Risks from COVID-19 Vaccines Far Smaller Than Risks From the Infection, Northwestern Experts Say

Concerns about vaccine safety are as old as vaccines themselves.

By Howard Wolinsky

These concerns are compounded in communities of color, where prior medical experiments conducted on these communities without consent have left a lasting fear of government and research-sponsored programs, including vaccination campaigns.

The rollout of COVID-19 has generated myths and unwarranted worries about safety even as recent concerns swirl around the J&J’s COVID-19 Vaccine.

The U.S. Food and Drug Administration paused the use of the J&J vaccine on April 13 because of emerging reports of a very rare type of blood clots now associated with several of the COVID-19 vaccines, according to experts from Northwestern University COVID-10 Vaccine Regulatory Consortium (CoVAXCEN).

But they said while all vaccines carry risks, the risks of infection from COVID-19 are far greater, especially for people with pre-existing health conditions.

Anyone can report any suspected adverse effects from the vaccine to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

There are thousands of reports already submitted, including deaths after the vaccine, but so far the only suspicious, and as yet unproven, connection with the J&J vaccine has been this rare form of blot clots in the brain associated with low platelet counts, said John Mattison, MD, internal medicine and intensive care physician and chair of the CoVAXCEN clinical workgroup.

At the time of publication, the risk of this rare disorder is ten times higher in patients with COVID-19 infections than in people who were recently vaccinated. “Even IF emerging data reveal that the vaccine causes this side effect, it is still ten times less frequent after recent vaccination than it is in people recently infected with the COVID-19 virus,” Mattison said.

“If I were worried about that specific blood disorder, all the evidence suggests that it’s a good idea to receive the vaccine to reduce the risk of both a COVID-19 infection by 70-90%, and also it appears to reduce the risk of getting this rare clotting disorder by 90% compared to those who get COVID-19 infections,” he said.

Mattison put the risks in perspective: these suspected but unproven and extremely rare events affect 4 out of 1,000,000 people vaccinated, whereas the risk of death resulting from a COVID-19 infection is closer to 1 out of 100.

 Experts estimate that an additional 30% of infected people also suffer long-lasting symptoms after the acute infection (a.k.a ‘long haulers’).

“The comparison between the risk of the vaccine and the risk of serious health consequences from an infection are just in different galaxies of magnitude. There’s just no contest,” said Mattison.

He said anaphylaxis, an allergic reaction that might occur shortly after receiving the vaccine, is the greatest known risk of the vaccine. But anaphylaxis is easily treated with epinephrine, and so far these cases are rare (2.5-11.1 per million vaccinations), and all have been treated effectively with no deaths or long-term consequences reported at this time.

Symptoms include feeling lightheaded or faint, breathing difficulties such as fast, shallow breathing, wheezing, a fast heartbeat, clammy skin, confusion and anxiety, and collapsing or losing consciousness.

Omar Hakim, a CoVAXCEN staff researcher, who is completing his doctorate in pharmacy at Purdue University, said patients are screened at immunization clinics for a history of anaphylactic shock.

 He noted that staff at the clinics are trained to manage cases of anaphylactic shock with an EpiPen, which injects epinephrine (a.k.a adrenaline) into the patient. Epinephrine releases chemicals in the body that prevent and reverse anaphylactic shock by constricting blood vessels and reversing low blood pressure.

“Anaphylaxis, when it’s witnessed and treated appropriately, is rarely a problem,” Mattison said.

Hakim noted that people are asked to wait at least 15 minutes after their immunizations to see if they have anaphylactic reactions or any reactions. He added that people who have had previous anaphylactic reactions to vaccines should consult their doctor before doing so, and the CDC has advised these patients to wait 30 minutes after vaccination before leaving.

The CDC also advises patients who have had anaphylactic symptoms or immediate reactions (such as hives, swelling, and wheezing) within four hours of being vaccinated with their first dose, to not have second shots of the Moderna and Pfizer vaccines. (The J&J vaccine is a single dose.)

Other common reactions to the vaccines include pain at the injection site, redness, swelling, fatigue, headaches, chills, body aches, and mild to high temperatures. “These symptoms are not unusual and are simply an indication that the immune system is kicking in and doing its job,” Mattison said.

(For more on side effects, go to the Centers for Disease Control and Prevention site, linked here.)

In the case of the Moderna and Pfizer-BioNTech vaccines, some people have more intense reactions with the first shot, while most people have more intense reactions after the second shot. Mattison said side effects can interfere temporarily with some individual’s ability to carry out activities of daily life, but they are typically mild and go away in a matter of days.

He said that while some people experience severe side effects initially, they are only temporary, and hundreds of millions of people have been vaccinated globally with either minor or no side effects.

As with the regular flu shot, some worry the COVID-19 vaccines will cause infections. Mattison said that’s not possible since patients are not given whole particles of the virus in the vaccines.

He said the rumors of infection after the vaccine have emerged because occasionally people do become infected with a viral illness at nearly the same time they receive their vaccination.

“The public has a really hard time understanding that among the hundreds of millions of people already vaccinated worldwide, there will be thousands of people who develop new diseases at some point after vaccination that they were going to get independently of their vaccination,” Mattison.

He said these other events are “just a coincidence until proven otherwise.”

He added: “The bottom line is that with ALL the information we have so far, the vaccines from J&J, Astra-Zeneca, Moderna, and Pfizer are all effective, and each one is consistently far safer than is an infection with COVID-19.”

The Northwestern COVID-19 Vaccine Communication and Evaluation Network (CoVAXCEN) brings together a panel of experts in immunology, infectious disease, epidemiology, regulatory science, and health communication.

Headquartered in the Institute for Global Health's Center for Global Communicable and Emerging Infectious Diseases with the cooperation of the Center for Communication and Health, CoVAXCEN seeks to achieve consensus on a variety of issues related to the safety and efficacy of COVID-19 vaccines and then produce and disseminate written materials for scientists, healthcare professionals, and the general public describing its conclusions.