Johnson & Johnson is evaluating booster injections in clinical trials that recruited nearly 2,300 participants, but when announcing data to support additional vaccination, the company only pointed out that one study came from fewer than 20 people.
Johnson & Johnson has been collecting booster data in two Phase 1/2a studies that started last year, which recruited people who had previously been vaccinated with the company’s single-dose Covid-19 vaccine.company Announce On Wednesday, it had new preliminary data showing that the booster produced “a rapid and strong increase in spike-bound antibodies, 9 times higher than 28 days after the initial single-dose vaccination.”
In addition, Johnson & Johnson stated that the second injection “significantly increased” the binding antibody response of study participants aged 18 to 55 and participants 65 and older who received low-dose boosters. The company did not specify how many participants participated in the analysis and how many months after the first injection the second dose was injected. The results have not been published and peer reviewed. Johnson & Johnson stated that the abstract has been submitted to the preprint online archive medRxiv.
Johnson & Johnson uses engineered adenovirus to manufacture vaccines, which are used to deliver vaccine components into cells. The company’s vaccine technology, Idaq, Is the same FDA-approved platform used to develop Janssen Ebola vaccineAlthough the technology has proven that it can produce vaccines, it is not entirely clear whether it is suitable for boosters. Adenovirus is a virus that causes the common cold. Although Johnson & Johnson designed it so that it does not replicate and cause infection, introducing it into the body may trigger the production of antibodies against it. In the second injection, these antibodies will recognize the vaccine and attack it. (Chemical & Engineering News has a very good Interpreter here. )
Clinical trial records show that Johnson & Johnson has two placebo-controlled Phase 1/2 studies that evaluated boosters given under different dosing schedules. The first clinical trial recruited 1,085 adults, divided into five groups. After the initial vaccination, the different dosing intervals tested were 2, 6, 8, 12, 14, and 26 months. A group evaluating participants 65 years and older is testing a single dose, as well as two doses eight weeks apart.
The second phase 1/2 study recruited 1,210 participants, divided into 13 different groups. Ten of them will receive the second vaccination in four months; the other three groups will receive the second vaccination after six months. In this study, the initial vaccination was one injection or two injections, 28 days or eight weeks apart. Three groups will be given a single dose.
The only data that Johnson & Johnson pointed to came from a sub-study – from a set of one of its vaccine’s two phase 1/2a tests –Publish In the New England Journal of Medicine last month. This sub-study evaluated the immune response of 20 people 8 months after the initial one or two doses of the vaccine; five people took a placebo. Antibody and T cell responses were measured 8 months after a single injection (10 participants) or 6 months after two injections (10 other participants).
The antibody response of the trio increased dramatically within eight months. One had a breakthrough infection, and the other two received messenger RNA vaccines. Excluding these three people, the study reported that during the eight-month period, antibody levels were relatively stable.
The research seems to support the durability of the Johnson & Johnson vaccine at the eight-month mark, but it is not clear whether these small sample results support booster injections. The study authors wrote that they observed an expanded range of neutralizing antibodies at eight months, including targeting delta variants and two worrying variants, “this shows that even without further enhancement, the B cell response has matured. “
Now, Johnson & Johnson says its data (not yet disclosed) supports the booster. With these results, Mathai Mammen, head of global research and development at Johnson & Johnson subsidiary Janssen, said the company plans to discuss with regulators to strengthen injections.
Mammen said in a prepared statement: “We have determined that one injection of our Covid-19 vaccine will produce a strong and powerful immune response that can last for eight months.” “Through these new data, We also see that the booster dose of Johnson & Johnson’s Covid-19 vaccine further increases the antibody response of study participants who have previously received our vaccine. We look forward to discussing with public health officials the potential strategy of our Johnson & Johnson COVID-19 vaccine in the main single dose Eight months or more after vaccination.”
last week, Federal health officials announced a plan to provide booster injections for eight months after the second injection starting in September Two doses of messenger RNA vaccine from Moderna or Pfizer/BioNTech. At the time, U.S. Department of Health Director Vivek Murthy said that officials were still waiting for more Johnson & Johnson data on enhancers.
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