Sunday marked an important day in the battle against coronavirus as the FDA issued a EUA for the use of convalescent plasma, meaning that it could be used in medical healthcare throughout the country. This decision was taken after the FDA analyzed that the benefits and potential of convalescent plasma went far and above the risks that could be brought forth by such a method of treatment. The Food and Drug Administration of America mentioned how close to 70,000 people had recovered after using convalescent plasma as their main therapeutic tool. Although there are convalescent plasma side effects, the convalescent plasma treatment might actually be the missing link in America’s war against coronavirus.
The convalescent plasma that has been used is simply the plasma that was donated by patients who recovered from Coronavirus. And this important medical discovery led the President of the United States of America, Mr. Donald Trump declared that it was quite a historic moment when the healthcare sector of the government actually brought something out that would make a major difference in the way diseases were treated, and especially how coronavirus was being diagnosed in the country.
Nonetheless, newspaper reports have also stated that Donald Trump might have strong-armed the FDA to sign the convalescent plasma treatment with the EUA so that his flagging popularity could be bolstered. And when previously they didn’t want to be doing just that yet- owing to certain clinical trials that were underway, and whose results mattered heavily on the final outcome, the President determined that their reasons were strictly political, and not in consideration with the general sentiments of the public.
Yet the FDA stated that they didn’t want to approve it simply because they had inconclusive data that could make the treatment quite catastrophic if not properly conducted. Sunday also brought out a close representative of the White House Coronavirus Taskforce who mentioned that the FDA were so hesitant on signing something that important simply because they still had to review and tweak out a few data, which they were unable to.
Convalescent Plasma Meaning: What is It?
To put it simply, convalescent plasma is taken from the blood of those who have recovered from coronavirus. Their blood must contain anti-bodies which would be helpful in dealing with the virus. Back in March, the FDA had allowed for scientists to start their test trials on convalescent plasma treatment on patients, and since then close to 70,000 people have been saved. But there are certain convalescent plasma side effects- and the biggest one is of pure logistics.
There aren’t enough donors and the rate at which doctors administer convalescent plasma to patients, it can get really scarce in the long run. Also, there has been no conclusive trials on the subject, making it really hazardous to be using it without FDA approval. Although there are several clinical trials being conducted throughout the world on convalescent plasma, there hasn’t been any randomized trial which would offer the solution, or the approval.
Experts say more data is needed
In a briefing in the White House, the secretary for the Department of Health and Human Services, Alex Azar mentioned how important it was for the medical industry to start its procedure with convalescent plasma, meaning that there were enough conclusive results which would really enforce the beliefs of both patients and doctors that this might just work.
With a volunteer frame size of 70,000, Azar mentioned how the chances of survival was said to increase almost 35% when the patient was administered a convalescent plasma transfusion within three days of diagnosis. It was also imperative that the patient receiving the transfusion needed a heavy anti-body plasma that would be able to deal with the virus. And if there is an improvement in the chances of survival by 35%, convalescent plasma means a lot to hapless patients and hopeless doctors who would resort to anything to keep their patients alive.
Next, Azar also spoke about a test that had been conducted but wasn’t peer-reviewed due to it not being conclusive. Over 35,000 volunteers were chosen, and the results actually seem favorable when looked at from a bigger picture. The results showed that only 8.7% of the 35,000 volunteers died after being administered the convalescent plasma transfusion within three days of diagnosis- also the anti-body count in the plasma was extremely high to facilitate survival.
On the other hand, around 12% of the volunteers died after being administered a transfusion after 4 days since diagnosis. This was an improvement of 37%, and these were odds that the White House liked. It is quite indicative of how important high anti-body plasma is when we realise that people who received that in the transfusion have a 35% more chance of survival than those who didn’t.
But interestingly, that is not how you conduct a clinical trial for any drug or therapeutic tool that you are about to bring out for the masses. Every clinical trial, from an aspirin to something as complicated as a convalescent plasma, meaning something that could get potentially fatal if not researched upon, has a series of steps that the FDA needs to follow without fail. During a clinical trial, not all the volunteers are given the test drug- everyone except one was given placebo drugs, while one of them got offered the drug material. For, the analysis was not of how many ways could a patient recover when given the same medicine- the trial is always to analyse if a recovery has been made possible by the presence of the drug, or by any external factor.
If these questions are answered correctly, the drug may be approved by the FDA. Also, the biggest negation in the trials of convalescent plasma has been that most clinical trials don’t base their results on the duration or point at which a patient got the drug. Rather, their tests were meant to establish if a drug caused a difference in the person, or were they the same in comparison to the other volunteers. In the tests of convalescent plasma, meaning that every trial that brought this up, it was completely thrown out of the window.
