POLICY BRIEFING – WEEK IN REVIEW
If not for patients in Liberia, Guinea and the Democratic Republic of Congo, no large-scale clinical trials of remdesivir would exist right now. A commentary traces the history of remdesivir and its origins as a novel treatment for the Ebola virus. Because of these willing patients, Gilead (the company that manufactures the drug) was able to conduct necessary safety trials, ultimately proving the drug was safe for humans, although it was not found to be effective against Ebola. With human safety trials therefore already having been completed years ago, Gilead was able to quickly secure orphan drug approval from the FDA in March and subsequently proceed to effectiveness trials. In a cruel twist however, the very same patients who risked their health as participants in early clinical trials for Ebola have no current access to the drug during the covid-19 pandemic, as the U.S. has purchased the entire global supply and has shown no indication of any willingness to share it. The issue of global access to costly drugs is not new to Gilead, as the company has faced criticism of its distribution of HIV and Hepatitis C drugs in the past, even finding ways to reap benefit by donating some of its products. The commentary authors suggest that Gilead place the patent for remdesivir in a United Nations patent pool that would facilitate low-cost generic manufacturing of the drug. Regardless of the lingering questions as to remdesivir's effectiveness, it seems unconscionable to deploy the drug domestically knowing that those who paved the way lack access themselves. 28 July 2020.
Last week the Centers for Disease Control and Prevention (CDC) updated its isolation guidelines based on updated epidemiologic data. The new supporting evidence essentially shows that viral load and the chances of replication-capable transmission (i.e. contagion) decreases after symptom onset. The data also suggest that serologic evidence of infection—blood tests for antibodies which indicate prior infection and which likely imply some level of immunity—may persist for months. To date there have been no confirmed documented cases of reinfection, though experts have debated whether some patients who recovered from covid-19 who later had similar symptoms and who retested positive for SARS-CoV-2 were actually reinfected, or whether the causes of these second illnesses were unrelated, but just occurring in patients who were still shedding detectable though not contagious levels of the novel coronavirus.
Based on all of this, the CDC's new recommendations are as follows: for most coronavirus infections, isolation may be terminated ten days after symptom onset and twenty four hours after the last occurrence of a fever; those with confirmed infections who never display symptoms may now cease quarantine ten days after their first positive test. In general, serology-based decisions (blood tests for antibodies) to end quarantine are only recommended in severely immunocompromised patients and in consultation with infectious disease experts, or when the results would indicate that it would be safe to discontinue isolation before the ten day period had elapsed. The CDC is discouraging routine serologic retesting within three months, with exceptions for patients who develop new symptoms without an alternate explanation. Finally, serologic testing should not be used to establish presence or absence of infection. The Centers for Disease Control and Prevention. 27 July 2020.
After initially delaying the release of its school reopening guidelines under reported pressure from the White House, the Centers for Disease Control and Prevention (CDC) has published the new recommendations. Without specifically recommending re-opening, the document strikes a pro-opening tone, citing the decreased rate of infection and mortality among children, as well as the emotional and behavioral harm incurred by school closures, especially for underprivileged children or those with disabilities. The paper discusses reports low rates of transmission between student and teacher, with the important caveat that this has only been demonstrated in areas with low community transmission. The argument for re-opening focuses on the role in-person education plays in student education, safety, nutrition, and physical activity. Missing from this document, unfortunately, are any concrete steps or recommendations for how schools can achieve safe reopening, from use of social distancing to sanitization procedures. The Centers for Disease Control and Prevention. 29 July 2020.