An adverse reaction to a Phase III COVID-19 vaccine clinical studies highlights the need for vaccine awareness. 

The fight to be the first country to produce a vaccine to stop COVID-19 is on. But are the vaccine makers trying to forgo the usual safety measures to be the first to fight the COVID-19 pandemic? And, is the COVID-19 vaccine about health, money, or politics?

Because of the current global pandemic, scientists and pharmaceutical companies across several nations are developing vaccines and conducting clinical trials. The scientific community is concerned that some politicians are sending the wrong health messages about when the COVID-19 vaccines will be available. They fear that fast-tracking the COVID-19 vaccine process will compromise its safety and efficiency, causing more harm than good. Vaccine awareness will reassure the public that having a COVID-19 vaccine is important and necessary.

Chinese authorities are trying to inoculate thousands of their citizens with vaccines that are not yet approved. The safety of these vaccines are called to attention and may have harmful side effects. In a later report, an official claimed that from September 25, the World Health Organization (WHO) is backing China’s use of experimental vaccines. However, clinical trials haven’t finished. This is an example of politicians putting pressure on scientists to forego safety precautions.

Another example of politicians pressuring scientists to fast track a COVID-19 vaccine is the US President, Donald Trump. He told CNN that the White House can overrule any tough guidelines proposed by the Food and Drug Administration (FDA).

Vaccine Awareness

Before members of the public decide whether to get a COVID-19 vaccine shot, there needs to be an awareness of how the vaccine will protect them from getting sick. It will be necessary for health professionals to counsel their patients on how important it is to complete all stages of dosage to achieve the ultimate protection the vaccine provides. 

In the article, “The Red Flags That Alarm Experts as COVID-19 Vaccine Trials Reach Final Stage” Susan Koletar, director of the Division of Infectious Diseases at Ohio State Wexner Medical Center is quoted as saying that even though she hoped that “there will be a vaccine sooner than later … we shouldn’t sacrifice safety to push that forward.” 

Public Reactions To Vaccines

In a survey conducted by the UsAgainstAlzheimer’s organization, one response echoes that of experts. “I would need to be assured that its safety has been verified and that it hasn’t been rushed to market for political purposes.” Responses such as this indicate that the American public are wanting politicians to stay out of scientific research decisions.

Another survey conducted by Pew Research Center, shows that Americans are concerned about the uncertainty about reactions to vaccines. Some Amercians, in the same study, state that another reason for not getting a COVID-19 vaccine shot is the possibility that it may not work.  

A poll conducted by the Kaiser Family Foundation echoes that of other recent surveys. In this survey, 62 percent of adult Americans are worried that political pressure on the FDA may cause safety concerns. They are worried that political pressure would lead the FDA to rush out a vaccine before one is ready. The question then becomes, will governments listen to their citizens?

In light of the public concerns, Dr. Dan Barouch, MD director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston recognizes that, “there needs to be a lot of work to convince the public that vaccines are safe and effective. That starts with the data.” 

Adverse Reaction Causes A Pause In AstraZeneca Clinical Studies

It’s important to remember that some of the vaccines may be rushed without the adequate safety checks. Vaccine developers claim that their experimental vaccines are safe.

An example of this is the coronavirus vaccine that is being developed by the pharmaceutical company AstraZeneca and Oxford University. The US Biomedical Research and Development Authority has provided funding the development of a COVID-19 vaccine forward. Other country governments are also funding clinical trials for the same purpose.

Did AstraZeneca’s Vaccine Cause Neurological Problems?

Despite the vaccine maker’s reassurance that their vaccine is safe their clinical trials were put on hold. A woman in the United Kingdom developed symptoms similar to that of transverse myelitis after being given the vaccine. Transverse myelitis can cause pain, muscle weakness, paralysis, sensory problems and bladder dysfunction. It isn’t clear which of these problems the UK clinical participant developed. 

It begs the question, how many other clinical study participants are having adverse effects due to experimental vaccines? An anonymous individual has revealed that this development has not just affected other current AstraZeneca vaccine trials. Additionally, it’s impacted clinical trials carried out by other vaccine manufacturers too. 

Different Types of Adverse Reactions

What is disconcerting is the fact that there are several different types of serious adverse reactions. These reactions can result in hospitalization and cause life-threatening illness and even death.

The Lancet’s July issue has published the findings of a study that assessed the “safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2.” 

The study authors reported that there were some expected and protocol-defined local site reactions. These include injection site pain, tenderness, swelling, muscle ache, joint pain, fatigue, nausea, headache, chills. 

Participants in other clinical trials conducted by several vaccine developers have experienced some of the mild symptoms already mentioned. As the trials progressed, some companies have decided to discard their highest doses as participants in their trials reported severe reactions.

