which COVID- 19 vaccine is better to take?

 

There is a vaccine for COVID-19 and people are lining up to get it, but is it safe? 

Are there any side effects?

 Read on to learn more.

While the COVID-19 vaccines now on the market in the United States are safe and effective, reports of unusual adverse events or side effects have raised concerns. On July 12, 2021, the Food and Drug Administration approved an amendment to the Johnson & Johnson COVID-19 vaccine fact sheet that adds an increased risk syndrome, a rare nerve disease. Previous research has linked the J&J vaccine to a rare blood clot.

While such reports may be frightening, they are proof that the vaccine safety reporting system is working. They also emphasize the importance of putting the relative risks of rare side effects like this into context.

I have witnessed how uncertainty and fear of potential side effects can cause vaccine hesitancy while leading operations for the University of Virginia Health System's COVID-19 vaccine program for the past seven months. Understanding how adverse event data is collected and what it means for vaccine safety can help consumers make more informed health decisions.

Safety monitoring before, during, and after approval

Before a new vaccine can be made available to the public, the FDA requires manufacturers to go through rigorous testing and approval processes. The methods necessary to test the safety and effectiveness of a new drug are the same whether it is approved through the traditional FDA approval process or under an Emergency Use Authorization (EUA). By speeding up the regulatory process, the EUA can bring the vaccine to the public faster, but there are no shortcuts. All precautions are taken to ensure the safety and efficacy of the vaccine.

Clinical trials of vaccines are divided into four phases. Study investigators are the ones who detect, quantify and document safety risks in the first three phases.  In most cases, most likely side effects are discovered at this point.

After the FDA reviews the Phase 1 data and determines that the vaccine is safe enough to be tested further, it will be given to larger groups of people over a longer period in Phases 2 and 3. Investigators use this phase to determine the best dosing and monitor for any unusual side effects.

If Phase 2 and 3 evidence meets FDA clearance criteria, the vaccine will advance to Phase 4 and become available to the general public. The vaccine is tested on much larger groups of people over a long period, and manufacturers are required to regularly monitor and report potential safety issues to the FDA.

In this last step, which is unique, the public can participate in the safety report. The FDA and the Centers for Disease Control and Prevention operate the Vaccine Adverse Event Reporting System (VAERS), a national safety surveillance system. While healthcare providers are required to report some types of adverse events, such as injuries during vaccination and serious outcomes, anyone can make a report. VAERS has identified recent adverse events associated with COVID-19 vaccinations, including syndrome and thrombosis at Johnson & Johnson and myocarditis at Pfizer.

Vaccines have a low risk of serious side effects

A rare adverse event can take months or even years to discover for one simple reason: it's unusual. Because a very small number of patients use some drugs that are less commonly used, it takes longer to discover new safety data. For example, the thing Rix shingles vaccine was approved in 2017, but it wasn't until March 2021, after more than 3.7 million patients had been vaccinated, that the FDA reported a possible increased risk of guilt syndrome. And it's still unclear whether the Sharing Rix vaccine is to blame for the nerve problem.

COVID-19 poses a greater threat than vaccine-related adverse reactions

Understandably, individuals would be reticent to take on any greater risk than they have to during such unusual circumstances as a pandemic. However, there are safety nets for tracking COVID-19 vaccines that continue to function properly.

The COVID-19 vaccines are extremely safe for the vast majority of people. More than 40,000 patients were enrolled in J&J's clinical trials before the company applied for emergency use authorization, similar to the Pfizer and Modern trial samples. In the J&J study, 0.4 percent of subjects had significant adverse events that were not related to COVID-19 infection.