Today, the U.S. Food and Drug Administration issued an emergency use permit (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe respiratory coronavirus syndrome 2 (SARS-CoV-2).
The EUA permits the distribution of the Janssen COVID-19 vaccine in the United States for use in individuals 18 years of age and older.
“The authority of this vaccine is expanding the availability of vaccines, the best medical prevention for COVID-19, to help us fight this widespread pandemic. half a million lives in the United States, “said FDA Acting Commissioner Janet Woodcock, MD
“The FDA, through our open and transparent scientific review process, has now approved three COVID-19 vaccines with the urgency required through this pandemic, using the organisation’s stringent standards. for the safety, efficiency, and quality of manufacturing required to support an emergency use permit. “
The FDA has confirmed that the Janssen COVID-19 vaccine has met the statutory criteria for EUA withdrawal. The completeness of the available data provides clear evidence that the Janssen COVID-19 vaccine may be effective in inhibiting COVID-19. The data also show that the known and potential benefits of the vaccine outweigh the known and potential risks, supporting the company’s application for the vaccine. vaccine use in people 18 years of age and older. In making this decision, the FDA can assure the public and the medical community that it has thoroughly evaluated the available safety, efficacy, and manufacturing information.
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 special “spike” protein of the SARS-CoV-2 virus.
Although adenoviruses are a relatively common group of viruses, Ad26, which can cause cold symptoms and a pink eye, has been modified for the vaccine so that replication in the human body cannot cause illness.
After a person is vaccinated, the body can make the protein spike for a period of time, which does not cause infection but stimulates the immune system to learn immune, triggering an immune response against SARS- CoV-2.
After careful analysis of the data, FDA scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and efficacy appropriate for emergency vaccine use. With today ‘s license, we are adding another vaccine in our medical device box to fight this virus. At the same time, Americans can be reassured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19 . “
Peter Marks, MD, PhD, Director of the Center for Biological Assessment and Research, Food and Drug Administration
FDA assessment of available safety data
Janssen COVID-19 vaccine is administered as a single dose. The safety data available to support the EUA include a study of 43,783 participants enrolled in a randomized, placebo-controlled follow-up study, conducted in South Africa, specific countries in South America, Mexico and the USA
Participants, 21,895 of whom received the vaccine and 21,888 of whom received placebo saline, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.
As part of the authorization, the FDA notes that it is mandatory for Janssen Biotech Inc. and vaccine providers report the Adverse Event Vaccination Reporting System (VAERS) for Janssen COVID-19 vaccine: adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 hospitalization or death.
It is also essential for vaccine providers to report all vaccine administration errors to VAERS for their awareness and for Janssen Biotech Inc. to include a summary and analysis of the vaccine administration errors identified in monthly safety reports submitted to the FDA.
FDA evaluation of the available efficacy data
The efficacy data to support the EUA include an analysis of 39,321 participants in the randomized, placebo-controlled follow-up study conducted in South Africa, specific countries in South America, Mexico, and the USA had no evidence of SARS-CoV-2 infection before receiving 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 / acute COVID-19 at least 14 days post-vaccination and 66% effective in preventing COVID. -19 moderate to severe / urgent occurrence at least 28 days after vaccination.
In addition, the vaccine was approximately 77% effective in preventing severe / emergency COVID-19 at least 14 days post-vaccination and 85% effective in preventing COVID. -19 severe / urgent 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. 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 period.
Starting 14 days after vaccination, there were 14 severe / urgent cases in the vaccine group against 60 in the placebo group, and starting 28 days after vaccination, there were 5 severe / urgent in the placebo. vaccine group against 34 cases in the placebo group.
At present, data are not available to determine how long the vaccine lasts, and there is no evidence that the vaccine prevents the administration of SARS-CoV-2. passed from person to person.
EUA process
On the basis of the decision by the Secretary of the Department of Health and Human Services on February 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and safety of living US citizens abroad, and have issued assurances that there are circumstances that justify the emergency use permit of unapproved products, the FDA may issue EUAs to allow unauthorized medical products or practices of permitted medical products used in emergencies to diagnose, treat, or prevent COVID. -19 when appropriate, agreed and unavailable options.
The issuance of an EUA is different from an FDA (licensed) vaccine, in that a vaccine available under an EUA will not be approved.
In determining whether an EUA should be issued for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses risks. known or potential and any known or potential benefits if the product meets the efficiency standard and the benefit- risk assessment is favorable, the product will be available during the emergency.
Once a manufacturer submits an EUA application for the COVID-19 vaccine to the FDA, the agency then evaluates the application and determines whether the relevant statutory criteria are met, taking into account the completeness of the scientific evidence about the vaccine available with the FDA.
The EUA also wants information leaflets providing important information, including dosing instructions, and information on the benefits and risks of the Janssen COVID-19 vaccine, to be made available to vaccine providers and vaccine recipients. .
Janssen Biotech Inc. has submitted a pharmacovigilance plan to the FDA outlining its commitment to monitoring the safety of the Janssen COVID-19 vaccine. The surveillance plan includes a plan to complete long-term safety work for participants enrolled in ongoing clinical trials.
The surveillance plan also includes other actions aimed at monitoring the safety profile of the Janssen COVID-19 Vaccine and ensuring that any safety concerns are identified and evaluated in good faith. time.
The FDA also expects that manufacturers holding EUV-authorized COVID-19 vaccines will continue their clinical trials to obtain additional safety and efficacy information and obtain a license (license).
The EUA for the Janssen COVID-19 vaccine was awarded to Janssen Biotech Inc., Janssen Pharmaceutical Company of Johnson & Johnson. The authorization shall be effective until the verification of conditions justifying the use of drug and biological consent for the prevention and treatment of COVID-19 has been completed.
The EUA for the Janssen COVID-19 vaccine can be reviewed or revoked if it is determined that the EUA no longer meets the statutory criteria for issuance.
Source:
Food and Drug Administration