Over the past few weeks, we’ve been sharing our QMS plans, and insights, and it’s now time you meet the people behind our newly established Quality Management Team.
MHRA updates report on COVID-19 vaccine adverse reactions
On 1st April 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) updated a report covering adverse reactions to approved COVID-19 vaccines. The report includes data up until 21st March 2021.
FDA revises Moderna COVID-19 Vaccine EUA
On 1st April 2021, the U.S. Food and Drug Administration (FDA) announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorises the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted. Revisions are intended to help frontline workers administering vaccines understand the number of doses that can potentially be extracted per vial.
FDA issues EUA for the Symbiotica COVID-19 Self-Collected Antibody Test System
On 6th April 2021, the FDA announced the issue of an emergency use authorisation (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorised for use with home collected dried blood spot samples. The authorisation is for prescription use with a fingerstick blood sample that is self-collected by an individual age 18 years or older or collected by an adult from an individual 5 years of age and older. The test is intended to aid in identifying individuals who developed an adaptive immune response to SARS-CoV-2, indicating a recent or prior infection.
FDA issues update on its ongoing COVID-19 response effort
On 6th April 2021, the FDA announced more actions taken in its ongoing response effort to the COVID-19 pandemic. Updates include the implementation of new guidance: Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers.
EMA publishes PRAC recommendations on safety signals
On 6th April 2021, the European Medicines Agency (EMA) published an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting on the 8-11th March 2021 and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.
Under-30s set to be offered an alternative to the AstraZeneca’s Covid vaccine in the UK
On 7th April 2021, at a briefing by the MHRA and the Joint Committee on Vaccination and Immunisation (JCVI) it was announced that for adults under-30s in the UK will be offered Pfizer or Moderna’s vaccine rather than AstraZeneca’s vaccine over concerns over rare risk of blood clots. The MHRA is now issuing updated guidance for healthcare professionals on how to minimise risks, as well as further advice on symptoms for vaccine recipients to look out for 4 or more days after vaccination.
Issue Number: WN0005
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