April 1, 2021

Covid-19 roundup: Factory error contaminates 15M J&J doses

Daily Briefing

    Canadian and German health authorities restrict use of AstraZeneca's vaccine, FDA authorizes Amazon's coronavirus test, and more.

    • Canadian and German health authorities earlier this week restricted the use of AstraZeneca's Covid-19 vaccine due to concerns about the vaccine's possible link to blood clots, the New York Times reports. According to the Times, Canada on Monday suspended the vaccine's use among people ages 55 and under, following a report from German's vaccine regulatory body, Paul-Ehrlich Institute, which found that at least seven people who'd recently received AstraZeneca's vaccine developed an extremely rare and potentially fatal condition involving blood clots. The institute said the number of cases was significantly higher than normal for the country's population of 1.6 million adults who'd received the vaccine by March 15. On Tuesday, Germany similarly paused the vaccine's use among adults under the age of 60 (Porter/Schuetze, New York Times, 3/29).
    • FDA on Thursday authorized the emergency use of Amazon's real-time reverse transcription polymerase chain reaction (RT-PCR) for detecting the novel coronavirus. FDA said the test is designed to detect the virus in nasal swab specimens self-collected by adults ages 18 and older, either under a provider's supervision or unsupervised at home. According to FDA, the test is intended for pooled samples containing up to five nasal swab specimens. The test is a modified version of BGI Genomics' FDA-authorized RT-PCR Covid-19 test and can only be used by laboratories designated by STS Lab Holdco, a subsidiary of Amazon.com Services, that are certified under the Clinical Laboratory Improvement Amendments of 1988 and meet requirements to perform high-complexity tests (Modern Healthcare/GenomeWeb, 3/29).
    • HHS last week announced the federal government is no longer distributing Eli Lilly's Covid-19 monoclonal antibody therapy bamlanivimab for use on its own due to a "sustained increase" in new variants of the novel coronavirus. HHS said the government stopped distributing the FDA-authorized treatment on March 24 because of the increase in coronavirus variants that are resistant to bamlanivimab when administered alone. In addition, the agency said the availability of alternative authorized antibody therapies appear to be effective against the variants, including Regeneron's antibody cocktail REGEN-COV and bamlanivimab in combination with etesevimab, another antibody therapy developed by Eli Lilly. HHS said health care providers can continue to use REGEN-COV and bamlanivimab in combination with etesevimab to treat certain Covid-19 patients (Christensen, CNN, 3/25). 
    • Future shipments of Johnson & Johnson's Covid-19 vaccine in the United States are being delayed while FDA investigates the accidental contamination of up to 15 million doses of the vaccine at a manufacturing plant in Baltimore, the New York Times reports. According to the Times, the doses were contaminated when workers at the plant—run by Emergency BioSolutions, a manufacturing partner for J&J and AstraZeneca—mixed up the ingredients of two different Covid-19 vaccines. J&J spotted the error during quality control checks before the doses left the plant, and reported the situation to federal regulators, whose investigation into the matter will delay the authorization of the plant's production lines. The situation does not affect the J&J dose deliveries that have already shipped, including shipments that states are expecting to arrive next week, the Times reports, as those doses were manufactured at different plant located in the Netherlands. However, people close to the situation said the delay could affect the 24 million additional doses J&J was scheduled to ship in April, all of which were slated to be produced by the Baltimore plant. For its part, J&J has said it should still be able to meet that goal, given the steps it's taken with Emergent, including additional J&J staff to oversee quality control and more measures to stave off future lapses—although the timing will ultimately depend on FDA regulators, the Times reports (LaFraniere/Weiland, New York Times, 3/31).
    • The World Health Organization (WHO) in a long-awaited report released Tuesday said the novel coronavirus likely spread from bats to humans via small mammal species—but officials from WHO, the United States, and more than dozen countries have raised concerns about the report and called for a deeper investigation into the virus's origins. WHO in the 319-page report presented inconclusive findings from a four-week mission conducted by Chinese scientists and WHO experts to determine how the coronavirus pandemic began. Citing insufficient data to draw conclusive results, WHO in the report recommended further research on where the virus originated, including a closer review of Chinese hospital records, blood samples predating the first known coronavirus cases, and farms linked to early outbreaks. "Further data and studies will be needed to reach more robust conclusions," WHO Director General Tedros Adhanom Ghebreyesus said Tuesday. Similarly, officials from the United States, United Kingdom, and 12 other countries in a joint statement Tuesday recommended a more extensive evaluation of the virus's origins, noting WHO's report had been "significantly delayed" and relied on incomplete data. Separately, White House press secretary Jen Psaki said, "The report lacks crucial data information and access—it represents a partial and incomplete picture" (Furlong, Politico, 3/30; Hinshaw et al., Wall Street Journal, 3/29; Doucleff/Lohmeyer, "Goats and Soda," NPR, 3/29; Hinshaw/Page, Wall Street Journal, 3/30; Thrush, New York Times, 3/30; Reuters, 3/30).

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