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So CNN is fake news then? https://edition.cnn.com/2021/08/23/health/fda-approval-pfize...
You are countering my primary source with a secondary source. Did you read the letter? Please at least skim the letter and then form your own conclusion about CNN.
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You are incorrect, the FDA only approved extending the emergency use authorization yesterday, but for some reason the media suggested that it was formally approved. Read for yourself: https://www.fda.gov/media/150386/download
Quoting the FDA letter you linked: > On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave f…
This link overly politised and does not offer technical details about these problems. The Moscow Times article [1] makes a better job. [1] https://www.themoscowtimes.com/2021/08/20/leaked-sputnik-v-r...
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Quoting the FDA letter you linked: > On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave f…
Also something I never thought about, the EUA appears to permit the vaccine be given "without an individual prescription for each vaccine recipient".
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Also something I never thought about, the EUA appears to permit the vaccine be given "without an individual prescription for each vaccine recipient".
Forgive my ignorance here, but wasn't this already the case? Nobody has needed to get a prescription for the vaccine, just like a flu shot. Perhaps I am misunderstanding this comment?
The “prescription” here isn’t something the patient will see or be aware of, it’s just part of how the legal requirements around dispensing medications and the logistics of vaccination providers interact.
There’s some information on this from a pharmacist perspective here: https://naspa.us/resource/pharmacist-authority-to-immunize/ .
The language the article uses, is a bit inflammatory. It may well be correct, but the tone gives me pause. Sounds like the author has an axe to grind.
The vaccine was being "touted" by Bolsonaro? He publicly disparaged it several times.
I mean, not surprising. Here's an older hacker news thread about Brazil rejecting the Russian Vaccine.[0] It's so depressingly unsurprising in this post-truth era. [0] https://news.ycombinator.com/item?id=26975783
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Figures released by the United Arab Emirates Ministry of Health, on some 81,000 individuals who had received two doses of the vaccine, suggested 97.8% efficacy in preventing symptomatic COVID-19 and 100% efficacy in preventing severe disease.
Since then, an as-yet unpublished study from the Buenos Aires health ministry in Argentina, involving 40,387 vaccinated and 146,194 unvaccinated people aged 60–79, found that a single dose of Sputnik Light reduced symptomatic infections by 78.6%, hospitalizations by 87.6% and deaths by 84.7%.
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Or, here is an article on Moscow Times published today reporting a trial from a different Russian group, independent from the manufacturer [2]:
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The study tracked outcomes for almost 14,000 patients who contracted Covid-19 in St. Petersburg between July 3-Aug. 9. It was led by Anton Barchuk, head of the Institute for Interdisciplinary Health Research at the European University in St. Petersburg, and eight other scientists from Russian universities.
Of the 12,154 patients who tested positive for Covid-19 in the study and were not vaccinated, some 467 were hospitalized — a ratio of 3.8%. Meanwhile just 17 of the 1,291 vaccinated patients who caught the infection — 1.3% — were hospitalized. After adjusting for age and sex, the scientists assessed the vaccine’s effectiveness at preventing hospitalizaiton among those who were infected with Covid-19 at 81%.
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I am pretty sure Sputnik V is fine. It has been administered to tens of millions inside Russia itself. If there were massive problems with it, we would know by now.
[1] https://www.nature.com/articles/d41586-021-01813-2
[2] https://www.themoscowtimes.com/2021/08/24/sputnik-v-gives-st...
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Also something I never thought about, the EUA appears to permit the vaccine be given "without an individual prescription for each vaccine recipient".
Forgive my ignorance here, but wasn't this already the case? Nobody has needed to get a prescription for the vaccine, just like a flu shot. Perhaps I am misunderstanding this comment?
I'm just as ignorant as you, and your point about the flu shot is a good one. I'm not aware of a prescription being required for that.
But as I read the document, it implied that with a regular approval and without the EUA, a prescription would be required and so that was one of the reasons for renewing it.
I mean, not surprising. Here's an older hacker news thread about Brazil rejecting the Russian Vaccine.[0] It's so depressingly unsurprising in this post-truth era. [0] https://news.ycombinator.com/item?id=26975783
Russia isn't the only country to have trialed Sputnik. From a recent Nature article (July 2021) titled "Mounting evidence suggests Sputnik COVID vaccine is safe and effective" [1]: --- Figures released by the United Arab Emirates Ministry of Health, on some 81,000 individuals who had received two doses of the vaccine, suggested 97.8% efficacy in preventing symptomatic COVID-19 and 100% efficacy in preventing severe d…
No, we wouldn't. Because most of the Vaccine AEFI tracking is based on voluntary reporting, and is known to only report around 1% of the events.
Even if it was not the case, we wouldn't still know without a control group. Basically this is why systematic trials are done to measure these things.
So this logic does not absolve Sputnik vaccine, or any other current vaccines in use.