Johns Hopkins professor slams the FDA for holding up approval of COVID vaccine with red tape
Professor Marty Makary slammed the FDA for meeting to review the Pfizer vaccine on December 10 even though it had already gained approval in the U.K. on Wednesday
A professor at Johns Hopkins slammed the Food and Drug Administration on Friday for continuing to hold off their approval of the COVID-19 vaccine – dubbing the agency’s progress ‘Operation Turtle Speed.’
‘FDA regulators are wasting precious time in greenlighting a COVID vaccine as more than 2,000 Americans are dying each day and the pandemic continues to starve American society,’ Makary declared in the scathing op-ed.
Britain on Wednesday became the first country in the world to approve the jab, after regulators gave it the green light in the wake of evidence showing it was up to 95 per cent effective and safe.
It prompted a major international row, with both the EU and the United States lashing out at the speed at which it was approved. Donald Trump’s top medic Dr Anthony Fauci accused the UK drug regulator of failing to adequately scrutinize data from manufacturers.
Britain on Wednesday became the first country in the world to approve the jab, after regulators gave it the green light in the wake of evidence showing it was up to 95 per cent effective and safe
But Makary asserted that the FDA’s review could be done ‘within 24 to 48 hours without cutting any corners.’
‘They just need to work harder,’ he added.
‘Contrary to popular belief, the FDA process is not hands-on—it does not interview vaccine trial patients or look under a microscope at the immune cells. It’s doing a statistical analysis and looking at data.
‘For the vaccine trial, the data set is small and straightforward. If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour.’
‘FDA regulators are wasting precious time in greenlighting a COVID vaccine as more than 2,000 Americans are dying each day and the pandemic continues to starve American society,’ Makary declared in the scathing op-ed
‘For the vaccine trial, the data set is small and straightforward,’ he claimed. ‘If my research team, normally tasked with analyzing data on millions of patients, was asked to review the smaller Pfizer vaccine study of 43,000 patients, it would take about one hour’
Makary credited the European Medications Agency for using rolling reviews, reviewing data in the real time for the sake for efficiency. He implored the FDA to begin doing that as well.
‘Today, as the career FDA staff sit on the Pfizer and Moderna vaccine applications, we health care workers continue to work in highly infected ICUs and testing centers,’ he said.
‘Vulnerable seniors grow lonelier, and more American families fall behind financially. During a health emergency, the FDA should be convening a single, day-long meeting immediately when the data is submitted, in the same way American businesses have emergency board meetings when a crisis occurs.
‘The FDA has a moral and civil obligation to review the data with a sense of urgency. It’s not too late—the FDA could call an emergency meeting today.’
The op-ed comes as President-elect Joe Biden raised concerns Friday about what he said was a lack of detailed planning for end-stage distribution of the coronavirus vaccine, following discussions with current Trump administration officials.
Biden made the statement after speaking in Wilmington about a ‘grim’ jobs report that he also called ‘dire.’
‘There is no detailed plan that we’ve seen anyway as to how you get the vaccine out of a container into an injection syringe into somebody’s arm,’ Biden said.
The number of Americans hospitalized with COVID-19 hit an all-time high in the U.S. on Thursday at 100,667, according to the COVID Tracking Project.
That figure has more than doubled over the past month, while new daily cases are averaging 210,000 and deaths are averaging 1,800 per day, according to data compiled by Johns Hopkins University.
In the United States, there are more than 14,300,000 people who have tested positive with the coronavirus. Some 278,083 Americans have died as states across the country look to go into stricter lockdowns.
California Governor Gavin Newsom (above) announced Thursday he will plunge regions of the state into lockdown within a matter of days, banning outdoor dining for hard-hit restaurants
On Thursday, California Governor Gavin Newsom announced he will plunge regions of the state into lockdown within a matter of days, banning outdoor dining for restaurants already teetering on the brink of collapse amid the pandemic.
The new order divides the state into five regions – Northern California, San Joaquin Valley, Greater Sacramento, Southern California and the Bay Area
But Newsom said four of the regions are on track to hit that threshold within a few days and the fifth – the Bay Area – is expected to meet it by the middle of the month.
When they do surpass 85 percent capacity of ICU beds being full, the state will order affected regions to close hair salons and barber shops, limit retail stores to 20 percent capacity and only allow restaurants to offer take-out and delivery for at least three weeks.
WHY THE FDA IS TAKING SO LONG TO APPROVE PFIZER VACCINE
FDA Commissioner Steve Hahn said on Wednesday that scientists needed more time to review the raw data from the Pfizer vaccine trial before they’d make a decision.
Before December 10, when the will all meet to discuss it, this is what happens;
Multiple teams examine different data sets
Hahn said that ordinarily, 150 scientists would look at an application. It’s unclear if more have been added for the Pfizer application or the Moderna application given the urgency of the situation
They will separately look at data for different components of the vaccine including;
All the different groups will then come together on the 10th to discuss their findings and if, collaboratively, they can recommend approval
The FDA scientists make a recommendation to the advisory council
The advisory council has already started meeting to discuss who would get the vaccine first if it is approved.
They also have to decide, ultimately, if it is safe for approval.
If they do that, the doses will start being shipped out on December 15.
Source: | This article originally belongs to Dailymail.co.uk