- AstraZeneca on Saturday released details on its clinical trials for its coronavirus vaccine candidate, following public pressure on drugmakers to be more transparent about the methods they're using to evaluate potential coronavirus vaccines. According to Eric Topol, a clinical trials expert at Scripps Research, AstraZeneca's trials, along with trials that are underway to test Moderna's and Pfizer's respective coronavirus vaccine candidates, have a problematic feature: They will take into account whether individuals who received the experimental vaccines develop fairly mild cases of Covid-19, the disease caused by the virus, when measuring the candidates' efficacies, which could make it more difficult to identify whether the experimental vaccines prevent people from developing moderate or severe cases of the disease (Grady et. al., New York Times, 9/19).
- Tom Shimabukuro of CDC's Covid-19 Vaccine Planning Unit on Tuesday said the first patients to receive any authorized coronavirus vaccines in the United States will also receive a series of follow-up text messages from CDC during the first week following their vaccinations. The text messages will ask patients if they have experienced any adverse symptoms either at the injection site or overall, and if so, whether those symptoms kept the patient from going to work or performing daily activities or required them to seek care from a health professional. Any patients who report severe symptoms will receive a call from CDC's vaccine call center, and CDC will pass those patients' information along to FDA (Weise, USA Today, 9/22).
- FDA during a virtual town hall meeting last week reported results from the agency's evaluations of molecular diagnostic coronavirus tests. According to FDA, the best-performing test was developed by PerkinElmer, which had a reported limit of detection of 180 nucleic acid amplification test-detectable units (NDU) per milliliter, followed by ScienCell Research Laboratories' test, which had a reported 540 NDU/ml. Chris Mason, a genomics researcher at Weill Cornell Medicine and a scientific advisor at Resilience Health, said the findings are significant because "[t]here is clearly a wide range of performance for various [coronavirus] tests on the market." He explained that FDA's "work," as well as other "benchmarking efforts … will help adjudicate the limitations of any tests and help confirm that primers in use for diagnostics are valid" (Madeleine Johnson, 360Dx/Modern Healthcare, 9/17).
- Johnson & Johnson (J&J) on Wednesday announced that it has started the final stage of its clinical trial for its coronavirus vaccine candidate. According to the New York Times, J&J's vaccine candidate could require patients to receive just one dose instead of two, and it does not need to be frozen, giving it a potential advantage over other vaccine candidates. The company intends to enroll 60,000 participants in the final stage trial, and J&J said it could know whether the experimental vaccine is effective by the end of this year (Zimmer/Thomas, New York Times, 9/23).
- Novavax is set to launch a final stage clinical trial for its coronavirus vaccine in the United Kingdom. The company will launch an additional clinical trial in the United States next month, joining four other companies in late-stage trials supported by the federal government's Operation Warp Speed (Thomas/Zimmer, New York Times, 9/24).
- Roche last week reported that, in a large study that mostly consisted of people of color, its rheumatoid arthritis drug tocilizumab, sold as Actemra and RoActemra, helped to prevent hospitalized Covid-19 patients from having to be placed on ventilator. The study was conducted in Brazil, Kenya, Peru, South Africa, and the United States, and it featured 389 patients. About 85% of those were Black, Hispanic, Native American, or of another ethnic or race other than white. About 12% of the patients in the study required a ventilator or died within 28 days of receiving the drug, compared with 19% of patients who were given a placebo, Roche said (Marchinoe, Associated Press, 9/18).
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