For what it is worth, every Canadian physician I know in the academic and 
clinical community - feels quite contrary to this. I am in the Toronto area, 
and I do not detect anything like this reaction, from lay people either. 
Naturally people are upset when politicians are (a) lame (b) do not do what 
they tell others to (c) not apparently aware of scientific facts. However, this 
is nonsense. One rebuttal here: 
https://factcheck.afp.com/canadian-doctors-make-inaccurate-covid-19-claims-video
Separately - 
https://www.theleftberlin.com/post/looking-under-the-hood-the-instrumentation-of-a-pandemic
 and https://www.theleftberlin.com/post/the-petty-bourgeois-threat-of-qanon

As for more current news re COVID: the Astra-Zeneca shenanigans continue: 
https://www.nytimes.com/2021/03/22/world/us-health-officials-question-results-from-astrazenecas-vaccine-trial-less-than-a-day-after-theyre-released.html
and:
Opinion ( https://www.nytimes.com/section/opinion )

********************************************************************
The Most Important Thing You Should Know About AstraZeneca’s Vaccine
********************************************************************

The intense public scrutiny is vaccine safety at work.

By Keren Landman

Dr. Landman is an infectious diseases epidemiologist and journalist.

March 23, 2021

* 
* 

The most important thing to know about AstraZeneca’s Covid-19 vaccine is that 
it’s safe and it works — in spite of the missteps that have marred nearly every 
stage of its rollout.

New data ( 
https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html
 ) shared Monday showed the vaccine was 79 percent effective in preventing 
symptomatic infections in a trial of over 32,000 people, and the company said 
it would prepare to apply for emergency authorization from the Food and Drug 
Administration in the coming weeks.

But health officials said Tuesday ( 
https://www.nytimes.com/2021/03/22/world/us-health-officials-question-results-from-astrazenecas-vaccine-trial-less-than-a-day-after-theyre-released.html
 ) that the results from the trial may have relied on “outdated information” 
that “may have provided an incomplete view of the efficacy data.”

AstraZeneca said ( 
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/update-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.html
 ) Tuesday that it plans to announce results from the primary analysis within 
48 hours.

The study findings shared Monday briefly boosted confidence in the vaccine 
after the last week’s disaster for AstraZeneca: As coronavirus cases rose in a 
third ( 
https://www.cnbc.com/2021/03/19/europes-third-coronavirus-wave-has-arrived.html 
) surge across Europe, reports began to emerge that a handful of people who 
received AstraZeneca’s vaccine experienced rare but serious and unusual blood 
clotting. More than a dozen nations suspended use of the vaccine. The European 
Medicines Agency quickly reaffirmed ( 
https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots
 ) the benefit of getting the vaccine and said the clotting cases would be 
investigated further.

As AstraZeneca’s drama plays out in public, many public health advocates have 
watched with horror, afraid they are witnessing the legitimacy of global 
vaccine development being destroyed. But this process, warts and all, is how 
vaccine safety is supposed to work. And if the AstraZeneca vaccine deserves 
people’s confidence after months of stumbles, this process is how it will earn 
it.

>From the very beginning, AstraZeneca made errors that led to a loss of trust. 
>When it first reported ( 
>https://www.nytimes.com/2020/11/25/business/coronavirus-vaccine-astrazeneca-oxford.html?searchResultPosition=71
> ) early clinical trial results of the vaccine it developed in partnership 
>with the University of Oxford, the company was swiftly met with criticism over 
>the trials’ design and how the data was shared. A subset of the people in the 
>trial had been given the wrong — but ultimately more effective — dose of the 
>two-shot vaccine by mistake; the company had inappropriately pooled data from 
>differently designed, multinational studies; and company personnel had 
>consistently shared safety and efficacy data with industry analysts and 
>investors before disseminating information to the public.

By the end of November, as Pfizer-BioNTech and Moderna awaited emergency use 
authorization for their vaccines in the United States, AstraZeneca was enduring 
widespread ( https://twitter.com/nataliexdean/status/1331355221549670400 ) 
criticism ( 
https://www.cnn.com/2020/11/26/europe/astrazeneca-oxford-vaccine-data-concerns-intl/index.html?utm_content=bufferd74c2&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer
 ) for its lack of transparency and rigor. Its vaccine is still not approved in 
the United States, where the F.D.A.’s review process is typically more intense 
and time-consuming than that of other countries’ regulators. The clinical trial 
data released on Monday is an important step toward the vaccine’s application 
for emergency authorization.

