Blog May 25, 2020

Coronavirus Impacts on Industry: Part 1

 The race to develop new tests, vaccines, and treatments

covid1As the COVID-19 pandemic rages on, the effects of the virus are being felt not only by the global populace, but by the various sectors of the health care industry and those that support them. The urgency of the situation is spurring a race to develop new diagnostics, drugs and vaccines against the virus, supported by an easing of some regulatory requirements from the U.S. Food and Drug Administration, aimed at making promising advances available more quickly. At the same time, the pandemic is causing companies to pause or halt clinical trials and much other research and development activity aimed at advancing treatments for other conditions. In this first of a two-part post, we look at how the pandemic is spurring development in areas designed to respond to the challenge of COVID-19. We’ll follow that up next week with observations on how the pandemic is slowing work in other areas.

Coronavirus Testing

Testing for those who have been infected by the virus has been among the most pressing needs in a region’s ability to deal with the pandemic. Widespread testing is still lacking in many areas, with delays resulting from shortages of supplies, lack of funding, and poor prioritization of patient samples. 

To help curb these issues, on March 17 the U.S. FDA began allowing companies to introduce new diagnostics without first submitting them for full agency review or obtaining an official emergency clearance. The agency has been providing technical assistance to developers to help facilitate the availability and distribution of tests, and has authorized state health departments to authorize the use of new lab-developed tests directly. 

As a result, a large number of companies have launched or are preparing to introduce tests that are capable of providing results in less than an hour. Such rapid testing is considered by experts to be an essential requirement for increasing by as much as 10-fold the testing needed to track the virus, get infected patients into quarantine, and warn those they’ve exposed of their potential infection risk.

Several of the fastest of the new tests are finger-prick serology assays that look for antibodies to COVID-19 in a patient’s blood; some of these are point-of-care diagnostics that could be used in a variety of settings. While serology tests are less accurate in the earliest days of an infection (before a patient is symptomatic and antibodies develop), such diagnostics could be particularly useful as a rapid test for those showing symptoms and for determining who might have post-infection immunity. A saliva-based DNA diagnostic has been developed by Rutgers University, and once the FDA approves the process of sample collection by spitting into a tube, patients could self-test at home. At least one rapid point-of-care test in development is designed to track both viral antigen and antibodies, and additionally rule out other coronavirus infections. A rapid antigen-detecting test has also recently been introduced.

While the FDA’s move to relax its oversight of new diagnostics prior to their use has helped get tests to market quickly, it has also come with a significant downside. The inherent accuracy of many of the tests has been limited by high numbers of false positives or negatives. In the case of PCR-based tests, these inaccuracies can be further exacerbated by poor sample collection; testing patients too early or too late in their infection when there is insufficient virus present in their cells; and letting samples sit for too long before testing, resulting in viral RNA degradation. For serological tests, a study by researchers from the University of California, San Francisco, suggests the sensitivity of most of these tests is at least 90% and specificity at least 95%. However, if the incidence of infection in a population is low, experts say these tests would still lead to a high false positive rate. 

Vaccines and Medicines

testkitsMany medical experts have said that the availability of a coronavirus vaccine will be a key element to ending the pandemic, and that a vaccine is unlikely to be commercially available in less than a year.

That said, at least 30 companies are racing to develop and test vaccines, with the hopes that some may be available to health care workers by early 2021.

Global regulators, through the International Coalition of Medicines Regulatory Authorities, have also joined forces to issue a uniform set of considerations on how they intend to strike a balance between the rapid deployment of COVID-19 vaccines and the need to generate sufficiently robust safety and efficacy data to guide their decision-making.

Moderna is leading the pack of vaccine developers, with a messenger RNA vaccine candidate that entered Phase 1 clinical testing in March and recently reported encouraging early results in its ability to stimulate antibody production against the virus. The company had already been working for two years on a MERS vaccine; realizing that the genetic structure of the COVID-19 virus, SARS-CoV-2, was very similar, they quickly shifted focus to the new virus. Moderna is now scaling up its manufacturing capacity to be able to produce millions of doses per month, and preparing to begin a Phase 2 trial of its vaccine. The company is hopeful that if the vaccine proves to be safe and effective, they can make it available to health care workers by late autumn. The U.S. Department of Health and Human Services and its Biomedical Advanced Research and Development Authority (BARDA) is helping to fund Moderna’s vaccine work, as well as lending financial support to Johnson & Johnson’s Janssen Research & Development for their vaccine effort, expected to enter the clinic soon. Novavax, BioNTech, VBI, Inovio, and CureVac are also among those working on their own COVID-19 vaccine programs, with several expected to enter clinical testing over the next few months.

In the area of therapeutics, companies are developing both antiviral medicines for COVID-19 and drugs that help manage the infection’s harshest symptoms, particularly the pneumonia and cytokine storm that is responsible for damage to the lungs and other organs. 

Most advanced is Gilead’s antiviral remdesivir. While some early clinical data was mixed, a 1,000 patient placebo-controlled trial conducted by the National institute of Allergy and Infectious Disease (NIAID) found that remdesivir sped the recovery of hospitalized patients with severe COVID-19 infections by 31% compared to placebo. Based on this study, the FDA issued emergency authorization on May 1 for remdesivir’s use in treating hospitalized patients with low blood oxygen or on mechanical ventilation. Gilead began ramping up production of its drug in early April and is donating 1.5 million vials (enough for 140,000 patients based on a 10-day course of the drug), 40% of which will go to U.S. hospitals. 

Hundreds of drugs are now being tested against the virus or the damaging immune over-response it can stimulate, although few results of trials will be available before the end of 2020. Many of these are looking to repurpose drugs originally approved or studied for other indications. Existing drugs being explored for utility against COVID-19 include various antivirals, alone or in combinations, such as those currently used to manage flu or HIV infections. Anti-inflammatories and immunomodulators, including arthritis and cancer medications such as the old arthritis drug colchicine, Genentech’s Actemra (tocilizumab) and Novartis’ Jakavi (ruxolitinib), are also being studied for their ability to manage the cytokine storm associated with many of the severe effects of COVID-19 infection.