COVID-19 vaccines and medicines: updates for February 2021
A summary of advice recently issued by the MHRA relating to coronavirus (COVID-19), up to 16 February 2021.
In January 2021, we included the latest advice for the Pfizer/BioNTech and COVID-19 Vaccine AstraZeneca.
Here we include a summary of key MHRA advice issued since the publication of the January 2021 edition of Drug Safety Update and up to 16 February 2021.
Yellow Card reporting data confirms safety of vaccines
In February 2021 we published the first summaries of the Yellow Card reporting for the COVID-19 vaccines being used in the UK.
The data confirms that the vast majority of reported side effects are mild and short-lasting, reflecting a normal immune response to vaccines – including a sore arm and fatigue.
The report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy.
We take every report of a suspected adverse reaction seriously and encourage everyone to report through the Coronavirus Yellow Card reporting site.
Pfizer/BioNTech vaccine: advice on six doses
On 26 January 2021, information for the Pfizer vaccine was amended from containing five doses to containing six doses when the latest guidance for Healthcare Professionals is followed.
Moderna vaccine authorised for use
On 8 January 2021, the COVID-19 Vaccine Moderna was approved for use by the MHRA after meeting required safety, quality, and effectiveness standards. This followed a rigorous, detailed scientific review by the MHRA’s expert scientists and clinicians and on the basis of the advice of its scientific, independent advisory body, the Commission on Human Medicines (CHM).
See Information for Healthcare Professionals and Information for UK Recipients, which also includes subsequent updates to information on the quantity of doses in the vials.
Update on conditions of regulatory authorisation
The MHRA has updated the ‘Conditions’ for the three vaccines (Pfizer/BioNTech, AstraZeneca, Moderna) authorised under Regulation 174 to clarify how the approval interacts with the broader regulatory context.
COVID-19 Therapeutic Alerts
On 1 February 2021, the Chief Medical Officer (CMO) issued a COVID-19 Therapeutic Alert to recommend that NHS trusts/health boards consider prescribing either tocilizumab or sarilumab to hospitalised patients with COVID-19 pneumonia. Please see the Central Alerting System website for more information and subsequent alerts.
On 28 January 2021, the CMO issued a COVID-19 Therapeutic Alert to inform that antimicrobials (azithromycin and doxycycline) were not beneficial in the management of COVID-19 patients. Please see the Central Alerting System website for more information.
Article citation: Drug Safety Update volume 14, issue 7: February 2021: 5.