...vaccinated—this doesn’t mean the vaccines don’t work

https://blogs.bmj.com/bmj/2021/08/25/significant-proportions-of-people-admitted-to-hospital-or-dying-from-covid-19-in-england-are-vaccinated-this-doesnt-mean-the-vaccines-dont-work/

Kit Yates, Senior Lecturer, University of Bath, UK.

The BMJ [British Medical Journal:https://www.bmj.com/]

"More vaccinated people are dying of the delta variant of covid than unvaccinated people, according to a recent report from Public Health England. The report shows that 489 of 742 people (65.9%) who died of the delta variant within 28 days of a positive covid test between 1 February 2021 and 2 August 2021, had received at least one dose of the vaccine. 54.1% (402 of 742) had received both doses. This seems like an alarming set of statistics, but with an imperfect vaccine and high vaccination coverage, it is exactly what we would expect."

I think the author is referring to Table 5: Attendance to emergency care and deaths of sequenced and genotyped Delta cases in England by vaccination status (1 February 2021 to 15 August 2021)

Link to the PDF: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1012644/Technical_Briefing_21.pdf

Although I don't quite see those specific numbers

The applicable row seems to be the one labeled: Deaths within 28 days of positive specimen date (pages 22-23)

Among the columns listed are

From an NPR article in February

https://www.npr.org/sections/health-shots/2021/02/19/969143015/long-term-studies-of-covid-19-vaccines-hurt-by-placebo-recipients-getting-immuni

RICHARD HARRIS
February 19, 2021 5:00 AM ET

"Tens of thousands of people who volunteered to be in studies of the Pfizer-BioNTech and Moderna COVID-19 vaccines are still participating in follow-up research. But some key questions won't be easily answered, because many people who had been in the placebo group have now opted to take the vaccine.

***************************************

Mott was one of about 650 volunteers who took the experimental Moderna vaccine at a company called Johnson County Clinical Trials in Lenexa, Kan. Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine.

"During that visit we discussed the options, which included staying in the study without the vaccine," he says, "and amazingly there were people — a couple of people — who chose that."

He suspects those individuals got spooked by rumors about the vaccine. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.

"It's a loss from a scientific standpoint, but given the circumstances I think it's the right thing to do," he says.

People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots.

Dr. Steven Goodman, a clinical trials specialist at Stanford University, says losing those control groups makes it more difficult to answer some important questions about COVID-19 vaccines.

"We don't know how long protections lasts," he says. "We don't know efficacy against variants — for which we definitely need a good control arm — and we also don't know if there are any differences in any of these parameters by age or race or infirmity."

Related link: https://www.democraticunderground.com/100215792289

https://www.bloomberg.com/news/articles/2021-08-30/new-zealand-reports-first-death-linked-to-pfizer-covid-vaccine
By Matthew Brockett
August 29, 2021

New Zealand health authorities reported what they believe to be the country’s first death linked to the Pfizer Covid-19 vaccine.

A woman died from myocarditis, an inflammation of the heart muscle wall, following her Pfizer vaccination, New Zealand’s Covid-19 Vaccine Independent Safety Monitoring Board said in an emailed statement on Monday. It said myocarditis is known to be a rare side effect of the Pfizer vaccine.

related: https://www.health.govt.nz/news-media/media-releases/clinicians-reminded-be-aware-myocarditis-and-pericarditis-symptoms

"Clinicians reminded to be aware of myocarditis and pericarditis symptoms

Media release
30 August 2021

The COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) has advised the Ministry of Health to ensure that healthcare professionals and consumers remain vigilant and are aware of the signs of myocarditis and pericarditis. This advice follows the CV-ISMB's review of the death of a woman following her Comirnaty Pfizer COVID-19 vaccination.

The CV-ISMB extends their sympathies to the woman’s family and friends during this difficult time and thanks the family for their assistance with this investigation.

The CV-ISMB has considered that the woman’s death was due to myocarditis, which is known to be a rare side effect of the Pfizer COVID-19 vaccine.

The case has been referred to the Coroner and the cause of death has not yet been determined. The CV-ISMB considered that the myocarditis was probably due to vaccination. The CV-ISMB noted that there were other medical issues occurring at the same time which may have influenced the outcome following vaccination.

Further details cannot be released while the Coroner investigates.

In New Zealand, adverse events following vaccinations are reported to the Centre for Adverse Reactions Monitoring (CARM). All cases with a fatal outcome are referred to the CV-ISMB for review. CARM provides as much information on the case as possible for the clinical experts on the CV-ISMB to help them in their consideration of whether there was a link to vaccination."

https://www.nbclosangeles.com/news/sports/no-masks-vax-proof-to-see-matches-at-full-capacity-us-open/2679698/

By Howard Fendrich • Published August 25, 2021 •

Spectators will not be required to wear masks or show proof of their vaccination status to attend matches at the U.S. Open when the tennis tournament returns at full capacity next week, one year after all fans were banned from the event because of the coronavirus pandemic.

“The goal is not to prevent all cases of COVID. The goal, really, is to be certain that we don’t have an outbreak of COVID that’s going to be unusual or that we would regret,” Dr. Brian Hainline, a U.S. Tennis Association first vice president and member of its medical advisory group, said on a conference call with reporters on Wednesday. “We’re still relying on the goodwill of people. The unvaccinated — although it’s not going to be enforced — they really should be wearing masks. I expect many vaccinated individuals are going to be wearing masks, as well."

https://www.ox.ac.uk/news/2021-06-23-ivermectin-be-investigated-possible-treatment-covid-19-oxford-s-principle-trial

23 June 2021

PRINCIPLE is one of UK Government’s national priority platform trials of COVID-19 treatments, and the world’s largest currently taking place in community settings looking for treatments at home.

