Side effects of COVID-19 booster shots are likely to be almost mild

Dr. Michael KakovicObstetricians at The Ohio State University Wexner Medical Center say there is a lot of variability in side effects after COVID-19 vaccination.

one study In the UK, only 22% had systemic side effects such as fatigue, headaches and chills after the second dose of the Pfizer-BioNTech vaccine.

68% had only local reactions such as pain or tenderness at the injection site.

Side effects after the third dose may also vary from person to person, and some people minimize discomfort.

“The few patients I talked to who received the booster reported fewer side effects. [than after the first two doses]”Kakovic said.

Last week, Pfizer and BioNTech announced the results of a phase 3 clinical trial that was boosted between 4 and 8 months after the second dose.

Similar to the first vaccine series study, the most common side effects were injection site pain, malaise, headache, muscle and joint pain, and chills.

The frequency of these side effects was “same or better than after the second dose,” the company said. Press release..

Results have not yet been published in peer-reviewed journals.

A Pfizer spokesperson told the CDC’s Vaccine Advisory Board on August 30 that additional additional immunological study data may be available by late September or early October. report Helen Branswell on Twitter STAT.

The company last week Data submission has started To the FDA about an application for approval of a booster vaccine for Americans over the age of 16.

This is the age range in which the double dose regimen of the vaccine is fully approved.

The FDA does not indicate when to end the review of Pfizer’s booster application.

Agency in august Approved third dose Development of mRNA vaccines for people with weakened immunity. These are not considered booster doses.

People with immunodeficiency may need additional doses to help generate a strong immune response that is more consistent with the immune response of people with a healthy immune system.

With another recent booster studyA group of Israeli researchers investigated the efficacy of a third dose of the Pfizer-BioNTech vaccine in people over the age of 60.

Israel began deploying booster immunity to this age group at the end of July, and some people are eligible if they have been fully vaccinated with a second vaccination at least five months ago.

Researchers have found that a third dose reduces the risk of severe COVID-19. However, they did not release data on post-booster side effects.

This study has not yet been peer reviewed.

No side effect data from booster immunological studies have been published for Moderna-NIAID and Johnson & Johnson vaccines.

The Biden administration expects people who have been vaccinated with the J & J vaccine to be advised to take a second dose, but is waiting for data from clinical trials before setting a deployment date.

largely Side effects Two mRNA vaccines or one J & J vaccine are mild to moderate and short-lived.

However, there were also more worrisome but rare side effects.

Both the Pfizer-BioNTech vaccine and the Moderna-NIAID vaccine have a low risk of heart inflammation such as myocarditis and pericarditis. This is common in young people, especially men.

NS In most cases According to data released by the authorities’ Vaccine Advisory Board on August 30, what was reported to the CDC was recovered by treatment.

But when it comes to heart inflammation, he said, “the risk of the coronavirus itself affecting you is much higher than the risk of the vaccine affecting you.” Dr. Irataub, Pediatric cardiologist at Akron Children’s Hospital.

Two recent studies have confirmed an increased risk of myocarditis after being infected with the coronavirus. Preprint study Extensive study by Taub and his colleagues, and in Israel New England Journal of Medicine..

Taub said safety data from booster immunological studies of mRNA vaccines need to be confirmed, but expects this side effect to be rare after booster vaccination.

“If I was pretty surprised [myocarditis] The third vaccination was more than a rare event, “he said.

The J & J vaccine has a low risk of blood clots with low platelet levels, in addition to mild and moderate side effects.This side effect More general Female 18-49 years old.

There were no data on the likelihood of this condition occurring after the second dose of the J & J vaccine.

Before the FDA and CDC approve boosters for people in the United States, authorities will review data on the safety and efficacy of these additional doses.

They will also continue to monitor the vaccine after booster immunization has been deployed.

Booster doses are not widely available to people in the United States, but the fully approved vaccine allows doctors to prescribe a third dose of the Pfizer-BioNTech vaccine “off label.”

Dr. David Juurlink, a drug safety researcher at ICES in Toronto, warns against doing this before safety data becomes available.

“Before giving a third dose to (already protected, relatively young) people, we need solid evidence that the expected benefits of doing so outweigh the potential harm,” he says. .. I have written On Twitter.