Several experts have commented on the haste with which FDA approved the convalescent plasma, meaning that they particularly didn’t like the haste. Dr. Jonathan Reiner of the George Washington University mentioned how there wasn’t really much data to decipher if the convalescent plasma was at all useful- and without much conceivable harm. Dr. Thomas File mentioned that although there were some good signals that the convalescent plasma treatment gave off, there still was a long way to go before the FDA stamp of approval.
Since there was no randomized clinical trial, it would be pretty ignorant to approve it before conclusive data was provided. Dr. Paul Offit went a few steps forward and said that there was some bullying by the White House to bring this to the ground so soon. Since the treatment was still in a trial phase, there must have been several disgruntled workers at the FDA who probably would want it to go out after some serious trials.
And these are not the only experts that voiced their concerns. Dr. Francis Collins, and Dr. Anthony Fauci too expressed their disapproval at the speed with which convalescent plasma was brought to the masses.
Convalescent Plasma: ‘Great demand from patients and doctors’
At the end of the briefing at the White House, the President of the United States wasn’t one who would be mincing his words. He clearly mentioned that there were several key figures in the FDA who would rather see the convalescent plasma treatment have a hold up more than is necessary. And he believes that they had political reasons to be doing so- simply because they were not so sure if an approval would be the accurate course of action given the time frame and the lack of conclusive data available.
On the other hand, Hahn mentioned that there was no way that any decision taken by the FDA in relation to the convalescent plasma therapy would be a political one. He stated that as a doctor for the last three decades, his one agenda in life was to not harm a patient’s life by his own negligence. And he stated quite explicitly that the reasons for the delay was because the officers at the FDA weren’t confident enough to bring it out to the masses. He also made it clear that while the FDA believed the treatment would actually be of major help, as convalescent plasma meant a lot to a lot of people and doctors, (precisely why they signed the EUA), it wasn’t the same as an approval.
For, there were clinical trials going on at all times where a placebo would be used along with convalescent plasma would be distributed to the volunteers- but they had to be strong armed due to the massive expectations of both doctors and patients due to convalescent plasma, meaning that it was slowly turning into a ray of hope- rather than a simple blood transfusion that it really was.
Scientific uncertainties and limitations regarding the use of convalescent plasma, meaning that they might not be safe just yet
Although convalescent plasma therapy seems like a good alternative to several other treatment methods in the market, they also come with convalescent plasma side effects.
- A distinct lack of conclusive studies could seriously deter its development.
- People dealing in the transfusion may get infected accidentally if proper care hasn’t been taken.
- People can’t just donate convalescent plasma, meaning the donors need to have a heavy anti-body count- or else it would be completely futile.
- The centres for donating plasma have to relax certain criterias, and assess the situation sustainable, so that more donors would be able to provide their plasma.
- The fatality rate involved in the trial of convalescent plasma is not only the work of the transfusion, but also involves the care taken by the clinical centre in question.
- Monoclonal antibodies might turn out more effective if used in immunotherapy.
- The first world countries might not have issues with experimental trials, or supportive treatment but the developing countries might not have enough resources or funds to fully incorporate convalescent plasma, meaning there would always be a large section of the population not being able to receive it.
- In order to make a convalescent transfusion safe, the healthcare authorities need to make sure that the process involves removing pathogens which can cause problems later on- in spreading infections.
What mechanisms exist for providers to access COVID-19 convalescent plasma therapy clinical trials or other mechanisms to deliver this treatment to patients?
Back in March, the FDA decided to institute an Emergency IND which would enable doctors to use convalescent plasma, meaning the very blood transfusion to treat their patients who might be suffering from a very serious disease. The next month, the FDA launched the National Expanded Access Protocol which made it easier for every adult to procure convalescent plasma treatment irrespective of them already suffering from a serious disease, or running a risk of it.
Currently, there are a lot of FDA authorized clinical trials functioning throughout the USA and other countries, with every single trial focusing on a different subject for the study- while some would do it on children, others would do it on people with heart diseases.
Convalescent Plasma means a lot to people these days, with doctors and patients both expecting it to pay dividends. And therein lies the trouble with convalescent plasma therapy- the expectations have been set so high that doctors are willing to transfuse a lot of convalescent plasma without checking for the convalescent plasma side effects, or if the antibody count is high. The tool is useful, no doubt about it- but time will tell if it was a good thing for the FDA to sign the EUA, or maybe they should have waited to approve it.