FDA Issues Emergency Use Authorisation for Third COVID-19 Vaccine

March 1, 2021

The US Food and Drug Administration (FDA) issued an emergency use authorisation (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 Janssen COVID-19 vaccine to be distributed in the United States for use in individuals aged 18 years and older.

“The authorisation of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Janet Woodcock, MD, Rockville, Maryland. “The FDA, through our open and transparent scientific review process, has now authorised 3 COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorisation.”

The Janssen COVID-19 vaccine uses adenovirus type 26 (Ad26) to deliver a piece of the DNA that is used to make the distinctive spike protein of the SARS-CoV-2 virus. The adenovirus has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives the vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

The vaccine is administered as a single dose.

The available safety data to support the EUA include an analysis of 43,783 participants enrolled in an ongoing randomised, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the United States. The participants, 21,895 of whom received the vaccine and 21,888 of whom received saline placebo, were followed for a median of 8 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 to 2 days.

As part of the authorisation, the FDA notes that it is mandatory for Janssen Biotech Inc., and vaccination providers 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 that result in hospitalisation or death.

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

The effectiveness data to support the EUA include an analysis of 39,321 participants in the ongoing randomised, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the United States who did not have evidence of SARS-CoV-2 infection prior to 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.

Additionally, 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 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 in the vaccine group versus 34 cases in the placebo group.

At this time, data are not 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 issuance of an EUA is different than an FDA approval (licensure) of a vaccine, in that a vaccine available under an 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 effectiveness standard and the benefit-risk assessment is favourable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact 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 vaccination providers and vaccine recipients.

Janssen Biotech Inc., has submitted a pharmacovigilance plan to the FDA describing its commitment to monitor the safety of Janssen COVID-19 vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up 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 evaluated in a timely manner.

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

The EUA for the Janssen COVID-19 vaccine will be effective until the declaration that circumstances exist justifying the authorisation of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated. The EUA for Janssen COVID-19 Vaccine may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

Reference: https://www.fda.gov/news-events/press-announcements/fda-issues-emergency...

SOURCE: US Food and Drug Administration