Johnson & Johnson (J&J) is planning to seek authorisation for a booster shot of its COVID-19 vaccine in the United States, according to a media report. The Federal Drug Administration (FDA) has already authorised a booster dose of the Pfizer-BioNTech vaccine. US Surgeon General Dr Vivek Murthy said 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: people who are 65 or older; or have a medical condition such as obesity, diabetes, high blood pressure, and chronic kidney disease that puts them at high risk of severe illness with COVID-19. 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 as part of its effort to curb the impact of the highly transmissible Delta variant.
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.
Meanwhile, J&J declined to comment on the New York Times report and said it has submitted available data to the US health regulator and intends to submit the data to other regulators.
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.”