The European Union’s drug regulator on Dec. 15 concluded that a Johnson & Johnson (J&J) COVID-19 booster dose may be considered for people who are 18 and older at least two months after their initial shot.
The agency noted that the risk of a previously reported side effect, namely a type of clot called cerebral venous sinus thrombosis in combination with low levels of blood platelets, isn’t known after a booster is administered, adding that it’s “being carefully monitored.”
“As for all medicines, EMA will continue to look at all data on the safety and effectiveness of COVID-19 Vaccine Janssen,” the agency said in the statement. Janssen is a pharmaceutical unit of J&J.
Earlier this year, multiple countries on a global level recommended not using the J&J shot until the investigation into cases of post-vaccination blood clots was completed. The halt came after dozens of cases, which included deaths, were reported after people got the shot.
The EMA also said that a dose of the J&J shot can be used as a booster dose in those who have received two doses of one of the mRNA vaccines from Pfizer-BioNTech or Moderna, in line with its recommendation on mixing vaccines.
In the United States, the Food and Drug Administration (FDA) gave the green light in October to the J&J booster dose. The FDA also said, similar to the EMA, that J&J boosters can be given to the eligible population who have previously taken a different vaccine brand.
Dr. Anthony Fauci, chief medical adviser to the Biden administration, advised Americans on Dec. 12 to get a COVID-19 booster shot because it can raise “the level of protection high enough that it does do well against the Omicron.”
