For the last two weeks, we have witnessed a media frenzy of rejoicing in response to the preliminary drug-company announcements about the COVID-19 vaccine trials. First, on the 9/11/20, an interim press release by Pfizer-BioNTech reported that early data from their research trial suggested that the vaccine was ‘more than 90% effective in preventing COVID-19’. A week later, this news was trumped by Moderna who claimed that provisional results had indicated that their chemical was 94.5% effective. And then, on the 23/11/20, Oxford-AstraZeneca announced that their vaccine had shown an ‘average efficacy of 70%’, but potentially up to 90% depending on dosage. These news releases have evoked unbridled elation in politicians (of all colours) and across the mainstream TV networks, as if – finally – the coronavirus-busting cavalry has appeared on the horizon to liberate us from the torturous restrictions.
But is this euphoria justified?
I am not a die-hard anti-vaxxer, but I believe there are valid reasons to be cautious about the benefits likely to accrue from the COVID-19 vaccines. Here are five points to consider:
1. Trials are not designed to show that vaccines confer immunity
Contrary to common-sense expectation, the research trials are not designed to demonstrate that vaccination confers immunity to SARS-COV-2 (the virus responsible for COVID-19). Instead, the primary aim of the studies is to show that vaccines can significantly reduce the severity of COVID-19 symptoms in those people who subsequently contract the virus. Any claims that the vaccines promote immunity will be based on secondary observations of the research data, a much less robust evidence base. This research limitation was acknowledged by Tel Zaks (the Chief Medical Officer at Moderna) when he admitted that the trial results ‘do not show this vaccine can prevent you from transiently carrying the virus and infecting others’.
2. Big Pharma is the most corrupt industry in the world
In the last 20 years, the pharmaceutical industry has – in total – been fined over $14 billion for a variety of malpractices. For example, Pfizer (one of the front runners in the COVID-19 vaccine race) has been compelled to pay out a total of $4.7 billion, including $3.3 billion for 10 offences relating to ‘unapproved promotion of medical products’ and $104 million for five offences of ‘drug/medical equipment safety violation’. AstraZeneca (another pioneer in the vaccine race) has been fined over $1.1 billion by the regulatory authorities, incorporating $543 million for 12 instances of ‘false claims’ and a $5.5 million penalty for ‘kickbacks and bribery’. Given this murky history, it is wise to display a degree scepticism about the validity of the initial proclamations about the success of their vaccine trials.
3. Additional safety concerns from using novel technologies
Some of the vaccine development projects, including the Pfizer-BioNTech and Moderna trials, are deploying a never-before-used technology which involves the injection of genetic material (modified mRNA) rather than the more traditional process of vaccinating with inactivated or weakened forms of the virus itself. This new scientific method, together with the unprecedented speed with which these vaccines are being developed, should raise additional safety concerns.
4. Ambiguous reporting of trial results
Research trials sponsored by the pharmaceutical industry are notorious for their self-serving distortions (Goldacre, 2012). Common sleights of hand include: use of trivial outcome measures that are of little consequence to the patient; comparing the new drug against one already known to have significant side effects (to make the former look better); and failing to report the intended outcomes because they show the new drug in a poor light. There is more than a whiff of these manoeuvres in the preliminary reports of the vaccine trials. For example, claims of ‘90% effectiveness’ would be underwhelming if it turned out to entail the lowering of the severity of COVID-19 symptoms from moderate to mild – in essence, similar to taking a prophylactic Lemsip for a bad cold that you will probably never catch. Furthermore, the preliminary report of the results of the Oxford-AstraZeneca trial – with its reference to efficacy ranging from 62% to 90% ‘depending on dosage' – smacks of bad science, where the planned outcome measure was disappointing so they’ve trawled the statistical permutations to find something better.
5. Doubtful whether vaccination will achieve benefits for the large majority of people
With an Infection Fatality Rate (IFR) in the range of 0.15 to 0.2 % , a median age of those dying of around 82, and 80% of those infected displaying either no or very mild symptoms, it is highly questionable whether vaccination will provide a net benefit for the large majority of the population. This is reinforced by the fact that some previous vaccines, such as that for the swine flu in 2009, have caused recipients serious damage. It is, therefore, difficult to see how consenting to vaccination would be a rational decision for healthy people under 70 years of age.
Based on the above, it is reasonable to conclude that the hype and euphoria surrounding the preliminary findings of the vaccine trials are, at best, premature and may turn out to be completely unjustified. On what we know to date, it seems the best we can realistically hope for is that a COVID-19 vaccine will provide a useful option for those who are elderly and/or who suffer with serious pre-existing medical conditions.
Reference:
Goldacre, B. (2012). Bad Pharma: How drug companies mislead doctors and harm patients. London: HarperCollins.