Johnson & Johnson says booster of its one-dose vaccine makes the shot 94% effective against COVID-19

 Johnson & Johnson said on Tuesday that a booster shot of its COVID-19 vaccine is highly protective against severe illness.

The company said on Tuesday that a second shot given about two months after the first increased effectiveness to 94 percent against symptomatic disease.

This compares to 70 percent protection seen 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 a Delta variant-fueled surge and J&J - the only drugmaker with a single-shot COVID-19 vaccine approved in the U.S. - has been under pressure to produce evidence on the effectiveness of an additional dose.

'A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population,' Dr Paul Stoffels, J&J's chief scientific officer, said in a statement.

'At the same time, we now have generated evidence that a booster shot further increases protection against COVID-19 and is expected to extend the duration of protection significantly.' 

Johnson & Johnson 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 New Brunswick, New Jersey-based firm published details of three studies examining different aspects of its vaccine. 

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

The first study found that a booster shot was 94 percent effective against symptomatic COVID-19 in the U.S. and 100 percent effective against critical illness at least 14 days post-vaccination.  

There was only one case of COVID-19  in the vaccine group and 14 in the placebo group.

J&J said that a booster given two months after the first dose increased antibody levels between four-fold and six-fold. 

When given six months after the first dose, antibody levels shot up nine-fold after one week and 12-fold after four weeks.

These increases were seen regardless of age. 

Side effects with two doses were comparable to those seen in studies with the single-dose vaccine. 

The data are yet to be peer reviewed but will be submitted for publication in the coming months.

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 company also shared data from a real-world study comparing 390,000 people who received the standard one-dose J&J vaccine to 1.52 million unvaccinated people from March 2021 to late July 2021. 

The vaccine was found to be 79 percent effective against COVID-19 infection and 81 percent against hospitalizations 

'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,' said Dr Mathai Mammen, global head of research an development at J&J, in a statement.

'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.'

To date, only Pfizer-BioNTech have submitted sufficient data for U.S. regulators to evaluate whether boosters are warranted.

Last month, boosters were approved for immunocompromised Americans after data showed they were less likely to develop high antibody levels after two doses.

At least 2.21 million people in the U.S. have received booster doses as of Monday, according to data from the Centers for Disease Control and Prevention (CDC)..

The White House also announced last month booster shots would become available for all Americans starting on September 20 due to data suggesting waning efficacy of the initial shots. 

However, an independent panel at the U.S. Food and Drug Administration (FDA) has voted on Friday to only to give vaccines to specific at-risk groups.

A first vote by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) was 16-2 against boosters for all healthy Americans.

Members said said there was not enough evidence that a third dose was safe and effective for use in people under age 65. 

A second vote unanimously recommended approval of booster doses for the Pfizer-BioNTech COVID-19 vaccine to older adults aged 65 and older and those who are at high risk of developing a severe case of the virus.  

The FDA is not bound to follow the advisory group's recommendations but the agency rarely goes against the guidance of VRBPAC.

The next step before the FDA can issue authorization is a recommendation for approved by the advisory committee for the CDC.

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