TOP TRENDING

Donald Trump accuses the FDA of withholding the Pfizer vaccine until after the election


Donald Trump has accused the Food and Drug Administration of deliberately delaying work on a coronavirus vaccination to thwart his hopes for re-election.

On Monday, Pfizer announced that their vaccination was 90 percent effective in clinical trials. Your details will now be sent to the FDA for approval, and once the FDA gives the green light, a mass vaccination program can begin.

Donald Trump Jr. said the timing was "shameful" and because his father was hated by the pharmaceutical industry for forcing them to lower their prices.

On Monday evening, the president accused the FDA of trying to sabotage his campaign as well. The FDA is headed by a President-appointed commissioner.

"@USFDA and the Democrats didn't want me to have a WIN vaccine before the election, so it came out five days later instead – like I've been saying all along!" he tweeted.

He tweeted when the FDA approved the emergency COVID-19 experimental antibody treatment by Eli Lilly and Co, which Trump has commended and vowed to make available to all Americans free of charge.

A major breakthrough has been announced in the search for a coronavirus vaccine

A major breakthrough has been announced in the search for a coronavirus vaccine

He insisted that his actions resulted in the creation of a vaccine in record time, arguing that if Joe Biden had been president, it would have taken much longer to find treatment.

"If Joe Biden were president, you wouldn't have the vaccine for another four years, nor would @USFDA ever have approved it so quickly. The bureaucracy would have destroyed millions of lives! & # 39; he said.

And he said that the alleged raid cost the FDA lives.

& # 39; As I've said for a long time, @Pfizer and the others wouldn't announce a vaccine until after the election because they didn't have the courage to do so beforehand.

"Likewise, the @USFDA should have announced it earlier, not for political reasons, but to save lives!"

The timing of the announcement, which came shortly after Biden's victory and less than a week after the election, has already raised questions as Trump repeatedly announced that a vaccine would be ready before the election.

Pfizer originally announced that it would know if its vaccine would be effective by October but postponed that schedule last month to say it was expecting a search US FDA approval for emergency use of the vaccine in the third week of November. The drug maker is still on track to meet this schedule.

In its announcement on Monday, Pfizer said the results of the interim analysis came after talking to the FDA. It is not yet clear exactly what these discussions were about or when they took place.

The company merely stated that as a result of these discussions it had decided to conduct the interim analysis based on at least 62 cases instead of an initial number of 32 cases. The cases relate to the number of the 44,000 people involved in the study who received COVID-19. The 90 percent rate was ultimately based on 94 cases.

Disclosure of such early data is unusual in a clinical trial and it was not immediately clear why Pfizer chose to announce the first results today. Pfizer's CEO and head of vaccine research immediately tried to distance themselves from the timing of the announcement and insisted they weren't being driven by politics.

Announcing the approval of the Eli Lilly antibody six days after the election will further anger the president, who sees enemies everywhere he turns.

The FDA said its emergency approval was based on clinical studies showing that treatment with bamlanivimab reduced the need for hospital stays or emergency rooms in COVID-19 patients at high risk for disease progression.

It can be used to treat mild to moderate COVID-19 in adults and pediatric patients over the age of 12, according to the FDA.

As today's actions show, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing timely access to new therapies for sick patients, if necessary, while supporting research to further evaluate whether they are safe and effective, ”said Stephen M. Hahn, FDA commissioner since December 2019.

"As part of our program to accelerate coronavirus treatment, the FDA continues to operate around the clock, using every tool available to us in this effort."

The drug will be shipped "immediately" to main distributor AmerisourceBergen, Lilly said.

Last month, the US government signed a $ 375 million deal with Lilly for 300,000 doses of the antibody drug to be distributed over the two months following approval for emergency use (EUA).

The government will have the option to purchase an additional 650,000 cans through June 30th.

Although Lilly did not specify how many doses are currently ready to use, she had previously indicated that 100,000 doses of the antibody drug could be made available within days of the EEA.

Bamlanivimab is assigned weekly to states based on how many confirmed cases were recorded in the Department of Health and Human Services (HHS) data for each jurisdiction in the past seven days, an Informa editor reported Twitter.

It's unclear how much the drug will ultimately cost, or how the federal government will deliver on Trump's promise that antibody treatment – a class of drugs that usually comes with a six-digit price tag – will be free to anyone who needs it.

