Viewpoints: Be Optimistic, But Watch Authorization Of Vaccine Very Closely

Stat: Make Pre-Approval Covid-19 Vaccines Available Via Expanded Access
On Monday, Pfizer and BioNTech announced that their experimental Covid-19 vaccine candidate prevented more than 90% of infections in healthy volunteers. Based on these encouraging data — potentially among the most effective for any infectious disease — the companies plan to apply for emergency use authorization, which would let the Food and Drug Administration formally authorize an unapproved medical product during a state of emergency. While well-intentioned, this approach is ultimately misguided. The world faces a crisis not an emergency. (Matthew W. McCarthy, David Oshinsky and Arthur Caplan on behalf of the Vaccine Working Group on Ethics and Policy, 11/9)

The Wall Street Journal: How Vaccines Prove Their Safety
As acute and infectious disease neurologists, we are often asked if a vaccine is safe. Pfizer’s announcement Monday that its Covid-19 vaccine is 90% effective makes the question even more pertinent. Earlier this year, two late-stage clinical trials, from Johnson & Johnson and AstraZeneca, were briefly paused after reports of neurological concerns in individual study participants. Each of these rare instances was carefully scrutinized as an adverse event—a serious clinical observation that requires review by the Data and Safety Monitoring Board. (Kevin N. Sheth and Serena Spudich, 11/9)

Stat: Covid-19 Is Speeding Transformation In The Clinical Research Industry 
Before the onset of the coronavirus pandemic, leading organizations in clinical research had been gradually discovering, experimenting with, and implementing remote technology. The pandemic has catapulted their transformation agendas forward. (Andrea Bastek, 11/10)

Los Angeles Times: Vaccine A Ray Of Hope For An End To Coronavirus — In 2021
On Monday, a still-divided America received some pandemic news that just about everyone can be happy about: An experimental COVID-19 vaccine developed by drug manufacturer Pfizer and BioNTech, a German pharmaceutical company, is just weeks away from filing for federal approval to start producing millions of doses. What’s more, preliminary data show this vaccine is a whopping 90% effective in protecting against a COVID-19 infection without causing serious side effects. Health officials would have been pleased with a COVID vaccine that protected 70% of the people who took it. The Food and Drug Administration requires only a 50% efficacy rate. (11/10)

Bloomberg: Pfizer Vaccine Success Offers Real Pandemic Optimism
Last week I wrote that based on clinical trial math, the earliest looks at coronavirus vaccine data were less likely to succeed. I've never been happier to be wrong. Pfizer Inc. and BioNTech SE announced Monday that their vaccine candidate prevented over 90% of Covid-19 cases in an early look at results from their 44,000-person clinical trial.It's fantastic news and a historic scientific accomplishment. Not only do we have the first effective vaccine, but the data also looks robust. Instead of evaluating the shot at the first possible moment, Pfizer waited for more data, which gives weight to the impressive results. (Max Nisen, 11/9)

The New York Times: Don’t Get Too Excited About The Coronavirus Vaccine
The announcement that Pfizer’s coronavirus vaccine is more than 90 percent effective at preventing Covid-19 infections — much better than many anticipated — is cause for celebration. With a vaccine of this efficacy, suppression of the disease is entirely realistic. Unfortunately, this development doesn’t mean we can all relax and start doing more things. It means we need to tighten up even further until the vaccine becomes available. (Aaron E. Carroll and Nicholas Bagley, 11/10)

The Washington Post: The Vaccine News Is Exciting. But Keep Your Mask On.
Prepare for many more ups and downs, but the announcement from Pfizer and its partner BioNTech of Germany is a genuinely promising moment in the difficult battle against the coronavirus pandemic. No one has ever won regulatory approval for an effective vaccine that uses messenger RNA (mRNA) to stimulate an immune response. Now, the pharma companies say their experimental vaccine is more than 90 percent effective at preventing covid-19. (11/9)

The Washington Post: Trump Politicized Covid-19. Let’s Not Politicize The Vaccine.
On Monday morning, pharmaceutical giant Pfizer announced that its new covid-19 vaccine was proving 90 percent effective in trials. This was spectacularly good news, if it holds up, far exceeding the expectations of many epidemiologists and sending the stock market soaring. But almost immediately, this development — like everything else that seems to happen in modern America — became subsumed in a political fight. (Max Boot, 11/9)

CNN: How Pfizer Vaccine News Affects Coronavirus Control 
The latest surge of Covid-19 infections in the US could not be occurring at a worse time -- not just because the winter and influenza seasons are approaching or because the entire country is already worn down by the pandemic, but rather because we have entered into the lame-duck period between Election Day and the inauguration of President-elect Joe Biden on January 20, 2021. This interval is a non-trivial 5% of the entire Donald Trump presidency. (Kent Sepkowitz, 11/9)

The Hill: Pfizer COVID-19 Announcement: Early Victories In A Race Not Yet Won 
As COVID-19 cases caused by the novel coronavirus, SARS-CoV-2, continue to surge, U.S. drugmaker Pfizer announced early results indicating that its vaccine is more than 90 percent effective. The announcement represents a major milestone toward controlling the COVID-19 pandemic. However, these are interim results and continued patience and vigilance are required to see a safe and efficacious vaccine to the finish line. There are currently ten other COVID-19 vaccines in late-stage trials. (Felicia Goodrum Sterling and James Alwine, 11/9)

The Washington Post: I Was Part Of A Trial For Pfizer’s Covid-19 Vaccine. It’s A Miracle For Genetic Medicine.
“Look me in the eyes,” the doctor ordered, staring at me from behind her plastic face guard. Her eyes were blue, almost as blue as her hospital mask. Yet, after a moment, I started to turn and face the doctor on my left, who was jabbing a long needle deep into the muscle of my upper arm. “No!” the first doctor snapped. “Look at me!” Then she explained. Because I was part of a double-blind clinical trial of an experimental covid-19 vaccine, they had to make sure that I didn’t get any clues about whether I was being injected with a real dose or merely a placebo made of saline solution. (Walter Isaacson, 11/9)

Bloomberg: Pfizer Vaccine Shouldn’t Stall Covid-19 Fiscal Relief In Congress
Monday’s very favorable news from Pfizer Inc. – that its Covid-19 vaccine candidate was found to be more than 90% effective at preventing disease in early clinical-trial results – raises hopes for a day, and soon, when the pandemic is behind us. It is also just one of the many vaccines that are under development. With such good news, it may be tempting for Congress to conclude that a major fiscal relief effort is no longer needed. That would be a mistake. (Mohamed A. El-Erian, 11/9)

JAMA: Misguided Use Of Hydroxychloroquine For COVID-19: The Infusion Of Politics Into Science 
This issue of JAMA contains yet another study, and certainly among the best published to date, demonstrating the lack of efficacy of hydroxychloroquine as a treatment of coronavirus disease 2019 (COVID-19). This study, from the National Heart, Lung, and Blood Institute PETAL Clinical Trials Network, focused on hospitalized patients with moderate to severe disease. In this well-conducted, appropriately powered clinical trial, the authors randomized 479 patients to receive hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237). The trial was stopped early at the fourth interim analysis for futility. For the primary outcome, clinical status at 14 days measured on a 7-category ordinal scale, there was no significant difference between the hydroxychloroquine and placebo groups (median [interquartile range {IQR}] score, 6 [4-7] vs 6 [4-7]; adjusted odds ratio, 1.02 [95% CI, 0.73-1.42]). (Michael S. Saag, 11/9)