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Johns Hopkins professor slams FDA for taking three weeks to approve Pfizer vaccine

‘There’s a war going on but you wouldn’t know it by their timeline’: Johns Hopkins professor slams the FDA for taking so long on Pfizer vaccine approval and blames them for 35,000 American deaths

  • Martin Makary wrote for Med Page Today on Thursday to slam the FDA’s slow approach 
  • He said there was ‘no reason’ for the FDA to be taking as long as it is to approve the vaccine
  • Pfizer submitted its trial analysis for emergency authorization on November 23
  • Since then, 35,000 Americans have died from COVID-19 
  • The FDA’s advisory committee is meeting today to finally vote on the vaccine
  • But it may take days yet before the vaccine is approved, much less rolled out 

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

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. 

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

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

‘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. 

An 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. Even though the meeting started at 9am, the scientists will spend most of the day discussing the state of the pandemic in the US. 

Pfizer will then make its case and then the FDA will give a presentation but that won’t happen until after lunchtime.  

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 FDA advisory panel is currently discussing the vaccine in a virtual summit (above) that is expected to go on all day. Even then, it might not be approved today

The FDA advisory panel is currently discussing the vaccine in a virtual summit (above) that is expected to go on all day. Even then, it might not be approved today 

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

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. 

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