Immediate release:

Today, the US Food and Drug Administration issued an Emergency Use Authorization (EUA) for the third prevention of Coronavirus Disease 2019 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). EUA allows the distribution of the Janssen COVID-19 vaccine in the United States for use by individuals 18 years and older.

“The authorization of this vaccine expands the availability of vaccines. This is the best medical prevention method for COVID-1

9 to help us fight this epidemic, which has claimed more than one million lives in the United States. “The acting FDA commissioner said. Dr. Janet Woodcock: “The U.S. Food and Drug Administration (FDA) has approved three COVID-19 vaccines through our open and transparent scientific review process. This vaccine is urgent during the pandemic. Authorized to use the strict safety, effectiveness, and production quality standards required by the agency to support emergencies.”

The FDA has determined that the Janssen COVID-19 vaccine has met the legal standards for the issuance of the EUA. The total number of available data provides clear evidence that the Janssen COVID-19 vaccine can effectively prevent COVID-19. The data also shows that the known and potential benefits of the vaccine outweigh the known and potential risks, which supports the company’s requirements for the use of the vaccine for people over 18 years of age. In making this decision, the FDA can assure the public and the medical community that it has thoroughly evaluated the available safety, effectiveness, and manufacturing quality information.

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 to produce the unique “spike” protein of the SARS-CoV-2 virus. Adenovirus is a relatively common type of virus that can modify the Ad26 vaccine, which can cause cold symptoms and pink eye disease, so it cannot replicate in the human body and cause disease. After a person receives this vaccine, the body can temporarily produce spike protein, which does not cause disease, but triggers the immune system to learn a defensive response, thereby generating an immune response against SARS-CoV-2.

“After a comprehensive analysis of the data, FDA scientists and doctors determined that the vaccine meets FDA’s expectations for safety and effectiveness and is suitable for emergency use of vaccine authorization,” said Dr. Peter Marks, MD, Director of the FDA Center for Biologics Evaluation and Research . “With today’s authorization, we are adding another vaccine to the medical toolbox to combat this virus. At the same time, through a comprehensive and rigorous evaluation of the submitted data for the prevention of COVID-19 vaccine, Americans can be convinced that the FDA is A firm commitment to public health.”

FDA’s assessment of available safety data

The Janssen COVID-19 vaccine is given in a single dose. The safety data available to support EUA includes an analysis of 43,783 participants in an ongoing randomized, placebo-controlled study in certain countries in South Africa, South America, Mexico, and the United States. After 21,895 participants received the vaccine, 21,888 of them received a placebo with saline for a median follow-up of eight weeks. The most common side effects are pain at the injection site, 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 authorization, the FDA pointed out that for Janssen Biotech Inc. and vaccination providers, the following must be reported to the Janssen COVID-19 Vaccine Adverse Event Reporting System (VAERS): serious adverse events, multiple systemic inflammatory cases leading to hospitalization Or death syndrome and COVID-19 cases.

Vaccination providers must also report all vaccine management errors to VAERS they know, and Janssen Biotech Inc. must also include a summary and analysis of all identified vaccine management errors in the monthly safety report submitted to the FDA.

FDA’s assessment of available validity data

The data supporting the effectiveness of EUA includes the analysis of 39,321 participants in some ongoing randomized, placebo-controlled studies in South Africa, South America, Mexico, and the United States that have no evidence of SARS-CoV-2. Infection before vaccination. Among these participants, 19,630 received the vaccine and 19,691 received a placebo with saline. In general, the vaccine is effective in preventing moderate to severe/severe COVID-19 from occurring at least 14 days after vaccination, and about 66% in preventing moderate to severe/critical COVID-19 from occurring at least 28 days after vaccination.

In addition, the vaccine is effective in the prevention of severe/critical COVID-19 that occurs at least 14 days after vaccination, and the effective rate of prevention of severe/critical COVID-19 that occurs at least 28 days after vaccination is 85 %.

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

Currently, there is no data to determine how long the vaccine will provide protection, and there is no evidence that the vaccine can prevent the spread of SARS-CoV-2 from person to person.

U.S. procedures

According to the public health emergency identified by the Secretary of Health and Human Services on February 4, 2020, the event has a great potential to affect national security or the health and safety of citizens living in the United States abroad, and a statement that exists can be approved Reasons for emergency use of unapproved products, the FDA may issue EUA to allow unapproved medical products or unapproved medical products to be used in emergency situations to diagnose, treat or prevent COVID -19, if not Sufficient, approved and available alternatives.

EUA issuance is different from FDA vaccine approval (licensing) because the EUA-regulated vaccine is not approved. When determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product is effective, and evaluates any known or potential risks and any known or potential benefits. Risk assessment is beneficial, and the product can be used in emergency situations. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency will evaluate the requirement and determine whether it meets the relevant statutory standards, taking into account the total amount of scientific evidence available for the vaccine. FDA.

EUA also requires a fact sheet that provides important information (including dosage instructions) and information about the benefits and risks of the Janssen COVID-19 vaccine to vaccination providers and vaccine recipients.

Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA, which describes its commitment to monitoring the safety of the Janssen COVID-19 vaccine. The pharmacovigilance plan includes a plan to complete long-term safety follow-ups for participants in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety of the Janssen COVID-19 vaccine and ensuring that any safety hazards are detected and evaluated in a timely manner.

The FDA also hopes that manufacturers of COVID-19 vaccines authorized by the EUA to continue their clinical trials to obtain more safety and efficacy information and seek approval (license).

The EUA for the Janssen COVID-19 vaccine has been issued to Janssen Biotech Inc., Johnson & Johnson’s Janssen pharmaceutical company. The authorization will remain in effect until a statement that there is a reason to prove that the emergency use of drugs and biological agents can be used to prevent and treat COVID-19. If it is determined that the EUA of the Janssen COVID-19 vaccine no longer meets the legal issuance standards, it can be revised or abolished.

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