Welcome to ‘Is It Safe?’, a newsletter about medicines and their harms.
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While clarity on when a vaccine for COVID-19 will be ready for widespread distribution is difficult to find, it is clear that monitoring for safety and the safety messaging around the vaccine(s) will be key. The mere fact the vaccines are being developed faster than normal might be enough to create unease and vaccine hesitancy, but when it is linked concerns that politics may be interfering in the normal evaluation of efficacy and safety that effect may be vastly increased. Pertousis-Harris has an excellent primer in Drug Safety on vaccine safety. This warning about future problems within it is key:
Deploying any new vaccine based on data from expedited clinical trials into a population without a functioning safety monitoring system in place is reckless and irresponsible given the tools that are available. While there are international collaborations aimed at supporting coordinated efforts in COVID-19 vaccine safety assessments, vaccine nationalism and a lack of a globally coordinated vaccine safety effort could limit the potential in this space. Furthermore, deployment of vaccines before the successful completion of robust clinical programmes could threaten not only public confidence in COVID-19 vaccines but also immunisation programmes in general.
It is worth remembering that when deploying a vaccine to large populations rare events will become ‘common’, and rare adverse effects are precisely the ones hard to find before mass use. Here is the basic maths from vaccine safety scientist Rebecca Chandler.
And of course, the risks of the vaccine have to be balanced against the benefits, and the benefits vary based on the age cohort who received the vaccine. Clearly there are going to have to be very clear communication strategies to manage harms that are detected, and that is going to have to vary dependent on the nature of any concerns that arise, and the age group affected. If an age cohort who handle COVID-19 well, are being asked to take a vaccine they feel isn’t ‘safe’ then we will have a problem. There is a very real danger that a beneficial vaccine could be undermined if this is not handled well, and there are plenty of actors out there will will do their utmost to ensure it is.
Scandals versus widespread failure
At the heart of consideration of poor quality care is the paradox that while studies commonly estimate that in the order of 1 in 10 hospital patients are in some way harmed by the care they receive,11 the sorts of scandals mentioned above shock, in part, because of their rarity. They are not ‘normal’ (indeed, perverse normalisation of shockingly poor care is part of what causes these rare scandals.12 In other words, there is a danger of only concentrating on the notorious scandals while missing the slow accretion of suboptimal care (and especially systems of care with in-built inequity), which at the population level is responsible for more damage.
It’s the old plane crash versus general build of road crash fatalities argument…
Readers may be familiar with the PINCER trial. The East Midlands Academic Health Science Network reports on the roll out of PINCER. It is now used in about two-thirds of CCGs in England, and seems to be preventing thousands of patients being exposed to risky medication. For example, 10,559 patients have had risk factors for a GI bleed removed.
Dexamethasone is in the news
“Some White House staff members wondered whether Mr. Trump’s behavior was spurred by a cocktail of drugs he has been taking to treat the coronavirus, including dexamethasone, a steroid that can cause mood swings and can give a false level of energy and a sense of euphoria.”
"It is a scandal that this approach [large simple randomised trials] has not been replicated worldwide in order to capture a very much larger proportion of those admitted to hospital with Covid-19. Had this been done we would have had much more rapid and much higher quality answers to vital clinical questions about treatment."
That’s all, and don’t forget to tell any anyone you think might be interested about the newsletter.
Don’t forget to report your suspected adverse effects from medicines. In the UK, this is the Yellow Card Scheme