- FDA on Tuesday in a letter to health care providers cautioned that while antigen tests for the novel coronavirus can provide quick results, there is a danger of false positives—particularly if users don't follow the testing instructions. To minimize the risk of false positives, FDA recommended that providers and clinical staff carefully follow testing instructions, including storing the test components properly, reading the test at the specified time, and avoiding the risk of cross-contamination among patient samples. The agency said it would continue "to monitor and evaluate these reports [of false positives] and other available information about device safety and performance" (Szaniszlo, Boston Herald, 11/3).
- Pfizer confirmed that it will not use the federal government's selected distribution partner, McKesson, if and when the drugmaker receives FDA approval for its Covid-19 vaccine candidate, opting instead to rely on its own delivery system to get the vaccine to providers, according to Tanya Alcorn, Pfizer's VP for biopharma global supply chain. In an email to FiercePharma, a Pfizer spokesperson said, "Our distribution model, as agreed with the U.S. government, is built on a flexible, just-in-time system which will ship the frozen vials directly from our plants to the point of vaccination." According to FiercePharma, Pfizer has already secured a $1.95 billion deal with the federal government to provide up to 100 million doses of its potential vaccine if approved—and to allocate 40 million of those doses before 2021 (Weintraub, FiercePharma, 11/4).
- According to new guidance from CDC, more than 12 retail pharmacy chains are partnering with the federal government to act as vaccination sites for the Covid-19 vaccine, including Walgreens Boots Alliance, CVS Health, Walmart, Kroger, and Costco Wholesale, among others. The agency shared the information via an updated "interim playbook" for states, territories, and local governments that outlines how the vaccine would be distributed to hospitals, clinics, and other vaccination sites, beginning with supplies for health care workers and individuals at high-risk of infection. The pharmacies, which together include more than 35,000 locations, would come into play during the playbook's second phase, first ordering the vaccine from the federal government and then receiving them free from charge to administer to the public. According to the Wall Street Journal, pharmacies under the plan are required to sign agreements with the government specifying their site locations, as well as the capacity of each location to store vaccines at subzero temperatures, and they must provide daily updates to CDC on their dose status. However, the plan also specifies that states have the authority to bar pharmacies within their state lines from getting vaccines from the federal government (Hopkins, Wall Street Journal, 10/30; Ponnezhath, Reuters, 10/30; Jaspen, Forbes, 11/2).
- Clear, a biometrics firm based in New York, has inked two separate deals to partner with Quest Diagnostics and LabCorp to include the labs' novel coronavirus test results on Clear's Health Pass app. In its current form, the app enables employers and building owners to screen people for the novel coronavirus; users are required to download the app, verify their identity by taking a selfie, complete a brief symptom quiz, and then stand before a Clear kiosk to get their face and temperature scanned—a process that produces a red or green light to show whether someone can enter. According to Clear CEO Caryn Seidman-Becker, under the new partnerships, the app would bolster that process by giving people "a discreet, secure way to share their test results when they enter public settings and workplaces." However, while Clear says employers and building owners will not have access to individuals' health data—they'll see only the red or green light—several industry stakeholders have voiced privacy concerns about the technology, Modern Healthcare/Crain's New York Business reports (Deffenbaugh, Modern Healthcare/Crain's New York Business, 10/8).
- Regeneron Pharmaceuticals last week said that, due to safety concerns, it had suspended testing of REGN-COV2, its antibody drug for Covid-19, among the sickest patients enrolled in the study. Regeneron made the announcement after an independent data monitoring committee on Friday cited "a potential safety signal and an unfavorable risk/benefit profile" for "patients requiring high-flow oxygen or mechanical ventilation," and advised Regeneron to suspend enrollment of such patients "pending collection and analysis of further data on patients already enrolled." According to the Wall Street Journal, the decision does not affect other testing of the drug, including the enrollment of non-hospitalized Covid-19 patients and hospitalized Covid-19 patients who are on low-oxygen support or who require no oxygen support (Walker, Wall Street Journal, 10/30; Adams, FierceBiotech, 10/30).
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