Fewer journalists ask whether the hype around Pfizer’s announcement is warranted. It makes sense to be hopeful but circumspect. Pfizer released their claims in a press release; there’s no peer-reviewed study yet, unlike in August when they published the results of their BNT162b1 Phase I/II trial in Nature.[6] What that press-friendly account tells is pretty typical for an intermediate vaccine trial. For example, it tells us that Pfizer began the third phase of their BNT162b2 trial (they don’t tell us what happened to the BNT162b1) on July 27^th. They also tell us that, as of yesterday, November 8th, 38,955 have received a second dose of the BNT162b2 vaccine candidate. Pfizer openly admits they released their data after only 94 people had been exposed and analyzed by an unidentified “external, independent Data Monitoring Committee (DMC).”[7] In fact, Pfizer’s “primary efficacy endpoint”—in other words, the way they measure success—is 7 days after the second dose of the vaccine, which is administered three weeks after the first dose. This delivery method is a full week faster than any of the other vaccine trials of its type. It’s also a completely untried bio-delivery mechanism. The vaccine operates by inserting a “nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD).”[8] In other words, the vaccine triggers the immune system to create antibodies to the spike protein on the outside of the coronavirus that allows it to infect us and gives it the “crown” in its name.

It’s a hopeful story, and more data is expected soon to support the vaccine. Still, the scientific community urges caution. Aside from Dr. David Gorski, who questioned the trustworthiness of the CDC and FDA, given its pollution by Trump political appointees, one of the most important voices pulling back on the reins belongs to Dr. Michael Osterholm, director of the University of Minnesota’s Center for Infectious Diseases Research and Policy. Osterholm appeared on Joe Rogan’s podcast warning about coronavirus and refuting the “flu is worse” counternarrative back on March 10^th. Osterholm is excited about the vaccine, as we all are. He also reminds us that Pfizer and BioNTech have not released information on whether the vaccine prevents COVID-19 cases that can lead to hospitalization and death. Nor have they told us whether their vaccine prevents those without symptoms from becoming unknowing spreader of disease. Basically, “it’s too early to start predicting how much of an impact the vaccine could make,” Osterholm warns.[9] And, even if it is actually 90% effective—even Pfizer and BioNTech try to dampen that hope with a helpful “the final vaccine efficacy percentage may vary”—that doesn’t account for how the vaccine will be manufactured.[10] A major confounding factor, left unannounced by most media outlets today, is that the BNT162b2 vaccine requires storage of minus-70˚C (minus-120ºF). This is a temperature below the capabilities of most freezers at, say, physician’s offices or hospitals.[11] It creates a cold storage supply chain issue. So, while the news media sees hope for an effective vaccine under a Biden administration, the most informed scientists recognize that we still have some serious hurdles to overcome.[12] We are a wealthy nation, capable of throwing great force at a problem when we want to. Hopefully, the efforts made to develop the vaccine can now be directed to manufacturing and distributing it. 

Notes

[1] “Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study,” Business Wire, November 9, 2020, https://www.businesswire.com/news/home/20201109005539/en/%C2%A0Pfizer-and-BioNTech-Announce-Vaccine-Candidate-Against-COVID-19-Achieved-Success-in-First-Interim-Analysis-from-Phase-3-Study.

[2] Azeen Ghorayshi and Dan Vergano, “Pfizer’s Coronavirus Vaccine Is More Than 90% Effective, Early Data Says,” BuzzFeed News, November 9, 2020, https://www.buzzfeednews.com/article/azeenghorayshi/coronavirus-vaccine-pfizer-results; “Pfizer Says Its Coronavirus Vaccine Is 90 Percent Effective,” TODAY.com, November 9, 2020, https://www.today.com/video/pfizer-says-its-coronavirus-vaccine-is-90-percent-effective-95576133567.

[3] Katie Thomas, David Gelles, and Carl Zimmer, “Pfizer’s Early Data Shows Vaccine Is More Than 90% Effective,” The New York Times, November 9, 2020, sec. Health, https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html.

[4] David Badash, “‘Era of Lying Is over’: Mike Pence Pummeled for Wrongly Handing Trump Credit for Pfizer COVID Vaccine,” Rawstory, November 9, 2020, https://www.rawstory.com/2020/11/era-of-lying-is-over-mike-pence-pummeled-for-wrongly-handing-trump-credit-for-pfizer-vaccine/.

[5] CBS/AP, “Pfizer Will Seek Emergency-Use Authorization for COVID-19 Vaccine,” CBS News, October 27, 2020, https://www.cbsnews.com/news/covid-vaccine-pfizer-emergency-use-authorization-fda/.

[6] Mark J. Mulligan et al., “Phase I/II Study of COVID-19 RNA Vaccine BNT162b1 in Adults,” Nature 586, no. 7830 (October 22, 2020): 589–93, https://doi.org/10.1038/s41586-020-2639-4.

[7] Pfizer, “Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study,” Pfizer Inc. Pressroom, November 9, 2020, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against.

[8] Mulligan et al., “Phase I/II Study of COVID-19 RNA Vaccine BNT162b1 in Adults,” 162.

[9] Matthew Herper, “Covid-19 Vaccine from Pfizer and BioNTech Is Strongly Effective, Data Show,” STAT, November 9, 2020, https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/.

[10] Pfizer, “Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.”

[11] Beth Mole, “Here’s Everything You Need to Know about Pfizer’s Positive Vaccine News,” Ars Technica, November 9, 2020, https://arstechnica.com/science/2020/11/heres-everything-to-know-about-pfizers-positive-vaccine-news/.

[12] Ewen Callaway, “What Pfizer’s Landmark COVID Vaccine Results Mean for the Pandemic,” Nature, November 9, 2020, https://doi.org/10.1038/d41586-020-03166-8; Hannah Osborne, “Pfizer COVID Vaccine—Scientists React with Caution and Questions,” Newsweek, November 9, 2020, https://www.newsweek.com/covid-vaccine-pfizer-scientists-cautious-questions-1546018.