For immediate release:

Today, the US Food and Drug Administration issued an emergency 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 Janson COVID-19 vaccine to be distributed in the United States for use in people 18 years of age and older.

“Allowing this vaccine expands the availability of vaccines, the best method of medical prophylaxis for COVID-1

9, to help us fight this pandemic, which has claimed more than half a million lives in the United States,” he said. FDA Commissioner Janet Woodcock, PhD, through our open and transparent scientific review process, has already authorized three COVID-19 vaccines with the urgency required during this pandemic, using the agency’s strict safety, efficacy and safety standards. production quality needed to support emergencies use a permit. “

The FDA has determined that Jansen’s CansID-19 vaccine meets the statutory criteria for issuing an EUA. The totality of the available data provides clear evidence that the Jansen CANID-19 vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits of the vaccine outweigh its known and potential risks, supporting the company’s demand for the vaccine in people aged 18 and over. In making this decision, the FDA may assure the public and the medical community that it has made an in-depth assessment of the available information on safety, efficiency and quality of production.

The Janssen COVID-19 vaccine is produced 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 create the distinctive protein spike of the SARS-CoV-2 virus. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold and pink eye symptoms, has been modified for the vaccine so that it cannot replicate in the human body to cause disease. Once a person receives this vaccine, the body can temporarily produce a protein that does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“After an in-depth analysis of the data, FDA scientists and doctors have determined that the vaccine meets the FDA’s expectations for safety and efficacy, suitable for authorizing an emergency vaccine,” said Dr. Peter Marx, Ph.D., director of the Center. for the evaluation and research of FDA organic products. “With today’s permission, we are adding another vaccine to our medical box 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 assessment of the data provided for vaccines to prevent COVID-19. “

FDA assessment of available safety data

The Janssen COVID-19 vaccine is given as a single dose. Available safety data in support of the EUA include an analysis of 43,783 participants included in an ongoing randomized, placebo-controlled study conducted in South Africa, some countries in South America, Mexico, and the United States. Participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for an average of eight weeks after vaccination. The most commonly reported side effects are injection site pain, headache, fatigue, muscle aches and nausea. Most of these side effects are mild to moderate and last for 1-2 days.

As part of the permit, the FDA notes that Janssen Biotech Inc. is required. and vaccination providers to report to the Adverse Event Reporting System (VAERS) for the Janssen COVID-19 vaccine the following: serious adverse events, cases of multisystem Inflammatory Syndrome, and cases of COVID-19 that result in hospitalization or death.

It is also mandatory for vaccination providers to report any errors in the administration of VAERS vaccines that they have become aware of, and for Janssen Biotech Inc. include a summary and analysis of any identified errors in the administration of vaccines in the monthly safety reports submitted to the FDA.

FDA Evaluation of available performance data

Efficacy data in support of the EUA included an analysis of 39,321 participants in an ongoing randomized, placebo-controlled study conducted in South Africa, some South American countries, Mexico, and the United States who had no evidence of SARS-CoV-2 infection prior to receiving of the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received placebo saline. Overall, the vaccine was approximately 67% effective in preventing moderate to severe / critical COVID-19 occurring at least 14 days after vaccination, and 66% effective in preventing moderate to severe / critical COVID-19 occurring for at least 28 days. after vaccination.

In addition, the vaccine was approximately 77% effective in preventing severe / critical COVID-19 that occurred at least 14 days after vaccination, and 85% effective in preventing severe / critical COVID-19 that occurred at least 28 days after vaccination.

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

There are currently no data to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents SARS-CoV-2 transmission from person to person.

The process in the United States

Based on the order of the Secretary of the Department of Health and Human Services of February 4, 2020, that there is a public health emergency that has significant potential to affect national security or the health and safety of U.S. citizens abroad, and declare that there are circumstances justifying the authorization for the emergency use of unapproved products, the FDA may issue an EUA to allow unauthorized medical devices or unauthorized uses of approved medical devices to be used in emergencies for the diagnosis, treatment or prevention of COVID, 19, when there are no adequate, approved and available alternatives.

The issuance of an EUA is different from the FDA approval (licensing) of a vaccine because the available vaccine under the EUA is not approved. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits if the product meets the standard of effectiveness and risk assessment. is favorable, the product is provided during an emergency. After the manufacturer submits an application to the EUA for a vaccine against COVID-19 to the FDA, the agency then evaluates the application and determines whether the relevant legal criteria are met, taking into account the body of scientific evidence for the vaccine available to the FDA.

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

Janssen Biotech Inc. submitted to the FDA a pharmacovigilance plan outlining its commitment to monitoring the safety of Jansen’s CansID-19 vaccine. The pharmacovigilance plan includes a plan for longer-term safety monitoring of participants involved in ongoing clinical trials. The Pharmacovigilance Plan also includes other activities aimed at monitoring the safety profile of the Janson COVID-19 vaccine and ensuring the timely identification and assessment of all safety concerns.

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

The EUA for the Janson COVID-19 vaccine has been issued to Janssen Biotech Inc., a Janssen pharmaceutical company of Johnson & Johnson. The authorization will be effective until the declaration that there are circumstances justifying the authorization of the emergency use of drugs and biologics for the prevention and treatment of COVID-19 is terminated. The EUA for the COVID-19 vaccine from Jansen may be revised or revoked if it is found that the EUA no longer meets the legal criteria for issuance.

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