AstraZeneca’s vaccine got approval in the European Union in January and formed 
the backbone of many countries’ vaccine campaigns. But the company has 
continued to find itself on its heels, as production ( 
https://www.thechemicalengineer.com/news/what-is-causing-astrazeneca-s-vaccine-production-woes/
 ) challenges ( 
https://www.wsj.com/articles/behind-astrazenecas-covid-19-vaccine-stumble-11611871968
 ) in its Belgian factory left the European Union with significantly fewer 
doses ( 
https://www.aljazeera.com/economy/2021/3/12/bb-astrazenecamaymisssecond-quarter-eu-vaccine-deliveries-report
 ) than it was expecting this quarter.

The latest fiasco, over the clotting cases, appeared to be a particularly 
damaging setback for both the drugmaker and public health more broadly. Last 
week, public health authorities gave stern warnings ( 
https://www.washingtonpost.com/world/europe/astrazeneca-covid-europe-third-wave/2021/03/17/94740210-868f-11eb-be4a-24b89f616f2c_story.html
 ) against halting vaccinations while investigating the clotting cases, with 
some experts arguing that the suspensions were politically motivated ( 
https://www.thesun.co.uk/news/14357073/italy-france-ban-astrazeneca-vaccine-covid-resume/
 ) and would open the door to an even steeper rise ( 
https://www.nytimes.com/2021/03/17/world/europe/AstraZeneca-vaccine-trust-Europe.html?action=click&module=Top%20Stories&pgtype=Homepage
 ) in cases across Europe. Epidemiologists furiously differentiated association 
from causation; many have argued that a handful of blood clots in recently 
vaccinated millions signifies nothing.

But the public nature of this process is a crucial part of restoring trust in 
it.

Vaccine pharmacovigilance — the process of determining vaccine safety — is a 
science. Before rolling out a vaccine, epidemiologists list things that might 
go wrong after vaccination, whether the health issues are caused by the vaccine 
or not. They then select the most likely ones, which might include problems 
associated with other vaccines or conditions caused by the disease the vaccine 
is intended to prevent (such as blood clotting, which is a known symptom of 
Covid-19 infection).

Before the vaccine is distributed, scientists determine how common these health 
issues are in the general public to create a baseline to measure against if 
they see the health events among people getting the vaccine. As people receive 
immunizations, scientists repeatedly analyze real-time adverse event data, 
hunting for rates that exceed what they would typically expect. Elevated event 
rates — called “safety signals” — often lead to extensive reviews of patient 
information, results of which are shared publicly in a timely way.

It can be tricky to explain to people why a few cases of blood clots among the 
millions of people who were vaccinated constituted a red flag. Several experts 
have said ( 
https://www.cnbc.com/2021/03/17/us-health-experts-try-to-ease-covid-vaccine-fears-as-astrazenecas-shot-faces-concerns-in-europe-.html
 ) the rate of clots in AstraZeneca vaccine recipients is not higher than 
what’s expected in the general population.

But in this case, it’s not the general population that the findings should be 
compared against, says Daniel Salmon, who directs the Institute for Vaccine 
Safety at the Johns Hopkins Bloomberg School of Public Health. In a report ( 
https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/hp-news/faq-temporary-suspension-astrazeneca.pdf?__blob=publicationFile&v=5
 ) published last Tuesday, German health ministry scientists wrote that six of 
seven clotting events had taken place in relatively young, recently vaccinated 
women. The group whose baseline rate they should be compared against isn’t the 
general population — it’s other, unvaccinated, relatively young women, says Dr. 
Salmon.

Making that calculation publicly — and explaining why its results are 
concerning — signals to members of the public how seriously scientists take 
their safety. And that is how the vaccine safety process builds trust rather 
than undermines it: by showing plainly how methodical and uncompromising it is.

During a pandemic, vaccine safety questions make headlines. And a world where 
pandemic vaccine safety is not sensationalized by the news media and 
misunderstood by the public, either willfully or accidentally, is a fantasy. 
Experts’ concerns about vaccine safety protocols playing out in public are 
rooted in these communication failures. If we don’t have these conversations 
the right way, they fear, people will get the wrong message — they’ll think all 
vaccines are unsafe.

But being transparent can only improve the perceptions of safety. After all, 
the bulk of AstraZeneca’s current problems are a consequence of being 
inadequately public and timely about its earlier mishaps. While its product has 
enormous potential, it cannot reach people without trust — and it’s not clear 
that the company has the currency necessary to build trust on its own.

The vaccine safety process exists to do what AstraZeneca, for whatever reason, 
has been unable to do for itself: Prove that the vaccine is worth the trust its 
makers haven’t earned.

This article has been updated to reflect news developments.

Keren Landman ( https://www.kerenlandman.com/ ) is a physician who specializes 
in infectious diseases and a journalist who writes about public health.
________________________________________________________________________


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