investigation and demonstrated good safety and efficacy of a single dose of ChAdOx1 nCoV-19 in the rhesus macaque model that they had previously established.

We were able to review the data before vaccinations in the clinical trial were initiated. There are also animal studies underway in Australia and the UK, and the results will be published once those studies are complete. What does the study involve? In total this study will enrol up to 10,260 adults and children across the UK.

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of adults and children:

Aged 56-69 Aged over 70 Aged between 5-12 years

For these groups, researchers are assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children. The group of children will be recruited later in the trial, once extensive safety data is available from the adult studies.

• The phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18.
• This group will allow assessment of how well the vaccine works to prevent people from becoming infected with COVID-19.
• Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison.

What is the MenACWY vaccine? The MenACWY vaccine is a licensed vaccine against group A, C, W and Y meningococcus which has been given routinely to teenagers in the UK since 2015 and protects against one of the most common causes of meningitis and sepsis.

1. This vaccine is also given as a travel vaccine for high risk countries.
2. The MenACWY vaccine is being used as an ‘active control’ vaccine in this study, to help us understand participants’ response to ChAdOx1 nCoV-19.
3. The reason for using this vaccine, rather than a saline control, is because we expect to see some minor side effects from the ChAdOx1 nCOV-19 vaccine such as a sore arm, headache and fever.

Saline does not cause any of these side effects. If participants were to receive only this vaccine or a saline control, and went on to develop side effects, they would be aware that they had received the new vaccine. It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study.

Participants must:	Participants must NOT:
Be in one of the relevant age categories	Have tested positive for COVID-19
Be in good health	Be pregnant, intending to become pregnant, or breastfeeding during the study
Based in one of the recruiting areas	Have previously taken part in a trial with an adenoviral vaccine or received any other coronavirus vaccines

Full inclusion and exclusion criteria is available in the participant information sheet. Find out more about taking part in the study here, How will the trial work? The main focus of the study is to find out if this vaccine is going to work against COVID-19, if it won’t cause unacceptable side effects and if it induces good immune responses.

The dose used in this trial was chosen based on previous experiences with other ChAdOx1 based vaccines. Study participants will not know whether they have received the ChAdOx1 nCoV-19 vaccine until the end of the trial. To recruit the large number of participants needed for this trial, multiple clinical research sites across the UK are involved in delivering the study.

This is a collaborative effort led by the University of Oxford and a full list of our study sites is available on our website. Vaccinations will be taking place across the sites in May and June. What about after the vaccination? Some participants will be given an E-diary to record any symptoms experienced for 7 days after receiving the vaccine and if they feel unwell for the following 3 weeks.

There is also a weekly survey that participants will be asked to complete about any household exposure to COVID-19. In order to monitor exposure to COVID-19 in people who do not have symptoms, participants in some areas will be asked to collect swabs at home to be sent to the laboratory for testing. Following vaccination, participants will attend a series of short follow-up visits.

During these visits, the team will check participants’ observations, take a blood sample and review the completed E-diary and questionnaire. These blood samples will be used to assess the immune response to the vaccine. If participants develop COVID-19 symptoms during the study, they can contact a member of the clinical team, and we will assess them to check whether they have become infected with the virus.

1. If a participant was very unwell, we would call our colleagues in the hospital and ask them to review the volunteer if appropriate.
2. When will the results be available? To assess whether the vaccine works to protect from COVID-19, the statisticians in our team will compare the number of infections in the control group with the number of infections in the vaccinated group.

For this purpose, it is necessary for a small number of study participants to develop COVID-19. How quickly we reach the numbers required will depend on the levels of virus transmission in the community. If transmission remains high, we may get enough data in a couple of months to see if the vaccine works, but if transmission levels drop, this could take up to 6 months.

Recruitment of those who have a higher chance of being exposed to the SARS-CoV-2 virus is being prioritised, such as frontline healthcare workers, frontline support staff and public-facing key workers, in an effort to capture the efficacy data as quickly as possible. What if it doesn’t work? A significant proportion of vaccines that are tested in clinical trials don’t work.

If we are unable to show that the vaccine is protective against the virus, we would review progress, examine alternative approaches, such as using different numbers of doses, and would potentially stop the programme. Author : Dr Tonia Thomas, Oxford Vaccine Group

What happens in phase 3 of vaccine trials?

Phase 3 Trials – If the product is seemingly effective, safe, and tolerable in the previous two phases, Phase 3 clinical trials can begin. These trials often involve thousands of patients and further assess safety, monitor side effects, and, if applicable, compare the product to other treatments currently on the market.

What is in the 3 in 1 vaccine?

Tetanus, diphtheria and polio (Td/IPV or 3-in-1 teenage booster) The Td/IPV vaccine, also known as the 3-in-1 teenage booster, is given to boost protection against 3 separate diseases: tetanus, diphtheria and polio.

How long do Phase 3 vaccine trials last?

Phase 3 trials may take six to nine months to allow early assessment of safety and efficacy, particularly if conducted in areas with a high risk of infection, but with follow-up continuing for two years or more to assess long-term safety and efficacy.