For immediate release:

Today, the US Food and Drug Administration issued an Emergency Use Authorization (USA) 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 USA allows the Janssen COVID-19 vaccine to be distributed in the US for use in people 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 more than half a million lives in the United States,” said the Acting FDA Commissioner. Janet Woodcock, MD “The FDA, through our open and transparent scientific review process, has now licensed three COVID-19 vaccines with the urgency required during this pandemic, using the rigorous standards of safety, effectiveness and manufacturing quality of the agency needed to support the emergency. authorization of use “.

The FDA has determined that the Janssen COVID-19 vaccine has met the legal criteria for the 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 shows that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for use of the vaccine in people 18 years of age and older. By making this determination, the FDA can assure the public and the medical community that it has conducted a thorough evaluation of the available information on safety, efficacy, and manufacturing quality.

The Janssen COVID-19 vaccine is made using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. While adenoviruses are a relatively common group of viruses, Ad26, which can cause cold and pink eye symptoms, has been modified for the vaccine so that it cannot replicate in the human body and cause disease. After a person receives this vaccine, the body can temporarily produce the spike protein, which does not cause disease, but causes the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After a thorough analysis of the data, FDA scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and efficacy appropriate to the authorization of a vaccine for emergency use,” said Peter. Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s authorization, we are adding another vaccine to our medical toolbox to combat this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our thorough and rigorous evaluation of the data submitted for vaccines to prevent COVID-19. “

FDA evaluation of available safety data

The Janssen COVID-19 vaccine is given as a single dose. The safety data available to support the USA includes an analysis of 43,783 participants enrolled in an ongoing randomized placebo-controlled study conducted in South Africa, certain countries in South America, Mexico, and the U.S. Participants, 21,895 of whom received the vaccine and 21,888 of whom received a saline placebo, were followed for an average of eight weeks after vaccination. The most frequently reported side effects were injection site pain, headache, fatigue, muscle aches, and nausea. Most of these side effects were mild to moderate in severity and lasted 1 to 2 days.

As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for the Janssen COVID-19 vaccine: Serious Adverse Events, Cases of Multisystemic Inflammation Syndrome and COVID-19 cases resulting in hospitalization or death.

It is also mandatory for vaccination providers to report all known vaccine administration errors to VAERS and for Janssen Biotech Inc. to include a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted. to the FDA.

FDA evaluation of available effectiveness data

The effectiveness data to support the USA includes an analysis of 39,321 participants in the ongoing randomized placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the US who had no evidence. of SARS-CoV-2 infection before receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received a saline placebo. Overall, the vaccine was approximately 67% effective in preventing the occurrence of moderate to severe / critical COVID-19 at least 14 days after vaccination and 66% effective in preventing the occurrence of moderate to severe COVID-19 severe / critical at least 28 days after vaccination.

Additionally, the vaccine was approximately 77% effective in preventing the occurrence of severe / critical COVID-19 at least 14 days after vaccination and 85% effective in preventing the occurrence of severe / critical COVID-19 at least 28 days after vaccination.

There were 116 COVID-19 cases in the vaccine group that occurred at least 14 days after vaccination, and 348 COVID-19 cases in the placebo group during this time period. There were 66 COVID-19 cases in the vaccine group that occurred at least 28 days after vaccination and 193 COVID-19 cases in the placebo group during this time period. From 14 days after vaccination, there were 14 severe / critical cases in the vaccinated group versus 60 in the placebo group, and from 28 days after vaccination, there were 5 severe / critical cases in the group of the vaccine against 34 cases in the placebo group.

At this time, no data is available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents human-to-human transmission of SARS-CoV-2.

The USA process

Based on the determination of the Secretary of the Department of Health and Human Services on February 4, 2020, that a public health emergency exists that has significant potential to affect national security or the health and safety of the citizens of the United States. United States living abroad, and issued statements that there are circumstances that justify the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no suitable, approved, and available alternatives.

The issuance of an EUA is different from the approval (licensing) of a vaccine by the FDA, in that a vaccine available under an EUA is not approved. To determine whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also evaluates any known or potential risks and any known or potential benefits Whether the product meets the standard of effectiveness and benefit – The risk assessment is favorable, the product is available during the emergency. Once a manufacturer submits a US request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines if the relevant legal criteria are met, taking into account the totality of the scientific evidence about the vaccine that is currently in use. available to the FDA.

The EUA also requires that fact sheets providing important information, including dosing instructions, and information on the benefits and risks of the Janssen COVID-19 vaccine, be available to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA that outlines its commitment to monitor the safety of the Janssen COVID-19 vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Janssen COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are licensed by the US to continue their clinical trials to obtain additional information on safety and efficacy and to seek approval (license).

The USA for the Janssen COVID-19 vaccine was issued to Janssen Biotech Inc., a Johnson & Johnson Janssen pharmaceutical company. The authorization will be effective until the declaration that there are circumstances that justify the authorization of the emergency use of medicines and biologics for the prevention and treatment of COVID-19 ends. The EUA for the Janssen COVID-19 vaccine may be revised or revoked if it is determined that the EUA no longer meets the legal criteria for issuance.

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