The previous Monday, Donald Trump Jr. had done his best to sound the alarm when Pfizer's COVID-19 vaccine breakthrough was announced two days after the election for Biden.

Donald Trump Jr. raised suspicions Monday after Pfizer announced two days after Joe Biden's election that his vaccine was 90% effective after previously delaying results

Donald Trump Jr. raised suspicions Monday after Pfizer announced two days after Joe Biden's election that his vaccine was 90% effective after previously delaying results

Pfizer announced that its vaccine was 90 percent effective in study participants and would produce 1.3 billion doses by the end of next year – enough to treat 650 million people.

The breakthrough was unexpected given earlier remarks by the company's CEO that it would be late in the month before critical data could be submitted to the FDA for emergency approval.

In September, Pfizer CEO Albert Bourla promised that they would know whether or not the vaccine would be effective by the end of October, a deadline in line with Trump's promise to find a vaccine that would work before the November 3 election.

PFIZER VACCINE TIMELINE

13.SEPTEMBER: Anthony Bourla, CEO of Pfizer, says they will know if the vaccine is effective by the end of October

OCTOBER, 16TH: In an open letter, Bourla again promises to know if the vaccine will be effective by the end of October

He said the company wouldn't know if all three components – efficacy, safety and manufacturing – were up to date by the third week of November

OCTOBER 30th – NOVEMBER 8th: No update of vaccine effectiveness

NOVEMBER 3RD: Presidential election

7 NOVEMBER: The election is scheduled for Joe Biden

NOVEMBER 9: Pfizer announces efficacy study results, says they expanded the scope after consulting the FDA but doesn't say when or why

But this deadline came and went with no news. America went to the polls on November 3rd. Many told respondents that dealing with the crisis was one of the most important issues on their minds.

Then, suddenly on Monday, after the whole country had waited four days for an election result, Pfizer announced its breakthrough, hailing it as a "great day for humanity" and science.

Effectiveness is one of three components the company had to consider when submitting for FDA approval. The other two are security and whether or not it can be mass-produced to the right standards.

While Monday's announcement doesn't technically speed up the process of getting the vaccine up and running to the masses (Pfizer still says it will need to collect all of the data by the end of November in order to apply for a permit), it causes great global excitement and Some industries have seen tremendous growth in the markets.

Along with Pfizer's own share price, airline shares soared on the Monday following the announcement as people finally saw a "light at the end of the tunnel".

It also came around the same time that Biden began introducing his COVID-19 task force.

Trump Jr. sarcastically tweeted: & # 39; The timing for this is pretty amazing. Nothing shameful about the timing, right? & # 39;

Data on how effective it was – the clearest sign of whether it is working or not – was expected by the end of October.

Pfizer said the results of the interim analysis came after speaking with the FDA. It is not yet clear exactly what these discussions were about or when they took place.

Pfizer didn't announce the effectiveness of its vaccine until Monday morning

Pfizer didn't announce the effectiveness of its vaccine until Monday morning

SEPTEMBER 13: Pfizer's Greek CEO Albert Bourla said they would know if the vaccine would be effective by the end of October

SEPTEMBER 13: Pfizer's Greek CEO Albert Bourla said they would know if the vaccine would be effective by the end of October

The company merely stated that as a result of these discussions it had decided to conduct the interim analysis based on at least 62 cases instead of an initial number of 32 cases. The cases relate to the number of the 44,000 people involved in the study who received COVID-19. The 90 percent rate was ultimately based on 94 cases.

Biden said he learned about it from his "health advisors" on Sunday evening.

He will not take office until January 20th.

“Last night my health advisors were informed of this excellent news.

"I congratulate the brilliant women and men who contributed to this breakthrough and who give us cause for hope," he said.

Biden went on to say that the fight against COVID is far from over, although it is good news.

Trump himself initially resisted questioning the timing of the announcement and instead tweeted his excitement about it.

He tweeted: & # 39; LAGERMARKT LARGE, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SO BIG NEWS! & # 39;

New York Governor Andrew Cuomo continued Good morning America to say that he and other governors would try to stop Trump's roll-out plan.

& # 39; It's good news, bad news. The bad news is that it will take about two months for Joe Biden to take over and that means this government will be putting a vaccination plan in place.

