Focus on Infectious Disease
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COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA

COVID-19 Assay’s False-Negative Results Culminate In Class I Recall Designation From FDA

Source : Medtech Insight

A recall of the Lyra SARS-CoV-2 Assay (M120) made by Quidel has been designated as high-risk class I by the US Food and Drug Administration.

The FDA said on 7 July...

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NEED OF COVID-19 BOOSTER DOSE RECOMMENDATION
Does everyone need a booster dose of Covid-19 vaccine every 12 months, similar to an annual influenza vaccine, to maintain high levels of immunity against Covid-19 and its variants?
How do you address COVID-19 Vaccine hesitancy in patient community ?

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COVID-19 Vaccines: Declining Antibody Levels, Breakthrough Infections Could Spur Booster Recommendations

COVID-19 Vaccines: Declining Antibody Levels, Breakthrough Infections Could Spur Booster Recommendations

Source : 'The Pink Sheet'

Significant declines in antibody levels or concerning numbers of breakthrough infections in vaccinated individuals should spur consideration for booster doses of currently authorized COVID-19 vaccines, members of the Centers for...

  • 5yr
    Booster dose recommendations could be triggered when antibodies decline to a certain level
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FDA Pulls EUAs For Non-NIOSH Masks And Decontamination Systems

FDA Pulls EUAs For Non-NIOSH Masks And Decontamination Systems

Source : Medtech Insight

The US Food and Drug Administration has revoked emergency use authorization (EUA) for certain imported respirators for health care workers, and decontamination systems that were allowed due to...

  • 5yr
    Thankfully ... access to domestic supply of disposable respirators continues to significantly improve
  • 5yr
    Thankfully ... access to domestic supply of disposable respirators continues to significantly improve

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Start Designing Vaccines For The Next Pandemic, Urges NIH Chief

Start Designing Vaccines For The Next Pandemic, Urges NIH Chief

Source : 'The Pink Sheet'

US National Institutes of Health Director Francis Collins is putting out the call for the biopharma industry to start preparing to tackle the pathogens most likely to cause the next...