Written by Lisa Buffington
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.
“For many years, vaccines have been used to prevent deadly diseases
like smallpox, polio, measles, mumps, rubella, tetanus, diphtheria and
chickenpox — some of which have been eradicated in the U.S.,”
said Tammy Ginder, PharmD, assistant director of Pharmacy Services at
Torrance Memorial Medical Center and coordinator of the hospital’s
COVID-19 Vaccine Program. “Just as other vaccines have helped to
save lives and prevent disease, the COVID-19 vaccine will do the same
— allowing us to get back to normal.”
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.
Here’s what you need to know about the COVID-19 vaccine development
process called Operation Warp Speed and the proposed rollout after a vaccine
becomes available to the public.
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.
“For the COVID-19 vaccine, several companies were working in parallel
to develop a vaccine,” said Ginder. “No clinical trial steps
were skipped, and the research was not short-changed, but there was some
overlap which helped to expedite the process.”
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 (See COVID-19 Vaccine Distribution Plan on page
7). 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.
What has Torrance Memorial done to prepare for the COVID-19 vaccine?
In preparation for a vaccine, Torrance Memorial implemented a taskforce,
comprised of emergency medical personnel, physicians, nurses, infectious
disease specialists, pharmacy, supply chain and administrators who are
examining all necessary actions to facilitate storage, tracking and administering
the vaccines. This team uses the guidelines set forth from federal and
state agencies on the prioritization criteria and will continue to develop
specific details for our health system.
Torrance Memorial has the capacity to store a vaccine at ultra-cold temperatures.
This has allowed us to participate in the rollout of any EUA vaccines,
including the Pfizer BioNTech COVID-19 vaccine, which must be stored in
freezers at a required minus 94°F. Our pharmacy and clinical teams
have extensive experience handling and administering vaccines and therapies
for infectious diseases and are prepared to support our COVID-19 vaccine efforts.
Torrance Memorial Received First Round of COVID-19 Vaccine Last Month!
Torrance Memorial Medical Center was one of the first hospitals in California
to receive the Pfizer BioNTech COVID-19 vaccine. Delivered on December
16, Torrance Memorial began its frontline health care worker vaccine clinics
on December 19. “This is a great day – I am really optimistic,”
said Craig Leach, Torrance Memorial President/CEO. He also recognized
the efforts on behalf of the pharmacy staff and everyone involved in the
process of getting the vaccine to Torrance Memorial. Infectious disease
specialist and chair of the special pathogens committee, Dr. David Rand,
said, “The vaccine is the light at the end of tunnel for this pandemic.”
The vaccine administration has since been underway serving hospital acute
care staff and physicians with known COVID-related patient care or who
work in high-risk settings. At the time this magazine went to print there
was no information available regarding community distribution. For the
most up-to-date answers to questions on the COVID-19 vaccine allocation
and distribution please refer to the California Department of Public Health
website at www.cdph.ca.gov.
Vaccine Myths vs. Facts
Myth: The COVID-19 vaccine was developed too quickly and steps were skipped.
Fact: Although the COVID-19 vaccine was developed quickly, no steps were skipped
in the typical vaccine development process overseen by the FDA.
Myth: If I get the COVID-19 vaccine, I will get COVID-19.
Fact: You won’t get COVID-19 from the vaccine. However, you may develop
mild side effects related to your body’s immune response, such as
fatigue, fever or pain at the injection site. If mild side effects occur,
they usually only last a day or two. Serious side effects are rare.
Myth: All vaccines contain live viruses.
Fact: There are several types of vaccines. The two leading vaccines from Pfizer
and Moderna do not contain live virus. They contain genetic material called
messenger RNA (mRNA), which helps the body manufacture harmless viral
proteins that promote the development of protective antibodies. There
is another COVID-19 vaccine built on a platform containing a weakened
form of a common cold virus found in chimpanzees.
Myth: I already had COVID-19, so I don’t need to be vaccinated.
Fact: Even if you already had COVID-19, it is still important to get a COVID-19
vaccine. After you are infected with COVID-19, your body creates antibodies
to help you fight the infection. These antibodies may provide some protection
against future infection, but researchers aren’t sure how long that
protection lasts. A COVID-19 vaccine will provide longer-lasting protection
against future infection.
Myth: Life will return to normal right after I get my vaccine.
Fact: Not so fast. In order to receive the best possible protection, you will
need a second dose of the vaccine a few weeks after you receive the first
dose. Also, because not everyone will receive a vaccine right away, physical
distancing, hand washing, wearing a mask, and other precautions will need
to remain in place to protect those who have not yet been vaccinated.
As more people get vaccinated and infection rates fall, it may be possible
to ease some restrictions.
Top COVID-19 Vaccine FAQs
How were COVID-19 vaccines developed so quickly?
COVID-19 vaccines were developed under an accelerated vaccine development
program called Operation Warp Speed, which was funded and facilitated
by the U.S. government. Although no aspects of the vaccine development
process were skipped, Operation Warp Speed eliminated lag time and allowed
some steps to be completed simultaneously.
Are COVID-19 vaccines safe?
Yes. Even under Operation Warp Speed, COVID-19 vaccines must adhere to
strict safety standards and follow all vaccine development protocols established
by the U.S. Food and Drug Administration (FDA). After a vaccine is approved,
the FDA will continue to monitor its safety and effectiveness.
Do COVID-19 vaccines have side effects?
Vaccines are designed to generate an immune response which can sometimes
result in mild side effects. Experiencing side effects does not mean you
are infected with a less-severe version of the virus. Generally, vaccination
side effects are mild and last only a day or two. Side effects may include:
- Pain, swelling or redness where the shot was given
- Mild fever
- Chills
- Fatigue
- Headache
- Muscle and joint aches
Serious side effects and allergic reactions are rare and occur in 1 to
2 out of 1 million vaccinations.
When will a vaccine be available to the general public?
We understand our community is eager to learn when they will receive a
vaccine as well. We don't know yet when the vaccine will be widely
available and how members of the public will be prioritized. Our understanding
is that after healthcare workers, the vaccine is expected to be offered
to people age 75 and older and non-healthcare frontline essential workers.
Federal, state and county public health authorities are establishing guidelines
for COVID-19 vaccine distribution. When vaccines are available to the
public, Torrance Memorial will follow these guidelines. We will share
information as soon as we learn more. For more details about the distribution
of the vaccine in Los Angeles County and to sign up to receive Public
Health COVID-19 Vaccine email alerts,
click here.