Recent statistics in the United States reveal nearly 700,000
confirmed coronavirus cases and over 36,000 casualties. Mitigation strategies
and an improved awareness of the highly transmissible nature of COVID-19 have
over 95% of Americans on orders to stay at home. While therapeutic options to
treat infected people continue to be investigated, it is apparent that an
effective vaccine is needed to prevent people from contracting the deadly virus
and enable the world to return to a sense of normalcy.
Prior estimates from Dr. Fauci, the director of the National Institute of Allergy and
Infectious Diseases, for the development and approval of a potential
vaccine were 12 to 18 months, which would be much faster than the typical time
required for vaccine development. Data has shown that the rate at which
SARS-CoV-2, the virus that causes COVID-19, mutates is not as rapid as the
seasonal influenza virus. This is encouraging because if a vaccine becomes
readily available within the next couple of years, it could have a prolonged
effect by eliminating future cases. There are currently over 70 vaccines in
various stages of development globally.
The Coalition for Epidemic Preparedness Innovations (CEPI)
and the Biomedical Advanced Research and Development Authority (BARDA) have
contributed hundreds of millions of dollars to develop and facilitate the
costly process of finding a safe and effective vaccine. In addition, thirteen
drug companies have agreed to collaborate and share their proprietary molecular
compounds with a COVID-19 therapeutic accelerator launched by the Bill and
Melinda Gates Foundation in an effort to expedite the development, manufacture
and delivery of vaccines, diagnostics and treatments for COVID-19. Most
notably, Novartis, Boehringer Ingelheim, Eli Lilly, Gilead, GlaxoSmithKline, Johnson
& Johnson, Merck, and Pfizer are engaged in the race to develop the vital
vaccine. GSK and Sanofi have joined forces in an unprecedented collaborative
effort with the hopes that combining their resources and technology will have a
synergistic effect.
Among the vaccine technologies under consideration are
whole virus vaccines, recombinant protein subunit vaccines, and nucleic acid
vaccines. Any drug or vaccine must go through three phases of clinical trials
before FDA approval. There are two vaccines currently in Phase 1 of clinical
trials in the United States, with many more being evaluated around the world. The
purpose of Phase 1 trials is to determine the safety profile in healthy adults.
Moderna Therapeutics rapidly developed an early prospect
for clinical trials on March 16th, just 42 days after the genetic
sequence for SARS-CoV-2 was released. Their candidate, known as mRNA-1273 is a
novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for
a stabilized spike (S) protein of SARS-CoV-2. In their Seattle based trial, forty-five
healthy adults will be enrolled into one of three cohorts and will receive two
intramuscular injections four weeks apart to assess the safety and
reactogenicity of mRNA-1273, with subsequent evaluation at regular intervals
over the course of 12 months. It is important to note that the biotechnology
being utilized has been in existence for nearly 30 years, yet has never
produced a viable, FDA-approved vaccine for any human disease. This highlights
the fact that laboratory and animal studies cannot be extrapolated to determine
appropriate use in humans.
Inovio Pharmaceuticals announced on April 6th
that the FDA accepted its application for INO-4800, its DNA vaccine candidate.
DNA medicines are made of optimized DNA plasmids which are synthesized or
reorganized by computer sequencing technology with the hopes of targeting a
specific immune response. Preclinical data has shown positive immune response
results across numerous animal models. The Phase 1 study of INO-4800 will
enroll up to 40 healthy adults in Philadelphia and Kansas City where they will
also receive two doses four weeks apart. Initial immune responses and safety
data are expected to be available by late summer. Inovio plans to have a
million doses of the vaccine manufactured by the end of the year for additional
trials and emergency use, pending regulatory approval and funding.
Novavax announced on April 8th that it has
identified an “ideal” COVID-19 vaccine candidate and is set to begin their
first clinical human trial in May. The candidate, known as NVX-CoV2373, has
demonstrated an ability to produce immune responses and high levels of
antibodies against COVID-19 in animal studies. NVX-CoV2373 uses antigens
derived from the coronavirus spike protein to stimulate an immune response to
provide protection against COVID-19. Novavax is working with another firm,
Emergent BioSolutions, to expedite the process and they expect to have
preliminary human data by July.
