J&J One-Shot Vaccine Grant Responds in Early Study


Photographer: Angel Garcia / Bloomberg

Johnson & Johnson’s experimental one-shot Kovid-19 vaccine produced a long-lasting immune response in an early safety study that provided a glimpse into how it would perform in the real world as the company evacuated. Reaches close to US regulators.

More than 90% of participants made immune proteins, known as neutralizing antibodies, within 29 days after the report was received, and all participants formed antibodies within 57 days. The immune response lasted for a full 71 days of testing.

“Looking at antibodies, should be good hope J&J Chief Scientific Officer Paul Stoffels said in an interview Tuesday that there is good reason that the vaccine would work, with reports coming soon in the company’s late-stage clinical trial.

The one-shot vaccine produces more neutralizing antibodies than single doses of other front-runner Kovid-19 vaccines, which are all two-shot regimens. But when compared with the two shots of these rivals, the response to a single shot from Jammu and Kashmir falls into the same category, Stoffels said.

Interim results from the Phase 1/2 trial of 805 participants 18 years and older were published on Wednesday in the New England Journal of Medicine. The data expanded on J & J’s more limited findings, first published in September.

Shares of the New Brunswick, New Jersey-based drug maker rose 1.3% in after-market trading on Wednesday. Modern Inc., which manufactures a two-dose Kovid vaccine that was authorized for emergency use, fell 0.6% after the US markets closed.

J & J’s progress is being closely watched by top infectious disease experts as its vaccine has the potential to become the first that can protect people after just one shot, making a massive vaccination campaign easier . company A final phase study early next month is expected to yield definitive efficacy data, possibly leading regulatory authority by March.

Efficacy ambitions

The US has provided two vaccines to emergency use authorities, developed by Pfizer Inc. and its partners By Biotech SE, and others Modern Inc. Both use a technique called messenger RNA that has never been used in an approved product before, and each showed more than 90% efficacy against Kovid-19 traits.

Those results were better than expected. US government officials previously stated that any vaccine with more than 50% efficacy would be considered successful. Based on that guidance, J&J aimed for 60% effectiveness, Stoffels said, but “we expected and planned for 70%.”

Within the week, Jammu and Kashmir will learn how its vaccine performed in a late-stage trial of 45,000 volunteers. Based on early-stage findings and other factors, Stoffels now believes it has the potential to be more than 70% effective.

When the antibodies’ response to J & J’s shot is compared to the others through final-stage trials “there is good reason to believe that we can reach very high levels of efficacy, “Stoffels said. “Will it be north of 90%? I do not know. The data will tell us. “

Monsep Salai, the lead scientific adviser for the development and distribution effort of America’s Operation War Speed ​​Vaccine, said on Wednesday that he would show 80% to 85% effectiveness against Kovid-19, a one-shot vaccine from Jammu and Kashmir. J&J and its government partners cannot view data for a period of time, a standard measure to prevent bias.

One-Dos Advantage

Experts have stated that the single-shot vaccine offers advantages: ease of delivery and administration. Modern vaccines, AstraZeneca plc, and the Pfizer-BioNtech partnership all require two shots, meaning shipping and repeat clinical visits. While Modern and Pfizer-Bioentech shots must be freezed, Jammu and Kashmir shots can be stored at fridge temperature for up to three months.

“A single dose is going to be a lot more effective in the world,” Stoffels said. “We are very confident that it works,” but another test J&J is conducting with his vaccine as well as a booster shot “will give us a backup.”

The study released on Wednesday also found that the second dose of the Jammu and Kashmir tablet was administered two months later, causing a threefold increase in neutralizing antibodies. Stoffels said this is positive news, as drug manufacturers are still evaluating how long immunity from a single-shot will last, and whether higher antibody levels will be needed to combat new strains of the virus.

J&J discontinued a separate late-stage study of its two-dose vaccine regimen in November. Stoffels said the company was likely to finish enrolling 30,000 participants before the end of the first quarter, likely in March or April, and a data readout expected in the summer.

Running on platform

The J & J vaccine candidate is produced from a cold virus, called adenovirus, that is modified to make copies of the spike protein of the coronavirus that the pathogen uses to enter cells.

Although the transformed virus cannot replicate in humans, it induces an immune response that prepares the body for true Kovid-19 infection. It was first developed with researchers at Harvard University who have spent years working on the adenovirus platform, which is used in J & J’s Ebola vaccine, as well as its Zika, RSV, and HIV-tested vaccine candidates. is done.

The NEJM report showed that the vaccine was well tolerated among study participants. There was no difference in immune response between younger participants and the elderly, which is significant given that the given older population is the most vulnerable to the disease. The most frequent side effects were fever, fatigue, headaches, muscle aches, and injection-site pain.

()Combines post-market trading in the sixth paragraph)

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