3 Things to Know About Developing a COVID-19 Vaccine
Is it safe? Does it work? When will it get here? Check out the latest on the fast-paced search to solve the global pandemic.
If you’re like the rest of the world, you’ve probably been watching and waiting for months now for news about a COVID-19 vaccine. Developing a safe and effective vaccine takes a while—not exactly helpful when you’re trying to get your day-to-day back on track. With time of the essence, scientists are working hard to speed up the vaccine trial process without cutting corners, sacrificing quality, or compromising safety. Here are three things you should know about the development of a COVID-19 vaccine.
1. It’s Safe
Although the development of a vaccine is moving at a record-breaking speed, the safety of study participants and the general public remains a top priority throughout each phase of the research. None of the vaccines being tested can cause COVID-19, and no actual virus (living or dead) is used in making the vaccines.
The way the clinical trial phases are set up also works to ensure safety. In Phase 1, a small group of people is enrolled to evaluate the safety and potential side effects of the vaccine. Phase 2 expands to a larger group to assess safety, to determine the maximum dose that can be safely tolerated, and to determine if the immune system is having the desired response. The studies enrolling now are phase 3 – they have already gone through Phase 1 and 2 testing. Phase 3 involves thousands of participants, particularly people with an increased risk of exposure to the coronavirus, to continue to test for safety and to determine if the vaccine prevents new infections or if it can help to prevent more severe COVID-19 illness. So while developing an effective vaccine is obviously the goal, the priority in each phase is safety.
2. It’s Being Fast-Tracked
Scientists typically wait until they complete one phase of a clinical trial before proceeding to the next. Now, though, they are overlapping steps as they speed up their search for a COVID-19 vaccine or antibody, moving forward with the next phase even as long-term follow-up of people in the earlier phases continues. Moreover, everyone involved is working 24/7 with plenty of resources available, to make sure the data from each phase is reviewed quickly.
You might wonder if all this fast-tracking is safe. The answer is: Yes. Several factors are enabling scientists to move quickly without skipping steps, such as conducting larger Phase 3 studies to evaluate more people in a shorter period of time. Each one of these studies is enrolling at least 30,000 people – a typical phase 3 trial enrolls only a few thousand people. Also, the manufacturing procedures that are required to go from small to large batches of vaccines are being compressed and paid for by the United States government, so that companies do not have to raise additional money. And finally, the U.S. Food and Drug Administration (FDA) has tightened its standards for a COVID-19 vaccine and confirmed its commitment to only approving a vaccine that is proven to be safe and effective.
3. It’s a Multifaceted Approach
At the same time that scientists are working on COVID-19 vaccines, they are also developing antibodies to protect against the virus. The two projects are different, but compatible. Antibodies are proteins produced by your immune system that recognize the virus and bind to its surface to prevent it from attacking healthy cells. The development of antibodies is important because they can help protect you until a vaccine becomes available. Antibodies can also be used in people who might not benefit as much from a COVID-19 vaccine due to certain medical conditions or weakened immune systems, such as older adults aged 65 and over.
This two-pronged approach is complex, but the COVID-19 Prevention Network (CoVPN) is committed to stopping the spread of the virus as quickly and safely as possible. CoVPN was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the networks to focus their attention on addressing the pressing need for vaccines and monoclonal antibodies against SARS-CoV-2.
Please consider joining the COVID-19 Prevention Network to help find a vaccine that works for everyone (www.PreventCOVID.org). If you do not have access to a computer or need assistance to complete the online survey, please call 866-288-1919.