Johnson & Johnson’s one-shot COVID-19 vaccine is 66% effective across regions, 72% in USA, and only 57% in South Africa hit by new variant Updated for 2021

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Updated: March 7, 2021

Johnson & Johnson’s one-shot vaccine against COVID-19 is 66 percent effective, a bit lower than the ones already being produced by Pfizer-BioNtech and Moderna but which require two shots each within weeks, data released on Friday from the company shows.

The company said its late-stage trial in the United States and seven other countries showed that the vaccine was about 66 percent effective in preventing moderate to severe illness, and 85 percent effective against severe disease across all regions studied.

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Johnson & Johnson said the effectiveness of its vaccine increased over time with none of the vaccinated volunteers reporting severe severe disease more than 49 days after vaccination.

The company said in the United States, its vaccine was 72 percent effective against moderate to severe COVID-19, and in South Africa, it was only 57 percent effective against COVID-19. New variants, said to be more contagious, are currently circulating in South Africa, the United Kingdom and Brazil.

Unlike other vaccines from Pfizer-BioNtech and Moderna that are about 94 to 95 percent effective against COVID-19 but require two shots within weeks, the Johnson & Johnson vaccine requires only one shot.

Interim results released on Thursday from Novavax, a Gaithersburg, Maryland-based biotechnology company showed its COVID-19 candidate vaccine to be safe and about 90 percent effective against the virus.

The company released data from two clinical trials of its two dose candidate vaccine, one in the United Kingdom and another in South Africa where new variants have increased the rate of transmission.

A COVID-19 variant identified in South Africa was detected in the United States for the first time on Thursday, when South Carolina health officials announced that two cases had been diagnosed in the state.

The South Carolina Department of Health and Environmental Control said both cases did not appear to be connected, and the two persons involved did not have any history of recent travel, meaning there could be more undetected cases within the state.

The World Health Organization said on Thursday that COVID-19 cases and deaths are surging in Africa as new, more contagious variants of the virus spread to additional countries.

Over 175 000 new COVID-19 cases and more than 6200 deaths were reported in Africa in the last week while infections rose by 50% on the continent between December 29, 2020 and January 25, 2021 when compared with the previous four weeks. In the past week, there has been a small dip in cases in South Africa, but 22 countries continue to see their case numbers surge. Deaths rose two-fold in the same four-week period, with over 15 000 concentrated in 10 mainly southern and northern African nations. 

The 501Y.V2 variant, first identified in South Africa, is predominant and powering record case numbers in South Africa and the sub-region. It has been found in Botswana, Ghana, Kenya, the French Indian Ocean region of Mayotte, Zambia and in 24 non-African nations. 

“The variant which was first detected in South Africa has spread quickly beyond Africa and so what’s keeping me awake at night right now is that it’s very likely circulating in a number of African countries,” said Dr Matshidiso Moeti, the World Health Organization (WHO) Regional Director for Africa.

Matshidiso Moeti
Matshidiso Moeti

U.S. President Joseph R. Biden Jr. signed a proclamation on January 25 suspending entry into U.S. for all non-Americans in South Africa, UK, Brazil, Ireland and the Schengen Area.

The Biden proclamation, which is meant to protect the United States against the coronavirus affects any non-citizen of the United States who has been to South Africa, the United Kingdom, Ireland, Brazil and the Schengen area, 14 days prior to their trip to the United States.

Biden signs executive order at oval office

“The entry into the United States, as immigrants or nonimmigrants, of noncitizens who were physically present within the Schengen Area, the United Kingdom (excluding overseas territories outside of Europe), the Republic of Ireland, and the Federative Republic of Brazil during the 14-day period preceding their entry or attempted entry into the United States, is hereby suspended and limited subject to section 2 of this proclamation,” President Biden wrote in his proclamation.

Read full statement by Johnson & Johnson announcing its latest clinical trial results

NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.

“Johnson & Johnson embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective solution for the largest number of people possible, and to have maximum impact to help end the pandemic,” said Alex Gorsky, Chairman, Board of Directors and Chief Executive Officer, Johnson & Johnson. “We’re proud to have reached this critical milestone and our commitment to address this global health crisis continues with urgency for everyone, everywhere.”

Prevention of severe disease; protection against COVID-related hospitalization and death
The vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, [i] 28 days after vaccination in all adults 18 years and older. Efficacy against severe disease increased over time with no cases in vaccinated participants reported after day 49.

The Janssen COVID-19 vaccine candidate demonstrated complete protection against COVID-related hospitalization and death, 28 days post-vaccination. There was a clear effect of the vaccine on COVID-19 cases requiring medical intervention (hospitalization, ICU admission, mechanical ventilation, extracorporeal membrane oxygenation (ECMO)), with no reported cases among participants who had received the Janssen COVID-19 vaccine, 28 days post-vaccination.

“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance. Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”

In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. Moderate COVID-19 disease was defined as laboratory-confirmed SARS-CoV-2 and one or more of the following: evidence of pneumonia, deep vein thrombosis, shortness of breath or abnormal blood oxygen saturation above 93%, abnormal respiratory rate (≥20); or two or more systemic symptoms suggestive of COVID-19.

