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Johnson & Johnson says additional dose boosts Covid vaccine efficacy – Boston, Massachusetts

Boston, Massachusetts 2021-09-21 06:30:15 –

NSohnson & Johnson showed on Tuesday that a large global study showed that the Covid-19 vaccine was more effective when given as a double-dose regimen, with other data showing that the vaccine’s effectiveness remains undiminished. Said to show.

The double-dose regimen prevented 75% of moderate to severe Covid cases in all countries tested. It also prevented 94% of such cases in the United States, where the vaccine needed to address fewer variants of SARS-CoV-2. virus. Importantly, the double dose regimen was 100% effective for serious illness.

J & J seems to support using this data to make boosters widely available to people who received a single vaccination more than 6 months ago. The company’s press release did not say so explicitly, but said J & J would submit the data to the Food and Drug Administration and to other regulators and the World Health Organization.

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This data may also help increase vaccine use in the United States and around the world. Currently, it is the least frequently administered Covid vaccine approved or approved by the Food and Drug Administration in the United States.according to Centers for Disease Control and Prevention, 14.6 million Americans were vaccinated with the Johnson & Johnson vaccine, compared to 6.77 million for the Moderna vaccine and 99.3 million for the Pfizer BioNTech vaccine.

In a press release, J & J argued that summarizing the available data showed that the effectiveness of single-dose vaccines did not diminish and that booster vaccines made the vaccine more effective.

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“Given the ongoing epidemic of COVID-19 and the rapidly emerging variants, it is important to prioritize protecting as many people as possible from hospitalization and death. At J & J’s Chief Scientific Officer In a statement, Paul Stofels said a single-shot COVID-19 vaccine that was easy to use, distribute, and administer and provided strong, long-term protection was essential. “At the same time, booster shots provide protection against COVID-19. It has generated evidence that it is expected to be further strengthened and significantly extend the defense period. “

As with much of the vaccine data during the pandemic, the summary data for the J & J double dose study was published in a press release rather than in a scientific publication. Companies feel obliged to publish summary data from clinical trials immediately as a result of regulations to prevent insider trading, which is often done without the details scientists want to scrutinize. Means to be done.

Developed in collaboration with researchers when J & J began testing vaccines Dan Barouch, Harvard Medical School, Said it believed that single-dose vaccines would provide benefits in a pandemic. Vaccine efficacy when results announced in January 66% for moderate to severe illness.. Researchers supported the benefit, but it was less than the 94% efficacy shown with both the Pfizer-BioNTech and Moderna vaccines.

The deployment of the J & J vaccine was plagued by other issues. There was a problem with the supply. Regulators then suspended the use of the vaccine for 10 days and gained a clearer idea of ​​thrombosis with thrombosis, a rare side effect that causes both bleeding and the formation of dangerous blood clots at the same time. The vaccine was used again in April.

Johnson & Johnson organized the first study, ENSEMBLE 1, as well as the study of the second 30,000 patients, in which volunteers receive two doses at 56-day intervals, ENSEMBLE 2. Part of the reason for the long intervals is that there was data showing that J & J’s vaccine platform, which uses a modified virus called adenovirus, does not work well if the doses are too close.

In this study, there were 14 moderate to severe Covids in the vaccine group, compared to 52 in the placebo group (75% efficacy) and 8 in the vaccine group, compared to severe or severe. Covid was 0 cases. With a placebo arm. In the United States, there was 1 moderate to severe Covid in the vaccine group and 14 in the placebo group.

J & J also published further results from the ENSEMBLE 1 study of single-dose vaccines. There were 433 cases of moderate to severe Covid in the vaccine group compared to 883 in the placebo group, with an efficacy of 53%. Efficacy for hospitalization remained high at 76%. (16 patients in the vaccine group and 64 patients in the placebo group.)

When given twice instead of once, antibody levels increase 4- to 6-fold. However, the increase in antibody levels was much higher when the doses were far apart, and boost immunization was given at 6 months, J & J said. At 6 months, antibody levels increased 9-fold after 1 week and 12-fold higher 4 weeks after booster immunization.

J & J is also included Link to treatiseUse claims from insurance companies to analyze the effectiveness of actual single-dose vaccines in 390,000 people who received the J & J vaccine, compared to 1.52 million people who were peer-reviewed based on age, gender, and time. And it has not been peer reviewed. Zip code, and risk factors that may predict Covid’s results. These data showed vaccine efficacy in 79% of Covid-19 diagnoses and 81% of Covid-related hospitalizations. J & J claims that this indicates that the vaccine’s efficacy was stable.

This data appears to be ready to discuss whether the J & J vaccine should be considered as a regimen given twice every 6 months. To do so, regulators need to convene public meetings to publish more detailed data.



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