SARS-CoV-2 is the novel coronavirus responsible for the COVID-19 pandemic that has overwhelmed the global health care system. As of this writing, the CDC reports more than 28 million COVID-19 cases and more than 500,000 associated deaths.
Three COVID-19 vaccines have now received Emergency Use Authorizations (EUAs) from the U.S. Food & Drug Administration (FDA) — developed by Pfizer/BioNTech, Moderna, and Johnson & Johnson. Here’s what you need to know about the process that led to these authorizations.
A Lightning-Fast Response to An Unprecedented Health Crisis
The usual vaccine development, clinical trial, EUA, and manufacturing process for a vaccine can take a very long time. In fact, until now the mumps vaccine has held the world record for achieving its approval in just four years. Given the urgency of fighting the COVID-19 pandemic, such a long time frame would have been catastrophic.
Therefore, governments around the world invested heavily in efforts to accelerate the development of the COVID-19 vaccines. With the aid of this funding, vaccine manufacturers and researchers were able to conduct multiple parallel clinical trials.
Clinical Trials
Like all FDA-regulated products, the COVID-19 vaccines were tested in clinical trials comprised of three stages:
- Phase 1: A small group of participants was given the experimental vaccines to evaluate their safety.
- Phase 2: The pool of participants was expanded to reflect the populations for which the vaccines were intended, testing for efficacy as well as safety.
- Phase 3: Testing was expanded to a much larger population to further evaluate both safety and efficacy.
Emergency Use Authorizations
The FDA grants EUAs to expedite the availability and use of medical interventions, such as vaccines, during public health emergencies like the COVID-19 pandemic.
The FDA carefully reviewed the data from the vaccines that it has authorized, all of which demonstrated significant efficacy compared to placebo, with only very rare serious side effects. Based on these data, the agency concluded that the vaccines’ known and potential benefits for preventing COVID-19 infections outweighed their known and potential risks.
While the initial clinical trials only included participants who were at least 16 years old, trials are now in progress for 12 to 16 year olds. Assuming the vaccines prove safe and effective in these trials, the FDA is likely to authorize their use in this population.
The FDA continues to monitor the safety and efficacy of the vaccines. The agency will ultimately grant them full approval if additional data confirm the clinical trials’ initial results. Any serious negative reactions should be reported to the government’s Vaccine Adverse Event Reporting System (VAERS).
Vaccination Efforts In Our Area
Each state has its own roll-out process designed to immunize different groups based on their vulnerability to infection. Vaccination in Pennsylvania is being rolled out in a four-phase process. Like many states, the Commonwealth has experienced some significant challenges in coordinating vaccine distribution and administration. Therefore, it’s important to be patient — yet persistent — in attempting to get vaccinated. Everyone who wishes to receive the vaccine should be able to do so when it’s their turn. And that will make all of us safer.
Philadelphia residents may call 311 for assistance in registering to receive the vaccine.
We’re All In This Together
Independence continues to monitor the COVID-19 situation. Please visit our COVID-19 page for the latest information about care and services available related to the virus.
For information specifically on the vaccines:
- Visit our COVID-19 vaccine page.
- Read our list of 10 things to know about COVID-19 vaccines.
- See what Independence Medical Director Reetika Kumar, MD has to say about the significance of the vaccines and why their safety and efficacy can be trusted.
