European Union Regulators Say Have Not Found A Relationship Between Menstrual Changes And COVID-19 Vaccines

COVID-19 Vaccine Illustration. (Wikimedia Commons/Ministry of Defense Photo Gallery)

JAKARTA - The European Drug Administration (EMA) said on Tuesday it had not established a link between menstrual cycle changes and a COVID-19 vaccine, after a study in Norway showed some women experienced heavier periods after being vaccinated.

The Norwegian Institute of Public Health (FHI) study released on Tuesday asked nearly 6,000 women aged 18-30 about their menstrual cycles and bleeding patterns before and after vaccination. The study has not yet been peer-reviewed.

Preliminary results showed that about 7.6 percent of respondents reported a heavier period before the first vaccination, increasing to 13.6 percent after and 8.2 percent before the second vaccine, which rose to 15.3 percent after the second injection.

"Further studies will be needed where we measure hormone levels etc to fully determine that," Georgy Genov, head of pharmacovigilance at the European Medicines Agency told a news briefing.

He says it's important to note that any menstrual disorders seen in emerging studies are temporary.

Meanwhile, the Norwegian Institute said young women who experience heavy and persistent menstrual bleeding after receiving the COVID-19 vaccine, may need to delay receiving another shot until the cause is investigated and symptoms have stopped.

They should also consult their doctor to rule out other ailments that may require treatment. With a temporary menstrual change in the regular cycle, the next dose of vaccine can be given as planned.

However, says FHI, the change is a temporary side effect for most and shouldn't prevent women from getting the injection.

"Vaccination provides protection to individuals against the course of severe COVID-19, as well as contributes to the reduction of transmission in the community," he said.

To note, EMA's Genov said the agency has no data to show any vaccine, including the COVID-19 shot, affects people's fertility.