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J&J says second shot boosts protection for moderate-severe COVID-19 to 94%


CHICAGO, Sept 21 (Reuters) - Johnson & Johnson (JNJ.N) said Tuesday a second shot of its COVID-19 vaccine given about two months after the first increased its effectiveness to 94% in the United States against moderate to severe forms of the disease.

That compares to 70% protection with a single dose.

The data will help J&J make its case to U.S. regulators for a booster shot even as the company stresses the durability of its single-shot vaccine as a tool to ease the global pandemic.

President Joe Biden is pushing for booster shots in the face of surging hospitalizations caused by the Delta variant and J&J, the only drugmaker with a single-shot COVID-19 vaccine approved in the United States, has been under pressure to produce evidence on the effectiveness of an additional dose.

The company has now "generated evidence that a booster shot further increases protection against COVID-19," Dr. Paul Stoffels, J&J’s chief scientific officer, said in a statement.

J&J said a booster given two months after the first dose increased antibody levels four to six-fold. When given six months after the first dose, antibody levels shot up twelve-fold, data released last month showed, suggesting a large improvement in protection with the longer interval between doses.

Side effects with two doses were comparable to those seen in studies with the single-dose vaccine. The data is yet to be peer reviewed but will be submitted for publication in the coming months.

To date, only Pfizer Inc (PFE.N)/BioNTech SE have submitted sufficient data for U.S. regulators to evaluate whether boosters are warranted ahead of the Biden Administration's Sept. 20 deadline for rolling out booster shots. A decision on that vaccine is expected this week.
Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/File Photo/File Photo

On Friday, an FDA advisory committee voted to recommend emergency authorization of additional Pfizer shots for Americans 65 and older and those at high risk of severe illness, but voted to recommend against broader approval, saying they want to see more data.

J&J said it has submitted data to the FDA and plans to submit it to other regulators, the World Health Organization and other vaccine advisory groups worldwide to inform their decision-making.

The Phase III two-dose trial of up to 30,000 participants tested the effectiveness of a second dose given 56 days after the first in adults 18 and older.

While the study found that two doses of the J&J vaccine was 94% effective in the United States at preventing moderate to severe disease, there was only 1 case in the vaccine group and 14 in the placebo group, resulting in a wide confidence interval and raising questions about the certainty of the result.

The study had a short follow-up period of around 36 days, but found that a second dose was well tolerated, the company said.

The company also said on Tuesday that evidence from a separate real world study of nearly 400,000 people in the United States who got the J&J shot showed the vaccine was 79% effective at preventing COVID-19 infections and 81% effective at preventing hospitalizations compared with 1.52 million people of similar ages, genders and health issues who were unvaccinated.

J&J said there was no evidence of reduced effectiveness over the study's duration from March to late July - a period that included the impact of the Delta variant.

Vaccine effectiveness in the real world study varied by age. For those under age 60, the vaccine was 86% effective at preventing hospitalization versus 78% for those 60 and older.

Our Standards: The Thomson Reuters Trust Principles.

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I have generally always leaned Democrat. I diligently followed the pre-vaccine protocols and still pretty much do. I was very perturbed at the intransigence of people on the right to take the virus serious and to wear mask in indoor public places. I viewed them as conspiracy theorist, as well as others things not relevant to this particular issue. Way before the vaccines were being released I told myself that I would wait a year before making a decision of whether to take it or not. The reason being not that I am anti-vaccine, but because this was a new methodology that was rushed into release to the public. Every working braincell that I have, or had at that time, warned me to be cautious about something that new RUSHED. I know what happens when things are rushed, regardless of how smart the people are or how good their intentions. It has not been a year yet, but as I look at what is happening in other countries, as I always have, I just don't understand why vaccines are being pushed

The Shankster

Yesterday there was a press conference here in Germany, 3 pathologist (all retired professors) telling theirs results after done autopsy on 40 p. who died after vaccination one third died because of the vaccination. What they are telling us, showes it's a lot worse than expected. Ready to take back America from a treasonous Government?

The Shankster

WAKE UP! Support COVID19 Federal Whistleblower Jodi Omalley. They're caught.. and they want people to report concerns through their office of communications so they can file it in the circular file, I'm sure! The fake vax is probably what will tip the economy over the cliff, after two years of lockdowns most countries GDPs will be down, then every government is sinking millions if not billions into fake vaccines, and likely borrowing from China to do it. The crash is coming.


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