Dear Doctor: I’m surprised to learn that the COVID-19 vaccines are not FDA-approved, but are authorized for emergency use only. Why haven’t the vaccines been approved? Also, how is it that the mRNA vaccines got made so fast? It doesn’t seem safe.
Dear Reader: You’re not alone in asking about the status and history of the COVID-19 vaccines now in use in the United States. We continue to get these questions from a lot of readers. Some say the confusion keeps them from getting vaccinated. We’ve written about this before, but these are important topics, and the details bear repeating.
You’re correct that the Food and Drug Administration has granted something known as an emergency-use authorization to a trio of COVID-19 vaccines. These are the Pfizer, Johnson & Johnson and Moderna vaccines. An emergency-use authorization, or EUA, makes a medication, vaccine or medical procedure available prior to formal FDA approval when a public health threat exists. This doesn’t mean the COVID-19 vaccines have failed to qualify for FDA approval. In fact, all three vaccines are in the approval pipeline. However, this is a rigorous and structured process that takes time to complete.
While full approval is pending, the emergency-use authorization for the COVID-19 vaccines has allowed the U.S. to begin the process of returning to pre-pandemic normal. It’s also important to note that any drug or procedure that gets an emergency-use authorization continues to be closely monitored and evaluated. When needed, an EUA can be revoked immediately.
It’s true that the trio of COVID-19 vaccines now in use in the U.S. became available at record speed. This is due, in no small part, to previous research that went into developing similar mRNA vaccines. This includes vaccine development for MERS (Middle East respiratory syndrome) and SARS (severe acute respiratory syndrome), each of which are caused by a coronavirus. So when the call went out for a vaccine targeting the coronavirus that causes COVID-19, researchers weren’t starting from scratch. They were building on decades of existing research and development. Add in robust funding to the tune of about $10 billion, and project Warp Speed, a unique collaboration between the pharmaceutical industry and the federal government, got underway.
Also key to the rapid response was the vast and diverse pool of volunteers who made it possible to run multiple clinical trials at the same time. By the time vaccine developers reached the phase 3 efficacy trials, they had tens of thousands of volunteers taking part.
Bottom line -- the three vaccines now authorized for emergency use by the FDA have undergone thorough and rigorous testing. All three have been found to be safe and effective in preventing severe COVID-19. And each vaccine continues to undergo intense safety monitoring. As we saw in the slight pause of the Johnson & Johnson vaccine, potential problems are addressed immediately.
We continue to urge everyone who is eligible to, please, get vaccinated. You make the world safer not only for yourself, and also but for everyone else around you.
(Send your questions to [email protected], or write: Ask the Doctors, c/o UCLA Health Sciences Media Relations, 10960 Wilshire Blvd., Suite 1955, Los Angeles, CA 90025. Owing to the volume of mail, personal replies cannot be provided.)