The race is on to safely and effectively develop a preventative COVID-19 vaccination. There are currently 9 COVID-19 vaccines actively going through clinical trials. The trials are in the United Kingdom, China, the United States, and Canada. Traditionally, it takes several years for a vaccine to go from development to manufacturing, but the pressure is on to stop the spread of COVID-19 as quickly as possible.
Before a new vaccine is ever given to people, extensive lab testing is done that can take several years. Once testing in people begins, it can take several more years before clinical studies are complete and the vaccine is licensed. The Food and Drug Administration (FDA) sets rules for the three phases of clinical trials to ensure the safety of the volunteers (CDC).
Clinical Trial Phase 1
- 20-100 healthy volunteers
- Is this vaccine safe?
- Does this vaccine seem to work?
- Are there any serious side effects?
- How is the size of the dose related to side effects?
Clinical Trial Phase 2
- Several Hundred Volunteers
- What are the most common short-term side effects
- How are the volunteers' immune systems responding to the vaccine?
Clinical Trial Phase 3
- Hundreds or thousands of volunteers
- How do people who get the vaccine and people who do not get the vaccine compare?
- Is the vaccine safe?
- Is the vaccine effective?
- What are the most common side effects?
The FDA licenses a vaccine only if it’s safe and effective and the benefits outweigh the risks. Vaccines are made in batches called lots. Manufacturers must test all lots to make sure they are safe, pure and potent. The lots can only be released once FDA reviews their safety and quality. The FDA inspects manufacturing facilities regularly to ensure safety and quality. If the FDA licenses a vaccine, experts may consider adding it to the recommended immunization schedule (CDC).
COVID-19 Vaccine Clinical Trials
Based on the current clinical trial timelines, a COVID-19 vaccine is not expected for many months. Eight of the nine clinical trials are in Phase 1, while CanSino Biologics Inc. is currently in Phase 2 of development. Based on information publicly available, the soonest we could see a completed Phase 2 clinical trial would be January 2021.
Vaccines are vital to eradicating diseases such as COVID-19. The United States currently has the safest vaccine supply in its history. These vaccines keep children, families and communities protected from serious diseases (CDC). Leaders around the globe are doing everything they can to safely and effectively push these vaccines through clinical trials.
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Helmer Scientific is proud to support the safe storage and handling of temperature sensitive vaccines. We provide the highest quality and reliability when it comes to vaccine refrigerators and freezers. To learn more about our vaccine storage equipment, visit the link below.
References:
“Drugs and Vaccines Under Investigation for COVID-19
Treatment and Prophylaxis.” FORCE Medical Communications
- We Bring Science to Life, www.forcemed.com/services/resou
rces.
National Library of Medicine. “Clinical Trials.” Home - Cli
nicalTrials.gov, clinicaltrials.gov/ct2/home.
“The Journey of Your Child's Vaccine (Infographic).” Centers
for Disease Control and Prevention, 26 Jan. 2018, https://w
ww.cdc.gov/vaccines/parents/infographics/journey-of-child-vac
cine.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fvaccines
%2Fparents%2Finfographics%2Fjourney-of-child-vaccine-text.html
