The COVID-19 Vaccine Is Safe — Here’s Why
Healthcare workers across the country are rolling up their sleeves to get the first injections of the COVID-19 vaccine.
Within the next 6 months, it’s expected that all American adults who want the vaccine will be able to get it.
Yet with the vaccine having been developed in less than a year, some people are hesitant and are worried that it may not be safe. However, the top infectious disease experts in the nation — like Dr. Anthony Fauci (Director of the National Institute of Allergy and Infectious Diseases) and Dr. Stephen M. Hahn (FDA Commissioner) — have confirmed that the speed of development did not compromise safety.
Here are 5 reasons why we can rest assured that the recently approved Pfizer/BioNTech and Moderna COVID-19 vaccines are safe.
However, that doesn’t mean that the FDA grants EUAs to all vaccines. The FDA still reviews all current evidence. And just as they do when granting approval, they will only give the EUA if they believe the benefits are greater than the risks. The bottom line: The FDA doesn’t lower its standards for vaccine safety and quality when granting an EUA — they just need less evidence.
1. No steps were skipped.
Vaccines go through pre-clinical research in a laboratory and on animals before being tested on humans. They then go through a series of phases:- Clinical development (a three-phase process where increasingly larger numbers of people are given the vaccine, and the vaccine is tested for safety and efficacy)
- Regulatory review and approval
- Manufacturing
- Quality control
2. Finances — not rushing — sped up the process.
How were they able to get through all of these phases so quickly? For most vaccines, the approval process is much longer — but often, this is due to funding issues. Developing a vaccine is expensive. While costs vary depending on the type of vaccine, manufacturer, and country of development, experts estimate that most vaccines run up a bill in the $521 million to $5 billion range. This is a huge financial risk for funders to take on, so they typically do not want to spend all of the money upfront. Instead, they spread it out as they see success in early steps and gain confidence that the vaccine will come to fruition. For the COVID-19 vaccine, the financial burden was largely lifted. In the US, the federal government invested more than $12 billion upfront in vaccine development. Nonprofits and private donors, like Dolly Parton, also contributed. Even before research was complete, the government purchased billions of dollars in vaccine doses. This increased the financial risk to funders, but it didn’t make the vaccine any less safe.3. So did technology.
Many current vaccines use a weakened virus or a piece of the virus’s protein coat. This stimulates an immune response which creates antibodies — proteins your body develops after being exposed to a disease (through previous infection or vaccine) to protect you from getting the disease. The Pfizer/BioNTech and Moderna vaccines use mRNA technology. mRNA vaccines also elicit an immune system response that creates antibodies. But unlike traditional vaccines, mRNA ones give your cells instructions for making the spike protein that’s found on the surface of the COVID-19-causing coronavirus. It doesn’t introduce the actual virus into your body at all. mRNA technology has been a major factor in speeding up the vaccine development process. It’s easy to quickly make and produce large quantities of mRNA in a lab. One researcher at the University of Pennsylvania Perelman School of Medicine reported that their lab-created RNA within about a week — much less than the months it takes to grow and manufacture weakened viruses that are used in traditional vaccines.4. The vaccines went through the same review process as any other vaccine.
The COVID-19 vaccines have each been issued Emergency Use Authorization (EUA). This is different from a full approval from the US Food and Drug Administration (FDA). It allows the vaccine to be administered during an emergency (like a pandemic) before the FDA receives all of the evidence they require for official approval.
Vaccines must be granted a license by the FDA in order to be used by the general public — and the FDA won’t grant the license unless it finds that the vaccine’s benefits outweigh the potential risks.
Source: FDA.gov
However, that doesn’t mean that the FDA grants EUAs to all vaccines. The FDA still reviews all current evidence. And just as they do when granting approval, they will only give the EUA if they believe the benefits are greater than the risks. The bottom line: The FDA doesn’t lower its standards for vaccine safety and quality when granting an EUA — they just need less evidence.
5. Side effects do not mean that the vaccine isn’t safe.
It’s normal to be concerned about side effects of the vaccine or to worry that researchers didn’t have enough time with COVID-19 vaccine trials to discover long-term effects. But if the worry about side effects is making you hesitant to get the vaccine, there are a few things to remember:- Most vaccines take 10 to 15 years to develop. If we waited to see the long-term effects before approving a vaccine, it would take decades.
- All vaccines, regardless of how long it took to develop them, come with some risk of serious effects — but the risk is incredibly small. For example, anaphylaxis (a life-threatening allergic reaction) is only reported in about 1 per 1 million vaccine doses in the US.
- Minor side effects, such as fever or tiredness, are actually signs that the vaccine is working and your body is building protection. If you experience these side effects, don’t worry — they should go away within a few days.
Talk To Your Provider
If you have any questions or concerns about the COVID-19 vaccine, you don’t need to rely on Dr. Google for the answers. Talk to your primary care provider to learn more about the safety of the vaccine and when it will be available to you and your family. And rest assured that despite being developed so quickly, the COVID-19 vaccine is safe — and promises to be one of our best protections against this virus.Can we help you create COVID-19 content for your website? Let us know!
6 Things We Know — And Don’t — About The COVID-19 Vaccine
On January 21, 2020, the US had its first confirmed case of COVID-19.
On February 3, the US declared a public health emergency.
On March 11, the World Health Organization (WHO) officially declared COVID-19 a pandemic.
Just 5 days later, on March 16, Jennifer Haller became the first person outside of China to receive an experimental vaccine.
Since Jennifer Haller received that first shot, researchers around the world have begun testing more than 200 experimental COVID-19 vaccines.
