This week is headed towards being a big news week on the COVID front, as the UK approved the Pfizer/BioNTech vaccine previously and began administering it this week. In the US, our FDA has an outside advisory panel meeting tomorrow (as NIH director Francis Collins mentions in this interview) to decide on Pfizer’s vaccine, and Dec. 17 to decide on the Moderna one. But in advance of that, there are a couple of other things worth thinking about.

False side effects are going to make big news

With these vaccines starting to roll out, though, scientist Derek Lowe highlighted how we should be ready for news of “false side effects”. Here’s the deal: Suppose I was going to die tomorrow of natural causes (a heart attack, say) whether I was vaccinated or not, but I happened to get vaccinated today. If I then suddenly die tomorrow, what are the odds my family would blame it on the vaccine? Probably pretty high, since the vaccine is new.

Shortly, we’re likely going to see a huge burst of exactly this kind of news – anecdotal reports of people suddenly being seriously ill immediately after being vaccinated. Here’s how Lowe summarizes the basic problem:

Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.

This is just looking at what happens to people without anything going on in their lives, vaccine or otherwise. If you vaccinate this many people (and 10 million is just a starting point) some of them are going to happen to have heart attacks, or get cancer, or have strokes, for reasons that have nothing to do with whatever treatment they received. That’s just the statistics of it. Lowe then goes on:

But if you took those ten million people and gave them a new vaccine instead, there’s a real danger that those heart attacks, cancer diagnoses, and deaths will be attributed to the vaccine. I mean, if you reach a large enough population, you are literally going to have cases where someone gets the vaccine and drops dead the next day (just as they would have if they didn’t get the vaccine). It could prove difficult to convince that person’s friends and relatives of that lack of connection, though.

So, the basic upshot is that as soon as vaccinations start being done en masse we’re likely going to start seeing lots of news of all the serious illness they cause. Yes, governments and Pfizer/Moderna/etc. will be carefully monitoring the statistics to ensure that the vaccines are NOT actually causing issues. But this likely won’t help stop all the anecdotal reports which will come out in the news and on social media.

The Pfizer/BioNTech data is out and looks good

As Derek Lowe also highlights, Pfizer/BioNTech has their data out ahead of the FDA meeting tomorrow. This was tested on about 38,000 people, roughly half in each of the treatment and placebo groups, and it looks very good – no serious safety concerns, and the vaccine appears quite effective.

How effective is it? The final numbers tell us that there were 170 cases among the 38,000 patients in the trial. 162 of these were in the placebo group (which got no vaccine) and eight in the vaccinated group. That corresponds to a final efficacy of 95%.

In terms of safety concerns, there were some issues with soreness, fever, headaches, etc., but no more life-threatening events in the vaccine group than the placebo group (see above). Folks with long histories of serious immune reactions may need to be careful here as with any vaccine, but that’s to be expected.

I would definitely get the vaccine based on this data. Lowe doesn’t answer precisely that question, but instead looks at whether the FDA is likely to approve it for emergency use:

The data that Pfizer and BioNTech have presented look like far more than would be needed for an Emergency Use Authorization. I expect the FDA to grant that, and very soon.

But, this is only the beginning of the story, not the end of the story. It’ll begin being used, but there will be a lot of ongoing monitoring to ensure it’s safe for everyone and to answer remaining unanswered questions. From the trials, though, it’s clearly better than anything else we have available at present, and much less hazardous than the virus itself. So Lowe concludes this:

That word “emergency” is there for a reason: this authorization is for something extremely serious for which there is no available alternative. That’s exactly the situation we find ourselves in, on both counts, and I think that the risk/benefit ratio is clearly, overwhelmingly in favor. Let’s do it.

That said, this is not at all the end of the vaccine road. Pfizer’s vaccine requires ultracold storage and distribution, which taxes supply chains, and a limited number of doses are available. Production is ongoing, but this won’t be enough to vaccinate everyone who needs it in any reasonable amount of time. We will need more options.

From what I read, and from the Collins interview, even if the Pfizer vaccine is approved tomorrow, we’re still looking at a timeline of roughly summer 2021 before we can vaccinate enough of our population to resume “normal” activities. Hopefully availability of additional vaccines will change this.

Other vaccine news

As noted above, Moderna’s vaccine will be evaluated Dec. 17, so we should have more news next week, too.

If you want to know more about how the FDA is vetting these, the WSJ had a decent article last week – the same day British regulators approved the Pfizer vaccine for distribution. The FDA’s internal review is summarized this way:

In an interview with The Wall Street Journal, Dr. Hahn said his agency has had 150 people working days, nights and weekends in parallel teams to review the test data submitted by Pfizer and German partner BioNTech SE.

Tomorrow’s meeting is an unusual step, and involves an outside advisory committee making recommendations in order to help alleviate any public concerns.

Assuming the Pfizer approval goes through, one lingering question is how to use it. It’s intended to be administered as two doses, spaced out, but even a single dose appears to help. Do we use up all of the current available stock giving 35 million single doses, or vaccinate only half as many people so we have two doses for each? Former FDA commissioner Scott Gottlieb is arguing for the former both because the first dose already begins to provide some protection, and because more are being made. He wants to see as many people vaccinated as quickly as possible.

In one other piece of news, the trials on the Oxford/AstraZeneca vaccine got a bit muddled and, while the vaccine likely has some value, it may take more effort to sort out how effective it will be, due a number of mistakes in how the trials were done.