A day after a panel of the Food and Drug Administration’s outside advisers voted to endorse the third doses of Moderna’s COVID-19 vaccine, the committee voted unanimously Friday to back booster shots for the 15 million Americans with Johnson & Johnson’s vaccine, at least two months after they were first vaccinated.
The meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee came as new CDC data suggests infections and deaths among vaccinated Americans were worse in those who received Johnson & Johnson’s COVID vaccine.
While the unvaccinated were still 6.1 times more likely to test positive for COVID-19 and 11.3 times more likely to die from the disease compared to all fully vaccinated people, breakthrough cases of COVID-19 among vaccinated Americans have also climbed in recent months. Rates of cases and deaths among people who were vaccinated with Johnson & Johnson’s dose were higher than in those who received two shots of vaccine from Pfizer or Moderna.
However, severe COVID-19 remains unlikely for most vaccinated younger adults. Hospitalizations in adults under 50 was just 1.8 per 100,000 fully vaccinated people, in the CDC’s COVID-NET surveillance, compared to nearly 15 per 100,000 in seniors 65 and older.
“The overall perspective is that, regardless of whether or not there’s been waning or if this was the true effectiveness after a single dose, the effectiveness or protection with a single dose of the J&J vaccine is not equivalent to protection, at this time, with either two doses of an mRNA vaccine,” the CDC’s Dr. Amanda Cohn told the panel.
Like with Moderna’s authorization, recipients of Johnson & Johnson’s vaccine will need to wait until the CDC issues formal guidance around use of the shots before boosters can be rolled out. The CDC’s Advisory Committee of Immunization Practices is scheduled to meet Thursday to discuss COVID-19 vaccines.
“ACIP really can’t expand or be broader than FDA’s conditions of use. However, we can be more narrow. So for example, FDA could go down on age, and ACIP would not have to,” Cohn told the FDA’s committee on Thursday.
Johnson & Johnson told the panel that the company believed their vaccine remained effective against severe cases of COVID-19, with “consistent” and “durable” immunity that might not wane over time like the mRNA-based vaccines from Pfizer and Moderna. However, the company’s top scientists acknowledged that there was “headroom to improve” the effectiveness of their shots, to reach levels similar to the other brands.
