Tornado Alley (PROG)

[fuagf]

rooster, Appreciate your going after information (is good for you) and including a link. Now understand that just looking only at what Trump did or says misses much context. Remember Pfizer was NOT involved in Warp Speed. You have been told that a number of times. Also the amount of credit Trump himself actually deserves for Warp Speed is highly debated. I'll say again, if you would only take information given to you here it will be a big help to all around you. Forget your oppositional position. That's negative for you. See

Redoocs, AP FACT CHECK: Trump’s claims on vaccine, election are wrong
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VACCINE

TRUMP: ”’President Trump told us for some time we would be getting a Vaccine by the end of the year and people laughed at him, and here we are with Pfizer getting FDA approval by the end of this month. He was right.’ @MariaBartiromo.” — tweet Tuesday.

THE FACTS: Trump’s suggestion — quoting Fox Business anchor Maria Bartiromo — that he stood alone in saying a COVID-19 vaccine was possible by year’s end is incorrect. Actually, top health experts said they considered that possible, though far from certain, and were more skeptical of Trump’s claim that a coronavirus .. https://apnews.com/hub/virus-outbreak .. vaccine would become available before the Nov. 3 election. The vaccine isn’t expected to become widely available to the general public before 2021.

Dr. Anthony Fauci, the government’s top infectious diseases expert, had previously said that he was “cautiously optimistic” that a vaccine will be ready by late 2020 or early 2021. On Monday, he called Pfizer’s news “extraordinary” but reiterated that it did not mean the U.S. had its immediate cure-all for the coronavirus.

The first step for Pfizer would be to apply for “emergency use authorization” by the Food and Drug Administration, likely later this month, which would allow for limited distribution before it seeks full FDA approval for wider use. Neither step is guaranteed to happen.

“There’s still some questions about, you know, the durability of the effect about whether how effective it is in the elderly versus younger people,” Fauci told CNN. “We know this is light at the end of the tunnel, but that doesn’t mean that we’re going to give up the important public health measures that we continually still have to do every single day.”

Pfizer’s interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the U.S. and five other countries.

Some participants got the vaccine, while others got dummy shots. Pfizer says only the data and safety monitoring board knows the breakdowns, not Pfizer researchers or executives. For the vaccine to be 90% effective, nearly all the infections must have occurred in placebo recipients. The study is continuing, and Pfizer cautioned that the protection rate might change as more COVID-19 cases are added to the calculations.

During the presidential campaign, Trump frequently suggested a vaccine might arrive before the Nov. 3 election.

“What I said is by the end of the year, but I think it could even be sooner than that,” Trump said in September about a vaccine. “It could be during the month of October, actually could be before November.”
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TRUMP: “As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!” — tweet Monday.

TRUMP: “The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along!” — tweet Monday.

THE FACTS: His claim that Pfizer and the FDA withheld vaccine information until after the election is false. The company itself learned of the interim results on Sunday, and the FDA was not involved in Pfizer’s decision to announce its early results.

Every vaccine study such as the one done on Pfizer’s is overseen by an independent “data and safety monitoring board,” or DSMB. These boards include scientists and statisticians who have no ties to the vaccine makers.

Before a study is complete, only the DSMB has the power to unlock the code of who got a real vaccine and who got a placebo, and to recommend if the shots are working well enough to stop testing early.

Those boards take sneak peeks at predetermined times agreed to by the manufacturer and the FDA. It provided the first interim analysis for Pfizer on Sunday.

John Burkhardt, senior vice president of drug safety research and development at Pfizer, said Monday that the timing of the company’s vaccine announcement was not related in any way to the presidential election and was made as soon as the efficacy data was ready. Pfizer CEO Albert Bourla told CNN the timing had nothing to do with politics.

Pfizer and the maker of the other leading U.S. vaccine candidate, Moderna Inc., have been cautioning for weeks that the earliest they could seek regulatory approval for wider use of their shots would be late November.

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TRUMP: “’Only because of President Trump, we are going to have a Vaccine by the end of the year.’ Ronny Jackson, Texas Congressman-Elect.” — tweet Tuesday.

VICE PRESIDENT MIKE PENCE: “HUGE NEWS: Thanks to the public-private partnership forged by President @realDonaldTrump, @pfizer announced its Coronavirus Vaccine trial is EFFECTIVE, preventing infection in 90% of its volunteers.” — tweet Monday.

THE FACTS: Trump (quoting his former White House physician) and Pence are wrongly seeking full credit for forging the partnership that made the potential breakthrough possible. Pfizer notably did not accept government money to develop, test or expand manufacturing capacity under Trump’s Operation Warp Speed initiative to quickly find a vaccine and treatments for the disease sweeping the country.

In fact, Pfizer partnered with the vaccine’s original developer, Germany’s BioNTech, in March and the following month announced the first human study in Germany. The White House announced Operation Warp Speed in May.

Pfizer opted not to join Operation Warp Speed initially but is following the same general requirements for the vaccine’s development as competitors who received government research money. The company says it has risked $2 billion of its own money on vaccine development and won’t get anything from Washington unless the effort is successful.

“Pfizer’s COVID-19 vaccine development and manufacturing costs have been entirely self-funded,” Pfizer spokeswoman Jerica Pitts said Monday. “We decided to self-fund our efforts so we could move as fast as possible.”

However, Pfizer did sign an agreement with the U.S. government in July worth $1.95 billion — if the vaccine pans out and is cleared by the FDA — to supply 100 million doses. That guarantees Pfizer a U.S. market, an important incentive.

The supply side of Operation Warp Speed also allows Pfizer logistical help, although the company will directly ship its own vaccine, while the government will control shipping of other COVID-19 vaccines.

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