covid vaccine Updated 01/05/21

With the first COVID-19 vaccine approved and the start of vaccinations among healthcare workers in motion, many people have questions about the vaccine itself and what it might mean for the future. And although most people have likely received other vaccines in the past, the COVID-19 vaccine raises some unique questions and concerns because it is new and was developed quickly in response to a global health emergency.

Torrance Memorial was selected as one of the first hospitals in California to receive the Pfizer BioNTech COVID-19 vaccine in mid-December. The hospital received 2,350 vaccines
to administer to its highest-risk frontline clinicians. Other vaccines are likely to enter the market in 2021.

Before vaccines are licensed by the U.S. Food and Drug Administration (FDA), they undergo extensive laboratory testing and clinical trials to ensure they are safe and effective — and the COVID-19 vaccine is no exception.

What is Operation Warp Speed?

Although it sounds like something out of a science fiction novel, Operation Warp Speed is the name the US government gave to its accelerated COVID-19 vaccine development program. It’s important to note no steps in the typical vaccine development process were skipped under Operation Warp Speed. However, some steps — such as the clinical trials for safety and efficacy and the ramp-up of manufacturing — were conducted at the same time instead of sequentially.

Additionally, some non-clinical steps were streamlined. For example, vaccine manufacturers did not have to apply for grants due to the availability of government funds, and lag-time between steps in the process was reduced. Manufacturing capabilities were also ramped up while clinical trials were being conducted.

And scientists weren’t starting from scratch. Thanks to previous research on other coronaviruses called severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), which are closely-related to COVID-19, vaccine developers already had a few ideas in mind for how to create a safe and effective COVID-19 vaccine.

Emergency Use Authorization - Critical Safety Steps

Vaccine developers file for Emergency Use Authorization (EUA). Using safety and efficacy data from clinical trials, vaccine developers will request EUA from the FDA. An EUA is used to provide more timely access to drugs, diagnostic tests and other critical medical products such as vaccines, during a public health emergency when there are no other approved or available options. The FDA will meet to review the available data on the COVID-19 vaccine, weigh the risks and benefits of vaccine approval and approve or deny the EUA request.

If EUA is approved, vaccine distribution will begin. After a vaccine receives FDA approval, it will be distributed in accordance with a plan established by the federal government. The plan includes a phased rollout and focuses on equitable distribution of the vaccine to vulnerable populations such as high-risk healthcare workers, older adults in nursing homes and people with health conditions who are at higher-risk of COVID-19-related complications.

Vaccine Development: Normal Process vs. Operation Warp Speed

The vaccine development process follows a standard set of steps to ensure vaccines are safe and effective. For the COVID-19 vaccine under Operation Warp Speed, no steps were skipped, but they were accelerated to get a vaccine to market more quickly. These steps include:

Step 1: Obtaining Funding

Normal Process:

Pharmaceutical companies that wish to develop a new vaccine need to find a way to pay for the project. Often this involves applying for research grants from HHS and other government agencies. The application process can take years.

Operation Warp Speed:

For the COVID-19 vaccine, funding was made available by the federal government — no grant applications were required.

Step 2: Preclinical Trials

Normal Process:

Pharmaceutical companies hoping to develop a new vaccine need to find a way to pay for the project. Often, this involves applying for research grants from HHS and other government agencies. The application process can take years.

Operation Warp Speed:

Previous research into other coronaviruses gave vaccine developers information they could use to create a safe and effective COVID-19 vaccine, streamlining the preclinical research process.

Step 3: Phase I Clinical Trials

Normal Process:

Phase I clinical trials are conducted with only a few dozen human volunteers to assess short-term safety and side effects, such as soreness at the injection site and fever with different vaccine doses.

Step 4: Phase II Clinical Trials

Normal Process:

Phase II clinical trials assess safety and measure immune responses caused by the vaccine in a larger group of volunteers.

Step 5: Phase III Clinical Trials

Normal Process:

Phase III clinical trials assess whether the vaccine is safe and effective compared to a placebo and often include thousands of volunteers.

Step 3-5: Phase I, II, and III Clinical Trials

Operation Warp Speed:

All steps of the clinical trial process were completed when developing the COVID-19 vaccine. However, some steps were combined — such as Phase I and Phase II, or Phase II and Phase III — to expedite the process. Phase III clinical trials were also completed more quickly in the midst of a pandemic because it was easier to measure the effectiveness when compared to a placebo.

Step 6: Regulatory Approval

Normal Process:

After the Phase III clinical trial is complete, the vaccine manufacturer must submit a Biologics License Application providing data on safety, immune responses and effectiveness. The FDA reviews data to determine whether the vaccine should be approved.

Operation Warp Speed:

If scientific evidence suggests a vaccine may be safe and effective, the FDA may authorize vaccine use through an Emergency Use Authorization (EUA).

Step 7: Preparing for Manufacturing

Normal Process:

After Phase III clinical trials are complete, vaccine manufacturers begin ramping up their ability to produce a large number of vaccine doses. The FDA also conducts periodic inspections of manufacturing facilities.

Operation Warp Speed:

The U.S. government and other stakeholders took steps to ramp up manufacturing capacity before the findings from Phase III trials were available. Two vaccine candidates use messenger RNA (mRNA) instead of live or inactive viruses. Vaccines using mRNA are easier to manufacture than live or inactivated vaccines because they do not require handling large quantities of the virus.

Step 8: Distribution and Rollout

Normal Process:

After manufacturing capacity is established, vaccine manufacturers make plans to distribute the vaccine to private partners and state health departments, who distribute doses to local health care providers. Part of this step involves ensuring proper shipping and storage methods are used to preserve the vaccine. The FDA also issues guidelines for who should receive the vaccine and how it should be administered.

Operation Warp Speed:

The U.S. government created a coalition of experts from the Department of Defense, the Centers for Disease Control and Prevention, and Health and Human Services to work with private partners and state health departments to expedite vaccine distribution, as well as guidelines for its administration. Manufacturers are working closely with distribution partners to ensure vaccines can be stored and transported under proper conditions (particularly the Pfizer BioNTech COVID-19 vaccine which requires ultra-cold storage). The government has also issued a phased rollout plan which prioritizes distribution to vulnerable individuals..

Step 9: Vaccine Safety Monitoring

Normal Process:

After a vaccine receives FDA approval, the agency continues to monitor its safety in partnership with the U.S. Centers for Disease Control and Prevention (CDC) through the Vaccine Adverse Event Reporting System (VAERS).

Operation Warp Speed:

This step remains the same under Operation Warp Speed. VAERS will still be used to track side effects of the COVID-19 vaccine.