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.