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FDA scientists are casting a positive tone forward of the vote this week

The Janssen Johnson & Johnson COVID-19 vaccine.

Allen J. Cockroaches | Los Angeles Times | Getty Images

Food and Drug Administration officials on Wednesday pitched a more favorable tone on Johnson & Johnson’s Covid-19 booster syringes, saying that giving a second dose two months after the first vaccination could potentially be beneficial.

However, staff admitted that data to support boosters was limited and the agency has not yet reviewed all of the information.

“Although not independently confirmed by the FDA from independent datasets, summaries of the data suggest that a second dose given approximately 2 months after the primary dose may have a benefit compared to efficacy in the pivotal study COV3001,” they wrote in a 54-page document published on Wednesday.

They also said that a J&J dose was consistently less effective than the Pfizer and Moderna mRNA vaccines in both clinical trials and real-world trials.

“The highest effectiveness estimates (including for more severe COVID-19 illnesses) in clinical trials and real-world effectiveness studies evaluating the Janssen COVID-19 vaccine are consistently below the highest effectiveness estimates for the mRNA COVID-19 vaccines,” they said.

Overall, the data shows that the J&J single-shot vaccine “still offers protection from severe COVID-19 illness and death in the United States”.

The report by FDA scientists is set to brief the agency’s Advisory Committee on Vaccines and Related Biological Products, which will meet on Friday to discuss data on the safety and effectiveness of a second J&J syringe in adults. The published documents give an insight into the agency’s perspective on further recordings.

Unlike Pfizer and Moderna’s two-shot mRNA vaccines, J&J hoped to offer a one-shot solution that would protect the public sufficiently to end the coronavirus pandemic. But its 72% protection in the US was viewed by some as inferior to Moderna and Pfizer vaccines, both of which touted efficacy rates of over 90%.

A second dose of J & J’s Shot provides similar performance to the mRNA vaccines and increases protection against symptomatic infection to 94% when given two months after the first dose in the U.S., according to company data adenovirus released Sept. 21, In order to trigger an immune response, the agency asked to approve a booster of their single-dose vaccine for people aged 18 and over on October 5.

However, in the documents released on Wednesday, FDA scientists suggested that there wasn’t enough data on the elderly or the fast-moving Delta variant to draw a conclusion about the benefits of boosters.

They said the sample size J&J provided for people 60 years and older “limits the possibility of inferring an increase in efficacy after the second dose in this group”.

“Finally, the small number of defendants confirmed to be caused by the Delta variant precludes any conclusion as to effectiveness against the variant,” they added.

Staff said no new safety issues were observed after a second dose given two or three months after the first dose, but noted that it is currently unknown “if after” an increased risk of these or other side effects there is an additional dose.

The FDA advisory group is due to discuss data on the safety and effectiveness of booster vaccinations for Moderna in adults on Thursday and J&J on Friday. The agency could make a final decision within days of the meetings and hand it over to the Centers for Disease Control and Prevention and their Vaccine Advisory Committee for their own decision, expected next week.

FDA scientists declined to support a booster of Moderna’s Covid vaccine in an unusual move on Tuesday

Last month, U.S. regulators approved Covid booster shots of the vaccine from Pfizer and BioNTech for a wide variety of Americans, including the elderly, adults with pre-existing medical conditions, and those who work or live in high-risk environments such as health and food workers.

Norman Baylor, former director of the FDA’s vaccines office, said last week he did not recommend presenting Moderna’s vaccine to an advisory committee because it uses a platform similar to Pfizer’s vaccination, which has already been approved for booster vaccination. J&J is different, however.

It “gets a little trickier” because a second dose of J & J’s vaccine appears to work “extremely well,” Baylor said. “Maybe it should have been a two-dose [vaccine] at the beginning.”

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