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Johnson & Johnson Says Its Booster Shot Provides Increased Protection From COVID-19
Enlarge this image Johnson & Johnson shared data from the Phase 3 trial of its booster shot on Tuesday indicating a booster shot at six months provided a 12-fold increase in antibodies. Eva Marie Uzctegui/Bloomberg via Getty Images hide caption
toggle caption Eva Marie Uzctegui/Bloomberg via Getty ImagesJohnson & Johnson shared data from the Phase 3 trial of its booster shot on Tuesday indicating a booster shot at six months provided a 12-fold increase in antibodies.
Eva Marie Uzctegui/Bloomberg via Getty ImagesPeople who receive a Johnson & Johnson COVID-19 vaccine booster shot are better protected against the coronavirus for a longer period of time, according to the pharmaceutical company's latest trial results.
The one-dose Johnson & Johnson vaccine has been found to be 66% protective against moderate and severe disease overall worldwide and 72% protective against such cases in the U.S. But when a person receives a booster shot two months after getting the pharmaceutical company's one-dose vaccine, the protection against COVID-19 increased to 94%.
A booster shot at six months provided a 12-fold increase in antibodies.
The company had previously shared earlier evidence from this trial that people who received its one-shot COVID-19 vaccine could benefit from a booster shot after six months. The information shared Tuesday was part of the company's Phase 3 trial.
Sponsor Message"Our large real-world-evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine provides strong and long-lasting protection against COVID-19-related hospitalizations. Additionally, our Phase 3 trial data further confirms protection against COVID-19 related death," said Mathai Mammen, global head of Janssen research and development for Johnson & Johnson, in a statement.
Experts have said coronavirus boosters will be needed down the road because the efficacy of these vaccines, including the two-dose Pfizer and Moderna shots, wanes over time. Johnson & Johnson's trial data provides further support that a COVID-19 booster shot could go a long way in providing continued protection from the virus.
"Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases," Mammen said.
Shots - Health News COVID Booster Shots Are Coming. Here's What You Need To Know Pfizer's own data indicates booster shots can restore its vaccine's efficacy to 95%. A third dose of the Moderna vaccine, given six months after the initial two doses, also significantly boosts immunity, according to the company's data.
Despite President Biden's earlier announcement that the U.S. Plans to get booster shots in the arms of already-vaccinated Americans, it's unclear when health officials would approve such a move for the general public.
Health officials have already recommended a third shot of the Pfizer or Moderna vaccine for a more limited population — people who are moderately to severely immunocompromised. But last week, the Food and Drug Administration recommended against approval of a booster dose of the Pfizer-BioNTech COVID-19 vaccine for people 16 years and older.
That ruling didn't weigh in on a Johnson & Johnson booster shot, however.
The company says it has provided available data to the FDA and plans to submit the data to other regulators, the World Health Organization and National Immunization Technical Advisory Groups worldwide to inform decision-making on vaccine administration strategies.
Johnson & Johnson's findings indicate increased protectionData from Johnson & Johnson's booster trial showed strong protection against severe COVID-19 infections soon after the second-dose was administered.
At least 28 days after a patient received the second Johnson & Johnson shot, data showed at least 75% overall efficacy against severe or critical COVID-19 infections, across all age cohorts and all countries included in the study.
Enlarge this image Doses of the Johnson & Johnson Janssen COVID-19 vaccine. Elijah Nouvelage/Bloomberg via Getty Images hide caption
toggle caption Elijah Nouvelage/Bloomberg via Getty ImagesDoses of the Johnson & Johnson Janssen COVID-19 vaccine.
Elijah Nouvelage/Bloomberg via Getty ImagesSpecifically for the U.S., the company reported a 74% efficacy against critical COVID-19 infections. The booster also provided 89% efficacy against hospitalization and 83% against COVID-19-related death.
A booster shot after two months provided 94% efficacy against COVID-19 in the U.S. According to the company, as early as two weeks after the booster shot was administered data showed 100% efficacy against critical COVID-19 infections.
When a booster of the Johnson & Johnson COVID-19 vaccine was given six months after the single-shot dose, antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster.
