WASHINGTON: US health advisers back Johnson & Johnson’s booster covid-19 vaccine on Friday, citing concerns that Americans who got the single-dose shot are not as safe as the two-dose brand.
J&J told the Food and Drug Administration that an additional dose provides significant protection only two months after the initial vaccination — but may work better if people wait until six months later. unable to decide the best time, FDAThe U.S. advisory panel voted unanimously that people should be offered boosters at least two months after getting their first shot.
“I think it was clearly always a two-dose vaccine,” said Dr. Paul Offitt, an FDA advisor at Children’s Hospital of Philadelphia. “It would be hard to recommend it as a single-dose vaccine at this point.” The FDA isn’t bound by the recommendation as it makes the final decision—and adding to the complexity of 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” the different shots showed that either type of booster revived people’s levels of virus-fighting antibodies — for at least a few weeks. For. And the most dramatic jump is a . came from giving pfizer Or the Moderna shot after the single-dose J&J vaccination.
FDA advisers did not vote on whether it should be recommended, but asked the government to allow flexibility with the booster, saying there were no safety red flags, even though it is not yet clear. That’s the difference between mixing and matching. -Duration protection.
Dr. Ofer Levy from Boston Children’s Hospital said, “All these combinations are already happening in the real world, so I think it’s something urgent for the FDA to do to help sort out the complex and challenging landscape.” ”
The government says all three US vaccines offer strong protection against hospitalization and death from Covid-19, and the priority is getting the first shot to the 66 million eligible but unvaccinated Americans who are most at risk. but with the spread of extra-infectious delta version And with signs of weakening immunity against mild infections, the nation is heading for a massive booster campaign.
Last month the Pfizer booster began to be offered to seniors and young adults at high risk from Covid-19 because of poor health, job or living conditions – at least six months after their initial vaccination. On Thursday, an FDA advisory panel recommended a similar approach for half the dose. Modern Booster.
But the J&J vaccine has consistently shown low effectiveness levels in a series of studies—and the FDA panel eventually settled on another shot for any recipient 18 or older at least two months after their first vaccination. .
Dr. Archana Chatterjee from Rosalind Franklin University said, “It’s really — with the second dose — I think it’s on par with those other vaccines in terms of effectiveness.”
The FDA will use the recommendations of its advisors to decide whether to authorize boosters for both J&J and Moderna. Next, the Centers for Disease Control and Prevention will rule on who should roll up their sleeves.
Most of the 188 million Americans who have been fully vaccinated against Covid-19 have received either Pfizer or Moderna options, while J&K recipients account for only about 15 million.
J&J’s vaccine is made with a different technology and on Friday the company introduced its boosters as a way to fortify a stronger vaccine, which they said has maintained its protective potency over eight months. But FDA scientists apparently challenged that claim.
“There is data that suggests the effectiveness of this vaccine is actually less robust than the company’s presentation is,” said Dr. Peter Marks, the FDA’s top vaccine official. And this is of particular concern as has been seen potentially in minority communities and others.”
As its booster, J&J presented the results of a large study in which 94% of symptomatic Covid-19 in US recipients given a second dose just two months after the first bumped up to 94%. Instead of giving that booster six months later, there was an even bigger jump in virus-fighting antibodies.
But in their review, FDA scientists noted only a small fraction of cases involving the delta variant, which was by far the major strain in the US, and while FDA reviewers had no new safety concerns about the second dose of J&J Found, he noticed other shortcomings. J&J followed the booster recipients for a little over a month, making it difficult to draw conclusions about the durability of the protection. In addition, FDA scientists stressed that they did not have time to independently verify the J&J data, which were presented shortly before the meeting. This is highly unusual and a matter of serious concern from the advisory panel.
The J&J vaccine was highly anticipated for its yet another made formulation. But its rollout earlier this year was hit by a slew of troubles including manufacturing problems and some rare but serious side effects, including a blood clotting disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of the shot outweighed those risks.
