GAO-20-583SP 1 (2020-05-26)

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                            Science, Technology Assessment,
GAO Iand Analytics




What is it? Vaccines protect people from disease by triggering the
immune system to produce antibodies that will fight the pathogen
attacking the body. In the case of COVID-19, the pathogen is the virus
SARS-CoV-2. Developing a vaccine is an expensive, lengthy process
that involves a rigorous series of steps to first identify a potential vaccine
candidate and then assess it for safety and effectiveness.

How does it work? A vaccine can use a virus that has been modified to
be safe or a molecule that resembles a part of the virus. Once antibodies
are produced, if the vaccinated person is exposed later to the virus, their
body will produce those antibodies again, increasing their chances of
fighting off infection.

Development starts with identifying a target, such as a protein, that can
induce an immune reaction. Researchers create a vaccine candidate
similar to that target that will induce production of antibodies effective
against the virus. The vaccine candidate is then moved through phases of
development, assessment, and approvals (fig. 1).

                        Traditional timeline
      10-15 years


Phase Ii


Phase III

Potential accelerated timeline with overlapping phases and EUA----
                                    late 2020 or beyond

BLA = Biologics License

EUA = Emergency Use

IND = Investigational
     New Drug

Source: GAO analysis of GAO-20-215SP, FDA, HHS, and Pharmaceutical Research and
Manufacturers of America (PhRMA) documentation. I GAO-20-583SP

      I The vaccine development process typically takes 10 to 15 years under a traditional
timeline. Multiple regulatory pathways, such as Emergency Use Authorization, can be used
to facilitate bringing a vaccine for COVID-19 to market sooner.

Under normal circumstances, the entire process typically takes 10 to 15
years, with more than 65 percent of candidates failing, according to an
MIT study. There is an effort to expedite this process for SARS-CoV-2.
As of May 15, 2020, there are more than 110 COVID-19 vaccines in
development globally; of those, at least three are being developed in the
United States with federal funding. These three use different mechanisms
to prompt the body to produce antibodies (fig. 2).

                       mRNA coding a
                         SARS-CoV-2 gene     Viral
                      @ Recombinant SARS-CoV-2
                         surface protein
                                                     Fo< rmation of
                                                 Viral      antibodes
                       * Viral vector packaging protein  agst
                         SARS-CoV-2 gene                    SARS-CoV-2
     Source: GAO. I GAO-20-583SP

       Vaccine candidates use different mechanisms, such as those shown above, to
prompt the body to produce antibodies against SARS-CoV-2.

The first candidate, developed by National Institute of Allergy and
Infectious Diseases scientists and their collaborators, uses a molecule
called mRNA specifically coded to generate proteins that will induce an
immune response. This is a newer method of vaccine development that
has shown promise in animals during the preclinical phase.

The second candidate uses a recombinant protein, which is produced by
genetically engineering bacteria or other cells to produce a protein that
mimics part of the spike protein found on the surface of the SARS-CoV-2
virus. The spike protein alone does not cause an infection but may be
sufficient to produce an immune response. Recombinant protein vaccines
are already being used successfully against other viruses, such as the
human papillomavirus (HPV), which can cause cervical cancer.

The third candidate uses a virus-adenovirus 26, or Ad26-but
researchers have removed its infectious aspects, making it safe as a
vector' to deliver a piece of SARS-CoV-2 to trigger a protective immune
response. This method is also in clinical trials against HIV and Ebola.

How mature is it? The process for developing a new vaccine as outlined
by the Food and Drug Administration (FDA) is well established. In the
exploratory phase, the target and candidate vaccine are identified. In the
preclinical phase, researchers use cells and animals to assess safety and
produce evidence of clinical promise, evaluated by the candidate's ability
to elicit a protective immune response.

GAO-20-583SP COVID-19 Vaccine Development

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