As 2020 comes to an end, COVID-19 cases are still climbing across the US. But there is finally good news. On November 9, Pfizer and BioNTech released the stunning results of their Phase 3 COVID-19 vaccine trial. One week later, Moderna published their equally impressive results. And for the third week in a row, we learned that another biopharmaceutical company — AstraZeneca — also had promising results from a trial of their vaccine.
Snapshot: How Effective Are COVID-19 Vaccines?
- A COVID-19 vaccine must have at least 50% efficacy to be approved by the Food and Drug Administration (FDA).
- The AstraZeneca vaccine is up to 90% effective at preventing COVID-19.
- Both the Pfizer and Moderna vaccines are about 95% effective at preventing COVID-19.
*Results are based on Phase 3 clinical trials and are current as of December 3, 2020
Other pharmaceutical giants worldwide are testing their own vaccines, with several poised to follow on the successful heels of their predecessors.
Here’s a look at what we know — and what we don’t know — about the COVID-19 vaccine.
1. The vaccine promises to be highly effective — but hold onto your mask.
The results of the first vaccine trials have been nothing short of incredible.
That’s undoubtedly exciting news, but it’s not an invitation to throw out your masks and abandon hand sanitizer once you’ve been vaccinated.
While the vaccine might protect you from becoming infected, it does not protect you from being exposed. If you’re in the early group, and most other people have not received the vaccine yet, the virus can still be circulating like it was before — leaving you exposed. And since the vaccine is not 100% effective, you should still avoid exposure as much as possible.
2. Healthcare workers and elderly residents at long-term care facilities will [probably] get the vaccine first.
The exact timeline of who will get the vaccine and when isn’t set in stone — however, we have a good idea of how it will go.
On December 1, the Centers for Disease Control and Prevention (CDC) recommended that once the COVID-19 vaccine has been authorized by the Food and Drug Administration (FDA), and has been recommended by Advisory Committee on Immunization Practices, the first recipients should be healthcare personnel and residents of long-term care facilities.
As we get into 2021, the eligibility criteria will expand to include people over age 65, frontline workers, and those with preexisting conditions. It’s most likely that the last group of people to get the vaccine will be young, healthy members of the general public. It’s predicted that by July-September 2021, most US adults who want a vaccine will have access to one.
3. It’s still going to be a while before we reach herd immunity.
Herd immunity is when there is a large enough percentage of a population immune to a disease that the spread of the disease is unlikely.
Some people have pushed for a natural herd immunity approach to fighting COVID-19, which involves letting people get exposed to the virus and build natural immunity. However, research and the failed attempt at achieving herd immunity naturally in Sweden made it clear that this was not going to be the best course of action for fighting COVID-19.
Vaccines are a much more effective and efficient way to reach herd immunity. But even though vaccines are on the horizon, we have to be a little patient. We’re not going to get to herd immunity right away.
For any vaccine to offer enough protection for herd immunity, a certain percentage of the population has to be immune. The percentage can range from 50% to 90% of the population needing to be immune, depending on the type of illness and its contagiousness.
The percentage needed for the COVID-19 vaccine isn’t yet known, but many believe that the magic number will fall somewhere between 70% and 80%. However, a November 17 Gallup poll found that only 58% of American adults say they would be willing to get the vaccine.
That doesn’t mean we will never get there. We just need to be patient.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), has stated that if enough people take the vaccine, we could start seeing at least a slight return to normal just a few months into 2021. And by the third and fourth quarters of 2021, we could be back to relative normalcy.
4. The vaccine was developed in record speed — but that doesn’t mean it’s unsafe.
One of the top concerns that people have had about the vaccine is that it was developed in less than a year, when most vaccines take upwards of 10 years. Once approved, it will claim the title of “fastest vaccine developed” from the mumps vaccine, which took 4 years. (Note that the H1N1 (swine flu) vaccine only took a few months. However, it is technically considered a type of flu vaccine, so it does not hold a record).
The nation’s top health experts have emphasized that the speed at which the vaccine was developed did not come at the expense of safety. Factors like increased funding, new methods for making vaccines, and manufacturing (but not distributing) the vaccine on a large scale before proven efficacy and safety have allowed researchers to follow all safety steps they would normally follow. There may be an increased financial risk, but there is no increase in product safety risk.
We also don’t know about long-term side effects, if any. But this is actually a risk that comes with many vaccines. If we waited a full lifetime to see the long-term effects, it would take decades for any vaccine to be available.
5. We don’t know how long immunity lasts.
Some vaccines, like the one for the flu, only last for a few months and require you to get vaccinated again the next year. Others, like the measles, mumps, and rubella (MMR) vaccine, typically provide lifelong immunity.
We haven’t had enough time with the vaccine to learn just how long it will actually protect you, and whether or not you will ever need to get vaccinated again.
It may be a few years before we have an answer — so just in case, you may want to keep some masks on reserve.
6. The vaccine will be free.
If you have been worried about being able to afford a vaccine, you can breathe a sigh of relief.
On October 28, the Centers for Medicare and Medicaid Services (CMS) announced a set of regulations to ensure that all Americans will have access to free COVID-19 vaccines.
Under their guidance, Medicare patients will not be charged for the vaccine itself or for administrative costs. Most private health plans and insurers will also be required to cover recommended COVID-19 vaccines and administrative costs, even if you receive it from an out-of-network provider.
If you are uninsured, you will still be able to get the vaccine for free.
We may not know exactly how long immunity will last, or how many people will get vaccinated. But as the new year begins, the promise of effective and safe vaccines provides a light at the end of the tunnel.
