For immediate release:

Today, the United States Food and Drug Administration issued an Emergency Use Authorization (EUA) for the third vaccine for the prevention of 2019 coronavirus disease (COVID-19) caused by the coronavirus 2 of severe acute respiratory syndrome (SARS-CoV-2). The EUA allows the Janssen COVID-19 vaccine to be distributed in the United States for use in people 18 years of age and older.

“The authorization of this vaccine expands the availability of vaccines, the best method of medical prevention of 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 commissioner of the FDA. Janet Woodcock, MD “The FDA, through our open and transparent scientific review process, has now cleared three COVID-19 vaccines with the urgency required during this pandemic, using the agency’s stringent safety standards. , efficiency and quality of workmanship necessary to support the emergency use authorization. “

The FDA has determined that the Janssen COVID-19 vaccine meets the statutory criteria for issuing an EUA. All 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 known and potential benefits of the vaccine outweigh its known and potential risks, confirming the company’s claim for the use of the vaccine in people 18 years of age and older. By making this decision, the FDA can assure the public and the medical community that it has performed a thorough assessment 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, which is used to make the distinctive SARS-CoV-2 virus ‘spike’ protein. While adenoviruses are a relatively common group of viruses, Ad26, which can cause cold symptoms and pink eyes, has been modified for the vaccine so that it cannot replicate in the human body to 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 respond defensively, producing an immune response against SARS-CoV- 2.

“After a thorough analysis of the data, scientists and doctors at the FDA determined that the vaccine meets the FDA’s expectations for safety and efficacy appropriate for the authorization of a vaccine for emergency use. Said Peter Marks, MD, Ph.D., director of the Center for Biologics Assessment and Research, FDA. “With today’s clearance, we are adding another vaccine to our medical toolkit 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 comprehensive and rigorous assessment of submitted data for vaccines intended to prevent COVID-19.

FDA Assessment of Available Safety Data

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

As part of the clearance, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccine suppliers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine: Serious Adverse Events , cases of multisystem inflammatory syndrome and cases of COVID-19 resulting in hospitalization or death.

It is also mandatory for vaccine suppliers to report all vaccine administration errors to VAERS of which they are aware and for Janssen Biotech Inc. to include a summary and analysis of all vaccine administration errors identified in the monthly safety reports submitted to the FDA.

FDA assessment of available efficacy data

Efficacy data supporting the EUA includes an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study conducted in South Africa, selected countries in South America, Mexico and the United States. United who did not have evidence of SARS-CoV-2. infection before receiving the vaccine. Of these participants, 19,630 received the vaccine and 19,691 received a saline placebo. 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 in at least 28 days after vaccination.

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

There were 116 cases of COVID-19 in the vaccinated group occurring at least 14 days after vaccination and 348 cases of COVID-19 in the placebo group during this period. There were 66 cases of COVID-19 in the vaccinated group occurring at least 28 days after vaccination and 193 cases of COVID-19 in the placebo group during this time. 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 vaccine group against 34 cases in the placebo group.

At present, data is not available to determine how long the vaccine will provide protection, nor is there any evidence that the vaccine prevents the transmission of SARS-CoV-2 from a person to person.

The American process

Based on the determination by the Secretary of the Department of Health and Human Services on February 4, 2020, that there is a public health emergency that could significantly affect national security or the health and safety of U.S. citizens living in abroad, and has issued statements indicating that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow the use of unapproved medical products or unapproved uses medical products approved in an emergency to diagnose, treat or prevent COVID -19 when there are no adequate, approved and available alternatives.

Issuing an EUA is different from FDA approval (licensing) of a vaccine, in that a vaccine available under an EUA is not approved. To determine whether to issue an EUA for a product, the FDA assesses the available evidence to determine whether the product can be effective and also assesses any known or potential risks and any known or potential benefits If the product meets the standard. efficacy and benefit – the risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA application for a COVID-19 vaccine to the FDA, the agency then assesses the application and determines whether the relevant regulatory criteria are met, taking into account all of the scientific evidence on the vaccine that are available to the FDA.

The EUA also requires that information sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Janssen COVID-19 vaccine, be made available to immunization providers and vaccinated.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA outlining its commitment to monitor the safety of the Janssen COVID-19 vaccine. The pharmacovigilance plan includes a plan to supplement longer-term safety monitoring for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities to monitor the safety profile of the Janssen COVID-19 vaccine and to ensure that any safety concerns are identified and assessed in a timely manner.

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

The EUA for the Janssen 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 of the existence of circumstances justifying the authorization of the emergency use of drugs and biologics for the prevention and treatment of COVID-19 is completed. The Janssen COVID-19 vaccine EUA may be revised or revoked if it is determined that the EUA no longer meets the statutory criteria for issuance.

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