Posted on 09/08/2020 8:08:09 AM PDT by SeekAndFind
The CEOs of nine companies developing vaccines against Covid-19 on Tuesday pledged to "uphold the integrity of the scientific process" amid concern Donald Trump will pressure regulators to approve a vaccine ahead of the presidential election in November.
"We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles," said the CEOs.
The statement was signed by AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.
Specifically, the companies said they would only seek emergency authorisations for vaccines "after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA," the Food and Drug Administration.
Some experts and former officials of this agency worry it has become politicised after it issued emergency use authorizations for two Covid-19 treatments without sufficient proof.
Both hydroxychloroquine, whose authorization was later revoked over safety fears, and blood plasma from recovered Covid-19 patients, were touted by Trump.
Joe Biden, the Democratic candidate for president, has accused Trump of "undermining public confidence" by regularly raising the possibility a vaccine will be ready ahead of the election on November 3.
Stephen Hahn, the head of the FDA, has also guaranteed that only science will decide when a vaccine is ready.
In theory, the FDA has to rely on independent expert committees that oversee clinical trials before they give their green light. The makers themselves must also apply for authorisation.
Among the companies, Moderna and Pfizer are in the most advanced stages of their trials, and the US Centers for Disease Control and Prevention (CDC) has asked states to have distribution networks ready by November 1.
The widely-respected Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, has said the results of clinical trials aren't expected to be known until the final two months of the year.
"I think it's extremely unlikely but not impossible," that the trials will have results to show before the election, Moncef Slaoui, the scientific head of the White House program tasked with producing and delivering vaccine doses, told NPR.
The Russian vaccine has not completed its phase 3 trials, which are considered key in demonstrating the safety and efficacy of a vaccine and are usually completed before regulatory approval is given.
https://www.businessinsider.com/germany-warns-putin-russia-coronavirus-vaccine-has-not-been-fully-tested-2020-8
people determine the risk and their health surrounding their decision.Like they get to do with hydroxychloroquine and other drugs.
Got it.
“The fact they have to pledge their integrity says all you need to know about the overall science integrity...There isn’t any.”
It should also be known that a special Vaccine Court was set up for vaccine injury compensation and has paid out close to $4 billion in claims.
Watch the documentary “Plandemic, indoctranation”
The CDC obtained a patent on it.
“It’s a fact a vacccine is needed...”
That is NOT a fact.
ok....explain why not....and your sources.
I happen to be a scientist, and I can relate that a large fraction of my fellow scientists (especially those in the regulatory parts of government) are slow movers, nearly to being the very model of inertia.
And related...
Considering that many of our fine Citizens are aged and immunocompromised, is this not unlike a RIGHT TO TRY issue?
Phrased another way, if a prospective vaccine has already passed phase 1 (safety), and if no reasonable alternative to a vaccine, then why could not our at risk citizens decide for themselves whether taking a safe vaccine of possibly uncertain effectiveness is the right choice for them?
.
I do my own investigation on ANY vaccine or medication I put in my body. And is what everyone should do.. As for who’s invested in the company’s producing them....frankly it doesn’t matter to me as long as they’re made here in the US. You can’t go around figuring out who or what investors are invested in when they have portfolios likely full of various entities.
I certainly don’t base my decisions on what political side of the isle someone is on. Rather the information I can access and determine whatever risk I chose or not to take.
A voice of reason is always appreciated in matters like this.
Thanks....good idea for people not to get wrapped up in the political drumbeat regarding Covid or the vacine. People will determine what they will and neither side politically will assume the blame if you’re wrong.
Exactly. Follow the science, not the political science.
IN FACT they used the exact same oath that our corrupt as heck congressmen do!
Yes...the same one...see, the words don’t actually matter so any oat will do.
Here is a clue:
“On the 28th February, yes that far back, the New England Journal of Medicine published a report by the National Institute of Allergy and Infectious Diseases, National Institutes of Health and the Centers for Disease Control and Prevention. In this paper ‘COVID-19 — Navigating the Uncharted’ they stated the following: “If one assumes that the number of asymptomatic or minimally symptomatic cases is several times as high as the number of reported cases, the case fatality rate (my underline) may be considerably less than 1%. This suggests that the overall clinical consequences of Covid-19 may ultimately be more akin to those of a severe seasonal influenza.” A case fatality rate considerably less than 1%. Their words, not mine. As they also added, ‘the overall clinical consequences of Covid-19 may ultimately be more akin to those of a severe seasonal influenza.”” Scroll down at https://drmalcolmkendrick.org/2020/09/04/covid-why-terminology-really-matters/ The author is an experienced Scottish physician. Reference links are at the end of his excellent article.
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