FDA commissioner suggests Pfizer vaccine may not be approved today


Scientists on the FDA’s COVID vaccine advisory committee are finally discussing whether or not to approve it and are questioning how long it will protect people for against the virus and whether or not trial participants who were given a placebo should receive it.   

The independent advisory committee is meeting today to discuss the findings of Pfizer’s trial but the deliberations aren’t due to begin until 3.10pm.   

Then, the committee will vote on whether or not the vaccine should be approved and the FDA will take the committee’s recommendation into consideration but it doesn’t translate into immediate approval.   

It prolongs an already slow response from the US to get the vaccine off the ground that has angered millions of Americans while COVID cases continue to soar. The vaccine has already been passed in the UK and Canada.

Speaking at the virtual meeting on Thursday, Peter Doshi, one of the experts, questioned how long it would last. 

‘Preventing COVID for two, three months is one thing but protection needs to last much longer. After six months or a year, will it still hit the FDA’s 50 percent threshold? It’s hard to say,’ Peter Doshi, of the University of Maryland, said.  

Another expert called it ‘one big human experiment’ and said the only guaranteed winners were big pharma. 

‘The public is the real world clinical trial – it is one big human experiment. 

‘The only ones who have 100% immunity in this are the pharma companies, they get all the benefits of sales without any legal liability should something go wrong,’ Kim Witczak from Woody Matters, said. 

 

The FDA advisory panel is currently discussing the vaccine in a virtual summit (above) that is expected to go on all day 

Another moral dilemma will be what to do with the 22,000 trial participants who didn’t get the vaccine and were given a placebo. 

The only way to prove if a vaccine works is to compare it to a placebo and the study ought to continue after emergency authorization so scientists can better understand the long-term effects of it. 

But Pfizer cannot stop the placebo participants from getting the vaccine once it becomes available to the public. 

The panelists questioned how the company will stop those people from leaving the trial to get the vaccine. 

 ‘The public is the real world clinical trial – it is one big human experiment. The only ones who have 100% immunity in this are the pharma companies, they get all the benefits of sales without any legal liability should something go wrong

Kim Witczak from Woody Matters

That would protect them from the virus but it would end the study and therefore offer no future data on the long term effects of the vaccine.    

Pfizer’s current plan is to offer the vaccine to trial participants who got the placebo, telling them that they received the sham shot, once they are eligible to get it under the emergency approval.

In other words, once the FDA gives the vaccine emergency approval, a health care worker who signed up for Pfizer’s trial could ask the trial runners if they got a placebo shot.

Pfizer would reveal what the participant got and offer the real vaccine.

But the problem with this is that Pfizer could soon be left with no placebo participants, and those who found out they did get the shot could start acting dangerously, going maskless and ignoring social distancing because they assume the vaccine protects them, explained Dr Steven Goodman, a Johns Hopkins University bioethicist.

FDA wants Pfizer to continue to study how well the shot works, and losing the placebo group would get in the way of that.

Dr Goodman proposed an odd solution: once they would be eligible for the shot outside the trial, give volunteers who got a placebo the real shot, and give those who unwittingly got the vaccine a placebo shot.

Sarah Christopherson National Women’s Health Network said there still was not enough data. 

‘We have serious concerns that moving onwards with [emergency authorization] based on so little data on so many of the communities hardest hit by this virus.

The UK approved the vaccine last week and people started receiving the shot on Tuesday. Above, a woman in  Cornwall, England, receiving the vaccine on Wednesday

The UK approved the vaccine last week and people started receiving the shot on Tuesday. Above, a woman in  Cornwall, England, receiving the vaccine on Wednesday

FDA Commissioner Steve Hahn said on Thursday that they may not approve the vaccine today, like many had hoped they would, and that the process could take even longer

FDA Commissioner Steve Hahn said on Thursday that they may not approve the vaccine today, like many had hoped they would, and that the process could take even longer

‘It will do little to assuage legitimate concerns in those communities about taking those vaccines,’ she said. 

It comes as a study revealed fewer than 25 percent of African Americans said they would take the vaccine despite the death rate from COVID among black people being three times what it is among whites. 

Eighty percent of the trial participants were white. Fewer than 2,000 African American people actually received the infection and only 131 Native American people received it. 

TIMELINE ON PFIZER VACCINE 

November 18: Pfizer announces its vaccine is 94% effective

November 23: Pfizer submits trial data to FDA for emergency approval 

December 3: UK approves Pfizer vaccine 

December 7: First doses are given in England 

December 8: FDA releases preliminary analysis saying vaccine is safe and effective but still doesn’t approve it 

December 9: Canada approves the vaccine 

December 9: Deadliest day for US with 3,045 deaths

December 10: FDA advisory committee meets to discuss the vaccine 

The breakdown is almost on par with the general population; 76 percent are white, 13 percent are black and 18 percent are Hispanic.   

The US recorded its deadliest day since the pandemic began on Wednesday with more than 3,045 deaths and hospitals around the country are filling up. 

The UK and Canada have both approved the vaccine and the first people in the world received it in England on Tuesday but no firm date has yet been given for when Americans can expect to have access to it.

Speaking on all three of the major morning shows – Good Morning America, Today and CBS This Morning – FDA Commissioner Steve Hahn refused to give an approval date on Thursday or be drawn on how long the process will take.  

