Johnson & Johnson (J&J) on Tuesday sought authorisation from the Food and Drug Administration (FDA) for a booster shot of its COVID-19 vaccine amid the Joe Biden administration’s push for providing extra protection to millions of vaccinated Americans against coronavirus.
J&J said it filed a request with the FDA to authorize boosters for people 18 and older who have already received the company’s one-shot vaccine. The company has submitted data on several different booster intervals, ranging from two to six months, but hasn’t formally recommend one to regulators, according to Associated Press.
The FDA has already authorised a booster dose of the Pfizer-BioNTech vaccine and could soon authorize half-dose boosters of the Moderna vaccine. People who are six months out from their last dose of the Pfizer vaccine are eligible for a booster if they fall into one of three high-risk groups: they are 65 or older, or have medical condition such as obesity, diabetes, high blood pressure, and chronic kidney disease. People eligible for the boosters also include those who work or live in a setting where they are at high risk of exposure to COVID-19.
The FDA’s Vaccines and Related Biological Products Advisory Committee panel will hold a meeting on October 14 to discuss Moderna’s application seeking authorization for a booster shot of its COVID-19 vaccince.
The Joe Biden administration announced the push for booster doses in August amid the highly transmissible Delta variant causing a surge in coronavirus cases.
The FDA has scheduled an October 15 meeting of its expert advisory committee to discuss whether to grant emergency use authorization for a booster shot of J&J’s vaccine.
Over 15 million Americans have received J&J’s single-dose, according to the latest data from the Centers for Disease Control and Prevention.
Last month, J&J said an additional second shot of the vaccine given about two months after the first increased effectiveness to 94%, compared with 70% protection with the single dose.
“Both J&J and FDA have a sense of urgency because it’s COVID and we want good data out there converted into action as soon as possible,” said Dr. Mathai Mammen, head of research for J&J’s Janssen unit.
The European Union’s drug regulator on Monday also recommended booster shots of the Pfizer-BioNTech COVID-19 vaccine for people 18 and older.
The European Medicines Agency said the booster doses “may be considered at least 6 months after the second dose for people aged 18 years and older.”