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What the New Coronavirus Means for the Pharmaceutical Industry
The emergence of the novel coronavirus strain, COVID-19, has left the pharmaceutical industry questioning its preparedness for potential pandemics and scrambling for a vaccine.
A novel strain of the coronavirus has the world scrambling to avoid a global pandemic. In December 2019, the new virus emerged in Wuhan, China.
Similar to the severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) viruses, this new strain has quickly infected over 87,000 globally, according to the World Health Organization (WHO).
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Patients across 59 countries report mild to severe respiratory symptoms including cough and shortness of breath. Because the disease spreads through person-to-person contact, it spreads quickly. The epidemic doubles in size every 6.4 days as every one person infected can spread the disease to 2.68 other people.
Less than a month after its emergence and after over 2,900 reported dead, the WHO declared the outbreak a public health emergency. Healthcare providers, public health officials, government leaders, and pharmaceutical developers are working nonstop to contain the virus and minimize its spread.
While many countries are leveraging travel bans and quarantine to slow the spread of disease, the pharmaceutical industry plays a unique role in the world’s response to COVID-19. High-quality diagnostic tests, effective treatment options, and possible vaccines need to be developed quickly if they are to curb the potential pandemic.
Diagnosing the Disease
To diagnose COVID-19, providers test respiratory samples from potentially infected patients in a laboratory. This can be a lengthy process as patients wait for confirmation.
While the laboratory tests are not certified by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) recently announced an Emergency Use Authorization (EAU) for the detection test.
Under this provision, the FDA expedites approval for diagnostic and medical products that are potentially lifesaving in a public health emergency.
These detection tests are enough at the moment, but performance errors related to the manufacturing of several reagents used in the tests leave many weary they will be enough for the impending swarm. So the FDA has shared the tests template with over 50 developers in order to push for a more comprehensive and accurate diagnostic test.
Ensuring the accuracy of diagnostic tests will help providers more quickly and accurately diagnose patients.
Testing Effective Treatment Options
Diagnosing the disease is unproductive if there are not appropriate treatment measures in place. Currently, there is no treatment for COVID-19. Providers treat symptoms that might arise such as a cough or fever, but there is no way of treating the underlying cause of disease.
Because of the similarities between COVID-19, SARS, and MERS, many researchers believe treatments for these diseases will help patients with the novel coronavirus.
To test this theory, the first randomized, controlled trial in the United States for a treatment of COVID-19 was announced on February 25. The trial will test the safety and efficacy of the drug remdesivir, a broad-spectrum antiviral treatment previously tested on the Ebola virus.
Remdesivir has shown promise in animal testing for treatment of MERS and SARS. The trial, sponsored by the National Institute of Allergy and Infectious Disease, a division of the National Institute of Health, can be adopted to patients in the United States and abroad.
A current clinical trial of remdesivir is ongoing in China, but the rigor of the randomized controlled trial will help scientifically prove if the treatment is a safe and efficacious option for patients.
“We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes,” said Anthony Fauci, MD, member of the US coronavirus task force and NIAID director in a news release. “A randomized, placebo-controlled trial is the gold standard for determining if an experimental treatment can benefit patients.”
But some are hesitant that a broad-spectrum treatment will be enough to curb the epidemic. Many, including the White House, are still pushing to unlock emergency funding for novel treatment options.
Vaccine Development and Dissemination
Developing a vaccine can take years. After the virus’ DNA sequence is isolated, the vaccine must be developed and tested on animals before it is tested on humans.
Advancement in genetic technology has allowed more rapid sequencing and earlier identification of the pathogen, leading to more rapid vaccine development. And genetic testing revealed COVID-19 and SARS were 75 to 80 percent identical.
Rather than shooting blind, researchers can work to develop countermeasures based on their work during the 2003 SARS outbreak.
Two major pharmaceutical companies have already announced their efforts to develop a vaccine: Sanofi and Clover Biopharmaceuticals.
Sanofi recently announced a partnership with the United States Department of Health and Human Services to develop a vaccine.
“Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate,” said David Loew, global head of Vaccines at Sanofi in an earlier press release. “While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak.”
Similarly, Clover Biopharmaceuticals, a China-based biotechnology company, announced a partnership to speed up vaccine development. They are partnering with GSK, the leading manufacture of vaccines globally, to speed the vaccine development process. In the partnership, GSK will provide Clover with its pandemic adjustment system, adding the vaccines to enhance the immune response.
Both companies are leveraging partnerships for funding and speedier vaccine development, recognizing that they cannot stop this disease alone.
Understanding Emergency Preparedness
In recent remarks to the press, the WHO director general said the organization is supporting national authorities in every country where the disease has emerged. They are attempting to track cases and understand how the disease spreads between humans.
In total, the WHO has sent over personal protective equipment to 21 countries and plans to ship to 106 more in order to ensure lab workers and healthcare workers who are at risk of interacting with COVID-19 are properly protected.
The FDA is also releasing additional resources for supply chain management to coordinate and identify potential vulnerabilities before they happen rather than after. Recognizing that if a lab or provider is not equipped to handle an infected patient, the consequences could be severe.
While this is a relatively standard response from the World Health Organization and FDA, the pharmaceutical industry has been delayed in its response.
It was almost 30 days after the virus made its way to the United States that a pharmaceutical company announced it would try to develop a vaccine. This was almost 50 days after the outbreak’s patient zero was infected.
Drug and vaccine development, while in the works, is slow, begging the question if the world is prepared for an outbreak or if such a slow response will lead to a global pandemic.