While vaccines undergo the beginning stages of development,
treatment options continue to evolve with data from around the world. Researchers
in the New England Journal of Medicine concluded that treatment with Remdesivir
in a clinical trial of 53 people resulted in clinical improvement in 68% of
patients. Rates of mortality, hospital discharges, and the ability to
discontinue ventilator use were the factors considered in determining clinical
improvement. No new safety concerns were observed, which is encouraging for an
uninhibited approval process.
Hydroxychloroquine continues to be a top therapeutic
candidate for the treatment of COVID-19 with clinical trials underway in
nations worldwide. However, a trial studying use of high-dose and low-dose
chloroquine in hospitalized patients in Brazil resulted in premature
termination of the high-dose arm due to safety concerns after only 81 patients
were treated. One of the most concerning adverse effects of chloroquine is QT
prolongation and arrythmia, which is an irregular heart rate and may be fatal. Azithromycin, an antibiotic often used in
conjunction with hydroxychloroquine to treat COVID-19, is also known to produce
QT prolongation in patients with certain cardiovascular disorders. For that
reason, the American College of Cardiology, American Heart Association, and
Heart Rhythm Society issued a joint statement outlining critical cardiovascular
considerations for use of hydroxychloroquine
and azithromycin for treatment of COVID-19.
Further studies and
anecdotal reports of hydroxychloroquine treatment of COVID continue to be
presented in the news. Reports include individuals such as a lawmaker, a New
Jersey healthcare provider, and a former NFL player who believe that
hydroxychloroquine helped them defeat the virus. Overall, these reports have
been both positive and negative. A small study in France in eleven consecutive patients failed to show an
improvement of symptoms and reduction in
viral load after being treated with hydroxychloroquine (600 mg per day for 10 days) and azithromycin (500 mg day 1 and 250 mg days 2 to
5) and discusses a patient who experienced QT interval prolongation before
treatment was discontinued. Another newly publicized study in Shanghai in 150
patients reported hydroxychloroquine failed to clear the virus better than
standard care but patients receiving it did show improvement in clinical
symptoms and a reduction of an important inflammatory marker in the blood. Side
effects observed in this study were mostly mild and reported in half of the patients
that received treatment. This prompted the study investigators to suggest that
hydroxychloroquine’s potential effects against COVID-19 may be its
anti-inflammatory mechanisms.
A large scale study,
titled “the Outcomes Related to COVID-19 treated with Hydroxychloroquine among
In-patients with symptomatic Disease study” (ORCHID Study), in Tennessee has
begun to evaluate the effects of the drug in a blinded, placebo-controlled
randomized clinical trial of over 500 adults. The study is enrolling patients
currently hospitalized with COVID-19 or in an emergency department with
anticipated hospitalization. The National Institutes of Health (NIH) is
overseeing this study, as well as one to evaluate Remdesivir in a similar
manner. This is a significant development because prior studies were not
conducted in a blinded, placebo-controlled randomized nature. These factors are
indicative of a more valid scientific approach and are more likely to have an
impact on FDA approval than small anecdotal type reports that were previously
reported.
Convalescent plasma and hyperimmune globulin from
individuals who have fought off the virus and have developed antibodies remain
a viable treatment option. The blood obtained from these people may be
administered to critically ill patients diagnosed with COVID-19. The FDA is
leading a collaborative effort with partners from the pharmaceutical industry,
academic institutions, and government partners to implement a protocol that
would involve the MAYO clinic and the American Red Cross to collect and
distribute plasma to patients around the country.
As the number of confirmed cases and deaths attributable to
COVID-19 continue to mount, researchers continue to work diligently to evaluate
which treatment options prove to be the most safe and effective. Vaccines
remain the only way to eradicate such a disease and from having catastrophic
effects in the future.
https://clinicaltrials.gov/ct2/results?cond=COVID-19&term=vaccine&cntry=&state=&city=&dist=&Search=Search
https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus-landscape-ncov.pdf?ua=1
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