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Dec 01

Rolling-out, and rolling-up sleeves: The current COVID-19 situation; the threats for mass inoculation, and impact on drug safety

A brief overview of several vaccines that are entering the market, potentially available for inoculation by early-mid 2021. This article alludes to how drug safety may be impacted by mass vaccination programmes, with particular focus of the UK.

As news of a mass rollout of COVID-19 vaccinations unfolds, the public are rolling up their sleeves at the prospect of a vaccination; predicted to be available by early to mid-2021.

With regards to not only preventing but reducing the spread of coronavirus, what we are hearing is hugely positive news.

Whilst the NHS are in the midst of drawing up plans to inoculate up to thousands of people a day, at mass vaccination sites, we take a closer look at drug safety; the predictions, plans and apprehensions surrounding these inoculations; as well as what may be the outlook and impact for pharmacovigilance.

Let’s recap some of the recent news and key considerations for COVID-19 vaccinations:

  • Early data from leading, final-stage trials are amongst the highest of several vaccine trials around the globe, showing efficacy ratings of above 90%
  • The logistics of distribution are made difficult: vaccines may require multiple doses to be administered, with it being unknown whether continuity of product is imperative to efficacy; in addition to timescales of doses and management of storage temperatures being uncertain.
  • A recent study suggests that more than half of Americans are hesitant to receive a vaccine, looking to concerns of adverse side effects and the lack of efficacy, with concerns that a vaccine may be released prematurely.
  • With rising percentages in claimed efficacy, which include profiles of different age groups and communities within the trials of thousands of participants, it is vital that patient safety and product efficacy remains at the forefront of considerations.
  • Closer to home: With the UK government funding efforts to develop a vaccine, new ‘megalabs’ are being announced; ultimately speeding up the process for finding a solution.

In the coming weeks and months, it is likely that many more vaccines shall join current leading phase-3 trials: The World Health Organisation are predicting that more than 200 companies are developing vaccines for the virus.

More vaccines should mean better global availability for treatment but leave copious amounts of data. Operating in different ways – key differences in their application of mRNA technology – and ranging in different degrees of success, the risk of adverse reactions is likely to increase in direct correlation to the rising number of vaccinations coming to market.

Whilst we are yet to hear of any reports of major safety concerns within current ongoing trials, with regards to the detection of significant adverse effects, it remains vital to persist with the highest level of caution during the clinical phase, as any issues overlooked here will undoubtedly concern the safety of patients from a queue capable of spanning across the equator.

PharSafer Comment

Impact of Adverse Drug Reactions  

Whilst there have not been any major safety concerns reported during the current clinical phase, the case remains that, just like any other drug on the market; following licensure, the immediate post-marketing safety of patients is not guaranteed.

As a result, a significant increase in demand for post-marketing safety reporting procedures is to be expected for the COVID vaccine, due to both the scale of release and speed of which it has come to market.

Therefore, many regulators and license holders of these vaccines are urgently seeking solutions for the improved reporting of potentially high volumes of adverse reactions due to the very large patient exposure over a concentrated period of time – with AI driven reporting tools, designed to process the high volume of COVID-19 vaccine Adverse Drug Reactions, being the clear and obvious solution – ensuring 100% accuracy of data entries and focussed follow up; in addition to attempting to get as much information as possible.

PharSafer are working hard, continuing to strive for innovative solutions, to make this a reality – whether your case processing needs are large or small; national or multi-national – contact us to find out how RAPTAR can change the way your case processing is performed; managed and improved.

Additionally, for all PharSafer industry updates, please follow us on our designated LinkedIn page or visit our website.

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