Are Vaccines Safe? How To Ensure Immunization Quality And Safety

Are vaccines safe? In recent years, vaccines have started to catch some serious heat from anti-vaccine proponents. Unfortunately, the opposing party has the support of many polarizing figures such as Bill Maher, Jim Carry and the famous star from the popular science sitcom The Big Bang Theory, Mayim Bialik. This type of backing certainly puts a significant portion of the public, who aren’t self-reliant, in a state of dilemma. Like a pendulum, they keep oscillating between whether to get themselves vaccinated or not.

I had a chance to have conversation with one of the fellows from the opposing side, the anti-vaccine group. He claimed that he wants to keep his children as far away from germs as possible, and he can’t let a doctor inject vial containing the same old pathogens, that has killed thousands of individuals before.
Yes, the same old anecdote.

The problem here lies in the fact that these individuals keep on disregarding the pre and post vaccination statistics. Look at Polio, when the Polio Vaccine was introduced in 1952 almost 3,000 people were dying annually from it in the United States, and just in the next 10 years, it was completely eradicated. Just to give you a perspective of what would have had happened otherwise, I wouldn’t take you to history, because we have a perfect example in South Asia.

Unfortunately, in countries like Pakistan, Bangladesh and Afghanistan, where individuals from the conservative background tend to not vaccinate their children, Polio still exists.

The movement is now calling for vaccine manufacturers to recall all the vaccines, as they claim their link to autism. Keep in mind this argument has no proven scientific backing.

Vaccines are generally recalled when they are suspected to cause a possible safety concern for the people and this is done before an injury or vaccine related incidence occurs. Rather, the manufacturer’s quality testing noticed some irregularity in some vaccine vials.  In these cases, the safety of these vaccines was monitored continuously before and after they were in use. The safety of child vaccinations requires a strict monitoring of the vaccines for children in real time. They are all test and subjected to rigorous quality control measures before being released for use.

CDC analyzed reports by the Vaccine Adverse Event Reporting System (VAERS) to search for any side effects that might have been caused by the irregularity. They found none. Any time an irregularity is found in a vaccine lot which could make it unsafe, the manufacturer, in collaboration with the U.S. Food and Drug Administration (FDA), will recall it immediately.  FDA also maintains a record of all the recalls of vaccines which have been carried out so far.

Vaccine Recall Protocol

In contrast to the popular belief. the manufacturer of the vaccine always initiates the recall of a vaccine, and this is done during the process of vaccine development. The recall is rarely issued by FDA, since in most of the cases the safety protocols of the company realize the need to recall.

If the safety of the vaccine in terms of posing risks to the health of the vaccinee is concerned, then it is made sure that the vaccine is recalled at the earliest. The manufacturer contacts vaccine distributors and healthcare facilities who might have purchased the vaccine to inform them of the suspected problem.

FDA oversees the manufacturer’s strategy and help ensure the recall goes well. FDA does not participate in the recall process directly; rather it provides the overseeing services to the whole process.

Communication Of Vaccine Recall

Doctors are the first to communicate it to you if a vaccine is recalled. If the vaccine to be recalled is used by a large portion of the population, then the news may also be communicated by the media and news outlets. Keep in mind that FDA does not communicate all the recalls via media outlets rather they are available on their website under the tab of weekly enforcement reports, so keep yourself updated with the information.

The vaccines with large target immunizations are:

CDC also maintains a record of all the vaccines which have been recalled so far. A list of these vaccines is available at the recalled vaccine page on the website of CDC.

Are Vaccines Safe? Testing For Safety Of The Vaccine Before It Is Approved

It is necessary for the vaccine manufacturer to acquire a license, as a certificate of approval from FDA, before the vaccine is deemed fit for immunization across the United States. There is a set of rules and regulations ensured by FDA which ensures that the vaccines which are certified are in their purest form while maintaining maximum efficacy after inoculation. The set of rules vary from vaccine to vaccine e.g. the certification procedure for pneumococcal vaccine varies from the rest of vaccines.

