Roughly eight months following the initial White House declaration of a shift from containing to mitigating the COVID-19 outbreak, the current administration is now centering its strategy on vaccinations to protect the populace and medical treatments to manage the illness.

Following the announcement of collaboration with tech companies Apple and Google on a contact tracing application (and close to two months after Apple and Google launched their exposure notification capabilities) and the commencement of extensive testing initiatives across the country through major pharmacy chains (which did not receive the necessary coordinated assistance), the administration now seems to be scaling back from a nationwide campaign to curb the COVID-19 epidemic.

During a conversation with CNN’s Jake Tapper, White House Chief of Staff Mark Meadows indicated that the United States will not achieve control over the pandemic itself, but will instead focus on securing vaccines, therapies, and other preventative measures.

This acknowledgement effectively concludes possibilities for a comprehensive federal response that might have included reinstating lockdowns to limit viral transmission, or implementing nationwide testing and contact tracing alongside other mitigation strategies. Meadows’ remarks coincide with a resurgence of infection rates across the U.S. As of now, the nation has recorded over 8.1 million cases and more than 220,000 fatalities since the first confirmed case within the country on January 20. 

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The primary emphasis has now shifted entirely to the vaccines, therapies, and treatments currently in development by both established pharmaceutical corporations and emerging companies as they progress through the evaluation procedures of global regulatory bodies.

Vaccines Currently Undergoing Phase-Three Clinical Trials

Worldwide, there are presently 12 vaccine candidates in extensive, final-stage clinical trials. These include those being developed by U.S.-based firms such as Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer. These companies are seeking participation from a large number of individuals in both the United States and the United Kingdom for testing purposes.

Within China, Sinopharm, a government-owned pharmaceutical organization, has submitted a request to the nation’s regulatory body for vaccine authorization. Reports in The New Yorker indicate that hundreds of thousands of Chinese citizens have already received vaccinations through emergency use authorizations granted by the Chinese government. Simultaneously, Sinovac, a privately-owned Chinese pharmaceutical company, is progressing with phase-three trials for its vaccine in Brazil, Bangladesh, and Indonesia. Furthermore, CanSino Biologics, another private Chinese firm, has created a vaccine that was already being administered to personnel within the Chinese military as of late July.

A joint effort between the University of Oxford in the U.K. and AstraZeneca, a European pharmaceutical company, is also actively enrolling volunteers in Brazil, India, the United Kingdom, the U.S., and South Africa. In Australia, researchers at the Murdoch Children’s Research Institute are investigating the potential of a tuberculosis vaccine to provide immunity against the coronavirus.

In Russia, the Gamaleya National Center of Epidemiology and Microbiology, working alongside the state-backed Russian Direct Investment Fund, asserts the development of a vaccine that has been officially registered as the first to be approved for broad distribution. However, Russia has not yet released any clinical trial data to substantiate the vaccine’s effectiveness, and the World Health Organization currently classifies the treatment as being in the initial phase of development.

Therapies in phase-three clinical trials

Alongside efforts to prevent infection through vaccination, numerous organizations are focused on developing treatments to lessen the severity of illness for individuals who contract Sars-Cov-2, the virus responsible for COVID-19.

According to the Milken Institute, 41 distinct therapies are currently undergoing phase three clinical trials – the final stage of testing prior to potential widespread approval.

These therapeutic approaches fall into five main classifications: antibody-based treatments, antiviral medications, cell therapies, RNA-based interventions, and the repurposing of previously existing drugs that may have been sidelined.

Antibody therapies utilize the body’s inherent defense mechanisms, employing antibodies sourced either from individuals who have recovered from infection or created within a laboratory setting, to hinder the propagation of viruses or bacteria. Conversely, antiviral drugs function by inhibiting viral replication, targeting the virus’s capacity to reproduce. Cell-based therapies aim to enhance the immune system’s ability to combat pathogens, such as viruses and bacteria. RNA-based treatments represent another strategy to halt viral replication by interfering with the production of viral proteins. Lastly, several companies are investigating their collections of established drug compounds to identify potential candidates for treating COVID-19.

To date, only three therapeutics have received approval for the treatment of COVID-19. Dexamethasone has been approved for use in both the U.K. and Japan, while favilavir is utilized in China, Italy, and Russia. Remdesivir, notably used in the treatment of a U.S. president, has been approved in the United States, Japan, and Australia.

In the U.S., convalescent plasma is also being administered to hospitalized patients under emergency use authorizations. Furthermore, specific cases, including that of the president, have been granted access to experimental treatments, such as Regeneron’s cell therapy, through emergency use authorizations.

Several U.S.-based startup companies are actively developing potential COVID-19 therapies within each of these categories.

Adaptive Biotechnologies, Cytovia Therapeutics and SAB Biotherapeutics are all engaged in the development of antibody treatments. Applied Therapeutics is leveraging existing pharmaceutical knowledge to create treatments for conditions linked to COVID-19. Cellularity is pursuing a cell-therapy designed to lower a patient’s viral load by activating natural killer cells to target infected cells. Humanigen has created a new drug intended to reduce fatalities among COVID-19 patients experiencing severe pneumonia. Partner Therapeutics is working on a medication that could enhance lung function in COVID-19 patients – and potentially stimulate antibody production and repair damaged lung tissue. Finally, Sarepta Therapeutics is collaborating with the United States Army Medical Research Institute of Infectious Diseases to explore how its RNA-based treatment can impede the spread of coronaviruses by disrupting their ability to replicate.

In addition to therapies, startups are discovering alternative ways to contribute to the national response to the COVID-19 pandemic.

“The U.S. currently lacks an optimal public health infrastructure, but simultaneously possesses world-class private companies that can often operate with greater efficiency than governmental bodies,” stated Eren Bali, chief executive of Carbon Health, during TechCrunch’s Disrupt 2020 conference. “We have also recently initiated a program to facilitate the swift recovery of COVID-positive patients, a rehabilitation program. As you know, even survival does not guarantee the absence of lasting effects on the body.”

The pursuit of more effective at-home tests and remote treatment options for individuals is becoming increasingly vital, particularly given the federal government’s apparent reluctance to prioritize the prevention of viral transmission, as consumers may proactively implement preventative measures if governmental action is lacking.

“This presents an opportunity to adapt a technology inherently focused on virus detection – which is the natural function of CRISPR in bacteria – and repurpose it for rapid coronavirus diagnostics,” explained Jennifer Doudna, the Nobel Prize-winning co-inventor of foundational CRISPR gene-editing technology. “Our laboratory findings indicate that this approach can yield faster results and a signal more closely correlated with the viral load.”