Statistics in the Pfizer Data – how good do they show the vaccine to be?

Statistics in the Pfizer Data – how good do they show the vaccine to be? I never found any virologist who predicted we would have a vaccine that was more than than 70% effective. To have a vaccine that is likely about 95% effective for people 18-64 is nothing short of a medical miracle: we really lucked out.  

However, when you look at the key statistical table (“Table 8: Subgroup Analyses of Second Primary Endpoint: First COVID-19 Occurrence From 7 Days After Dose 2, by Subgroup) things get murkier. More precisely, what one sees is exactly what I thought would happen, the signal becomes really bad for people over 65 and completely useless for people over 75. ...

My friends who think about these questions feel pretty strongly that while the vaccine will likely be less effective in people over 65 than it is in younger people, the dropoff won’t be great enough to make a big difference. For example, if it is 20-25% less effective in these age groups (which they think is the worst case scenario), you still get a vaccine that is roughly between 70% and 75% effective – which is still pretty darn good.  

Still I wish they had enrolled enough people >65 to have a better signal!

Oxford COVID-vaccine paper highlights lingering unknowns about results

Oxford COVID-vaccine paper highlights lingering unknowns about results:The first formally published results from a large clinical trial of a COVID-19 vaccine — which scientists hope could be among the cheapest and easiest to distribute around the world — suggest that the vaccine is safe and effective. But the data also highlight a number of lingering unknowns, including questions about the most effective dosing regimen and how well it works in older adults.

The vaccine, developed by the University of Oxford, UK, and the pharmaceutical firm AstraZeneca in Cambridge, UK, has been closely watched, in part because it is likely to be simpler to distribute than the two RNA-based vaccines from companies Pfizer and Moderna, which need to be stored at low temperatures. The Oxford team is also now the first of these three leading COVID-vaccine developers to publish results from its phase III trials in a peer-reviewed journal — so far, the findings have been disseminated only through press releases.

Chinese-made COVID-19 vaccine is 86% effective

Chinese-made COVID-19 vaccine is 86% effective, early data suggest : A Chinese-made COVID-19 vaccine is 86% effective at preventing infection, an early data analysis suggests.

The vaccine, developed by the state-owned corporation Sinopharm, was already granted "emergency use authorization" by the United Arab Emirates in September, which allowed frontline health care workers to receive the shot, according to a statement from the government. Now, after reviewing data from late-stage clinical trials, the U.A.E. has approved the vaccine for widespread use.

 

Costs Must Be Weighed Against Benefits

Costs Must Be Weighed Against Benefits: What about the benefits and costs of dealing with the COVID-19 pandemic? Much of the medical profession and politicians say that lockdowns, social distancing and mask-wearing are the solutions. CDC data on death rates show if one is under 35, the chances of dying from COVID-19 is much lower than that of being in a bicycle accident. Should we lockdown bicycles? Dr. Martin Kulldorff, professor of medicine at Harvard University, biostatistician and epidemiologist, Dr. Sunetra Gupta, professor at Oxford University and an epidemiologist with expertise in immunology, and Dr. Jay Bhattacharya, professor at Stanford University Medical School, a physician and epidemiologist were the initiators of the Great Barrington Declaration. More than 50,000 scientists and doctors, as well as more than 682,000 ordinary people, have signed the Great Barrington Declaration opposing a second COVID-19 lockdown because they see it doing much more harm than good. 

Efforts to keep very young from getting COVID-19, given most will not even realize they have it or will suffer only mild symptoms, may be counterproductive in that it delays the point where a country has herd immunity. According to the CDC, COVID-19 deaths in young people (from babies to college students) are almost nonexistent.

What you need to know about the coronavirus pandemic on 9 December

COVID-19: What you need to know about the coronavirus pandemic on 9 December: Top stories: US cases pass 15 million; WHO warns vaccine not ready to replace public health measures; Switzerland introduces new restrictions.

As of 09 December 2020, 14 320 392 cases have been reported in the EU/EEA and the UK: Portugal (325 071). As of 09 December 2020, 356 836 deaths have been reported in the EU/EEA and the UK: Portugal (5 041)

FDA announces deaths of two Pfizer vaccine trial participants

First Pfizer coronavirus vaccines expected to land on Wednesday: FDA announces deaths of two Pfizer vaccine trial participants  

FDA Briefing Document - Pfizer-BioNTech COVID-19 Vaccine: Serious Adverse EventsDeathsA total of six (2 vaccine, 4 placebo) of 43,448 enrolled participants (0.01%) died during the reporting period from April 29, 2020 (first participant, first visit) to November 14, 2020 (cutoff date). Both vaccine recipients were >55 years of age; one experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1. The placebo recipients died from myocardial infarction (n=1), hemorrhagic stroke (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age). All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.

It’s Time to Scare People About COVID

It’s Time to Scare People About COVID: Mister Rogers-type nice isn’t working in many parts of the country. It’s time to make people scared and uncomfortable. It’s time for some sharp, focused, terrifying realism.

Facts – Not Fear – Will Stop the Pandemic: The media relish negative news. “If it bleeds it leads” still holds, and perhaps it’s never been truer than in the COVID-19 era. Every day the news highlights the spread of the virus and tells the sad stories of some of its victims.

And yet, much of the media does not pay sufficient attention to the good news regarding improved treatments and survival of patients with the coronavirus. In contrast with the international media, the American press has been unrelentingly negative in its COVID coverage, even when there is good news to tell. That negativity is part of what fuels a culture of fear that affects local, state and federal politicians and the decisions they make.