How a Vaccine Is Approved

As COVID-19 continues to take a serious toll on the health and well-being of our communities, Premier Health is committed to providing the vaccinations that can help to bring the pandemic to an end. You may have questions about the COVID-19 vaccine approval processes and want to be sure no corners have been cut when it comes to safety. Understanding the process for developing and approving vaccines, and specifically the COVID-19 vaccines, may help to put your mind at ease.

Faster Process With Operation Warp Speed 

In response to the worldwide COVID-19 pandemic, Operation Warp Speed — a partnership between U.S. government agencies and private organizations — has accelerated the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Despite its speed, this process follows the same steps that ensure safety and efficacy for all vaccines. For the COVID-19 vaccine, parts of the process are happening at the same time, such as starting manufacturing during the approval process, according to Operation Warp Speed. This increases the financial risk, but not the product risk. 

Also speeding the process: In recent months, vaccine developers focused all of their efforts on COVID-19, bringing an extraordinary number of scientists and other resources together to solve this urgent problem. The fact that COVID-19 was circulating so widely in the world made it possible to test vaccine candidates much faster. In addition, the federal government provided funding for clinical trials. But no safety review steps were eliminated.

FDA Approves Vaccines In U.S.

In the United States, the Food and Drug Administration (FDA) oversees the safety, effectiveness, and quality of vaccines. All vaccines must meet the FDA’s high safety and quality standards.

Although there is a rigorous process for vaccine approval, there is no official timeline for developing a vaccine. In a public health emergency like the current pandemic, manufacturers can request vaccine release through Emergency Use Authorization (EUA) from the FDA. 

Because of the urgency of the pandemic, the approval process for COVID-19 vaccines was sped up to quickly and safely develop vaccines. However, this process included every step that ensures safety for all vaccines. Premier Health is confident in the safety and effectiveness of these vaccines.

First Step: Research

Vaccines work by stimulating the body’s immune system to build up defenses against the infectious bacteria or virus — without causing the disease. After vaccination, the immune system is prepared to respond quickly and forcefully when the body encounters the real disease-causing organism.

Vaccine development is a complex science that starts with laboratory research. If a vaccine candidate looks promising after initial testing, vaccine manufacturers submit the researchers’ data to the FDA for approval so they can begin clinical trials in people.

Clinical Trials Test Safety

Clinical trials are conducted in three phases:

  1. In Phase 1, the vaccine is given to a small number of generally healthy people to test its safety and effectiveness.
  2. In Phase 2, the vaccine is given to hundreds of people with different health conditions and from different races and ethnicities.
  3. In Phase 3, thousands of people across diverse demographic groups received the vaccine, and immune responses are compared against placebos, which are doses that do not contain any of the vaccine and are used for testing purposes only.

Two manufacturers , Moderna and Pfizer-BioNTech, began Phase 3 trials in July 2020. More than 43,000 people across all demographic groups participated in the Pfizer vaccine clinical trial, and more than 30,000 people participated in the Moderna clinical trial. A third manufacturer, Johnson & Johnson, began Phase 3 trials in September 2020. Nearly 44,000 people participated in the ENSEMBLE study for the Johnson & Johnson (Janssen) vaccine.

Before Approval, Close Review Of Results

Once Phase 3 trials are complete, the FDA reviews the data to determine whether the vaccine works and is safe. If so, the manufacturer files for approval. If the benefits outweigh any possible risks of the vaccine, and manufacturing quality can be ensured, the FDA will approve the vaccine for use.

Early clinical results showed that the Moderna and Pfizer vaccines are about 95 percent effective at preventing people from getting sick with the virus. Both manufacturers filed for Emergency Use Authorizations in November 2020. These vaccines were approved for emergency use in December 2020.

For the Johnson & Johnson (Janssen) vaccine, early clinical results showed that the vaccine is approximately 67 percent effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination. This vaccine was approved for emergency use in February 2021.

Next Steps

Clinical trials are being conducted to evaluate additional COVID-19 vaccines in many thousands of study participants following the FDA’s rigorous standards issued specifically for COVID-19 vaccines in June 2020. Currently in Phase 3 clinical trials is a vaccine candidate from AstraZeneca-Oxford.

After a vaccine is authorized or approved for use, many vaccine safety monitoring systems watch for adverse events (possible side effects). This continued monitoring can pick up on adverse events that may not have been seen in clinical trials. The FDA and Centers for Disease Control and Prevention (CDC) work together closely to monitor vaccine safety to help ensure the benefits continue to outweigh the risks for people who receive vaccines.