Nov 9: Pfizer releases data from its COVID-19 vaccine trial showing that the vaccination was 90% effective. The FDA issues an EUA for Eli Lilly’s bamlanivimab, a monoclonal antibody treatment that mimics the immune system’s response to infection with SARS-CoV-2 and appears to protect high-risk patients with COVID-19 from progressing to more severe forms of the disease. The Dow Jones Industrial Average soars in the wake of the news. Senate Majority Leader Mitch McConnell (R-Ky.) backs President Trump’s refusal to recognize President-elect Joe Biden’s election victory. Attorney General William Barr authorizes federal prosecutors to investigate “specific allegations” of voter fraud before presidential election results are certified. The Trump White House tells administration leaders not to cooperate with President-elect Joe Biden’s transition team.
“Today is a great day for science and humanity,” proclaims Dr. Albert Bourla, CEO and Chair of Pfizer, the pharmaceutical giant. Early this morning, his company announces its SARS-CoV-2 vaccine trial conducted with partner BioNTech is 90% effective. The news media erupts with heartfelt stories juxtaposing fears about the current increase in cases around the world with the promise of “millions of doses” of Pfizer’s vaccine in the next few months. University of Pennsylvania’s Dr. Paul Offit—the member of FDA’s vaccine advisory panel who proclaimed on CNN in early March that, “It’s really fear that we have to combat more than the [corona]virus itself”—welcomes the news. And he’s not alone. At least at first, the Trump group cheers along as well, even though Biden’s team is more cautious. Ken Farnaso, Deputy National Press Secretary claims this is part of “Operation Warp Speed,” the plan to dump money into the pharma companies in exchange for a vaccine. But it turns out Pfizer never got “Warp Speed” funds to make their vaccine; Kathrin Jansen, a senior vice president and the head of vaccine research and development at Pfizer maintained that they wanted to stay free from political entanglements, only taking government money to mass produce the already instantiated vaccine, not when developing it. The Twitterverse jumps on the false claim by Farnaso and by VP Pence, who parrots him.
As the day goes on, however, Trump supporters move from cheering to fuming. It’s not just that they want credit. Starting with one of the president’s sons, they insinuate that Pfizer withheld this information until after the election in order to hurt Trump — should be investigated for election interference. Pfizer’s announcement undercuts this possibility, since their analysis wasn’t conducted until just yesterday. On the contrary, Pfizer was already seeking Emergency Use Authorization from the FDA before the election. And with their stock slightly down this year, they’re promoting this “90% effective” news as loudly as they can, and their stock price is showing it.
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. 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 27th. 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).” 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).” 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 10th. 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. 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. 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. 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. 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.
 “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.
 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.
 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.
 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/.
 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/.
 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.
 Mulligan et al., “Phase I/II Study of COVID-19 RNA Vaccine BNT162b1 in Adults,” 162.
 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/.
 Pfizer, “Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study.”
 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/.
 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.
Mole, Beth. “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/.
Taquet, Maxime, Sierra Luciano, John R. Geddes, and Paul J. Harrison. “Bidirectional Associations between COVID-19 and Psychiatric Disorder: Retrospective Cohort Studies of 62 354 COVID-19 Cases in the USA.” The Lancet Psychiatry (November 9, 2020). https://doi.org/10.1016/S2215-0366(20)30462-4.
“Tripadvisor Reveals 2020 Thanksgiving Travel Index: Over Half (56%) of Americans Still Traveling.” Tripadvisor, November 9, 2020. https://ir.tripadvisor.com/news-releases/news-release-details/tripadvisor-reveals-2020-thanksgiving-travel-index-over-half-56.
It's hard to tell whether GOP leaders are being strategic and cynical (e.g. hoping to keep their base excited) when indulging claims of election-rigging, or are just wholly disconnected from reality. But in some ways I wonder if it's even possible to distinguish between the two.— Nate Silver (@NateSilver538) November 9, 2020
people like this fuckin crack me up bro they act like their lives are so hard hahaha pic.twitter.com/X4ImXbSiSf— kurtis conner (@kurtisconner) November 9, 2020
Ken Farnaso, Deputy National Press Security for Team lying Trump: "Thanks to President Trump’s Operation Warp Speed, we are one step closer to the #coronavirus #vaccine."— 🔴Lalyta 💔🇮🇹💔🇧🇴 (@lalytatweets) November 9, 2020
Pfizer: "We were never part of the Warp Speed"
Never-ending shameless lying
A national mask mandate? How bout national VOTER ID LAWS?!— Tomi Lahren (@TomiLahren) November 9, 2020
Why don’t Democrats want to know the truth about ballot integrity in Pennsylvania?— Rep. Jim Jordan (@Jim_Jordan) November 9, 2020
Is it even an official conference if you aren’t using Four Seasons Total Landscaping? By popular demand – we have a properly sized @zoom_us background. Drop a photo if you use it! #LawnAndOrder pic.twitter.com/7m8R3NpvIz— Four Seasons Total Landscaping (@therealfstl1992) November 9, 2020
The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right? 🙄 https://t.co/nS5rkywKXT— Donald Trump Jr. (@DonaldJTrumpJr) November 9, 2020
You see a man, sitting in the most powerful chair in the world for the last time. All his lies, deception and divisive rhetoric have failed. His embracement of Fascism, racism & white supremacy unmasked. Alone in his misery he begins his new nightmare in the Twilight Zone. pic.twitter.com/dQRr5X0Zrx— Jay David Murphy (@JayDavidMurphy) November 9, 2020
BREAKING: The parents of 666 kids, separated by this administration, have not been found. That’s over 100 more than the 545 previously in the news. We will search for these parents, but we need their phone numbers. After over a year, the government still hasn’t provided them.— ACLU (@ACLU) November 9, 2020
More testing was required and data hadn't even been peer-reviewed. This clearly wasn't ready to be distributed nationwide. pic.twitter.com/5Hr2eEpZjj— Luke Huizenga (@huizengard_) November 9, 2020