The vaccines are here. Stephen Parodi, MD, explains why we can — and should — trust them to help keep us safe.
Hope is in sight. COVID-19 vaccines are here, and some of the most vulnerable people are already getting vaccinated.
At the same time, you may be wondering how we can be sure the vaccines are safe and how the vaccine developers were able to determine so quickly that they work to prevent COVID-19 infection.
To discuss these and other key questions, we spoke with Stephen Parodi, MD, national infectious disease lead at Kaiser Permanente.
Groups of scientists, the pharmaceutical industry, multiple government agencies, and medical professionals recognized the urgent need to share resources and focus on stopping the pandemic.
The Food and Drug Administration saw the high infection rates and understood that safe, effective vaccines were crucial. As a result, the FDA was able to speed up certain parts of the approval process while still ensuring a thorough evaluation of these vaccines. For instance, enrolling patients in clinical trials, usually the longest part of the process, was accelerated.
In addition, our scientific community approached these vaccines in a new way. Most vaccines are developed by weakening or killing a virus or by producing part of the virus in the lab. These processes are time-consuming. For the Pfizer-BioNTech and Moderna vaccines recently authorized for use in the United States, the pharmaceutical companies used a new, faster method that is based on decades of research on related viruses.
All of this work was made possible by significant investments from both the government and private sources. Their sponsorships allowed pharmaceutical companies to devote ample resources to this important effort and test multiple approaches and move forward with the ones that worked.
To receive emergency use authorization, each COVID-19 vaccine candidate met the FDA’s stringent safety and efficacy standards.
While the speed of COVID-19 vaccine development is remarkable, several measures were taken to ensure the trials and the evaluation of the results were done with the highest level of integrity and confidence. During each phase of the clinical trials, data and safety monitoring boards followed the interim results closely to determine if the trial could continue. Finally, the Centers for Disease Control and Prevention and its expert Advisory Committee on Immunization Practices weighed in independently on all of the safety and effectiveness data.
Yes. As each COVID-19 vaccine gets authorized for emergency use in the United States, the vaccine’s safety and efficacy data is then released. At that time, our infectious disease and other clinical experts — along with state and federal public health officials —closely review the data. We also will continue to monitor the safety and effectiveness of these vaccines as we administer them over the coming months. This type of monitoring is normal, and we have done this kind of evaluation for other new vaccines.
The first 2 COVID-19 vaccines authorized, one developed by Pfizer and BioNTech and another by Moderna, both reported over 90% efficacy in their phase 3 clinical trials. These are incredibly encouraging results, which is welcome news given the current surge of COVID-19 cases. As a point of comparison, flu vaccine efficacy is generally around 50%, so the COVID-19 vaccine results are remarkable.
I understand that some of us may have concerns about a new vaccine. A number of safeguards were put in place to make sure the vaccine will protect us from this coronavirus in a safe way. Kaiser Permanente’s experts have reviewed the vaccine development process, been involved with the trials, and applied the same due diligence to make sure the data supporting the use of these vaccines is solid. By choosing to be vaccinated when it’s your turn, you’ll be doing your part to help us return to normal. I look forward to receiving the vaccine when I am eligible and recommend all my family and friends to do the same.
It will take some time for a large percentage of people to get vaccinated. Until then, physical distancing, frequent hand-washing, limiting group gatherings, restricting nonessential travel, and wearing masks all remain crucial in our fight to slow the spread of the virus (even after someone has been vaccinated).
For more COVID-19 vaccine information, including details on when the vaccines will be broadly available, review our vaccine FAQs or call our new 24/7 hotline for information in English or Spanish at 1-855-550-0951 (TTY 711).