WASHINGTON, D.C. – On Feb. 27, 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 Johnson & Johnson Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
The FDA has determined that the Janssen COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Janssen COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.
Janssen’s COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”
On Feb. 28, CDC Director Rochelle P. Walensky, MD, MPH, gave a statement on signing the Advisory Committee on Immunization Practices’ Recommendation to use Janssen’s COVID-19 Vaccine.
“This official CDC recommendation – which follows Saturday’s FDA decision to authorize emergency use of the vaccine – is another milestone toward an end to the pandemic.
“As vaccination scales up, so too does our nation’s overall protection from serious outcomes due to COVID-19. The Janssen vaccine has been shown to be safe and effective in preventing severe COVID-19 illness, hospitalization, and death.
“This vaccine is also another important tool in our toolbox to equitably vaccinate as many people as possible, as quickly as possible. As a one-dose vaccine, people do not have to return for a second dose to be protected. In addition, this vaccine does not need to be kept in a freezer and can be stored at refrigerated temperatures – so it is easy to transport and store and allows for expanded availability in most community settings and mobile sites, as supply scales up.
“This third safe, effective COVID-19 vaccine comes at a potentially pivotal time. CDC’s latest data suggest that recent declines in COVID-19 cases may be stalling and potentially leveling off at still very high numbers. That is why it is so critical that we remain vigilant and consistently take all of the mitigation steps we know work to stop the spread of COVID-19 while we work our way toward mass vaccination.
“I know that many Americans look forward to rolling up their sleeves with confidence as soon as a COVID-19 vaccine is available to them. Having different types of vaccines available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers. Getting vaccinated with the first vaccine available to you will help protect all of us from COVID-19.”
Not long after getting approvals from the FDA and CDC, officials at Johnson & Johnson responded.
“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.”
On March 2, President Biden announced that Merck, another New Jersey based pharmaceutical company, would assist in production of the Janssen vaccine.
