Washington, Oct. 16 (US) – US health advisers endorsed Johnson & Johnson’s COVID-19 vaccine boost Friday, citing concern that Americans who got one dose are not as protected as those who got two brand names. The Associated Press (Associated Press) reported.
J&J told the FDA that an extra dose adds important protection as early as two months after the initial vaccination — but it may work best if people wait until six months later. Unable to determine the best timing, the Food and Drug Administration’s advisory committee voted unanimously that the booster should be introduced at least two months after people got the early shot.
“I think this has always been a two-dose vaccine,” said FDA advisor Dr. Paul Offit of Children’s Hospital of Philadelphia. “It would be difficult to recommend this as a single-dose vaccine at this point.”
The FDA isn’t adhering to the recommendation because it makes a final decision—and adding to complicating the debate, new research also suggests that J&J recipients may have a stronger immune response if their booster dose is from a competing brand.
Preliminary results from an ongoing study of different ways to “mix and match” different shots show that any type of boost increases people’s virus-fighting antibody levels — at least for a few weeks. The most dramatic jump came from giving a Pfizer or Moderna shot after a single dose of the J&J vaccine.
FDA advisors didn’t vote on whether it should be recommended, but they did tell the government to allow flexibility with the boosters, saying there are no red flags for safety even if it’s not yet clear how much difference, if any, mixing and matching might make for a long-term-protection .
“In the real world, all of these kinds of combinations are already happening, so I think it’s somewhat urgent for the FDA to help sort through a complex and difficult scenario,” said Dr. Ofer Levy of Boston Children’s Hospital.
The government says all three US vaccines continue to provide strong protection against hospitalization and death from COVID-19, and that the priority is getting the first vaccines for the 66 million eligible but unvaccinated and most at-risk Americans. But with the spread of the highly contagious delta type and signs of waning immunity to milder infections, the nation is heading for a broader promotion campaign.
Last month, it began offering Pfizer boosters to seniors and young adults at high risk of COVID-19 due to poor health, jobs or living conditions — at least six months after the initial vaccination. On Thursday, the US Food and Drug Administration (FDA) advisory committee recommended the same method for half the dose of Moderna’s boosters.
But the J&J vaccine has consistently shown lower levels of efficacy across a series of studies — and the FDA panel eventually settled on another injection for any recipient 18 years of age or older at least two months after the first vaccination.
“This really – with the second dose – brings it, I think, on par with other vaccines in terms of efficacy,” said Dr. Archana Chatterjee of Rosalind Franklin University.
The FDA will use its advisors’ recommendations to decide whether to allow the use of boosters for both J&J and Moderna. Next, the Centers for Disease Control and Prevention will judge who should roll up their sleeves.
The vast majority of the 188 million Americans who were fully vaccinated against COVID-19 have received Pfizer or Moderna options, while J&J recipients represent only about 15 million.
The J&J vaccine was made using a different technology, and on Friday, the company offered its booster as a way to boost a powerful vaccine that they said retained its protective ability over eight months. But FDA scientists have clearly challenged this assertion.
“There is data to suggest that the effectiveness of this vaccine is actually less robust than the company’s presentation here,” said Dr. Peter Marks, the FDA’s senior vaccine officer. “This is a particularly troubling finding because it has been seen in potential minority communities and others.”
As for booster, J&J presented results of a large study that found giving a second dose just two months after the first protected against COVID-19 symptoms to 94% of 70% in US recipients. Instead, giving this booster six months later led to an even bigger jump in anti-virus antibodies.
But in their own review, the FDA scientists note that only a small portion of the cases involved the delta variant, by far the dominant strain in the United States, and while the FDA reviewers found no new safety concerns about a second dose of Johnson & Johnson, They have noted other shortcomings. J&J followed the booster recipients for just over a month, making it difficult to draw conclusions about the protection’s durability. Also, FDA scientists confirmed that they did not have time to independently confirm J&J’s statements, which were made shortly before the meeting. This is very unusual and has caused serious concern to the advisory committee.
The J&J vaccine was highly anticipated for its individual formulation. But its introduction earlier this year was hit by a series of problems including manufacturing problems and some rare and serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barré syndrome. Either way, regulators decided that the benefits of the shot outweigh those risks.
AOQ