What To Know About Booster Shots If You Received Johnson & Johnson's COVID-19 Vaccine
On Sept 22, 2021, Johnson & Johnson released data that answers two questions many people have likely been wondering about its vaccine: How good is it against the delta variant, and do I need a booster? Maureen Ferran is a virologist at the Rochester Institute of Technology and has been keeping tabs on the Johnson & Johnson vaccine. She broke down the new data and explains what it all means.
1. How effective is one dose of the Johnson & Johnson vaccine?Early clinical trial data released in January 2021 showed that four weeks after the first dose, the Johnson & Johnson single–shot vaccine was 66.3% effective at preventing COVID-19 infection. The initial studies also showed that it was 85% effective at preventing severe or critical disease.
But the original clinical trials and most subsequent studies were done before the delta variant became responsible for almost all of the COVID-19 cases in the U.S. Early studies suggest that although COVID-19 vaccines are still effective against this variant, in general their efficacy is lower compared to protection against the original strain.
On Sept. 21, 2021, Johnson and Johnson announced the results of a large, real-world Phase 3 clinical trail of their COVID-19 vaccine. This study collected data from March 1, 2020 through July 31, 2021 and found that the effectiveness of the vaccine did not diminish over the duration of the study, even after the Delta variant became dominant in the U.S. The one-dose vaccine was 79% protective against COVID-19 infections and 81% protective for COVID-19-related hospitalizations. This indicates that a single Johnson & Johnson shot performs well, even in the presence of Delta and other variants.
2. Why might someone need a booster?The amount of neutralizing antibodies in a person – antibodies that defend a cell from the coronavirus – is an accurate measure of protection within the first several months after vaccination. Studies show that individuals who received a Johnson & Johnson or an mRNA vaccine continue to produce some level of antibodies for at least six months after vaccination. However, neutralizing antibody levels generally start to wane over time and some evidence suggests that immunity provided by the Pfizer mRNA vaccine does the same.
This may sound bad, but it isn't clear that lower antibody levels correlates with an increased risk of severe infection. The immune system's long-term surveillance is done by "memory" immune cells that will prevent or reduce disease severity if a person is exposed to the virus at a later time.
Therefore scientists have been collecting real-world data from vaccinated people to determine when they may become vulnerable to infection again with and without a booster shot.
3. How effective is a Johnson & Johnson booster shot?In addition to the results of the single–shot study, on Sept 21, 2021, Johnson & Johnson also released data about booster shots. The trial gave people a second dose of the Johnson & Johnson vaccine either two or six months after the first dose. In both cases, it increased people's defense against COVID–19.
When given two months after the first dose, protection against moderate to severe disease increased from 85% to 94% and the amount of neutralizing antibodies increased four-fold. If the booster was administered six months after the first shot, antibody levels increased 12-fold when measured four weeks after the booster was given.
These findings suggest that although a single dose of the Johnson & Johnson vaccine provides strong, durable protection, people may still benefit from a booster because it improves the vaccine's efficacy.
One important question is whether someone who received the Johnson & Johnson shot should get a second Johnson & Johnson dose or mix and match – get a second dose of a different vaccine. As of late September, the FDA seems more likely to approve a second dose of the Johnson & Johnson vaccine because there isn't much data yet about a mix and match strategy.
4. What about the side effects?The vast majority of vaccines – including the Johnson & Johnson and mRNA vaccines – produce common side effects such as pain at the injection site, headache, fatigue, muscle and joint pain, chills and fever.
The recent study did not monitor side effects from the booster in detail, but according to Johnson & Johnson, the safety of the vaccine remained consistent and was generally well-tolerated when administered as a booster. Overall, researchers have repeatedly found that despite some rare complications, the benefits of the Johnson & Johnson vaccine far outweigh the risks.
A recent CDC study showed that unvaccinated people are almost five times more likely to be infected by the coronavirus and 29 times more likely to be hospitalized with COVID-19 compared to fully vaccinated individuals. Therefore, all the evidence suggests that the millions of Americans who are able to get vaccinated but are choosing not to are putting themselves – and others – at serious risk.