Protection was generally consistent across race, age groups, including adults over 60 years of age (N= 13,610), and across all variants and regions studied, including South Africa where nearly all cases of COVID-19 (95%) were due to infection with a SARS-CoV-2 variant from the B.1.351 lineage [ii] .

Multi-continent Study Provides Clinical Data on Multiple Emerging Viral Mutations
The ENSEMBLE study results include efficacy against newly emerging strains of coronavirus, including some highly infectious variants present in the US, Latin America and South Africa. The Phase 3 ENSEMBLE trial is being conducted at the height of the COVID-19 pandemic in eight countries and three regions, at a time when disease spread has accelerated throughout the world resulting in people having increased exposure to the virus.

“These results are a testament to the extraordinary efforts of everyone involved in our COVID-19 vaccine candidate clinical program, and we are extremely grateful to the clinical trial staff and trial participants for their invaluable contributions,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development. “Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible. The ability to avoid hospitalizations and deaths would change the game in combating the pandemic.”

Trial participants of the phase 3 ENSEMBLE study continue to be followed for up to two years for assessments of safety and efficacy. Therefore, these data may be updated based on ongoing analysis. The comprehensive available data set will be submitted to a peer-reviewed journal in the coming weeks.

Phase 3 ENSEMBLE Study Safety Data
The analysis included a concurrent review of the available Phase 3 ENSEMBLE study safety data by the Data and Safety Monitoring Board (DSMB), an independent group of experts, that did not report any significant safety concerns relating to the vaccine. A review of adverse events indicated that a single-dose of Janssen’s COVID-19 vaccine candidate was generally well-tolerated.

The safety profile was consistent with other vaccine candidates using Janssen’s AdVac® technology among more than 200,000 people to date. Overall fever rates were 9% and Grade 3 fever 0.2%. Overall serious adverse events (SAEs) reported were higher in participants who received placebo as compared to the active vaccine candidate. No anaphylaxis was observed.

Janssen Vaccine Candidate Access and Distribution
The Company is committed to bringing an affordable COVID-19 vaccine on a not-for-profit basis for emergency pandemic use, pending regulatory authorizations.

In addition, the Janssen vaccine candidate is compatible with standard vaccine distribution channels. If authorized, Janssen’s single-dose vaccine candidate is estimated to remain stable for two years at -20°C (-4°F), at least three months of which can be at temperatures of 2-8°C (36°F–46°F). The Company will ship the vaccine using the same cold chain technologies it uses today to transport other innovative medicines.

The Company intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization. It expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized. The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.

Phase 3 ENSEMBLE Study Design
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 Janssen vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints.

Phase 3 ENSEMBLE Study Demographics
The trial, conducted in eight countries across three continents, includes a diverse and broad population including 34% (N= 14,672) of participants over age 60.

The study enrolled 44% (N=19,302) of participants in the United States, 41% (N=17,905) in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% (N=6,576) in South Africa.

Forty-five percent of participants are female, 55% male.

Among participants globally, 59% are White/Caucasian; 45% are Hispanic and/or Latinx; 19% are Black/African American; 9% are Native American and 3% are Asian. In the United States, 74% are White/Caucasian; (15% are Hispanic) and/or Latinx; 13% are Black/African American; 6% are Asian and 1% are Native American.

Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19 (overall 41%, obesity (28.5%), type 2 diabetes (7.3%), hypertension (10.3%), HIV (2.8%); also other immunocompromised participants were in the study.

Janssen’s Vaccine Technology
The investigational Janssen COVID-19 vaccine candidate leverages the Company’s AdVac® vaccine platform , which was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its Zika, RSV, and HIV investigational vaccine candidates.

The Janssen AdVac® viral vector technology can induce potent and long-lasting humoral and cellular immune responses, enabling the pursuit of vaccines for disease targets that are currently unpreventable or untreatable.

Johnson & Johnson continues to develop and test its COVID-19 vaccine candidate in accordance with ethical standards and sound scientific principles . The Company is committed to transparency and sharing information related to its ongoing clinical studies – including the ENSEMBLE study protocol .

ENSEMBLE has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201700018C, and in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at the U.S. Department of Health and Human Services (HHS).

Janssen has worked with BARDA since 2015 on innovative solutions for influenza, chemical, biological, radiation and nuclear threats and emerging infectious diseases such as Ebola. In February 2020, Janssen and BARDA began work on the development of a COVID-19 vaccine based on Janssen’s AdVac® technology.

The Janssen Pharmaceutical Companies entered into a collaboration with the Beth Israel Deaconess Medical Center (BIDMC) to support the development of the preventive vaccine candidate for COVID-19.

Janssen’s COVID-19 vaccine program has been designed to be thorough and driven by science. As such, the Company is also investigating immune responses for different doses and dosing regimens as well as studying a two-dose regimen of its COVID-19 vaccine candidate for efficacy in the Phase 3 ENSEMBLE 2 study.

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Simon Ateba
Simon Ateba
Simon Ateba covers the White House, the U.S. government, the International Monetary Fund, the World Bank and other financial and international institutions for Today News Africa in Washington D.C. Simon can be reached on simonateba@todaynewsafrica.com

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