- For immediate release:
Today, the US Food and Drug Administration has issued an emergency use authorization (USA) for the third vaccine for the prevention of coronavirus 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 United States for use in individuals 18 years of age or older.
“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us fight this pandemic, which claimed more than half a million lives in the United States,” said the FDA Acting Commissioner. Janet Woodcock, MD “The FDA, through our open and transparent scientific review process, authorized three COVID-19 vaccines with the urgency required during this pandemic, using the agency’s strict standards for the safety, efficacy and quality of manufacture necessary to support emergency use authorization. “
The FDA determined that the Janssen COVID-19 vaccine met the legal criteria for issuing the USA. The totality of 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, supporting the company’s request for the use of the vaccine in people 18 years of age or older. In making this determination, the FDA can assure the public and the medical community that it has carried out a thorough assessment of available information on safety, efficacy and quality of manufacture.
The Janssen COVID-19 vaccine is manufactured with 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 “pico” protein distinct from the SARS-CoV-2 virus. Although adenoviruses are a relatively common group of viruses, Ad26, which can cause symptoms of cold and pink eye, 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 protein spike, which does not cause disease, but activates the immune system to learn how to react defensively, producing an immune response against SARS-CoV-2.
“After a thorough analysis of the data, FDA scientists and doctors determined that the vaccine meets FDA expectations for the appropriate safety and efficacy for the authorization of a vaccine for emergency use,” said Peter Marks, MD, Ph.D ., director of the FDA’s Center for Biological Research and Evaluation. “With today’s authorization, we are adding another vaccine to our medical toolbox to fight this virus. At the same time, the American people can be sure of the FDA’s unwavering commitment to public health through our comprehensive and rigorous assessment of data sent to vaccines to prevent COVID-19. “
FDA assessment of available safety data
The Janssen COVID-19 vaccine is administered in a single dose. Safety data available to support the US includes an analysis of 43,783 participants enrolled in an ongoing randomized placebo-controlled study conducted in South Africa, some South American countries, 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 were pain at the injection site, headache, fatigue, muscle pain and nausea. Most of these side effects were mild to moderate in severity and lasted for 1-2 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 Notification System (VAERS) for the Janssen COVID-19 Vaccine: 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 all vaccine administration errors to the 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 sent to the FDA.
FDA assessment of available efficacy data
Efficacy data to support the US includes an analysis of 39,321 participants in the ongoing randomized, placebo-controlled study conducted in South Africa, some South American countries, Mexico and the United States that had no evidence of SARS-CoV- 2 infection before receiving the vaccine. Among these participants, 19,630 received the vaccine and 19,691 received 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 at least 28 days after vaccination.
In addition, the vaccine was 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 vaccine group that occurred at least 14 days after vaccination and 348 cases of COVID-19 in the placebo group during this period of time. 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 serious / critical cases in the vaccine group versus 34 cases in the placebo group.
At the moment, there is no data available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.
The USA Process
Based on the determination of the Secretary of the Department of Health and Human Services on February 4, 2020, that there is a public health emergency that has significant potential to affect national security or the health and safety of United States citizens living abroad , and issued statements that there are circumstances that justify authorization for the emergency use of unapproved products, the FDA may issue a USA 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.
Issuing a USA is different from the approval (licensing) of a vaccine by the FDA in that a vaccine available under a USA is not approved. In determining whether to issue a USA for a product, the FDA evaluates the available evidence to determine whether the product can be effective and also evaluates any known or potential risks and any known or potential benefits if the product meets the standard of effectiveness and benefits . the risk assessment is favorable, the product is made available during the emergency. As soon as a manufacturer submits a US order for a COVID-19 vaccine to the FDA, the agency evaluates the order and determines whether the relevant legal criteria have been met, taking into account all the scientific evidence about the vaccine that is available to the FDA .
EUA also requires leaflets with important information, including dosing instructions and information on the benefits and risks of the Janssen COVID-19 vaccine, to be made available to vaccination providers and vaccine recipients.
Janssen Biotech Inc. submitted a pharmacovigilance plan to the FDA outlining its commitment to monitoring the safety of the Janssen COVID-19 vaccine. The pharmacovigilance plan includes a plan to complete long-term safety monitoring 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 assessed in a timely manner.
The FDA also expects manufacturers whose COVID-19 vaccines are authorized under a USA to continue their clinical trials to obtain additional safety and efficacy information and seek approval (licensing).
The USA for the Janssen COVID-19 vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The authorization will remain in effect until the declaration that there are circumstances justifying the authorization for the emergency use of medicines and biological products for the prevention and treatment of COVID-19 is closed. 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 emission.
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