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CDC: If you got J&J’s vaccine and booster, consider an mRNA shot now
Even combining a Johnson & Johnson vaccine with a booster of either Johnson & Johnson, or one of the two messenger RNA vaccines, wasn’t as strong as three shots of the messenger RNA vaccines in preventing emergency room visits or hospitalizations, according to the report.
Shortly after the study’s release, the CDC greenlighted a second booster, either of the Pfizer-BioNTech or Moderna shots, for those who received Johnson & Johnson’s vaccine and booster at least four months ago. It did not formally recommend the second booster but said people may get it if they choose. More than 1.3 million people received the Johnson & Johnson vaccines and booster, according to CDC data.
The study’s results confirm what health officials and scientists have known for some time based on earlier research. But the report is important because vaccine effectiveness data on the mix-and-match booster strategies in the real world has been limited.
The data, from a 10-state study conducted by independent researchers, may provide clarity amid a confusing stew of data about the single-dose vaccine. It shows that three doses of a messenger RNA vaccine perform the best, while a Johnson & Johnson vaccine followed by a messenger RNA booster shot is next best. Two shots of Johnson & Johnson provide a lower level of protection, with a single shot just 31 percent effective against hospitalization.
“That’s too low, especially in this world where we have access to other things,” said Natalie E. Dean, a biostatistician at Emory University’s Rollins School of Public Health. “One priority is making sure that people who only received one dose [of the Johnson & Johnson vaccine] are aware that they should go and get, preferably, a messenger RNA vaccine.”
The data also suggest a second boost with a messenger RNA vaccine may need to be considered, even for individuals who have received two doses of Johnson & Johnson, said Boghuma Titanji, an infectious-diseases expert at Emory University. “This is not yet a formal recommendation,” Titanji said, “but is something individuals who fall in this category should discuss with their health-care provider.”
The takeaway: “If you can get the messenger RNA vaccine series, and especially get one as a booster, this [study] confirms that is the way to go,” said Jeanne Marrazzo, director of the Division of Infectious Diseases at the University of Alabama at Birmingham.
Experts said the latest CDC study underscores what some experts say is a critical need for clearer recommendations on boosters.
“Right now, there aren’t recommendations for people who got two doses of J&J to get a third messenger RNA shot,” said William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. (Those who are moderately to severely immunocompromised are already recommended to get a third dose.) “The messenger RNA vaccines seem to be providing more protection. … What I’d like to see is a very simple recommendation: that everyone get three doses, and they should be messenger RNA vaccines.”
Several studies have shown the Pfizer and Moderna vaccines remain highly effective at preventing the worst outcomes from infections even as protection against less severe illness waned over time.
Although the Johnson & Johnson vaccine provides a lower level of initial protection than the messenger RNA vaccines, the company has pointed to evidence that its vaccine’s protection may not erode as quickly.
A study funded by the division of Johnson & Johnson that developed the vaccine and published in JAMA Network Open found that vaccine effectiveness was stable over six months — 81 percent effective at preventing hospitalization, though it measured a period before the omicron variant’s emergence.
“If there’s something we’ve learned in the pandemic — and it’s not a new lesson — the most informative papers come from people who are independent of the study,” said John P. Moore, a professor of microbiology and immunology at Weill Cornell Medicine.
Moss said it’s important for the public to keep in mind that the goal of vaccination is to prevent severe disease and death. But public messaging became muddled, he said, in part because early studies showed the messenger RNA vaccines provided protection against infection, raising “false expectations.”
It’s natural for the levels of virus-fighting antibodies in the blood to wane over time, Moss added. That’s part of the design of the body’s immune response. “Otherwise our blood would be chock full of antibodies and [blood] wouldn’t be able to flow … and deliver oxygen to the cells,” he said.
The CDC study analyzed data from more than 80,000 emergency room or urgent-care visits, and more than 25,000 hospitalizations among adults with covid-19-like illness in 10 states, from mid-December to March 7, a period that includes the omicron variant surge.
When researchers compared the effectiveness of several vaccine combinations in preventing emergency room or urgent-care visits, they found:
· A single Johnson & Johnson shot offered 24 percent effectiveness.
· Two Johnson & Johnson shots offered 54 percent effectiveness.
· A combination of Johnson & Johnson with one messenger RNA booster offered 79 percent effectiveness.
· Three messenger RNA shots offered 83 percent effectiveness.
Protection against hospitalization, meanwhile, was significantly higher with three doses of the messenger RNA vaccines, which offered 90 percent effectiveness. That compared with:
· A single Johnson & Johnson shot, which offered 31 percent effectiveness.
· Two Johnson & Johnson shots, which offered 67 percent effectiveness.
· A Johnson & Johnson shot with a messenger RNA booster, which offered 78 percent effectiveness.
