And now there’s 3 – Johnson & Johnson 1-shot vaccine approved

Saturday night statement from the FDA:

On February 27, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

Emergency Use Authorization Status: Authorized Name: Janssen COVID-19 Vaccine Manufacturer: Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.

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Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Janssen COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to the Janssen Pharmaceuticals Companies of Johnson & Johnson for its single-shot COVID-19 vaccine, called Ad.26.COV2S or JNJ-78436725. The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the spike protein found on the surface of the SARS-CoV-2 virus that causes COVID-19. Adenoviruses are a group of viruses that cause infections in the respiratory and gastrointestinal tracts; the adenovirus vector used in the Janssen COVID-19 vaccine has been modified so it no longer can replicate in humans and cause illness. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, supported late-stage clinical testing of the Janssen vaccine. It is the third COVID-19 vaccine in the United States to be granted an EUA by FDA. NIH Director Francis S. Collins, M.D. Ph.D., NIAID Director Anthony S. Fauci, M.D., and BARDA Director Gary Disbrow, Ph.D., released the following statements:

“This week marked a devastating milestone of 500,000 deaths from COVID-19 here in the United States. The loss attributed to the disease is almost unfathomable. To have a third vaccine that meets the expectations of an EUA for safety and effectiveness at preventing severe disease and death from COVID-19 brings us one step closer to protecting the American public, staying ahead of concerning viral variants, and finding our way out of the pandemic. I would like to thank the clinical staff who conducted the clinical trials of the vaccine as well as the thousands of study participants who helped us find the scientific answers necessary to reach this important day.” – NIH Director Francis S. Collins, M.D., Ph.D.

“The Janssen COVID-19 vaccine is a very welcome addition to the arsenal of COVID-19 vaccines and other prevention strategies. When tested among 45,000 volunteers, the single-injection vaccine proved 77 percent effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85 percent effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. The vaccine was approximately 67 percent effective in preventing moderate-to-severe/critical COVID-19 disease occurring at least 14 days after vaccination and 66 percent effective in preventing moderate-to-severe/critical COVID-19 disease occurring at least 28 days after vaccination. Importantly, the vaccine was 100 percent effective in protecting against death from the disease everywhere it was tested. In addition to meeting the expectations of safety and effectiveness to support emergency use authorization, the Janssen vaccine has the advantage of requiring only a single injection and can be easily transported and stored without special refrigeration requirements. To get control of the COVID-19 pandemic, stay ahead of worrisome viral mutations, and protect the American public, we must vaccinate as many Americans as we can as quickly as possible. The Janssen vaccine provides yet another option to help achieve those goals.” – NIAID Director Anthony S. Fauci, M.D.

“The FDA’s emergency use authorization of the Janssen COVID-19 vaccine is exciting news on many fronts. A single dose vaccine stored at refrigerated temperatures and that prevents hospitalizations and deaths from COVID has the potential to change the trajectory of the pandemic in the U.S. and globally. Janssen and BARDA have a history of working together, developing treatments and vaccines for influenza and Ebola. To manufacture their COVID-19 vaccine in the United States, Janssen is working with resources we established after the 2009 influenza pandemic: our Centers for Innovation in Advanced Development and Manufacturing and our fill-finish manufacturing network. With the development of this vaccine, we are seeing the results of years of work on platform technologies and public-private partnerships coming to fruition.” – BARDA Director Gary Disbrow, Ph.D.

Francis S. Collins, M.D., Ph.D., is Director of the National Institutes of Health in Bethesda, Maryland.

Anthony S. Fauci, M.D., is Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health in Bethesda, Maryland.

Gary Disbrow, Ph.D., is Director of the Biomedical Advanced Research and Development Authority (BARDA), in the HHS Office of the Assistant Secretary for Preparedness and Response.

Statement from Johnson & Johnson

Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use – First Single-Shot Vaccine in Fight Against Global Pandemic

• Data demonstrated protection against COVID-19 related hospitalization and death, across countries with different variants
• Available on not-for-profit basis for emergency pandemic use
• Shipping vaccine immediately, delivering more than 20 million doses to U.S. in March, 100 million doses in first half of 2021

Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.

The terms of the EUA allow use of the vaccine while more data are gathered. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021.

“This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We look forward to our continued efforts around the world as we collectively aim to change the trajectory of this global pandemic.”

Johnson & Johnson is committed to making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The Company plans to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines.

Johnson & Johnson also recently announced its submission of a European Conditional Marketing Authorisation Application to the European Medicines Agency as well as its filing for an Emergency Use Listing (EUL) with the World Health Organization for its COVID-19 vaccine candidate. In addition, rolling submissions for the single-dose COVID-19 vaccine candidate have been initiated in several countries worldwide.

The EUA follows a unanimous vote by the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021.

“We are thankful for the efforts of all those who have volunteered to participate in our clinical trials, our scientists, collaborators, clinical trial sites and investigators. Through the combined commitment of everyone involved, we have been able to discover, develop and manufacture a single-shot COVID-19 vaccine to protect people around the world,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson.

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When deciding which vaccine to take of the three, if people have a choice – Pfizer, Moderna, or Johnson & Johnson – the one big difference is J&J is one shot as opposed to two. None of the individuals who have taken any of the three vaccines have been hospitalized with COVID-19 or have died. The 70% efficacy of the Johnson & Johnson vaccine over 90% of the other vaccines can’t really be compared as parameters were different in what was compared.

Advice remains that if you can get a shot when it is your time – get it.