Johnson & Johnson JNJ -1.25%
He said Wednesday that a second dose of the Covid-19 vaccine was found in a study to generate a strong immune response, which warranted a booster shot after eight months.
The Centers for Disease Control and Prevention has said it expects recipients of a single-dose J&J vaccine to need reinforcements, but has refrained from making recommendations pending further data. Wednesday’s findings are expected to report on the U.S. strengthening strategy that will begin in September, when the United States plans to begin offering boosters to people who received messenger RNA vaccines. Later, he is likely to expand the program to include the J&J viral vector vaccine.
J&J said the researchers found that antibody levels multiplied again among people who received a second dose of their vaccine, compared with a month after receiving a first dose. The company did not specify exactly when or how many subjects received the second dose, although information published about the clinical trial in an online government database indicates that it was administered six months after the first shot.
J&J said it will send data from two studies to a prepress server, meaning the data has not been peer-reviewed or published in a scientific journal.
The company said the researchers observed significant increases in antibody responses in participants aged 18 to 55 years and in those aged 65 and over who received a lower booster dose.
J&J also said reinforcement is needed after eight months according to preliminary data it reported in the New England Journal of Medicine in July, which showed strong antibody responses eight months after vaccination with the shot. ‘a single dose of J&J.
“We look forward to discussing with public health officials a potential strategy for our Johnson & Johnson Covid-19 vaccine, increasing eight months or more after primary vaccination to a single dose,” said Drs. Mathai Mammen, head of global R&D at Janssen Pharmaceutical Cos. of Johnson & Johnson said Wednesday.
The Biden administration said last week that people aged 18 and over who received Pfizer’s Covid-19 vaccines Inc.
o Modern Inc.
should get an additional dose eight months later, reflecting increased concern for the highly contagious Delta variant and data showing initial immunity to Covid-19 decrease over time. The timeline suggested by J&J would be synchronized with this broader strategy.
Currently, promoters are only authorized for immunocompromised individuals who received messenger RNA dose vaccines. The Food and Drug Administration should authorize additional doses before they can be offered more widely, as recommended by the administration of Biden to those over 18 years of age who received messenger RNA dose vaccines, and expects to do so before September 20, when health authorities said messenger RNA boosters would be available
The CDC Expert Advisory Group on Vaccines will meet next week to discuss the Biden administration’s plans for booster vaccines.
The Biden administration has announced that Americans who have been completely vaccinated with a two-dose regimen against Covid-19 should receive a booster, citing the threat of the highly contagious Delta variant. WSJ breaks down what you need to know. Photo: Hannah Beier / Reuters
The J&J vaccine is authorized for emergency use in people over 18 years of age. Only the Pfizer vaccine and its partner BioNTech SE are fully FDA-approved for over-16s. Moderna’s two-shot messenger RNA vaccine has emergency authorization for people over 18 years of age.
Nearly 14 million people in the U.S. have received a single-dose J&J vaccine, according to CDC data.
“The single-dose vaccine is still highly protective, and we know this doesn’t decrease, but now we also know that a second dose given at six months substantially increases immune responses,” said Dr. Dan Barouch, who contributed to the development of the J&J vaccine but did not participate directly in the shared booster information on Wednesday. It was part of the New England Journal of Medicine study that showed vaccine protections for eight months.
The use of the J&J shot was reduced after U.S. health authorities in April temporarily halted the firing of shots to investigate reports of a rare blood clotting disease.
The company added a warning to its label in July that said its vaccine was related to a very small incidence of cases of a rare neurological disorder seen with other vaccines or viral infections, called Guillain-Barré syndrome.
Early studies have shown above all that the J&J vaccine holds up well against the Delta variant. A recent South African study involving nearly 480,000 health workers found that the J&J vaccine is up to 71% effective against hospitalization resulting from the Delta variant, 67% against hospitalization of the Beta strain. and up to 96% against death in general, although another study suggested that a single dose elicited a relatively weak antibody response against Delta.
J&J is also studying the effectiveness of two doses of its vaccine, in a separate effort from the results released Wednesday. These data will analyze two shots given more closely, rather than the six-month interval of a booster dose.
Write to Felicia Schwartz to [email protected]
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