When the Food and Drug Administration authorized Johnson & Johnson’s vaccine in February 2021 for all adults, many thought the one-and-done approach would make it a tool to vaccinate the world. But last spring, federal officials halted the use of the vaccine for 10 days while they looked into reports of six cases of a rare but potentially life-threatening type of blood clot among the millions of people who had received the shots in the United States. The vaccine’s use waned thereafter, due to supply problems, as well as concerns over the blood clot issue.
Nine deaths — seven women and two men — have been confirmed in connection with the blood clot issue through September. Seven of those patients, who were ages 28 to 62, had underlying medical conditions, including obesity, hypertension and diabetes.
Carolyn Y. Johnson contributed to this report.
CDC recommends Pfizer, Moderna vaccines over J&J’s
The new recommendation: “mRNA vaccines are preferred over the Janssen Covid-19 vaccine for the prevention of Covid-19 for those 18 years of age and over.”
Earlier Thursday, the CDC’s Advisory Committee on Immunization Practices endorsed the updated recommendation after hearing new data indicating that a rare blood clotting syndrome is more common among people who recently got a J&J vaccine than previously believed. CDC Director Dr. Rochelle Walensky accepted the updated recommendation within hours.
The CDC has logged 54 cases in the US of thrombosis with thrombocytopenia syndrome or TTS in the US since the vaccine became available. Nine people have died — seven women and two men.
Rates are higher than previously estimated among both men and women, the CDC’s Dr. Isaac See told the meeting. While only a few cases have been seen for every million people vaccinated by age group, they are higher than what was believed when vaccine advisers were last briefed.
“We’ve been struck on reviewing these cases by how rapidly a patient deteriorates … to death,” See said. Symptoms always begin within two weeks of getting the vaccine and, on average, within nine days.
“The US TTS case reporting rate following Janssen Covid-19 vaccination is higher than what was previously presented to ACIP and the case reporting rate for men 40-49 years and for women 50-64 is similar to that for women 18-29 years,” See told the meeting.
Thirty-nine of the 54 reported cases occurred before the CDC and the US Food and Drug Administration paused administration of the vaccine in April to investigate the link. The agencies resumed permission for the vaccine’s use later in April. Since then, CDC has learned of more cases, See said.
“The rates are now slightly higher for all age groups,” he said. The highest rate of TTS is among women — 10 per million vaccinations given in women ages 30 to 39 and 9 per million in women ages 40 to 49.
Committee weighed risks and benefits
The overall risk of developing TTS is 3.8 cases per million doses given. The death rate is less than one per million doses given: 0.57 per million. Risks are higher for women than for men, but they’re higher among men than previously known, the CDC’s Dr. Sara Oliver said.
ACIP members considered the new data and weighed it against numerous studies showing J&J’s vaccine is less effective than the Moderna and Pfizer/BioNTech vaccines in preventing infection.
“The U.S. supply of mRNA vaccines is abundant — with nearly 100 million doses in the field for immediate use,” the CDC said later Thursday in accepting the vote.
“This updated CDC recommendation follows similar recommendations from other countries, including Canada and the United Kingdom. Given the current state of the pandemic both here and around the world, the ACIP reaffirmed that receiving any vaccine is better than being unvaccinated,” it added.
“Individuals who are unable or unwilling to receive an mRNA vaccine will continue to have access to Johnson & Johnson’s COVID-19 vaccine.”
ACIP also discussed the risks of completely removing J&J’s vaccine as an option, as well as the potential confusion and mistrust that might be caused by changing recommendations about the vaccine. “We will absolutely emphasize how important education around the risk of these events is,” Oliver told the meeting.
“The VE (vaccine effectiveness) is lower for the Janssen vaccine compared to mRNA vaccines,” Oliver said.
The risk of myocarditis — a rare heart inflammatory condition — is lower for the Moderna and Pfizer/BioNTech vaccines than the risk of blood clots from the J&J vaccine. But younger men may be advised to avoid mRNA vaccines, so Oliver said that complete removal of recommendations for the J&J vaccine would cause problems. “It would remove the option of the vaccine for younger men, who are at higher risk for myocarditis,” she said.
Plus, the Janssen vaccine is often the only shot available for prison populations, the homeless and other high-risk groups.
Worries about undermining confidence in vaccines
There could be other fallout from a decision to remove support from the J&J vaccine, Oliver cautioned. “Diminished access could undermine confidence in the COVID-19 vaccine program,” she said. “Lack of vaccine choices could contribute to mistrust and misinformation about COVID-19 vaccines available,” she added.
Earlier this week, the FDA strengthened language in the fact sheet that goes along with the Janssen vaccine, saying it should not be given to anyone with a history of TTS. There is, however, no clear risk factor for predicting who will develop the condition after getting the vaccine, the CDC said.