Before a vaccine is approved by FDA for use by the public, results of studies on safety and effectiveness of the vaccine are evaluated by highly trained FDA scientists and doctors. In order to receive the certification of approval from FDA, it is necessary for the manufacturers to ensure that their manufacturing process for the current vaccine is according to the prevalent and approved current good manufacturing practices (CGMP).

FDA representatives personally visit the manufacturing facility of the vaccine in order to assess the situation and adherence to CGMP by the manufacturer.

How Vaccines Are Made? 

Long before a vaccine is ready for the animal or human subjects in the trials; it is manufactured and tested in the laboratory on a molecular scale. If a vaccine proves its worth in the laboratory experiments, it then moves on to the next level of testing which uses animals as test subjects. It is done so in order to avoid possible vaccine injury in the test animals as well. If the outcome of the animal tests is promising, then the scientists have an ideal candidate to be tested in human volunteers via carefully planned human trials.

The advance of a vaccine from laboratory testing to trials on human volunteers is not simple. During the various stages of testing in the laboratory on molecular scale as well as in the animals, all the results are duly noted and if there are side effects then the vaccine is returned to the experimental phase where possible steps are taken to remove the hindrance which kept it from performing at the molecular level or in the case of animals.

Clinical Trials

Before the vaccines reach the community, they are tested on human volunteers to check the efficacy of the vaccine. They aren’t sold commercially until and unless their safety isn’t proved. Vaccine trials consist of three predefined phases of testing. It is made sure by the FDA that vaccines for children which gets approved for immunization are first tested on adult volunteers and all the healthcare precautions are taken to ensure the safety of these volunteers.

For every vaccine trial, three phases of the trial are planned and discussed with the FDA by the manufacturer. FDA reviews and authorizes all they steps taken during these trials which are divided into three phases for every vaccine:

Phase 1

  • The focus of phase 1 trials is on the safety of the vaccines.
  • The number of volunteers who participate in the phase 1 trial ranges from a group of 20 people to a maximum 100.
  • Dose-effect relationship is studied deeply in the phase 1 trials where the scientists try to figure out the possible connection of side effects with the volume of the dose.
  • In phase 1, it is also a secondary goal of the scientists to find out the efficacy of the vaccines.
  • If the vaccine performs well in the phase 1 trial it is then allowed to move to the phase 2 of testing

Phase 2

  • The number of volunteers expands to several hundred in the phase 2 trials.
  • This trial mainly focuses on carrying out studies which can tie short term side effects with a particular dosage of the vaccine.
  • Dose effect is also studied in order to assess the immune response to particular doses.

Phase 3

  • The volunteer group for phase 3 expands to several hundred of even several thousands.
  • Control groups are also formed which may be administered with placebo or another vaccine.
  • The efficacy of the vaccine is recorded between the test groups and the control groups.
  • Comparison studies are also carried out amongst test and control groups in order to record the efficacy of the vaccine as opposed to its side effects.
  • The safety of vaccine also comes under strict scrutiny in the phase 3 trials.

FDA scientists and medical professionals carefully evaluate a wide range of information including results of studies on the vaccine’s physical, chemical, and biological properties, as well as how it is manufactured, to ensure that it can be made consistently safe, pure, and potent.

After everything has been done and dusted, it all comes down to the final verdict. The Lady Justice FDA, with its weighing balance decides if the benefits outweigh the potential risks trials. Only if a vaccine’s benefits are found to outweigh its potential risks does the FDA grant a license for the vaccine, allowing it to be used by the public?

Efforts To Ensure Vaccine Safety After Licensing (Post Market Analysis)

The process of monitoring the vaccine throughout its manufacturing and testing is not over with the issuance of an approval to begin the immunizations in the United States. As the immunizations are done using the approved vaccine it is continuously monitored.

