In most contexts, it is perfectly acceptable to use “approval” and “authorization” interchangeably. But not at the Food and Drug Administration (FDA) and certainly not when it comes to COVID-19 vaccines. If the subject appears at the Zoom holiday party, here is a deception sheet for specific uses of these similar terms.
Approval – No COVID-19 vaccines have been approved. Approval means that the FDA has officially decided that a product is safe and effective for its designated use. The approval process involves rigorous reviews of all available product data and can take several months.
Authorization – To speed things up in an emergency, such as a pandemic, the FDA may grant an emergency use authorization (EUA). An EUA, as its name suggests, authorizes the use of a product in unusually urgent circumstances if the benefits of its use outweigh any known or potential risks. A vaccine that fights a global pandemic is an ideal candidate for an EUA – we cannot afford to waste more time in the midst of a crisis, with an increasing number of deaths.
The FDA has granted a EUA for the Pfizer and BioNTech vaccine and is likely to do the same for the Moderna vaccine this week. As long as no serious damage caused by vaccines is discovered, they will maintain the authorization until the end of the pandemic. At that time, pharmaceutical companies will decide whether to seek FDA approval. Remdesivir, an antiviral drug, received an EUA for the treatment of COVID-19 in May before gaining approval in October.
The accelerated process for the authorization of COVID-19 vaccines does not mean that decisions are made willingly or unwillingly. FDA analysts had to analyze all currently available data from clinical trials before signing the Pfizer and BioNTech vaccine.
ROUND BONUS: Clearance – FDA approval is usually applied to devices – anything from heart rate monitor applications on a smart watch to X-ray machines.
The FDA groups medical devices into three classes based on the level of risk associated with their use. Low-stakes products, such as gauze and tongue depressors, are class I, while products such as pacemakers are class III. Class III devices are the only ones that require FDA approval before being placed on the market. Class I and II do not have to be approved for marketing. If they are a brand new low risk product, they can get something called a De Novo rating. Others may be authorized by the FDA if they can demonstrate that they are sufficiently similar to products that have already been reviewed.