J&J told the Food and Drug Administration that an additional dose provides significant protection only two months after the initial vaccination — but may work better if people wait until six months later. unable to decide the best time, FDAThe U.S. advisory panel voted unanimously that people should be offered boosters at least two months after getting their first shot.
“I think it was clearly always a two-dose vaccine,” said Dr. Paul Offitt, an FDA advisor at Children’s Hospital of Philadelphia. “It would be hard to recommend it as a single-dose vaccine at this point.” The FDA isn’t bound by the recommendation as it makes the final decision—and adding to the complexity of 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” the different shots showed that either type of booster revived people’s levels of virus-fighting antibodies — for at least a few weeks. For. And the most dramatic jump is a . came from giving pfizer Or the Moderna shot after the single-dose J&J vaccination.
FDA advisers did not vote on whether it should be recommended, but asked the government to allow flexibility with the booster, saying there were no safety red flags, even though it is not yet clear. That’s the difference between mixing and matching. -Duration protection.
Dr. Ofer Levy from Boston Children’s Hospital said, “All these combinations are already happening in the real world, so I think it’s something urgent for the FDA to do to help sort out the complex and challenging landscape.” ”
The government says all three US vaccines offer strong protection against hospitalization and death from Covid-19, and the priority is getting the first shot to the 66 million eligible but unvaccinated Americans who are most at risk. but with the spread of extra-infectious delta version And with signs of weakening immunity against mild infections, the nation is heading for a massive booster campaign.
Last month the Pfizer booster began to be offered to seniors and young adults at high risk from Covid-19 because of poor health, job or living conditions – at least six months after their initial vaccination. On Thursday, an FDA advisory panel recommended a similar approach for half the dose. Modern Booster.
But the J&J vaccine has consistently shown low effectiveness levels in a series of studies—and the FDA panel eventually settled on another shot for any recipient 18 or older at least two months after their first vaccination. .
Dr. Archana Chatterjee from Rosalind Franklin University said, “It’s really — with the second dose — I think it’s on par with those other vaccines in terms of effectiveness.”
The FDA will use the recommendations of its advisors to decide whether to authorize boosters for both J&J and Moderna. Next, the Centers for Disease Control and Prevention will rule on who should roll up their sleeves.
Most of the 188 million Americans who have been fully vaccinated against Covid-19 have received either Pfizer or Moderna options, while J&K recipients account for only about 15 million.
J&J’s vaccine is made with a different technology and on Friday the company introduced its boosters as a way to fortify a stronger vaccine, which they said has maintained its protective potency over eight months. But FDA scientists apparently challenged that claim.
“There is data that suggests the effectiveness of this vaccine is actually less robust than the company’s presentation is,” said Dr. Peter Marks, the FDA’s top vaccine official. And this is of particular concern as has been seen potentially in minority communities and others.”
As its booster, J&J presented the results of a large study in which 94% of symptomatic Covid-19 in US recipients given a second dose just two months after the first bumped up to 94%. Instead of giving that booster six months later, there was an even bigger jump in virus-fighting antibodies.
But in their review, FDA scientists noted only a small fraction of cases involving the delta variant, which was by far the major strain in the US, and while FDA reviewers had no new safety concerns about the second dose of J&J Found, he noticed other shortcomings. J&J followed the booster recipients for a little over a month, making it difficult to draw conclusions about the durability of the protection. In addition, FDA scientists stressed that they did not have time to independently verify the J&J data, which were presented shortly before the meeting. This is highly unusual and a matter of serious concern from the advisory panel.
The J&J vaccine was highly anticipated for its yet another made formulation. But its rollout earlier this year was hit by a slew of troubles including manufacturing problems and some rare but serious side effects, including a blood clotting disorder and a neurological reaction called Guillain-Barré syndrome. In both cases, regulators decided that the benefits of the shot outweighed those risks.
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