As many of you are aware, there is an ongoing measles epidemic in the USA (an Europe), which has struck over 600 Americans in 2019, nearly double the 2018 numbers. The best and only way to prevent measles is with the MMR vaccine against measles, mumps, and rubella.
Despite this overwhelming scientific evidence, the outrageous deceptions and lies of the anti-vaccine religion, starting with that cunning fraud, Andrew Wakefield, continue to scare parents from giving their children the MMR vaccines. The World Health Organization (WHO) has stated that vaccine hesitancy is one of the top 10 threats to global health.
What the FDA says about the MMR vaccine
Because of all of this, the US Food and Drug Administration (FDA) issued a statement that did not mince any words. It reiterated its strong confidence in the safety and effectiveness of the MMR vaccine, along with all vaccines in general.
Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER), issued a statement about the MMR vaccine:
The MMR vaccine has been approved in the United States for nearly 50 years to prevent measles, mumps and rubella (also known as German Measles). As a result of its use, measles and rubella were completely eradicated in the United States, and mumps cases decreased by 99%. Large well-designed studies have confirmed the safety and effectiveness of the MMR vaccine and have demonstrated that administration of the vaccine is not associated with the development of autism. However we’re seeing an increasing number of outbreaks of measles in communities across the country, including those in New York, New Jersey, Washington, California, and Michigan.
We cannot state strongly enough – the overwhelming scientific evidence shows that vaccines are among the most effective and safest interventions to both prevent individual illness and protect public health. Just to be clear, the FDA has determined that the MMR vaccine is both safe and effective in preventing these diseases.
Vaccinating against measles, mumps and rubella not only protects us and our children, it protects people who can’t be vaccinated, including children with compromised immune systems due to illness and its treatment, such as cancer.
We do not take lightly our responsibility to ensure the safety and effectiveness of vaccines, and work diligently to assess safety and effectiveness of all licensed vaccines for their intended uses. The MMR vaccine is very effective at protecting people against measles, mumps, and rubella. It also prevents complications caused by these diseases. And we have nearly 50 years of experience and evidence supporting that fact. In fact, according to the CDC, two doses of the MMR vaccine beginning at 12 months of age (the recommended dosing schedule) are 97% effective against measles, 88% effective against mumps, and 97% effective for rubella.
He also stated that not only does the MMR vaccine protect children against measles, mumps, and rubella, it prevents the serious and deadly complications that are related to those diseases, especially measles.
Now to refute the FDA conspiracy fallacies
I know what the anti-vaxxers are saying about these statements – the FDA is a tool of Big Pharma, doing whatever Big Pharma wants. Well, given the fact that less than 13% of drugs that enter Phase 1 clinical trials ever get approved by the FDA, they must not be hearing the orders from Big Pharma execs.
I have a suspicion that the anti-vaxxers believe that a New Drug Application (NDA) consists of a few pages of text along with a couple of crayon-scribbled graphs and a few $100 bills. Then the FDA reviewer spends a couple of minutes counting the $100 bills and gives the application a perfunctory review and approval.
Actually, I think the whole pseudoscience world believes this – and if only a few gold bars were included with the homeopathic potion application, it would get approved.
Not to get into all the details of the NDA process, but it is complicated and arduous. Moreover, the level of stress in those individuals at Big Pharma who are responsible for the NDA is overwhelming.
The new drug application (NDA) represents the end-point of the research and development of a new drug, like the MMR vaccine. The pharmaceutical company has discovered a potential new drug, tested it in various models, and gone through three (probably more) different clinical trials.
The next step is to gain regulatory approval. Although I have focused on the US-centric FDA process, most countries have nearly equivalent regulations and bureaucracies. And for most countries, there are often bilateral agreements to accept a regulatory finding from one country and apply it to another. But most countries require the same phases of clinical trials, similar documentation, and similar rigorous review.
The NDA itself is a massive document, written by staff in the Regulatory and Medical departments of the pharmaceutical company. Much of it is boilerplate with questions that must be answered, such as:
- Is the drug safe and effective in its proposed use(s) when used as directed?
- Do the benefits of the drug outweigh the risks?
- Is the drug’s proposed labeling (package insert) appropriate, and what should it contain?
- Are the methods used in manufacturing the drug, called good manufacturing practice (GMP), and quality control sufficient to maintain the drug’s quality and to preserve the drug’s identity, strength, and purity?
These answers are never one sentence long. Obviously, they are not yes/no answers, but are complex with hundreds of pages of supporting documents.
A full NDA is usually shipped in several boxes (PDF files don’t make sense for such a huge document) to the reviewer. It is examined carefully by a reviewer who continuously emails specific questions back to the regulatory team at the company that must be answered.
Then a team of independent reviewers, usually scientists and physicians who have knowledge of the field, must vote on the application.
Are mistakes made? Sure. But it’s very rare, although the anti-vaxxers will use their confirmation bias to point out these mistakes to condemn the whole process.
Because of this complex, and difficult process, the FDA is considered one of the best, most competent, drug regulatory agencies in the world. Many nations defer to FDA approvals.
So when the FDA says the MMR vaccine is safe and effective, and it’s supported not only by a thorough regulatory review but also by the scientific consensus, you can feel assured by the strong statement of the FDA.
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