The safety of the COVID-19 vaccines remains a top concern among those who are unvaccinated. Yet,researchersand medical doctorsat Penn State explain thatthe results of rigorously conducted clinical trials andcomprehensive safety monitoring afterwidespread vaccine uptake among the public suggests there islittleto fear, and they strongly encourage those who are on the fence to getvaccinated.
Theclinical trialsbehind the Food and Drug Administrations (FDAs)decision to grant emergency use authorization to the COVID-19vaccinesdemonstrate an excellent safety profileand since then,the vaccines have been given to millions and millions of people worldwidewith robust safety monitoring, said Catharine Paules, infectious diseases physician, Penn State Health Milton S. Hershey Medical Center. I dont think any drugs have ever been scrutinized to the degree that these vaccines have. I feel very confident in their safety.
What about side effects?
Before granting emergency use authorizations to Pfizer and Moderna in December2020and Johnson & Johnson in February2021, the FDA monitored side effects in tens of thousands of clinical-trial patients for two months following administration of the vaccines.
We do see some mild side effects specificallyfatigue, muscle aches, headaches, and less commonly fevers from the vaccines, but more severe side effects such asanaphylaxisandmyocarditis, and blood clots with the J&J vaccine are extremely rare,said Leslie Parent, vice dean for research and graduate studies, Penn State College of Medicine. Importantly,the risksassociated withCOVID-19far outweigh these very, veryraresafety concerns.
Parent added that the likelihood of any additional side effects showing up is unlikely.
Any side effects from the vaccines would have shown up within a few months of monitoring, she said, and long-term health problems have not been reported in millions of people who have been vaccinated.
Meanwhile, the FDA is continuing to monitor the clinical trial patients who have now been vaccinated for about a year. In addition, the vaccines have been distributed to the public since December 2020.
If we were going to see any significant long-term concerns related to safety, said Parent, we would have seen them by now.
How cansomething developedsoquickly be safe?
All three vaccines Pfizer-BioNTech, Moderna and Johnson & Johnson have been thoroughly tested and found to be safe and effective.
Absolutely nosafetycorners were cut, Paules said. Indeed, she added, the COVID-19 vaccines were developed faster than any other vaccines in history, but that doesnt mean theyre unsafe.
Paules explains that the COVID-19 vaccines were able to be developed quickly because different stages of development and production, which normally occur one after the other, were carried out in tandem,and the scientific community was leveraged in an unprecedented way.
Each of the stagesof development were conducted rigorously, but priority funding, scientific collaboration,rapid data review andclinical trialvolunteers made it possible to do these thingsquickly, she said.
Isnt thevaccinetechnology new? Can I trust it?
Some people have cited the newness of the vaccine technologyas a concern, but it turns out the technology is not new at all.
In fact, said Paules, mRNA vaccines have been in development for decades. Prior to the COVID-19 pandemic,bothPfizer-BioNTech and Modernahad been working on mRNA vaccines for influenza, and scientists had already conducted clinical trials of anmRNA vaccine for HIV.
The Johnson & Johnson vaccine uses an adenovirus to deliver the instructions for building the coronaviruss spike protein. This technology is not new either; theZabdeno/Mvabea Ebola vaccine uses a similar strategy.
Should I wait forthe FDAtofully approve the vaccines?
No. Waiting is a mistake, said Parent.
People who decide to wait to get vaccinated are putting themselves and those around them at serious risk of COVID-19 and associated complications, she said. Now is an especially dangerous time to be unvaccinated given that the highly transmissible and potentially more dangerous Delta variant is now the dominant strain in the U.S. If you havent been vaccinated yet, dont wait any longer. These vaccines have been shown to be safe and effective the sooner you get vaccinated, the less likely new dangerous variants will arise, and the safer we all will be.
You can help by getting the vaccine and encouraging everyone ages 12+ to do so, as well. Penn State students, faculty and staff are strongly encouraged to get the COVID-19 vaccine and shouldupload their vaccination recordsas soon as possible. With this information, University officials will be able to better assess vaccination rates across Penn State and plan for the fall activities that we all love. The latest vaccination information is available on Penn States virus information website.
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Can I trust in the safety of the COVID-19 vaccines? | Penn State University - Penn State News
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