Ivermectin, a widely used antiparasitic drug, has been added to the trial and is being evaluated in participants from today.

For COVID-19, ivermectin has shown promising results as a potential treatment in small studies in humans.

Anyone eligible and with COVID-19 symptoms can join the trial from anywhere in the UK, either online, over the phone or via their health care professional.

From today, ivermectin is being investigated in the UK as part of the Platform Randomised Trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE), the world’s largest clinical trial of possible COVID-19 treatments for recovery at home and in other non-hospital settings.

Led by the University of Oxford, PRINCIPLE is investigating treatments for people at more risk of serious illness from COVID-19 which can speed up recovery, reduce the severity of symptoms and prevent the need for hospital admission. The study has so far recruited more than 5,000 volunteers from across the UK.

Ivermectin is a safe, broad spectrum antiparasitic drug which is in wide use globally to treat parasitic infections."

It is not safe for use outside of a clinical trial .

related link: https://www.principletrial.org/news/ivermectin-to-be-investigated-as-a-possible-treatment-for-covid-19-in-oxford2019s-principle-trial

Matthew tested positive for COVID-19, despite both he and his wife taking two tests 24 hours before they left.

https://abc7news.com/coronavirus-covid-19-travel-restrictions-italy/10970244/

By Tim Johns
Monday, August 23, 2021

MOUNTAIN VIEW, Calif. (KGO) -- It's a trip many people dream of -- an anniversary trip to Italy.

But for Matthew and Katherine Walden of Mountain View, their anniversary to Milan has turned into a nightmare.

"The night that we arrived here in Italy, I woke up in the middle of the night with a fever," Matthew said.

The next morning, Matthew tested positive for COVID-19, despite both he and his wife taking two tests 24 hours before they left and both being fully vaccinated.

Now, they're stuck in quarantine in their hotel for anywhere between 10 and 21 days, depending on how things unfold."

https://www.schengenvisainfo.com/news/eu-to-reimpose-entry-ban-on-travellers-from-us-5-other-third-countries-on-monday-sources-say/

August 28, 2021

"Two officials within the European Union institutions have confirmed for Reuters that the EU Council will on Monday announce its decision to remove from the list of epidemiologically safe third countries a total of six countries, including the United States.

The removal from the list means that the Member States are advised to reimpose the entry ban on travellers from these countries so that the same are no longer eligible to enter restriction-free for non-essential purposes like tourism and business.

The complete list of the countries affected goes as follows:

Israel
Kosovo
Lebanon
Montenegro
North Macedonia
United States

All six have recently reported an increasing number of Coronavirus cases detected within their territory.

https://www.stereogum.com/2158930/neil-young-says-covid-era-concerts-are-irresponsible-these-are-super-spreader-events/news/
AUGUST 27, 2021 1:09 PM BY PETER HELMAN

"Neil Young announced last week that he was dropping out of Farm Aid 2021 due to COVID safety concerns. “I don’t want to let anybody down, but still can’t shake the feeling that it might not be safe for everyone. I worry about audiences coming together in these times,” Young wrote. “My soul tells me it would be wrong to risk having anyone die because they wanted to hear music and be with friends.” And now, in another blog post on his official Neil Young Archives website entitled “Concerts And Covid,” Young has blasted big concert promoters for continuing touring and spreading the virus.

“The big promoters, if they had the awareness, could stop these shows,” Young wrote."

OPINION: https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/

Peter Doshi, senior editor, The BMJ [British Medical Journal:https://www.bmj.com/]
August 23, 2021
Competing interests: I helped organize the Coalition Advocating for Adequately Licensed Medicines (CAALM), which has formally petitioned the FDA to refrain from fully approving any covid-19 vaccine this year (docket FDA-2021-P-0786). A full list of competing interests is available here.

"The “six month” preprint based on the 7% of trial participants who remained blinded at six months

The final efficacy timepoint reported in Pfizer’s preprint is “from four months to the data cut-off.” The confidence interval here is wider than earlier time points because only half of trial participants (53%) made it to the four month mark, and mean follow-up is around 4.4 months (see footnote).

This all happened because starting last December, Pfizer allowed all trial participants to be formally unblinded, and placebo recipients to get vaccinated. By 13 March 2021 (data cut-off), 93% of trial participants (41,128 of 44,060; Fig 1) were unblinded, officially entering “open-label followup.” (Ditto for Moderna: by mid April, 98% of placebo recipients had been vaccinated.)

Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

https://www.cnbc.com/2021/08/27/biden-says-us-health-officials-are-considering-covid-booster-shots-within-5-months.html
FRI, AUG 27 20211:05 PM EDTUPDATED MOMENTS AGO
Rich Mendez

"President Joe Biden said U.S. regulators are looking at administering Covid-19 booster shots five months after people finish their primary immunizations, moving up the expected timetable for a third shot by about three months.

Biden, who was speaking with Israeli Prime Minister Naftali Bennett on Friday, said health officials were considering following that country's lead on boosters.

"We're considering the advice you've given that we should start earlier," Biden said, adding that officials are debating whether the timeline should be shorter. "Should it be as little as five months and that's being discussed."