5. When might a booster be authorized?On Sept, 22, 2021, the FDA approved booster shots for people who received the Pfizer vaccine and are over 65 years of age, at risk of severe COVID illness or whose occupations put them at greater risk of exposure. Booster shots of the Johnson & Johnson or Moderna vaccines are not yet approved, but on September 19th Dr. Anthony Fauci said that the FDA could review booster data for the Moderna and Johnson & Johnson vaccines within a few weeks.
Editor's note: Johnson & Johnson is a funder for the PBS NewsHour.
Portions of this article originally appeared in a previous article originally published on Aug. 27, 2021. This article is republished from The Conversation under a Creative Commons license. Read the original article.
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Give NowJohnson & Johnson Booster Shot Prompts Large Increase In Immune Response, Company Says
CNN —
Booster doses of Johnson & Johnson's one-shot coronavirus vaccine generated a big spike in antibodies, the frontline immune system defenses against infection, the company reported Wednesday.
People who received a booster six to eight months after their initial J&J shots saw antibodies increase nine-fold higher than 28 days after the first shot, Johnson & Johnson said.
The data comes from two Phase 2 studies conducted in the United States and Europe, the company said in a statement. Some of the 2,000 or so people in the studies got booster doses six months after their first doses of J&J's Janssen vaccine.
"New interim data from these studies demonstrate that a booster dose of the Johnson & Johnson COVID-19 vaccine generated a rapid and robust increase in spike-binding antibodies, nine-fold higher than 28 days after the primary single-dose vaccination," the company said in its statement.
"We have established that a single shot of our COVID-19 vaccine generates strong and robust immune responses that are durable and persistent through eight months. With these new data, we also see that a booster dose of the Johnson & Johnson COVID-19 vaccine further increases antibody responses among study participants who had previously received our vaccine," Dr. Mathai Mammen, global head of research and development for Janssen, said in a statement.
J&J said it was in discussions with the US Food and Drug Administration, US Centers for Disease Control and Prevention, European Medicines Agency, World Health Organization and other health authorities about the need for offering a booster dose of the Janssen vaccine.
"We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson COVID-19 vaccine, boosting eight months or longer after the primary single-dose vaccination," Mammen added.
Many people who received the J&J vaccine have been clamoring for information about whether they will need a booster shot. US federal government officials have said they are preparing to start offering a booster dose to people who got Moderna's or Pfizer's Covid-19 vaccine after data showed boosters can amp up the antibody response – and after studies started showing an uptick in infections in both vaccinated and unvaccinated people. The more transmissible Delta variant is partly to blame, experts say, as is a waning immune response.
The Janssen vaccine was authorized at the end of February, more than two months after Moderna's and Pfizer's vaccines were authorized. About 14 million Americans have received the J&J vaccine, according to the CDC.
Dr. Dan Barouch, a vaccine researcher at Beth Israel Deaconess Medical Center and Harvard Medical School who is not involved in the two clinical studies but is helping study J&J vaccines, said the findings support getting a booster shot, but only after a delay.
"The boost at six months is going to look very impressive and substantially greater than what has already been reported in terms of the two month boost, and that is significant because it, in my opinion, the boost should not be at two months, but it really should be at six months or later," Barouch told CNN.
Neither of the studies looked at real-world efficacy, so the company has not demonstrated that people who get boosters will be less likely to become infected or to develop severe disease. But researchers are beginning to agree that antibody levels do indicate immune protection.
The Johnson & Johnson vaccine is made differently from Pfizer's and Moderna's. Those two vaccines use messenger RNA or mRNA, encased in little lipid particles, to carry instructions to the body to start an immune response.
The Janssen vaccine uses a crippled common cold virus called an adenovirus to carry in similar instructions. There had been worries that a booster dose of such a viral vector vaccine might not work effectively because of the possibility the body would generate an immune response against the vector, also.
"There was a theoretical concern that the generation of anti-vector antibodies by the first shot could impede the use of it again," Barouch said.
"I think these data put that to rest."
Federal health officials have said they believe a booster dose of the Janssen vaccine will be needed at some point.
"I'm quite certain that the FDA, CDC, NIH, White House will use these data to likely justify or recommend a booster for J&J-vaccinated people, probably with a second shot of J&J," Barouch said.
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