Photographer: Angel Garcia / Bloomberg
Photographer: Angel Garcia / Bloomberg
Johnson & Johnson’s one-shot experimental Covid-19 vaccine generated a long-lasting immune response in an initial safety study, which gave an insight into how it will work in the real world as the company approaches. to approach U.S. regulators for authorization.
According to the report, more than 90% of participants manufactured immune proteins, called neutralizing antibodies, within 29 days of receiving the vaccine, and all participants formed the antibodies within 57 days. The immune response lasted the full 71 days of the trial.
“Looking at the antibodies, there should be good ones hope and a good reason for the vaccine to work, ”in the company’s final phase clinical trial that will soon report the results, J&J scientific director Paul Stoffels said in an interview Tuesday.
The single-test vaccine generates more neutralizing antibodies than a single dose of other Covid-19 vaccines, which are two-shot regimens. But compared to two shots from these rivals, J&J’s response to the single shot is in the same range, Stoffels said.
The provisional results of the phase 1/2 trial of 805 participants aged 18 or older were published Wednesday in the New England Journal of Medicine. The data expanded on more limited findings that J&J first published in September.
Shares of the New Brunswick, New Jersey-based drug maker rose 1.3 percent in post-market trading on Wednesday. Moderna Inc., which manufactures a two-dose Covid vaccine authorized for emergency use, fell 0.6% after closing U.S. markets.
Leading infectious disease experts are closely monitoring J&J’s progress, as its vaccine may become the first to protect people after a single shot, making mass vaccination campaigns easier. The company expects to obtain definitive efficacy data from a final-phase study early next month, which may lead to regulatory clearance in March.
Efficiency ambitions
The U.S. has granted emergency use permits to two vaccines, one developed by Pfizer Inc. and his partner BioNTech SE, and the other of Moderna Inc. Both use a technology called messenger RNA that has never before been used in an approved product and each showed more than 90% effectiveness against the symptoms of Covid-19.
These results were better than expected. U.S. government officials had previously said any vaccine more than 50% effective would be considered a success. Based on this orientation, J&J intended to achieve 60% efficiency, Stoffels said, but “we expected and planned 70%.”
In a few weeks, J&J will learn how the vaccine was made in a final-stage trial of 45,000 volunteers. Now Stoffels believes it can be even more than 70% effective, based on initial phase results and other factors.
When comparing the antibody response to J&J firing with others that have gone through end-stage testing, “there is good reason to believe that we can achieve very high levels of effectiveness,” Stoffels said. “Will it be 90% north? I do not know. The data will tell us. “
Moncef Slaoui, the lead scientific advisor on the Operation Warp Speed vaccine distribution and distribution effort in the United States, said Wednesday that he expects J & J’s unique vaccine to show 80% to 85% effectiveness. against Covid-19. J&J and its government partners cannot see the data at the moment, a standard measure to avoid bias.
Advantage of a single dose
Experts have stated that a single-shot vaccine offers advantages: ease of distribution and administration. Modern Vaccines, AstraZeneca Plc and the Pfizer-BioNTech partnership require twice, which means repeated shipments and clinic visits. While photos from Moderna and Pfizer-BioNTech need to be frozen, photos from J&J can be stored at refrigerator temperature for three months.
“A single dose will be much more effective in the world,” Stoffels said. “We’re pretty sure it works,” but another test J&J is conducting of his vaccine plus a booster shot “will give us a backup.”
The study published Wednesday also found that a second dose of the J&J shot, administered two months later, caused a triple increase in neutralizing antibodies. Stoffels said this is positive news, as the drug maker is still assessing how long the single-shot immunity will last and whether higher levels of antibodies will be needed to fight the new strains of the virus.
J&J began separate study in the final phase of its two-dose vaccine regimen in November. Stoffels said the company is likely to finish enrolling the 30,000 participants before the end of the first quarter, likely in March or April, and expects summer to come for data reading.
Underlying platform
The vacant J&J candidate is made up of a cold virus, called adenovirus, which is modified to make copies of the coronavirus ear protein, which the pathogen uses to enter cells.
Although the altered virus cannot replicate in humans, it induces an immune response that prepares the body for an actual Covid-19 infection. It was first developed with Harvard University researchers who have been working on the adenovirus platform for years, which is also used in J&J’s Ebola vaccine, as well as its candidates for the virus vaccine. Zika, RSV and HIV
The NEJM report showed that the vaccine was well tolerated among study participants. There were no differences in immune response in younger and older participants, which is important as larger populations are more vulnerable to the disease. The most common side effects were fever, fatigue, headache, muscle aches, and pain at the injection site.
(Add post-market trade to the sixth paragraph)