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Defending the slow response to the approval of the Pfizer vaccine, the FDA says scientists need more time to review data


FDA Commissioner Steve Hahn has defended that it took so long to approve Pfizer's COVID vaccine after receiving the green light in the UK. On Wednesday, he said his scientists are taking longer to review the data because they are analyzing it "more robustly" than anyone else.

On Wednesday, UK health officials announced that they have approved the vaccine and that it will shortly be rolled out to those most in need.

But in the US, the FDA says it won't even meet to discuss emergency approval for Pfizer's vaccine or the vaccine that Moderna developed by December 10th.

Even then, it will be another five days before the first doses are introduced. This emerges from a document that CNN received on Wednesday.

Mark Milley, chairman of the Joint Chiefs, couldn't even give an exact schedule on Wednesday.

"Operation Warp Speed ​​should begin distributing COVID vaccines in the next one to two or three weeks," he said.

Stephen Hahn, the head of the FDA, attended a 30-minute Facebook Live with CBS on Wednesday to explain why it was taking so long.

He did not criticize the UK authorities but suggested that his agency take bigger steps to investigate the data.

FDA Commissioner Steve Hahn attended a 30-minute Facebook Live Wednesday defending his government, which took so long to approve the Pfizer vaccine. Its scientists took more time, despite the UK reviewing and approving it

“We have to go through it very carefully. Our processes are so robust, ”he said.

He refused to say whether he met with President Trump in the White House on Tuesday or whether Trump or anyone else had put pressure on him to speed up the process, saying only that the conversation was "robust".

Hahn said different groups of scientists are currently studying different areas of the Pfizer raw data.

Some will study safety and some will study effectiveness.

Everyone will come together on December 10th to discuss their results and then present them to the Advisory Board.

Only then will it be approved and it is unclear whether a decision will be made that day – or whether it will be approved at all.

“Our plan is to do that at great speed. It depends on what the data shows, but we expect this to be very soon after that.

“I can only tell you that very soon after these meetings you will not know the dates. I don't want to be ahead of the data … it wouldn't be the first time the FDA and Advisory Committee has found surprises.

& # 39; We sense the urgency of the situation.

“We are feeling the pressure to achieve this. We are committed to data and science and that will guide us, ”he said.

Hahn said the process had already been sped up significantly.

“With some regulatory processes, we have shortened ourselves a year or more without making any compromises.

"The right development process was carried out. We just cut the red tape in between," he said.

Hahn went to the White House Tuesday to hold "robust" meetings on the vaccine approval process, but he wouldn't say who he met or whether Trump is pressuring him to speed up the process. He is pictured in the WH in March

Hahn went to the White House Tuesday to hold "robust" meetings on the vaccine approval process, but he wouldn't say who he met or whether Trump is pressuring him to speed up the process. He is pictured in the WH in March

The vaccines are also touted as largely safe and effective by science.

Scientists from Operation Warp Speed, the Trump administration's COVID task force, have reassured the American people that science is standing up.

Pfizer says its vaccine is 95% and Moderna 94% effective, which scientists say is a higher standard than most vaccines, especially given the size of the test groups in which they were used. AstraZeneca, another brand, says its vaccine is 70%% effective.

President Trump has put pressure on the FDA to act quickly to get a vaccine out.

Sources say he and other White House officials are furious that it was previously approved overseas on US soil.

"It's crazy to think that the European Union or the UK could approve a vaccine developed in the US before us, right?" a source said.

Dr. Hahn was called to the White House on Tuesday to explain why vaccines were taking so long to get approved, but so far there has been no public explanation.

The administration did not immediately respond to inquiries on Wednesday morning.

There are already concerns about how many Americans will willingly take the vaccine, given the increasing politicization under which it was developed.

It became a focus of Trump's unsuccessful re-election campaign, and many fear that it was used as a campaign tactic.

