Doctor slams FDA for not approving AstraZeneca’s coronavirus vaccine

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Johns Hopkins professor Dr Marty Makary slammed the slowdown in the U.S. approving AstraZeneca


A doctor has slammed the U.S. Food and Drug Administration (FDA) for not approving AstraZeneca-University of Oxford’s coronavirus vaccine.

On Wednesday, Great Britain became the fist country in the world to grant authorization to the COVID-19 jab.

The vaccine holds great appeal because it’s inexpensive – costing $3 to $4 per dose – and can be stored in refrigerators for up to six months rather than at ultra-cold temperatures required for other vaccines.

However, a top Trump administration official has said Americans will likely not receive AstraZeneca‘s coronavirus shot before April – three months after the U.K.’s green light.

Dr Marty Makary, a professor in the School of Medicine at Johns Hopkins University Bloomberg School of Public Health, took to Twitter to blast the decision and said the FDA’s slow-moving ‘bureaucracy’ – not worries over safety – are the real reason for the delay.  

Johns Hopkins professor Dr Marty Makary slammed the slowdown in the U.S. approving AstraZeneca’s vaccine and said the real reason for the delay is due to a ‘broken [federal] bureaucracy’

On Wednesday, Great Britain became the first country to approve AstraZeneca's jab, which is cheaper and easier to store than other COVID-19 shots such as those manufactured by Pfizer and Moderna

On Wednesday, Great Britain became the first country to approve AstraZeneca’s jab, which is cheaper and easier to store than other COVID-19 shots such as those manufactured by Pfizer and Moderna

Dr Moncef Slaoui, head of the Trump administration's Operation Warp Speed, said the U.S. will likely not see approval until April. Pictured: Thabisle Khlatshwayo, a volunteer in AstraZeneca's vaccine trial, receives her second shot on November 30

Dr Moncef Slaoui, head of the Trump administration’s Operation Warp Speed, said the U.S. will likely not see approval until April. Pictured: Thabisle Khlatshwayo, a volunteer in AstraZeneca’s vaccine trial, receives her second shot on November 30

‘Americans have a right to ask why the UK approved the Ox/AZ vaccine today but the @US_FDA has not & is MONTHS away,’ he tweeted.

‘FACT: The 17,000-employee FDA turtle takes an [average] of 12 [years] to approve a new drug. FDA old guard argue they are slow for safety. Real reason = a broken [federal] bureaucracy.’

Makary did not immediately return a request for comment from DailyMail.com. 

U.S. regulators have been wary of AstraZeneca’s vaccine ever since a late-stage study was put on hold on September 9 when a British participant was rushed to the hospital after suffering a serious reaction that triggered spinal cord inflammation.

An internal safety report revealed the patient was diagnosed with transverse myelitis, an inflammation of a section of the spinal cord.

The condition damages the myelin sheath, an insulating barrier of fatty protein that protects the nerves, and interrupts messages sent by spinal cord nerves.

This results in pain, weakness, abnormal sensations, and problems of the bladder and bowel – and can even lead to permanent paralysis.

Transverse myelitis can be caused by several conditions including infections such as influenza and immune system disorders. 

Around 1,400 cases are diagnosed in the US each year, according to the National Organization for Rare Disorders. 

Following the incident, the drugmaker took one month to turn over data to the FDA.

At the time, a source told CNN the delay was due to data being stored differently at the European Medicines Agency – which evaluates and supervises medicinal products in Europe – than it is at the FDA.

‘They had to convert data from one format to another format,’ the unnamed source said.

‘It’s like taking stuff off a PC and putting it onto an Apple. They had to spend a lot of hours to get what they wanted.’

When the FDA allowed the trial to resume, it required researchers conducting the study to add information about the incident to consent forms signed by participants.

In addition, data from phase III clinical trials suggest AstraZeneca’s vaccine prevents COVID-19 about 70 percent of the time

This less than the approximately 95 percent efficacy seen in Moderna’s and Pfizer’s vaccines – both of which have been approved in the U.S. for emergency use.  

However, researchers found the vaccine could prevent up to 90 percent of infections when administered as a half dose followed by a full dose. 

This may be because AstraZenenca has been using a different technology and developed what is known as a viral vector vaccine.

The immunization combines genetic material from the new virus with the genes of the adenovirus, which causes the common cold.

It codes for the spike protein that the coronavirus uses to enter and infect cells in order to train the body to recognized the virus and induce an immune response if infected.

This is the same technology that Johnson & Johnson used to make an experimental Ebola vaccine for people in the Democratic Republic of Congo in late 2019.

Dr Moncef Slaoui, chief of Operation Warp Speed, has estimated earlier this year that AstraZeneca would be able to file for emergency use authorization (EUA) with the FDA by February.

He said he now expects this to occur in April.     

Slaoui said this is mainly because the vaccine’s efficacy on elderly people is ‘effectively unknown’ because not many senior citizens were enrolled early in clinical trials.

‘We project, if everything goes well, that the readout and emergency use authorization may be granted somewhere early in the month of April,’ Slaoui said during a call with reporters on Wednesday.   

HOW DOES ASTRAZENECA-OXFORD’S VACCINE WORK?

The vaccine – called ChAdOx1 nCoV-19 – uses a harmless, weakened version of a common virus which causes a cold in chimpanzees.

Researchers have already used this technology to produce vaccines against a number of pathogens including flu and Zika.

The virus is genetically modified so that it is impossible for it to reproduce  in humans and cause infection.

Scientists have transferred the genetic instructions for coronavirus’s specific ‘spike protein’ – which it needs to invade cells – to the vaccine.

When the vaccine enters cells inside the body, it uses this genetic code to force the body’s own cells to produce the surface spike protein of the coronavirus.

This induces an immune response because it makes those cells look like the virus, which effectively works as a training aid for the immune system to learn how to fight the virus if the real thing gets into the body.

In clinical trials Oxford’s vaccine was 62 per cent effective at preventing a coronavirus diagnosis if given as two doses, and 90 per cent when one half dose was given followed by a further full dose.

The difference, experts say, may be because a smaller dose the first time allows the body to create a better picture of what the virus will look like before it attempts to launch a full-scale attack, as with a full dose, giving quality first and then quantity later.



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