Reactions To The Vaccine

The final stage of testing is significant because it allows researchers to identify any undetected less common side effects from previous trials. Researchers use the final stage data to track which test subjects get sick from receiving the vaccine and those who receive the placebo. 

Adverse Effects Are Graded

There is a grading scale for adverse effects. They are:

  • Mild — transient or mild discomfort, no interference with activity, and no medical intervention or therapy required.
  • Moderate — mild to moderate limitation in activity which may require some assistance, and no, or minimal, medical intervention required.  
  • Severe — assistance required in activity, medical intervention required, and potentially life-threatening requiring hospitalisation.

Transverse myelitis has been noted on research tables as being an adverse reaction in past clinical trials. This means that there is a high chance that in this case, AstraZeneca’s trial vaccine may be responsible. However, the vaccine makers are claiming that the investigations by their team of experts have decided that their vaccine may not have caused transverse myelitis

Clinical Trials Are Unclear

As the results of the surveys show, the general public wants to know whether the vaccines will work. The difficulty when determining the safety of clinical trials is that most don’t determine whether the vaccine will stop them from permanently becoming gravely ill. Another unclear detail is the degree of COVID-19 the vaccine has been created for. 

Dr. Peter Doshi, associate professor at the University of Maryland School of Pharmacy, wrote an opinion piece for the New York Times discussing how the current COVID-19 clinical trials do not address one simple question. It is simply, “Do these vaccines prevent moderate or serious COVID-19?”

Exclusion From Clinical Trials

Another unclear condition of clinical trials is the exclusion of groups of people. This includes persons with underlying medical conditions, serious allergies, immunocompromised persons, pregnant people, lactating people, and adolescents. By excluding parts of a community a true indication that the COVID-19 vaccine is safe cannot be concluded.

On December 12th the Advisory Committee on Immunization Practices (ACIP) sent out an Interim Clinical Considerations for Use of Pfizer-BioNTech COVID-19 vaccine. The report states treatment options for administering the vaccine to “special populations.” Although the recommendations were written for the Pfizer-BioNTech vaccine, the principles can be applied to any other COVID-19 vaccine. 

As there is limited data about how much the vaccines will reduce transmission of COVID-19. The ACIP recommended that vaccinated people should still take the recommended precautions. Mask-wearing and physical distancing will continue to be important in stopping the spread of COVID-19.

Process Of Vaccine Approval

In the US, the authority responsible for ensuring that vaccines are safe and efficient is the Food and Drug Administration (FDA). in conjunction with the Center for Biologics Evaluation and Research (CBER). 

The National Law Review reported in September that FDA Commissioner Stephen M. Hahn, M.D told reporters that the FDA “will not cut corners” when it comes to ensuring that every medication and vaccine study trials are safe.

Further FDA Response

In response to the serious illness in the AstraZeneca trial, the FDA has broadened its investigation. They will look at data from earlier trials of similar vaccines developed by the same scientists.

The FDA has slowed down the production of the COVID-19 vaccine by posting new industry guidelines. These guidelines ask pharmaceutical companies to monitor study participants for at least two months after the first vaccine shots are given. This will allow the companies to have a better sense of whether the vaccine works as predicted. More importantly to take note of any side effects that may occur. 

The FDA updated its guidance on December 4th about how vaccine trials should be conducted. The December update states that the “current pandemic does not relieve investigators of their responsibility to review safety reports received from sponsors during the trials, or from reporting unexpected adverse events to the investigator’s institutional review board (IRB).”

Data And Safety Monitoring Board (DSM)

Every clinical study involving humans should have an independent group of experts. In the AstraZeneca case, the DSMB initiated a pause in clinical studies. Pauses are necessary to allow investigators to determine whether problems are caused by the vaccine. Not only should vaccine makers have a DSMB, but they also need to have a document that describes exactly how the clinical trials will be conducted. This document is necessary toensure the safety of participants and the integrity of the data collected during the study.”

Globally, scientists and governments seem to be taking shortcuts in order to have a COVID-19 vaccine ready as soon as possible. But how many other clinical trial participants have experienced serious events when safety has been compromised? How many have not been reported? On October 12th  a news report revealed yet another drug company has had to pause their clinical trials because a participant became ill.

Even when a vaccine has been proven to be safe, officials cannot anticipate every situation that may arise. There is no one-size-fits-all solution so promising a vaccine in a short period of time is misleading and inappropriate. 

Alternatives Medicines

A study published in the July 2020 issue of Journal of Traditional and Complementary Medicine claims that COVID-19 can be treated by using dietary therapy and herbal medicine. The study authors examined and reviewed vitamin C and vitamin D effectiveness in treating COVID-19. They concluded more clinical studies need to be carried out.

As with all the current COVID-19 vaccines, any alternative therapies have to comply with safety regulations set out by the FDA.

Kat is a freelance writer.

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