Photographer: Angel Garcia / Bloomberg
Photographer: Angel Garcia / Bloomberg
The Johnson & Johnson experimental single-image Covid-19 vaccine created a lasting protective response in an early safety study, giving us an insight into how it performs in the real world as the company gets closer to its performance. approaching U.S. regulators for approval.
More than 90% of participants made immune proteins, known as neutralizing antibodies, within 29 days of receiving the picture, according to the report, and all participants formed partner of the antibodies within 57 days. The immune response lasted for a full 71 days of the trial.
“Looking at the antibodies, it should be great hope and a good reason for the vaccine to work, ”in the company’s end-of-period clinical trial that will report results, J&J Chief Scientific Officer Paul Stoffels said Tuesday in an interview.
The single-dose vaccine generates more neutral antibodies than a single dose of Covid-19 antidepressant vaccine, and they are all two-dose regimens. But compared to two photos of those competitors, the response to J & J ‘s single is in the same area, Stoffels said.
Interim results from a phase 1/2 trial of 805 participants aged 18 and older were published Wednesday in the New England Journal of Medicine. The data on more limited J&J results expanded which was first published in September.
Shares of New Jersey-based drug dealer New Brunswick rose 1.3% in aftermarket trading on Wednesday. Moderna Inc., a manufacturer of Covid-authorized two-dose vaccines for emergency use, fell 0.6% after U.S. markets closed.
J & J ‘s progress is being closely monitored by leading infectious disease experts as its vaccine has the potential to be the first to protect people after just one shot, making major vaccine campaigns easier. The company expect to get definitive efficiency data from a final stage study by early next month, which could lead to regulatory approval by March.
Efficiency Desires
The U.S. has approved emergency use of two vaccines, one developed by Pfizer Inc. and his companion BioNTech SE, and the other with Moderna Inc. Both use a technology called messenger RNA that has never been used in an agreed product, and each showed an efficiency greater than 90% against Covid-19 signals.
These results were better than expected. U.S. government officials had previously said that any vaccine with an efficacy greater than 50% would be considered a success. Based on that guidance, J&J was aiming for 60% efficiency, Stoffels said, but “we were optimistic and were planning for 70%. ”
Within weeks, J&J will learn how his vaccine performed in a late trial of 45,000 volunteers. Stoffels now believes it has the potential to be even higher than 70% effective, based on the early results and other factors.
When an antibody response to a J&J bullet is compared to others that have been through end-of-phase testing “there is good reason to believe that we can achieve very high levels of efficacy,” Stoffels said. . “Will it be north of 90%? I do not know. The data will tell us. ”
Moncef Slaoui, chief scientific adviser of the U.S. Operation Warp Speed vaccine development and circulation effort, said Wednesday that the single-shot J&J vaccine is expected to show 80% to 85% efficacy against Covid-19. J&J and its government partners cannot see the data at this time, a standard measure to prevent bias.
One-dose benefit
Experts have said that single-shot vaccines offer benefits: easy distribution and administration. Vaccines from Moderna, AstraZeneca Plc, and the Pfizer-BioNTech partnership all require two designs, which means recycling and clinic visits. While Moderna and Pfizer-BioNTech photos need to be frozen, the J&J bullet can be stored at refrigerator temperature for three months.
“One dose is going to be much more effective in the world,” Stoffels said. “We’re very confident it’s working,” but another J&J test of his vaccine and a bullet boost will “support us.”
The study released Wednesday also found that a second dose of J&J, administered two months later, led to a threefold increase in the neutralization of antibodies. Stoffels said that this is good news, as the drug dealer is still assessing how long immunity from the same picture lasts, and whether higher antibody levels will be needed to counteract this. new strains of the virus.
J&J began the separate end-of-phase review of its two-dose immunization schedule in November. Stoffels said the company is likely to finish enrolling the 30,000 participants by the end of the first quarter, possibly in March or April, and expects to read data in the summer. .
Basic platform
J&J vaccine candidate is made from a cold virus, called adenovirus, that is modified to make copies of the coronary virus spike protein, which the pathogen uses to enter cells.
Although the modified virus cannot reproduce in humans, it stimulates an immune response that prepares the body for true Covid-19 infection. It was first developed by researchers at Harvard University who spent years working on the adenovirus platform, which is also used in the J&J Ebola vaccine, as well as the Zika, RSV, study vaccine candidates. and HIV.
The NEJM report showed that the vaccine was well received across the study participants. There was no difference in the immune response in younger and older participants, which is important because the elderly are more vulnerable to the disease. The most common side effects were fever, fatigue, headache, muscle aches and pain at the injection site.
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