It is true that the search for a vaccines and monoclonal antibodies against COVID-19 has been happening very quickly, but the Covid-19 prevention Network is not cutting any corners or skipping any steps. All the usual measures to ensure the safety of study participants or the general public are being followed. Our primary concern is the safety of study participants, and the general public who will ultimately get a vaccine that is proven to be effective.
However, finding a COVID-19 vaccine that works for everyone is not so simple. That's why volunteers from all communities are so important. You can help end the uncertainty and find a vaccine for all.
Howard University has been selected as a site for the next Phase 3 vaccine study by the National COVID Prevention Network (CoVPN). Phase 3 studies are needed to get reliable answers about safety and effectiveness of the vaccine being studied. If the results are good, the new vaccine can be approved for use by the public.
Register for a COVID-19 Vaccine Study
To register for a COVID-19 vaccine study, go to www.coronaviruspreventionnetwork.org or call 1-866-288-1919. If interested in the Howard University site, indicate site-code HOWU in the registration form.
Information About Vaccines
The Journey of a Vaccine: How a New Vaccine is Developed, Approved, and Manufactured
The U.S. Food and Drug Admnistration (FDA) sets rules for the four phases of clinical research so that researchers can learn about the effects of new therapies while keeping volunteers safe. This includes trials of new vaccines to protect against infection; researchers always test vaccines with adults first.
Phase 1: 20-100 healthy volunteers
Researchers try to answer these questions:
- Is this vaccine safe?
- Are there any serious side effects?
- How does the vaccine dose relate to any side effects?
Phase 2: Several hundred volunteers
Researchers try to answer these questions:
- What are the most common short-term side effects of the vaccine?
- What is the body's immune response?
- Are there signs that the vaccine protects against infection?
Phase 3: One thousand or more volunteers
Researchers try to answer these questions:
- How do infection rates compare between those who get the vaccine and those who do not?
- Are those who get the vaccine protected from catching the infection from others?
- Are there long-term or rare side effects?
FDA approves a vaccine only if:
- It is safe and effective
- Its benefits outweigh the risks
Phase 4: Treatment is approved by the FDA and made available to the general public.
FDA closely monitors the safety of the vaccine after the public begins using it. Researchers continue to collect data on the vaccine's long-term benefits and side effects.
Vaccine Adverse Event Reporting System (VAERS)
VAERS, a national monitoring program run by the FDA and the Centers for Disease Control and Prevention, collects and reviews reports of any health problems that develop after a person gets a vaccine. Anyone can submit a report, including patients and healthcare professionals.
Medical recommendations for taking the vaccine may change if safety monitoring reveals new information about its risks.
For more information, visit cdc.gov/vaccinesafety.