Boris Johnson has announced that the Pfizer vaccine will be distributed from next week. How did that happen, and are they cutting corners? Siouxsie Wiles explains.
The UK has become the first country in the world to approve a Covid-19 vaccine. It’s an emergency approval but means they’re likely to start vaccinating people in a matter of weeks. It’s the same vaccine the New Zealand government recently signed a binding agreement to secure early next year. Here’s the background to the UK announcement.
Which vaccine is this?
It’s the Pfizer vaccine that has been licensed from BioNTech. That’s one of the mRNA vaccines that’s made up of the genetic material that codes for a specific part of the SARS-CoV-2 virus. The mRNA vaccines are a completely new technology when it comes to making human vaccines which means there aren’t any that are currently fully licensed for use in humans.
A quick reminder: the idea behind these vaccines is that by introducing the virus’s genetic material into our body, our cells will read the code and make the protein for our immune system to see. As I’ve explained before, the advantages of this approach are that it is really quick to develop vaccines like this and much easier to upscale and manufacture. The downside is that they tend to need to be stored at very cold temperatures. Like -70 degrees Celsius cold. That’s because mRNA is pretty unstable so keeping it cold helps to stop it being degraded which would render it useless. The need for such cold storage means their rollout will be a little more complicated than the standard childhood vaccines.
How did the UK get to the front of the vaccine queue?
On November 20 Pfizer announced that they were submitting an emergency use authorisation to US Food and Drug Administration (FDA). In that press release they said they had already initiated “rolling submissions across the globe including in Australia, Canada, Europe, Japan and the UK”. At the same time, Pfizer also announced they expected to be able to produce up to 50 million doses before the end of the year and would be ready to distribute the vaccine within hours of it being authorised for use.
In other words, the UK are the first to announce they’ve looked at all the data provided by Pfizer and decided it shows the vaccine is safe and effective enough to grant it an emergency use authorisation. The FDA aren’t having their meeting till December 10.
What’s an emergency use authorisation?
Under normal circumstances, medicines have to go through a rigorous approvals process before they can be used outside of human trials. An emergency use authorisation allows this process to be bypassed temporarily. It applies to both unapproved medicines as well as unapproved uses of already approved medicines. It’s a way to ensure that in a public health emergency, medicines that may be of help can get to more people than would be possible if they were only available as part of a trial.
Importantly, the agencies involved do still look at the data provided by the companies to decide if the medicine is at least safe and preferably effective enough to start rolling out. But an emergency use authorisation does require a much lower level of evidence than a full-blown approvals process. That’s why the authorisation will be limited to a specific number of batches and isn’t a general authorisation to put the particular medicine on the market.
Does the emergency use authorisation mean the vaccine works then?
Not necessarily. Lots of experimental treatments have been given emergency authorisation use, especially in the US, only to be found not to work. Hydroxychloroquine is a good example. And examples like that have the potential to put people’s health and safety at risk as well as erode trust in our regulatory institutions.
What’s really important is that the data the regulatory institutions are using to make their decisions is made available for everyone to see. The data from the Phase I and II trials of the Pfizer vaccine has been published (see here and here and here) but the Phase III data hasn’t yet. Apparently, this is currently under review, but it would have been good if they had made it available to the research community as a pre-print while the formal peer-review process was happening.
Wait, so does that mean the vaccine might not work?
Possibly. Though another way of phrasing it would be that it might not end up working as well as we need it to or better than another vaccine. One big problem with emergency use authorisations in general is that they basically come at the expense of clinical trials. Once a medicine is granted emergency use authorisation, less people will want to be involved in a trial in case they end up in the placebo group and not receive the medicine at all. The less people in the placebo group, the bigger the risk that we end up with not enough data to really establish important long-term outcomes, like safety, or in the case of vaccines, how long protection lasts and whether it prevents infection or just the disease.
Why has the UK needed to go down the emergency use authorisation route?
Because their Covid-19 response has been absolutely abysmal. The Conservative government has spent much of the last decade dismantling the country’s welfare state and selling it off bit by bit, including to their friends and family. This has just accelerated during the pandemic. The best way to sum up their response is to just say that they gave billions of pounds to a private company to set up a new contact tracing system that doesn’t work. They’ve cleverly called it NHS Track and Trace so the publicly-funded national health service will be blamed for its failure. It is run by a former jockey who is married to Conservative MP who, wait for it, served as the UK’s anti-corruption “champion”.
Under Prime Minister Boris Johnson, the British response to this crisis has been characterised by buffoonery, venal self-interest and a blinkered, ideologically contorted incompetence. That is why people are dying. That is why people are desperate. And that is why they are being forced to rush through at a dangerous pace the rollout of this vaccine.