Ill omens
With the UK kicking off the global vaccine drive this week, the fight against the raging pandemic has entered a new stage. For months on end, vaccines have been portrayed as the only way back for our society to return to a world without Covid. Leaders across the world have promised a vaccine for all, a promise to leave no one behind. As such, questions have been raised over whether it would indeed be possible to inoculate everyone, willing or otherwise. A grave concern for many across the world is the idea that enough vaccines will not be available for the poorest nations and the poorest citizens. Reports have shown that developed economies such as Japan and Canada have combined vaccine orders that could innoculate their respective populations several times over. Moreover, new mRNA vaccines such as the Pfizer vaccine require special logistical arrangements and infrastructure for delivery and storage of the vaccines, another prohibitive factor for the use of such vaccines in poorer nations.
As such, while many nations have bought hundreds of millions of doses of the leading vaccine candidates, it is the AstraZeneca Oxford vaccine that is being pegged as the likely choice of vaccine for a significant portion of the world. AstraZeneca vaccine is a cheaper and more stable vaccine that can be refrigerated and stored normally and is, as such, the preferred vaccine with billions of doses on order across the world. Regulators in India and several other countries are expected to provide emergency authorisation for the use of the vaccine in coming weeks, based on clinical trials that were held outside the US.
Of course, in the complicated world of vaccines, things are not quite so straightforward and AstraZeneca has come under a great deal of criticism for what many experts see as a lack of transparency regarding its early results, design of their studies, safety issues and critically, the efficacy of the vaccine. While this has not been a major issue for regulators worldwide, many reports have indicated that the vaccine maker may well have burnt down most of its credibility with US regulators by this point. The US, at this point, has not authorised the use of the Oxford vaccine. Indeed, AstraZeneca is yet to even resume its trials in America which must come before any approval by the FDA. This was following a worldwide halt of the trials after a participant in its UK trials fell ill. Accidents and side-effects happen. This is part of the process and why trials are necessary in the first place. What shocked the FDA and damaged the credibility of the AstraZeneca in front of US regulators is the fact that the company did not itself divulge news of this complication to the FDA during a meeting. FDA officials heard the news in much the same way as any of us when the whole thing broke out on the news. The result? While trials continued elsewhere in the world, the US trials of the Oxford vaccine came to a screeching halt.
That was not all. Reports emerged later on that AstraZeneca's UK scientists had made a major 'mistake' during the trials that could not only further bring the efficacy of the vaccine to question but also potentially halt the approval process in the UK. After reporting a 90 per cent effectiveness of their vaccine, AstraZeneca revealed that this result came from a batch of volunteers that was first accidentally given half a dose and then a full dose at least a month later. The dosage that was actually the recommended dosage, a full two doses, actually only managed to be 62 per cent effective. AstraZeneca played off the whole affair as a happy accident with an end that justifies all the stumbling along the way. But as UK regulators later noted, this admission of a happy mistake actually leaves AstraZeneca on shaky ground as it raises serious questions over just how conclusive the trials actually were. This confusion is likely to further damage the chances of an FDA approval. Some analysts have gone so far as to say the vaccine will never be officially licensed in the US following such public 'blunders'. It was even reported later on that the effectiveness result that was reported by the company was actually combined from two very different trials held in the UK and Brazil. This 'patched-together' analysis is yet another red flag for many experts. It is likely now that the increased scrutiny that the vaccine maker is now under will come with even more criticism over time. All the same, this is not likely to change the fact that the Oxford vaccine will still likely be the most widely used vaccine. What this series of miscommunications and irregular trials will mean in the long run remains to be seen. After all, history has shown that any oversights in mass vaccination campaigns can have a significant cost.
