Sorry RFK, Vaccines Are Safe.
Let's Discuss The Rigorous Testing And Studies Vaccines Go Through To Ensure Public Safety. Yes, Including The COVID Vaccine.
With RFK Jr spreading anti-vaccine conspiracies on a national level as the Human And Health Services(HHS) director, I thought a short article on the efficacy and safety of vaccines is in order.
Let’s first discuss the rigorous testing the undergo, yes the COVID vaccine included, before discussing the risks and benefits involved.
Clinical Trials Before Market
Vaccines are tested in a multitude of ways long before ever reaching the market. It begins with research that connects a virus to causing a disease, this is then peer-reviewed, offering an initial and often undermentioned first layer of critique.
Then the beginnings of the vaccine undergo pre-clinical toxicology, this includes testing on cells and animals, to ensure the vaccine is safe at different dose levels.
After this, and adhering to the Food and Drug Administration’s (FDA) guidelines, an Investigational New Drug (IND) application can be sent to begin clinical trials.
In phase one of clinical trials, only 20 to 100 individuals receive the vaccine. Researchers gather information on how safe the vaccine is in people.
This includes identifying possible side effects, and studying how well the vaccine works to cause an immune response.
In phase two, 100-300 individuals in a demographic similar to the intended recipients for the vaccine. They will include groups of people from diverse backgrounds to ensure representation across different populations.
For phase three, 1,000–3,000 individuals are included in the trial. During this phase, researchers confirm how well the vaccine works at scale, monitor common and less common side effects, and collect information to support safe use in people
Testing doesn’t stop there either, even after approval and starting during Phase 3 clinical trials, the FDA will look at the company's proposed manufacturing process for the vaccine.
They will also inspect the manufacturing facility where the vaccine will be made to ensure the facility has everything necessary for reliable and consistent large-scale manufacturing.
The manufacturer makes batches of vaccine called "lots". These lots undergo a series of tests to ensure the vaccine is consistent from lot to lot.
The FDA requires manufacturers to submit data from these tests to support a successful manufacturing process, even after approval.
Additionally, they undergo concomitant administrative testing to specifically ensure they fit in the vaccine schedule so there are no additional adverse effects to be expected there.
This makes vaccines one of the most tested, if not the most tested, medicine available to the public and that's before taking into account the everyday real world data we get from the millions of vaccinated people.
Despite attempts from anti-vaccine proponents to claim the contrary, the coronavirus vaccine went through all of the same procedures we laid out for other vaccines. It was able to be fast-tracked due to global funding and efforts in hopes to quell the outbreaks.
Coronavirus research started decades prior after an early 2000s SARS outbreak, and we already had plenty of research on mRNA vaccines, so it’s not like researchers were starting with nothing.
Vaccine Efficacy.
All medicines are not without risk, anything that effects your body will come with some level of risk, which is why it’s important to understand the benefit-risk analysis for vaccines.
For a vaccine to even reach market, the risk it poses has to be an order of magnitude lower than that of the disease itself.
For example, post-infectious encephalomyelitis after measles infection happens in roughly 1 per every 2,000 cases, but only roughly 1 in over 100,000 cases after the vaccine.
Meanwhile, vaccines have multiple benefits for the public. They contribute to 40% of the decline in infant mortality in the last 50 years. Multiple deadly diseases, from Polio to Malaria, have been eradicated by vaccines.
Per The Lancet,
Vaccination has averted 154 million deaths, including 146 million among children younger than 5 years of whom 101 million were infants younger than 1 year. For every death averted, 66 years of full health were gained on average, translating to 10·2 billion years of full health gained
The efficacy here extends to the COVID-19 vaccines, with naysayers just outright denying science. Studies of sample sizes over 100,000 found over 95% effectiveness in the vaccine in preventing infection.
An NIH study of almost 20,000 found the virus was 74% less transmissible from those vaccinated. Meta-analysis of 22 studies including over 57 million cohorts found myocarditis over seven times more likely in those infected with coronavirus than those vaccinated against it.
Specifically with kids, meta-analysis including thousands of cohorts found no adverse effects in that population among the vaccinated. A second later meta-analysis also confirmed this as well.
I understand not wanting to trust the government, being skeptical of things they may push onto you.
Which is why I urge you to instead trust the science. Don’t believe vaccines are good because the government says so, but because the science indicates it, that way when someone like Donald Trump takes office your opinion remains unchanged.
Blind trust is indeed dangerous, which is why informing yourself is important, because blind skepticism isn’t any better.