- Johnson & Johnson on Tuesday revealed the second shot of its COVID-19 vaccine, given two months after the first, was up to 94% effective.
- By comparison, the standard single dose regimen is 70% effective against symptomatic disease.
- Antibody levels increased between four-fold and six-fold when the booster was given after two months, and 12-fold when given after six months.
- J&J said it has submitted the data to the FDA and plans to submit it to other regulators for authorization of booster shots.
Johnson & Johnson said on Tuesday that the booster shot of its COVID-19 vaccine is highly protective against serious illness.
The second shot, given nearly two months after the first increased the effectiveness of the first by 94 percent against the symptomatic disease, the company said Tuesday.
This compares to the 70 percent protection seen with a single dose.
The data will help J&J make its case for a booster shot to US regulators, even as the company stresses the durability of its single-shot vaccine as a tool to mitigate the global pandemic. Is.
President Joe Biden is pushing for booster shots in the face of a Delta variant-fuel surge and J&J – the only drugmaker with an approved single-shot COVID-19 vaccine in the US – is under pressure to present evidence on its effectiveness. extra dose.
“A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides robust and long-lasting protection, will help the global population,” said Dr Paul Stoffels, J&J’s Chief Scientific Officer. Getting vaccinated is important. Statement.
‘At the same time, we have now produced evidence that a booster shot further enhances protection against COVID-19 and is expected to substantially extend the duration of protection.’
Johnson & Johnson said on Tuesday it was given a second shot of its COVID-19 vaccine in the United States against moderate to severe forms of the disease, nearly two months after the first increased its effectiveness to 94%. This compares to 70% protection with a single dose.
New Brunswick, a 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 30,000 participants, looking at the effectiveness of the second dose given 56 days after the first in adults 18 years of age and older.
The first study found that a booster shot was 94 percent effective against symptomatic COVID-19 in the US and 100 percent effective against severe disease at least 14 days after vaccination.
There was only one case of COVID-19 in the vaccine group and 14 in the placebo group.
J&J said boosters 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 increased nine-fold after one week and 12-fold after four weeks.
These increases were observed regardless of age.
Side effects of the 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 presented for publication in the coming months.
J&J said it has submitted the data to the FDA and plans to present it to other regulators, the World Health Organization and other vaccine advisory groups around the world to inform its 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 from March 2021 to the end of July 2021 to 1.52 million people.
This vaccine was found to be 79 percent effective against COVID-19 infection and 81 percent effective against hospitalization
Dr Mathai Maimon, global head of research development in J&K, said, “Our large real-world evidence and Phase 3 studies confirm that the single-shot Johnson & Johnson vaccine is strong against hospitalizations associated with COVID-19. and provides long lasting protection. , in a statement.
‘Our single-shot vaccine produces a strong immune response and a long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 is further enhanced.’
To date, only Pfizer-BioNtech has submitted enough data for US regulators to evaluate whether the 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 US have received a booster dose as of Monday, according to data from the Centers for Disease Control and Prevention (CDC).
The White House also announced last month that booster shots would become available to all Americans starting on September 20, suggesting the effectiveness of early shots is low.
However, an independent panel from the US Food and Drug Administration (FDA) on Friday voted to give vaccines only to specific risk groups.
The first vote by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) against boosters for all healthy Americans was 16-2.
Members said there was not enough evidence that the third dose was safe and effective in people under 65 years of age.
A second vote unanimously recommended the approval of a booster dose for the Pfizer-BioNTech COVID-19 vaccine for adults 65 and older and those at high risk of developing a severe case of the virus.
The FDA is not obligated to follow the advisory group’s recommendations but the agency rarely goes against VRBPAC’s guidance.
The next step before issuing FDA authorization is a recommendation approved by the advisory committee to the CDC.