A dose of Coronavirus Disease (COVID-19) vaccination from BioNTech and Pfizer during the trials is pictured above

A dose of Coronavirus Disease (COVID-19) vaccination from BioNTech and Pfizer during the trials is pictured above

Others believe the virus and the entire pandemic are a hoax developed by the Democrats to encourage mail-in voting, rather than in-person voting, to fraudulently steal Trump's election. There is no concrete evidence of this.

In an interview Wednesday morning, one of Trump's advisors for Operation Warp Speed ​​said it was "very concerned" about the reluctance of so many people to receive the vaccine.

& # 39; It is a big problem that frankly the development process has become so politicized that it has created a high level of … decreased trust. No corners were cut.

& # 39; Development was done very quickly as we had great science that allowed us to do it in weeks rather than years. The clinical part has been done to a higher standard than what is normally done and with a higher number of people who will be safe for years to come over the long term, just because the pandemic is so high we do it early must use to save lives and return to normal life.

“Keep your ears open, mind open, listen to the experts after they see the data, and then make up your mind – if you do, most Americans will conclude that this is insurance.

"This is what will get us out of this pandemic," said Dr. Moncef Slaoui to Good Morning America.

Even if all 330 million people in the country want to get it, introducing it will be problematic.

On Tuesday, a former CDC director described it as "the most complicated vaccination program in American history".

While the wait for approval drags on, the committee that decides who will get it first has begun its own talks.

Across the board, health care workers and nursing home residents appear to be the first to receive the vaccine, in both the US and the UK.

The number of Americans hospitalized for coronavirus hit an all-time high of nearly 99,000 on Tuesday, marking the fourth day in a row

The number of Americans hospitalized for coronavirus hit an all-time high of nearly 99,000 on Tuesday, marking the fourth day in a row

On Wednesday morning, Sr. Ugur Sahin, who developed the Pfizer vaccine with his wife, said it was a "historic day" when the first doses were introduced.

& # 39; It's a historic day. I have to admit it is a historic day. It is indeed the beginning of the end of the pandemic, ”he said.

He said he expected it to be approved in the US "within the next two weeks."

Yesterday, the US recorded the highest death toll in a day since April 30, with 2,597 deaths, according to a DailyMail.com analysis of data from Johns Hopkins University.

And for the fourth time in a row, the number of Americans hospitalized for COVID-19 reached a record high: 98,691 people were hospitalized, according to data from the Covid Tracking Project.

More than 180,000 new infections were recorded across the country on Tuesday, with states like Kentucky, California, Delaware, Tennessee, Texas, and Arizona hitting a daily high for new cases, while Florida was the third state in the nation to have had a million coronavirus cases since the beginning of the pandemic.

HOW DO THE MODERNA AND PFIZER / BIONTECH VACCINES COMPARE?

Moderna and Pfizer / BioNTech have both released interim clinical trial results for their end-stage vaccines, both of which indicate that they are extremely effective.

How to Compare:

PFIZER (US) & BIONTECH (DE)

mRNA vaccine – Genetic material from the coronavirus is injected to stimulate the immune system to make "spike" proteins and learn how to attack them.

mRNA vaccine – both Moderna, Pfizer and BioNTech vaccines work the same way.

94.1% effective (90 positive in the placebo group, 5 positive in the vaccine group)

90% effective (an estimated 86 positive in the placebo group, 9 positive in the vaccine group)

The U.S. has secured 100 million doses for $ 1.525 billion (£ 1.16 billion), suggesting it will cost $ 15.25 (11.57 pounds) per dose. $ 30.50 (£ 23.14) per person.

The US will pay $ 1.95 billion (£ 1.48 billion) for the first 100 million doses, suggesting a price of $ 19.50 (£ 14.80) per dose. $ 39 (£ 29.61) per person.

Moderna will produce 20 million cans this year, which is expected to remain in the US.

The first vaccinations are expected in December.

What side effects does it cause?

Moderna said the vaccine was "generally safe and well tolerated". Most of the side effects were mild or moderate, but included pain, fatigue and headache, which "generally" were short-lived.

Pfizer and BioNTech did not provide a breakdown of the side effects, but said the Data Monitoring Committee "did not report any serious safety concerns."

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