[e-drug] Medical Product Quality Reports

E-DRUG: Medical Product Quality Reports
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Dear colleagues,

The COVID-19 pandemic is accompanied by a multitude of reports of diverted,
substandard and falsified (SF) medical products. Since the beginning of the
pandemic we have identified 906 relevant articles on quality problems with
COVID-19 medical products in the English language lay press.

Please readabout these in the Medical Product Quality Report - COVID-19 Issues
<https://www.iddo.org/mq/research/medical-product-quality-reports&gt;, that
hold reports from the scientific literature, public alerts/warnings, and
lay press.

The thirteenth issue, covering the months of August & September 2021, is
now available and reports on 64 different incidents of quality issues with
COVID-19 medical products from articles from searches in English language
Google News. It is out at
https://www.iddo.org/mq/research/medical-product-quality-reports

Similar to the previous report we have amalgamated the reports on COVID-19
medical products and on COVID-19 vaccines into one report because of the
increasing amount of work required.

COVID-19 VACCINES: In Part A, we have issued a further summary of public
domain reports on quality issues with COVID-19 vaccines we are aware of. So
far we have recorded 172 reports of incidents on quality issues with
COVID-19 vaccines linked to 44 different countries.

In August and September 2021, 22 new incidents were reported. For the first time quality issues were reported in Turkey, Spain and Zambia. Eight incidents involved falsified COVID-19 vaccines including products labeled as Pfizer/BioNTech, Covishield, and Johnson & Johnson. Several articles reported on apparently contaminated Moderna COVID-19 vaccines in multiple prefectures in Japan.

OTHER COVID-19 MEDICAL PRODUCTS: Part B discusses diagnostics, Personal
Protective Equipment (PPE), sanitisers & disinfectants, medicines, and
ventilation & oxygenation equipment and consumables. For PPE, masks remain
the main affected product. Some cases of poor quality remdesivir and
tocilizumab occurred. In Thailand shortly after approval of green chiretta,
a herbal medicine to treat asymptomatic COVID-19, a falsified version was
detected.

We remain very concerned about the global risk of diverted and SF COVID-19
medical products, especially vaccines and medicines. The incidents we
describe risk harm to people receiving SF products. We continue to urge
much more international coordination to mitigate the risks.

Any remarks or additions to content are greatly appreciated (please write
to medicinequality@iddo.org). We would be delighted if you could
disseminate this information within your networks.

Very best wishes,
Inthaphavanh Kitignavong, Kerlijn Van Assche, Céline Caillet, Paul N Newton
Medicine Quality Research Group,
Infectious Diseases Data Observatory (IDDO) &
Mahidol Oxford Research Unit (MORU),
Centre for Tropical Medicine
& Global Health, Nuffield Department of Medicine,
University of Oxford,
Oxford, UK
Kerlijn Van Assche <kerlijn.vanassche@iddo.org>