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With COVID-19, the disease caused by coronavirus, spreading quickly around the globe, researchers are rushing to create a vaccine to keep people safe. Although creating a new vaccine can take years, the U.S. Department of Health and Human Services (HHS) is taking steps to speed up the process of developing and manufacturing vaccines to prevent more cases of COVID-19.
When Will There Be a Vaccine for Coronavirus?
Unfortunately, we might not have a coronavirus vaccine for a while. That’s because it takes a long time to research, develop and test vaccines for new diseases, like COVID-19. According to the HHS, the first phase of clinical trials for a new vaccine is on track, with the hope of having a vaccine available for emergency use in the U.S. by early 2021. Before this happens, researchers need to take several important steps to get a vaccine approved.
How Do Vaccines Work?
The first step in developing a vaccine is understanding how the vaccine will work to prevent infection. Vaccines are sometimes made from a weakened form of the virus that causes that specific disease.
How Does Your Immune System Respond to a Vaccine?
Once the vaccine is injected into your body, your immune system reacts by producing antibodies to the disease — the same sort of reaction it would have if you were exposed to the disease. But with a vaccine, you develop an immunity to the disease without actually getting that disease.
Although vaccines can have side effects, such as a low-grade fever or pain where you had the injection, they are usually mild and go away on their own. It’s very rare for a vaccine to cause severe side effects that last a long time.
What Other Ingredients Are in Vaccines?
In addition to the virus that causes the disease, there are other important ingredients in vaccines that help ensure their effectiveness and safety. These ingredients may include adjuvants that help increase your immune system’s response to the vaccine and stabilizers that help keep the vaccine effective after it’s made.
How Are Vaccines Developed?
Before a vaccine can be developed for use in humans, researchers must submit an Investigational New Drug application to the U.S. Food and Drug Administration (FDA). This application includes information about the vaccine, how it has worked in animal testing and a proposal for clinical studies in people.
The Clinical Trial Process
In a Phase 1 trial, the vaccine is given to a small number of healthy people — usually about 20 to 100. During this phase, researchers are hoping to learn if the vaccine is safe and if it seems to work. The volunteers who get the vaccine are monitored closely for side effects.
Phase 2 studies involve hundreds of volunteers. In this phase, the researchers are looking to understand how the vaccine is working in the volunteers’ immune system and which side effects are most common.
By Phase 3, the trial enlists thousands of people to learn more about how the vaccine works and how their immunity to the disease compares to those who have not received the vaccine. This stage is important for providing the information the FDA needs to approve the vaccine.
At any stage, if the vaccine doesn’t seem to be safe or effective, the FDA may stop the study from continuing.
How Do Vaccines Get FDA Approval?
Before a vaccine can be manufactured and distributed for public use, it must receive FDA approval. After the three phases of clinical trials are complete, the vaccine manufacturer must present data to an FDA review team that proves the vaccine is safe and effective and that its benefits outweigh any risks.
Once a vaccine is approved, it must be properly labeled with its risks and benefits, as well as its correct use, so health care providers can share this information with their patients.
Before an approved vaccine can get distributed to the public, the manufacturer must test all batches of the vaccine, called lots, for safety, potency and purity. The FDA reviews this information before the lots can be released. The FDA also routinely inspects the facilities where the vaccines are produced to ensure the product’s safety and quality.
Are Vaccines Monitored for Safety?
Even after a vaccine gains approval and is licensed, its safety is closely monitored by the FDA and the Centers for Disease Control and Prevention (CDC). This helps identify any possible risks of the vaccine.
To help monitor vaccine safety, several reporting systems collect information about vaccine use:
- Clinical Immunization Safety Assessment Project (CISA) is a partnership between the CDC and seven research centers; it helps health care providers answer complex questions about vaccine safety and conducts clinical studies around vaccine safety
- Post-Licensure Rapid Immunization Safety Monitoring (PRISM) is a network of health care organizations from across the U.S. that analyzes the health care data of more than 190 million people
- Vaccine Adverse Event Reporting System (VAERS) collects reports of adverse side effects from health care providers, parents and patients, and then analyzes the information for safety concerns
- Vaccine Safety Datalink (VSD) is a network of health care organizations from across the U.S. that analyzes the health care records of more than 24 million people
If a vaccine is found to have a serious risk or side effect, the recommendations for its use may change.
How Do Vaccines Get Added to the Immunization Schedule?
Once a new vaccine is developed and is proven to be effective and safe, it may be added to to the schedule of recommended vaccines, like the flu vaccine and other vaccines that are recommended for kids and adults.
Overseeing this process is the Advisory Council on Immunization Practices (ACIP), a group of health experts who review clinical trials to develop a vaccine’s recommended use. The ACIP considers several factors before recommending a vaccine be added to the immunization schedule. These considerations include:
- How many people would get the disease without the vaccine
- How well the vaccine works at different ages
- The safety of the vaccine in different age groups
- The severity of the disease the vaccine prevents
Once the ACIP recommends a vaccine be added to the schedule, the director of the CDC must review and approve the recommendation before it can be listed on the U.S. childhood immunization schedule.
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