Joe Biden said Monday that he was briefed on the vaccine's effectiveness on Sunday evening

Joe Biden said Monday that he was briefed on the vaccine's effectiveness on Sunday evening

Trump initially resisted questioning the timing of the announcement on Monday

Trump initially resisted questioning the timing of the announcement on Monday

Democrats are already trying to stop the Trump campaign from introducing the vaccine. On Monday morning, New York Governor Andrew Cuomo said he and other governors want to stop their plan before they do "harm" by implementing it through private practices

Democrats are already trying to stop the Trump campaign from introducing the vaccine. On Monday morning, New York Governor Andrew Cuomo said he and other governors want to stop their plan before they do "harm" by implementing it through private practices

PFIZER & # 39; S GREEK CEO WHO & # 39; DISAPPOINTED AFTER THE DEBATE IN TRUMP & # 39; WAS AND THE MITCH DONATED MCCONNELL AND THE REPS – BUT NOT THE PRESIDENT

Pfizer CEO Albert Bourla

Pfizer CEO Albert Bourla

Albert Bourla's affiliation is not as clear-cut as that of some business leaders, but his disdain for Trump is evident.

He donated to Republican campaigns that year, including for Mitch McConnell and the Kentucky Republican Party, but he did not donate to the Trump campaign.

He gave $ 60,783 to committees affiliated with McConnell and Republican Senators John Cornyn, Cory Gardner, and Thom Tillis.

Bourla's compensation last year was $ 17.9 million.

He has been with Pfizer since 1993, first in his native Greece, then in New York, and took over the management last year.

He is very private and does not share any of his family life publicly.

He failed to talk about Trump other than saying he was "disappointed" when the president said Pfizer could move faster in developing a vaccine.

During the presidential debate, Trump made the remark.

“I've talked to Pfizer, I've talked to all of the people you need to talk to, Moderna, Johnson & Johnson and others. You can go a lot faster. It has become very political. We're weeks away from a vaccine, ”Trump said.

Bourla replied that he was at the pace of science.

On Tuesday evening, I joined the millions of Americans who took part in the presidential debate.

“Once again I was disappointed that the prevention of a fatal disease was discussed more politically than scientifically. The only pressure we feel – and it weighs heavily – is the billions of people, billions of corporations and hundreds of government officials who depend on us. & # 39;

Bourla is also a member of Catalyst, a not-for-profit organization dedicated to improving opportunities for women in the workplace. He sits on the boards of big business and big pharma organizations that Trump has made enemies of.

& # 39; It's very important. The Trump administration is implementing the plan and I believe it is flawed.

“If you reject a problem like Trump, you can never solve it. You will go through the private mechanism – through drug market chains.

"You have two months and we cannot let this vaccination schedule continue as the Trump administration plans. I've spoken to governors across the country about this.

"How can we design the Trump administration's vaccination schedule to fix or stop it before it does any harm?"

Senator Ted Cruz said Cuomo's remarks were "instructive".

Trump's handling of the pandemic has been one of the main Democrats' themes throughout the campaign.

They criticized his failure to implement things like a nationwide mask mandate, and Biden has already announced his own task force to reverse some of Trump's decisions.

That year, Pfizer CEO Albert Bourla donated to Republican campaigns, including Mitch McConnells and the Kentucky Republican Party, but he didn't donate to the Trump campaign.

He failed to talk about Trump other than saying he was "disappointed" when the president said Pfizer could move faster in developing a vaccine.

During the presidential debate, Trump made the remark.

“I've talked to Pfizer, I've talked to all of the people you need to talk to, Moderna, Johnson & Johnson and others. You can go a lot faster. It has become very political. We're weeks away from a vaccine, ”Trump said.

Bourla replied that he was at the pace of science.

On Tuesday evening, I joined the millions of Americans who took part in the presidential debate.

“Once again I was disappointed that the prevention of a fatal disease was discussed more politically than scientifically. The only pressure we feel – and it weighs heavily – is the billions of people, billions of corporations and hundreds of government officials who depend on us. & # 39;

Bourla is also a member of Catalyst, a not-for-profit organization dedicated to improving opportunities for women in the workplace. He sits on the boards of big business and big pharma organizations that Trump has made enemies of.

(tagsToTranslate) Dailymail (t) Nachrichten (t) Coronavirus (t) Donald Trump