FDA explains Background of Emergency Use Authorizations related to COVID-19 Vaccines

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25-27 June 2024
Munich, Germany

European Microbiology Conference 2024

Due to the current situation of the Corona pandemic, the development of vaccines is under high pressure. In Europe, a rolling approval procedure is being used to accelerate approval, and so-called "Emergency Use Authorization" are also being considered or have already been applied for in the USA. In order to provide more transparency in this procedure and to explain the modalities, the FDA has now published a document entitled: "Emergency Use Authorization for Vaccines Explained". With this document, the FDA wants to take into account what it says is its globally recognized reputation as an authority with high scientific standards for the safety, efficacy and quality of approved vaccines. The FDA, as the regulatory authority, provides appropriate scientific and regulatory advice to vaccine developers. In this context, the  authority conducts a rigorous and intensive evaluation of the information provided as well as of the products during the clinical phases, but also after approval. This also applies to studies that are continued after emergency approval.The FDA emphasises that it is aware of the severity of the current public health emergency and the public's expectations to have a vaccine available as soon as possible to control COVID-19.

In this context, the FDA defines the emergency approval process as follows:

"An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.
Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA."

When asked whether these quickly approved vaccines are also subject to a detailed and strict examination, the FDA answers with a clear Yes and explains that these vaccines are also evaluated in clinical trials with many thousands of participants in order to collect scientific data on efficacy, side effects, etc. The strict standards of the FDA are the basis for this.

In addition, the following questions are addressed:

• What safety and efficacy data must be submitted to the FDA for an EUA application for a vaccine to prevent COVID-19?
• What process do manufacturers follow to potentially make a vaccine against COVID-19 available through the EUA?
• Who are the experts at the FDA that evaluate EUAs for vaccines?
• What are the plans for further surveillance of COVID-19 vaccines approved by the FDA for emergency use?
• How are vaccine recipients informed about the benefits and risks of a vaccine that receives an EUA?
• How is it that COVID-19 vaccines have been developed so quickly?

This last question in particular is of concern to many people around the world when they think about a vaccination. A statement by Petra Falb, staff member of the Austrian regulatory and supervisory authority AGES, can serve as a summarising answer to the question "- How could it happen "so quickly?:

"Since SARS 1 and MERS - i.e. for 17 years - research has been conducted on this type of corona virus. In the case of SARS1, the development of the vaccine was already in clinical phase I, so there was no need to start from scratch. There are currently 3 vaccines in the approval process, one of which is a viral vector (this is a well known technology, such vaccines are already approved in both the veterinary and human sectors) and 2 mRNA. Although such a vaccine is not yet available on the market, the principle of the mRNA vaccine has been in development for several years. In addition, there is a unique situation that we have never had before in the world: thanks to the great state support and also the guaranteed acceptance in case of a successful approval, many companies have really risked to put all available resources into this project. That is never the case elsewhere and this is an absolute novelty.
- Is there only a rushed and sloppy approval procedure?
The admission procedure is shortened administratively (not technically!). You have a rolling review here. Normally, a company submits its registration dossier only after all data has been collected and compiled and then the procedure begins. In a rolling review, the company submits piece by piece what it already has and the relevant data packages are examined in parallel. This way the review is also almost complete when the last data package comes in, which saves a few months (by law an approval procedure takes 210 days, in reality it takes 1 - 1 1/2 or 2 years on average)."

For detailed answers to the other questions, please see "Emergency Use Authorization for Vaccines Explained" on the FDA's website.