Not all vaccines are made equal
The most important news in healthcare: Friday, November 27
Today, we’re covering the data on the newest vaccine to report results, which is decidedly fishier than what we’ve seen before.
Today’s Pulse is 700 words, or a 5 minute read.
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The pulse:
New week, new vaccine data - but this time, it’s not all roses. On Monday, pharma giant AstraZeneca announced results from its collaboration with Oxford, claiming 70% efficacy for a vaccine that is cheaper, easier to produce, and easier to store than the previously announced Moderna and Pfizer vaccines. Doubts around AstraZeneca’s data analysis and transparency, however, are threatening the vaccine’s approval for use for use in the U.S.
The data is…weird
AstraZeneca’s efficacy data is a little bit more complicated than the easy-to-interpret 70% they presented. They actually reported results from two different regimens:
Some patients received a half dose of the vaccine as their first shot, and a full dose in their second shot. In these patients, efficacy was reported to be 90% (!!).
Other patients received a full dose of the vaccine as their first shot, and a full dose as their second shot. In these patients, efficacy was reported to be 62%.
The average across these two regimens, AstraZeneca says, is 70%.
Wait…what? Why are patients who are receiving less vaccine getting more protection? We don’t know for sure, said AstraZeneca’s researchers, and even as scientists began to brainstorm reasons for this irregularity, news leaked that the more effective, half-dose regimen started out as a mistake - AstraZeneca never meant to do it, but incompetence in their dose distribution ended up making it happened. AstraZeneca’s executives have called this “serendipity,” but it’s slightly disturbing that their best data is the result of such a glaring mistake and that they did not report this mistake as soon as it happened.
In the days since AstraZeneca first announced their results, more irregularities have arisen. The data, strangely, combines studies from the UK and Brazil, which started at different times and had substantially different protocols. The dosing regimen, even for the fixed full dose, likely varied significantly between patients. The half-dose regimen group did not include any patients over the age of 55. Fewer than 2,800 people got the half-dose regimen, while almost 9,000 received the full dose regimen. And let’s not forget - the trial was put on hold over the summer due to a “serious adverse event” that has not been disclosed to date.
Source: Barrons.com
What does this mean for the vaccine?
The AstraZeneca vaccine was hyped not necessarily as the most effective option, but as a really cheap and really convenient option. Pfizer and Moderna’s vaccines cost $20 – 35 a dose and need to be stored in freezers. AstraZeneca’s vaccine, on the other hand, will cost $3 a dose and can be kept at fridge temperatures for months. This has large global implications, as it presents an option for countries without the cash or freezer setups to accommodate the Pfizer / Moderna vaccines.
In the U.S., however, experts are questioning whether the vaccine will be approved. Anthony Fauci has warned that we’ll need to see more data before making a conclusion, while Leerink analyst Geoffrey Porges issued a scathing comment:
We regard the data disclosure as premature and insufficient, and is likely to attract a raft of criticism. The companies are clearly already positioning the product as suitable for use in less developed countries, where their relatively favorable storage conditions may be advantageous…we believe that this product will never be licensed in the U.S.
There’s a lot to keep track of with all of these vaccines. Can you summarize what we know so far?
Sure…
There are three vaccines that we have data about:
Pfizer / BioNTech
Type: mRNA
Likely approval: December 10, 2020
Price: $19.50 per dose
Doses by year end: Roughly 50 million (2 doses needed per person)
Moderna
Type: mRNA
Likely approval: December 10, 2020
Price: $25 – 35 per dose
Doses by year end: Roughly 50 million (2 doses needed per person)
AstraZeneca
Type: Adenovirus-based
Likely approval: January 2021 is possible, but unclear whether it will be approved in the U.S.
Price: $3 per dose
Doses by year end: Roughly 30 million (2 doses needed per person)
Bottom line it for me:
AstraZeneca’s vaccine data is suspect, and there’s no room to be suspect for a product that over a billion people could receive. Even if you’re early in line for a vaccine, we’d advise avoiding off on this one until more definitive data is released.