The focus of post-license monitoring is to record any new side effects which may develop and have the potential to emerge into adverse effects. The real-time monitoring of the vaccines also ensures that the benefit of the vaccine to the health of the individual keeps on outweighing the possible risks and threats to the vaccines. The two important points which call for real-time monitoring are:

Some Side Effects Are Not Evident At First:

The clinical trials are designed in a way to ensure that all the possible side effects become evident and are documented. But still the clinical trials are not spread on a very large time frame and they are bound to end one day or the other. Because of this limitation, on rare occasions, one or more than one side effects may appear at a later stage after the immunization has begun with the approved vaccine.

The frequency of some rare side effects remains limited to a very small percentage such as one person in 0.1 million or even 1 in 0.5 million people who are vaccinated.

Assessment Of Side Effects In Special Groups:

Coming to the what we all had been waiting to hear, the safety assessment of vaccines among toddlers, pregnant women, and older adults. They may not be a part of the vaccine trial group but may be at a greater risk of developing side effects when immunized with a particular disease.

If a link is found between a possible side effect and a vaccine, public health officials take appropriate action. In the case of emergence of side effect at this stage, the immunization schedule is revised and a new immunization chart is issued which is to be followed onwards.

Role of Advisory Committee On Immunization Practices

The Advisory Committee on Immunization Practices or (ACIP) is a coalition comprising of medical experts and the experts on the subject of public health. It is the duty of ACIP to analyze the results of the vaccine development procedures and trials in order to give an opinion on the safety and efficacy of the vaccine. They are also the official body which looks after the development of suitable recommendations for the optimum use of particular vaccines. Baby vaccinations are also overlooked by the same advisory committee.

ACIP uses the real-time monitoring data of the FDA as well so that on the basis of their latest analysis they can update the recommendations and also make sure that the vaccine is working in the safety limits.

Are Vaccines Safe? Vaccine Adverse Event Reporting System

Centers for Disease Control and Prevention (CDC) and FDA require the input of data from the recipients of the vaccine in order to get a complete picture of the performance of vaccine. For this purpose, Vaccine Adverse Event Reporting System (VAERS) is established and made accessible to all the individuals. Being a national reporting system which can be used by a vaccinee to report any adverse reaction, VAERS is constantly used by CDC and FDA. This allows the authorities to keep an eye on the manufacturing and performance of the vaccine such as pneumococcal vaccine.

Not only the individuals who were immunized with a vaccine but also the health care professionals, the immediate family of the vaccinee, the manufacturers of the vaccine and the health care workers are encouraged by CDC and FDA to use VAERS without any hesitation in order to report an experience which seemed odd or which may be in the form of the occurrence of any adverse effect.

The data on VAERS is of interest for the scientists as well because it tells them about the adverse effects which need a thorough look into the link which led to the occurrence of such side effect. A team of medical experts looks into the daily reports of serious incidents and then reviews each case individually. The data on the VAERS system is helpful in predicting an adverse effect from causing much harm. Such data is used by medical experts as well as the officials at CDC and FDA to look into the safety of the vaccine and to be aware of the possible adverse effects which it may cause in the future.

Not all reports of adverse effects and reactions are followed by a launch of a research-based study into the matter, VAERS system only tags the occurrence of an adverse reaction if it happens more than the predicted frequency or when the pattern of occurrence of such effects is different from the one which was predicted.

VAERS data alone usually cannot be used to answer the question, “Do a certain vaccine cause a particular side effect?” This is mainly because adverse events reported to VAERS may or may not be caused by vaccines. There are reports in VAERS of common conditions that may occur by chance alone that are found shortly after vaccination. The investigation may find no medical link between vaccination and these conditions.

So, you see! The process of vaccine development is extremely sustainable. The regulatory authorities go to the extra mile to ensure the wellbeing of the community. It’s important that we play our roles as responsible human beings and not let fear mongers deny our children of the healthcare that will protect them from pathogens.

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