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.
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
- Quality control
Once they have been produced and administered, many vaccines go through phase IV trials to continue to test safety and efficacy, and to see if there are any long-term side effects.
One of the reasons that the vaccine was developed so quickly is that researchers and manufacturers were able to run certain phases simultaneously. For example, manufacturers started producing vaccines on an industrial scale before they completed the earlier steps — making them ready to distribute just days after being approved.
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.
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 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.
Also, once any vaccine is approved and given to the public, vaccine safety monitoring systems watch for side effects — particularly ones that weren’t seen in clinical trials. There are several already established, like the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD). In the wake of COVID-19, the FDA and Centers for Disease Control and Prevention (CDC) have expanded their safety monitoring even further.
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.