‘I’m not going to prejudge what the advisory committee says. 

‘This is an advisory board, it’s not binding to the FDA but we think their input is really important so we want to hear the scientific and medical discussion and then incorporate that into our decision making.

‘We can act quickly and we intend to – we understand the urgency of the situation. 

‘There may be issues, medical, scientific issues that we have to address after the discussion and we will do so. 

‘We want to make sure that we make the absolute best decision for the American people,’ he said on Good Morning America. 

He then told Today that the vaccine met FDA standards, but that they still want to hear from the advisory panel anyway. 

‘Our initial assessment is that this is a vaccine that does meet our criteria… But we do want to hear from the vaccine advisory committee,’ he said. 

One source of discussion at Thursday’s committee meeting will be that two British healthcare workers suffered an allergic reaction after receiving the shot. 

Hahn said that is the kind of thing they want to look more closely at before approving the vaccine. 

There is still no date for when people will actually start receiving the vaccine. 

The federal government had said that the first doses would go out this month.

Nursing home staff and residents will be the first to receive it then it will go to healthcare workers. 

After them, the general public will have access to it. 

Another potential roadblock will be whether or not there are enough doses of the vaccine to go around. 

The government is actively in talks with Pfizer, Moderna and other vaccine companies to try to acquire as many doses as possible.  

 

Daily deaths in the US reached their highest yet on Wednesday with 3,045 people dying 

Cases per day are eclipsing 200,000 on average for the first time on record. A total of 215,586 new coronavirus cases were reported yesterday

Cases per day are eclipsing 200,000 on average for the first time on record. A total of 215,586 new coronavirus cases were reported yesterday

Johns Hopkins professor slams the FDA for the 35,000 Americans who have died since vaccine was announced

Pfizer submitted to the FDA for emergency approval on November 23. This is how many people have died

Pfizer submitted to the FDA for emergency approval on November 23. This is how many people have died 

A Johns Hopkins professor has slammed the FDA for taking so long to review the Pfizer vaccine while thousands of Americans continue to die from COVID. 

Pfizer announced in early November that its vaccine was effective after a widespread global trial involving 44,000 volunteers, 

It submitted its findings to the FDA for approval on November 23 but has still not been approved. 

Since then, 34,000 Americans have died from the virus. 

Writing for Med Page Today on Thursday, Martin Makary MD said there was no reason for the delay. 

‘There’s a war on, but you’d never know it from the agency’s weeks-long review. 

‘We are in a health emergency. The U.S. will soon exceed 3,000 deaths per day from COVID-19 and in the time that the FDA has been reviewing the vaccine trial data, some 35,000 people will have died in the U.S. from the virus. 

‘That’s more Americans than died during the Iraq and Afghanistan wars and 9/11 combined. We are in a war now. Given the overwhelming results of the phase III trials and the dire projections for the next few months, the FDA should shift from peacetime to wartime speed. 

‘There is simply no scientific reason why the review that the FDA is tasked to do could not be done in a few days without cutting any corners on safety,’ he said.  

There remains a huge amount of skepticism around the vaccine in the US. 

Many fear it was politically motivated and rushed out to try to help President Trump’s election chances. 

The experts all say this is not the case and that they will be among the first to receive it when it’s available. 

But a huge 41 percent of the public say they are not yet convinced that it’s safe. 

‘This is concerning to me… We need to get to herd immunity, and that requires a substantial percentage of Americans to be vaccinated,’ Hahn said on Thursday. 

In a preliminary analysis posted online on Tuesday, one group of FDA scientists said it was safe. 

Among the 20,000 people who were given the vaccine in Pfizer’s global trial, 137 had allergic reactions but so did 111 people who were given the placebo, leading scientists to dismiss it as a potential hazard. 

Four people did get Bell’s Palsy after receiving it, a type of facial paralysis, but the trial scientists said it was not necessarily the jab that caused it and was on par with the general rate of Bell’s Palsy in the wider population. 

But Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday warned people with a severe allergy to food or medicine not to get it. 

In America, that applies to at least 200,000 people who have food allergies and many more who have drug allergies.  

The two healthcare workers who were affected both carry EpiPens but no other information has been given. They are now said to be recovering well. 

British scientists have told the public not to panic and say the vaccine is safe but there is still a large amount of skepticism surrounding it. 

It also raises the question of whether the US was right to take longer in approving the shot, despite receiving pressure from Americans to give it the go-ahead because Britain had.  

On December 3, Dr. Fauci warned that the Brits had moved too quickly. 

‘In all fairness to so many of my UK friends, they kind of ran around the corner of the marathon and joined it in the last mile,’ he said.

‘I think that would be a good metaphor for that…because they really rushed through that approval. I love the Brits, they’re great, they’re good scientists, but they just took the data from the Pfizer company and instead of scrutinizing it really, really carefully, they said, ‘OK, let’s approve it, that’s it.’ And they went with it. 

‘In fact, they were even rather severely criticized by their European Union counterparts who were saying, you know, ‘That was kind of a hot dog play,” he said. 

 He then apologized for his remarks and said they were driven by competitiveness.

On Wednesday, after the British cases became public, Fauci said he was ‘concerned’. 

The document will be reviewed on Thursday when the panel of experts convenes

The document will be reviewed on Thursday when the panel of experts convenes

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