A FDA advisory committee on Friday voted unanimously to recommend second dose s of the Johnson & Johnson COVID-19 vaccine to anyone over 18, the second vote in as many days to back a change to a COVID vaccine timeline.
The panel recommends that the second J&J dose come at least 2 months after the first shot. It’s not technically a booster, but it’s moving Johnson & Johnson from a one-dose vaccine to a two-dose one, similar to Moderna’s and Pfizer’s vaccines.
New England Journal of Medicinefound that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.Limited DataThe company’s data presented to the FDA panel in support of booster doses was limited but did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.
But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed that they had not had time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness. headtopics.com
Still Call It a Booster?In the end, the 19 members of the Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling it second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, a professor of internal medicine at Meharry Medical College in Nashville.The committee’s meeting is ongoing. This story will be updated.
WebMD Health NewsThe New England Journal of Medicine: “Effectiveness of Covid-19 Vaccines in Ambulatory and Inpatient Care Settings.”FDA Vaccines and Related Biological Products Advisory Committee, Oct. 15, 2021. Read more: WebMD »
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FDA panel debates lower-dose Moderna COVID shots for boosterU.S. health advisers are debating if millions of Americans who received Moderna vaccinations should get a booster shot -- this time, using half the original dose. Already millions who got their initial Pfizer shots at least six months ago are getting a booster of that brand. Oh wow this is pretty worrisome. The first science didn’t science good so let’s get some different science Sounds like science
FDA panel endorses lower-dose Moderna COVID shot for boosterU.S. health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine should get a half-dose booster to bolster protection against the virus. The panel of advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, adults with other health problems, jobs or living situations that put them at increased risk for COVID-19. 🤔🤣🤣 Follow the $$ Interesting. Johnson & Johnson where u at?
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