Shot in the arm
The most important news in healthcare: Friday, November 13th
Today, we’re covering every inch of Pfizer’s new COVID-19 vaccine roll-out. We promise, this is not one you’re going to want to skim through.
Today’s Pulse is 800 words, or a 6 minute read.
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COVID-19Pfizer’s mRNA vaccine shows 90% efficacy in preventing COVID-19
The pulse:
On Monday, Pfizer announced that its COVID-19 vaccine showed 90% efficacy in a preliminary readout from its global trial of nearly 44,000 participants. With the news, Pfizer hurtles to the front of the vaccine race.
The data
Pfizer has been working with the company BioNTech since July to conduct a large Phase 3 clinical trial in which half of participants received the new vaccine and the other half received a placebo. To date, 94 participants in the entire trial became sick with COVID. While the specifics of which groups each of these 94 individuals fell into has not yet been released, early analysis suggests that 85 or more of the cases were in the placebo group, meaning that the vaccine is at least 90% effective. It’s a staggering stat - for reference, the 2019 influenza vaccine was roughly half as effective, at 45%. Importantly, the Pfizer vaccine surpasses the 50% efficacy threshold the Food and Drug Administration (FDA) has set in order for a COVID-19 vaccine to get an emergency authorization.
Another bright point is that so far the vaccine appears to be safe, as there were no serious safety concerns reported in any of the participants, though some reported mild symptoms such as pain at the injection site and a low-grade fever. One downside is the vaccine requires two doses 21 days apart to be effective. Requiring multiple doses is a recipe for attrition – for example, research shows that less than one-third of young women who get their first human papilloma virus vaccine return for the remaining two doses of the series. Thus, while many people may line up for their initial dose, it’d likely be a smaller fraction receiving the full protection.
Let’s talk specifics
Pfizer’s vaccine relies on messenger RNA (mRNA), which makes it unusual - no other mRNA vaccine has been previously approved by the FDA. mRNA is a molecule our cells can read to produce proteins. An mRNA vaccine works by giving cells the ability to produce a viral protein that can then trigger an immune response. This is unlike most conventional vaccines - such as the influenza vaccine – which work through the administration of a weaker or “killed” version of the virus that can also trigger the immune system to maintain an attack.
One important advantage of an mRNA vaccine? It’s hypothesized they may actually be safer than traditional approaches, as there is little risk that a viral strain could become infectious (as a weakened virus vaccine may). On the other hand, mRNA is an infamously unstable molecule and highly vulnerable to degradation. This means the vaccine will have to be kept cold. Like really cold.
Ice, ice baby
Pfizer’s vaccine will have to be stored at -70 degrees Celsius. This could pose a significant challenge, as most doctor’s offices don’t currently have the special ultra-cold freezers needed for this. And it’s not exactly something that can just be added to your Amazon cart – these freezers can cost anywhere from $10,000 to $15,000 a pop. This means that the cost of storing the vaccine may be prohibitive, particularly for lower-resourced rural and small community-based health practices. And that might not be the only cause contributing to disparities in distribution.
Called it
Pfizer has announced a plan to produce 1.3 billion doses of the vaccine next year. While that may sound like a lot, it’s only about 17% of the global population. And it turns out, some people have called dibs – mainly the US, UK, EU, Canada, and Japan. The governments of these countries have already made agreements with Pfizer to pre-purchase about 80% of the supply. If you’re wondering how the rest of the world will share the remaining 20% of the supply, you’re in good company.
So do I get on a waiting list, or…?
Some hospital systems have already purchased the vaccine as frontline healthcare workers will receive first priority - potentially as early as the end of this year. Next in line will likely be the elderly and people with other health conditions that put them at high risk, such as obesity or diabetes. The general public will probably be offered vaccinations early next year.
Bottom line it for me:
Pfizer’s preliminary COVID-19 data is killer, and there’s likely more vaccine news on the way as Moderna is expected to share data in the next few days. Both companies are going to keep collecting safety and efficacy data on their vaccines for the next couple years, but with the U.S. crossing 160,000 cases, speed is the need of the hour.