What We’re Reading: COVID-19 Vaccine Trial Halted; Virus Spread at Motorcycle Rally; FDA Issues Efficacy Caution

September 9, 2020
AJMC Staff
AJMC Staff

AstraZeneca's phase 3 trial of a coronavirus disease 2019 (COVID-19) vaccine has been temporarily stopped; the Sturgis Motorcycle Rally may have led to over 250,000 COVID-19 cases; a potential treatment for breast cancer may not be effective.

Adverse Event Possible Cause of AstraZeneca COVID-19 Trial Stoppage

Late yesterday, AstraZeneca halted its phase 3 trial in the United States investigating a potential coronavirus disease 2019 (COVID-19) vaccine, pending a safety data review, reports STAT. Following an unknown adverse reaction that may have occurred in a patient in the United Kingdom, who is now recovering, AstraZeneca initiated the hold, hoping to expedite it “to minimize any potential impact on the trial timeline.” The trial began in August and has since expanded to 62 sites, and the pharma giant is collaborating on the vaccine’s development with Oxford University. Phase 3 trials are also investigating 8 other potential COVID-19 vaccines.

Sturgis Motorcycle Rally May Have Led to Superspread of COVID-19 Cases

Researchers from San Diego State University’s Center for Health Economics & Policy Studies claim the annual gathering of motorcycle enthusiasts in Sturgis, South Dakota, may have led to 266,796 cases of COVID-19, according to The Washington Post. Minimal mask wearing and social distancing, the 10-day length, and a sizeable out-of-town attendee population are likely causes of this reported uptick, which resulted in public health costs of close to $12.2 billion. The researchers used anonymized cell phone location data via smartphone pings to track attendee movement during and after the event, linking a 7% to 12.5% increase in cases to counties with the most residents in attendance. Meanwhile, detractors of the report’s case total question its data analysis and cite that the state was already experiencing rising cases.

Atezolizumab/Paclitaxel Combo Not Effective for Breast Cancer, FDA Says

Results from the Impassion131 phase 3, multicenter, randomized, double-blind, placebo-controlled trial show the combination of atezolizumab (Tecentriq) and paclitaxel was not effective against locally advanced or metastatic triple negative breast cancer (mTNBC), says a statement from the FDA. A slightly different combination therapy, atezolizumab plus paclitaxel protein-bound (Abraxane), is approved for use in mTNBC for tumors that express PD-L1, however, and the FDA noted that health care professionals administering that treatment should continue to do so. The survey data showed that the risk of cancer progression and death did not improve and that the control group receiving paclitaxel plus placebo had superior interim overall survival vs the group receiving paclitaxel plus atezolizumab.