The changes to the recommendation should reassure Americans that public health experts are watching over the safety of the vaccines, ACIP members said.
“I want to remind everybody that this is in part a reflection of the strength of our vaccine safety surveillance system,” Dr. Matthew Daley of the Institute for Health Research at Kaiser Permanente Colorado told the meeting.
“This whole process should increase confidence in our vaccine safety surveillance system,” Dr. Sandra Fryhofer of Emory University and a non-voting liaison to the committee for the American Medical Association, said.
“I do think this vaccine needs to be made available,” she added. “We need a variety of vaccine platforms.”
The Pfizer/BioNTech and Moderna vaccines use a technology known as messenger RNA or mRNA to elicit an immune response, while the Johnson & Johnson vaccine uses a so-called vector — a non-replicating common cold virus called an adenovirus — to carry the active vaccine material into he body.
Different vaccine types stimulate different immune responses. That could be important, Fryhofer said. “We don’t know what variant is next,” she said.
About 16 million Americans have been given the Janssen vaccine.
Dr. Penny Heaton, global therapeutic head for vaccines at Janssen, told the meeting that the J&J vaccine is unique.
“We are confident in the positive benefit/risk profile of our vaccine. It is saving lives in the US here today and on every continent around the globe. Our vaccine is different. It’s long-lasting. It offers high levels of protection, and it offers breadth of protection,” Heaton told the meeting. “It’s easy to store and transport.”
Heaton said the J&J vaccine provides a different type of immunity that grows more slowly but lasts longer. It’s a one-dose vaccine, but the CDC now recommends that everyone who gets it receive a booster dose of any available vaccine.
“Even in the US, given its durable protection, it may be the preferred choice for people who can’t or won’t return for multiple vaccinations,” Heaton argued. She said the company has several studies underway to understand risk factors for TTS.
“While TTS continues to be a rare event, unfortunately, cases of Covid-19 are not,” she said, noting that Covid-19 carries a much higher risk of blood clots than vaccination does
Covid vaccine boosters are now available. Here’s who’s eligible for Pfizer, Moderna and J&J’s shots
A patient receives their coronavirus disease (COVID-19) vaccine booster during a Pfizer-BioNTech vaccination clinic in Southfield, Michigan, U.S., September 29, 2021.
Emily Elconin | Reuters
Nearly 100 million people nationwide are immediately eligible to receive Covid booster shots after the Centers for Disease Control and Prevention authorized extra doses of Moderna and Johnson & Johnson’s vaccines Thursday night.
The agency’s decision also enables fully immunized people to pair their boosters with doses from different manufacturers after research from the National Institutes of Health showed it was safe and effective to mix and match vaccines. Pfizer and BioNTech’s boosters were widely cleared for use in the U.S. on Sept. 24.
Some 11.6 million individuals across the country have already received their boosters, and the CDC’s approvals opened them up to tens of millions of more people. But not everyone is eligible. Here is who’s allowed to get the extra doses in the U.S. based on their first round of shots:
Pfizer-BioNTech
More than 47 million Pfizer vaccine recipients who received both shots at least six months ago became eligible for a booster Friday, according to data presented Thursday before the CDC’s advisory committee. That includes:
- Anyone 65 and older.
- All adults age 18 to 64 who have cancer, dementia, diabetes, heart disease, HIV and other medical conditions that increase their likelihood of Covid complications.
- Anyone 18 or older who live or work in a long-term care facility, homeless shelter and prison or other congregate setting.
- Front-line personnel 18 or older who are at a higher risk of Covid exposure due to their job, including first responders, teachers, supermarket staff and mass transit employees.
Moderna
More than 39.1 million Moderna vaccine recipients who received both shots at least six months ago became eligible for a booster Friday, according to the CDC presentation. The CDC adopted the same criteria for Moderna recipients as Pfizer since the two companies use the same mRNA technology in their Covid vaccines. They include.
- Anyone 65 and older.
- All adults age 18 to 64 who have cancer, dementia, diabetes, heart disease, HIV and other medical conditions that increase their likelihood of Covid complications.
- Anyone 18 or older who live or work in a long-term care facility, homeless shelter and prison or other congregate setting.
- Front-line personnel 18 or older who are at a higher risk of Covid exposure due to their job, including first responders, teachers, supermarket staff and mass transit employees.
Johnson & Johnson
The CDC adopted a slightly different criteria for J&J’s one-shot Covid vaccine, making almost 13 million recipients eligible as of Friday. That includes
- All adults who were vaccinated with J&J’s Covid vaccine at least two months ago, instead of six months with Pfizer and Moderna.
- All adult J&J recipients are eligible for a booster even if they don’t have underlying medical conditions or work in a profession or live where there’s a higher risk of Covid.