FDA panel supports J&J COVID-19 vaccine booster shot for all Americans who got a first dose

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johnson and johnson vaccine A federal panel decided Friday that those receiving initial authorization should be considered a two-dose vaccine rather than a one-and-done shot.

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The committee felt that the 15 million Americans who “got one more” received one dose of the J&J vaccine would be much better protected with another.

“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 19-0 unanimously to support describing J&J as a booster, at least two months after the initial shot.

Watch:FDA panel endorses low dose of Moderna COVID booster

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Live COVID-19 Updates:Vaccine panel recommends J&J booster after data, vaccine effectiveness has ‘headroom for improvement’

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 drugs. The company’s studies show that J&J’s protection persists over time, while effectiveness against less severe disease appears to decline with the other two.

Committee members said they felt the urgency to provide an additional dose of the vaccine to people from Jammu and Kashmir receiving a single shot.

“There’s a public health imperative here because what we’re seeing is that this is a group with the overall low efficacy that we’ve seen with mRNA vaccines. So there’s something urgent to do,” said the committee chair. Doctor. Arnold Monto, a professor of epidemiology at the University of Michigan School of Public Health.

In response to questions raised by the committee, Dr. Penny Heaton, head of vaccine global therapeutics for Johnson Pharmaceuticals, a Johnson & Johnson company that developed the vaccine, agreed on the effectiveness of their vaccines in different groups of studies , although it was “consistent and sustainable” within groups – in other words, it did not decrease over time.

“However, because the magnitude is less than I think would be desired — estimates similar to those seen with mRNA vaccines — there is headroom for improving efficacy,” she said.

Heaton told the committee Friday that adding a second dose 2 to 6 months after the initial J&J shot has the same effect as mRNA vaccines.

Watch:Pfizer files for emergency use of COVID vaccine for children 5-11

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J&J claims that its vaccine is 75% effective worldwide against any infection and 70% effective in preventing serious illness and hospitalization. Lower rates were seen in other countries, J&J said, possibly because of the variety of spreads 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, Moderna vaccine recipients have the highest vaccine effectiveness at 95%, followed by Pfizer-BioNtech at 80% and J&J at 60%. report good Published by CDC on 17 September.

Amanda Cohn, a vaccine specialist at the CDC’s National Center for Immunization and Respiratory Diseases, said the two mRNA vaccines are more effective, even as their potency tends to decrease over time.

“There was some other data which showed that the real-world effectiveness (for J&J) is hovering higher in the range of 50 to 60%,” she said. “Efficacy or safety with one dose of J&J vaccine is not equivalent to protection with two doses of one mRNA vaccine, and certainly not in groups that are now authorized to receive booster doses of mRNA vaccine Is.”

Professor of Preventive Medicine at Infectious Diseases Vanderbilt University Medical Center in Nashville, Dr. “The contrary has not been so strictly stated before,” said William Schaffner, who is not a member of the committee.

To counteract the decline in effectiveness over time, the committee has approved booster shots for people who have already received: pfizer-biontech Or modern vaccines and satisfy certain conditions.

The decisions of the committee on complementary shots of both Moderna and J&K still need to be verified by a separate advisory panel as well as by top federal officials. The CDC advisory panel is expected to meet on October 20 and 21 to discuss additional doses for Moderna and J&K recipients.

The CDC continues to recommend that people receive additional doses of the same vaccine they received the first time.

It is unclear whether the panel’s decision on Friday will affect the definition of “complete immunization” for those receiving the J&K shot.

Government officials have said the basic dose of vaccine – one shot from J&K and two each from Moderna or Pfizer-BioNtech – will be considered “fully immunized” for purposes of employment, travel and site entry.

about 15 million Americans have been completely Vaccinated with J&J VaccineCompared to 103 million who received Pfizer and 69 million who received Moderna. So far, 8.8 million Americans have received a booster dose of the Pfizer vaccine.

Contact Elizabeth Weiss at [email protected] and Karen Weintraub at [email protected]

Health and patient safety coverage at Granthshala is made possible by a grant from the Massimo Foundation for Ethics, Innovation and Competition in Healthcare. The Massimo Foundation does not provide editorial input.

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