Johnson & Johnson’s vaccine should be considered a two-dose vaccine rather than the one-and-done shot that had received initial authorization, a federal panel decided Friday.
The committee felt the 15 million Americans who got a single dose of the “one and done” J&J vaccine would be substantially better protected with a second one.
“It was always going to be a two-dose shot,” said Dr. James Hildreth, president of Meharry Medical College in Nashville.
The Vaccines and Related Biological Products Advisory Committee voted unanimously, 19-0, to support what J&J describes as a booster at least two months after the initial shot.
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Data from J&J and real-world experience show that the single shot provides less protection against COVID-19 than the Moderna and Pfizer-BioNTech vaccines, which are both two-dose regimens. Company studies suggest J&J’s protection continues over time, while effectiveness against less severe disease appears to fade with the other two.
Committee members said they felt urgency to provide an extra dose of vaccine to people who received the single shot of J&J.
There is an urgent public health need because we are seeing a lower level of efficacy in this group than with the mRNA vaccinations. So there is some urgency there to do something,” said committee chair Dr. Arnold Monto, a professor of epidemiology at the University of Michigan School of Public Health.
In response to pointed questions by the committee, Dr. Penny Heaton, head of the vaccines global therapeutic area for Janssen Pharmaceuticals, a Johnson & Johnson company that developed the vaccine, agreed the effectiveness of their vaccine varied across study different groups, though it was “consistent and durable” within groups – in other words, it didn’t decrease with time.
“However, because the magnitude is lower than I think what would be desired – the estimates that have been seen with the mRNA vaccines – there is headroom to improve the efficacy,” she said.
Adding a second dose 2- to 6-months after the initial J&J shot would provide the same effectiveness as the mRNA vaccines without their fading protection, Heaton told the committee Friday.
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J&J claims its vaccine is 75% effective worldwide against any infection and 70% effective at preventing severe disease and hospitalization. There were lower rates seen in other countries, J&J said, likely because of different variants circulating there.
But surveillance by the Centers for Disease Control and Prevention has found that the J&J vaccine is only 68% effective against hospitalization in most adults.
For all age groups, vaccine effectiveness is highest in Moderna vaccine recipients, at 95%, followed by Pfizer-BioNTech at 80% and J&J at 60%, a report published by the CDC on Sept. 17 found.
The two mRNA vaccines are more effective, even considering that their strength seems to wane over time, said Dr. Amanda Cohn, a vaccine expert with CDC’s National Center for Immunizations and Respiratory Diseases.
“There were some other data which showed that real-world effectiveness (for J&J) is hovering more in the 50 to 60% range,” she said. “The effectiveness or protection with a single dose of the J&J vaccine is not equivalent to protection with either two doses of an mRNA vaccine, and certainly not in those groups who have now been authorized to receive a booster dose of an mRNA vaccine.”
The contrast is striking and has never been expressed so clearly before,” stated Dr. William Schaffner (a professor of preventive medicine at Infectious Diseases Vanderbilt University Medical Center, Nashville), who isn’t a member.
The committee approved booster shots to counter the gradual decline in effectiveness. This was done for those who have received Moderna or Pfizer BioNTech vaccines.
The committee decisions on both the Moderna and J&J supplementary shots still need to be verified by a different advisory panel as well as top federal officials. The CDC advisory panel is expected to meet Oct. 20 and 21 to discuss extra doses for Moderna and J&J recipients.
The CDC recommends that individuals continue to receive additional doses of the vaccine they received the first time.
After the vote on the J&J second vaccine dose, the committee considered a study by the National Institutes of Health posted Wednesday which looked at mixing and matching booster doses of vaccine.
It included nearly 500 people and found that the J&J shot followed by either the Moderna or Pfizer vaccine as a booster produced a stronger immune response than two doses of J&J. A booster dose of either Moderna or Pfizer mRNA vaccine worked well for people who received either the Moderna or Pfizer two-dose series.
A committee of experts decided more information was required from its ongoing research before making any recommendations about whether or not to give people a different booster shot from their first vaccine.
One dose of the J&J vaccine still counts as “full vaccination,” according to the CDC.
Government officials have said that the original doses of vaccine – one shot of J&J and two each of either Moderna or Pfizer-BioNTech – would continue to be considered “fully vaccinated” for the purposes of employment, travel and venue entry.
About 15 million Americans have been fully vaccinated with the J&J vaccine, compared with 103 million who’ve gotten Pfizer and 69 million who’ve gotten Moderna. So far, 8.8 million Americans have received a booster dose of the Pfizer vaccine.
USA TODAY’s coverage of patient safety and health is possible in part thanks to a grant from Masimo Foundation for Ethics, Innovation and Competition in Healthcare. Editorial input does not come from the Masimo Foundation.
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