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FDA scientists strike favorable tone ahead of vote this week




Food and Drug Administration staff on Wednesday struck a more favorable tone on Johnson & Johnson’s Covid-19 booster shots, saying there might be a benefit in giving a second dose two months after the initial shot.

However, the staff acknowledged that data to support the boosters was limited and the agency has not verified all the information yet.

“Although not independently confirmed by the Food and Drug Administration from data sets, data summaries indicate that there may be a benefit in a second dose given approximately two months after the initial dose, when compared with the efficacy seen in the pivotal study COV3001,” They wrote in a 54-page document was published on Wednesday.

They also said that a single dose of J&J has always been less effective than mRNA vaccines made by Pfizer and Moderna in clinical trials and in real-world studies.

They said, “The higher efficacy estimates (including for the more severe COVID-19 disease) across clinical trials and real-world efficacy studies evaluating the Janssen COVID-19 vaccine are consistently lower than the highest efficacy estimates for COVID-19 mRNA vaccines.

Overall, the data shows that the J&J single-shot vaccine “continues to provide protection against severe COVID-19 disease and death in the United States.”

The report, prepared by FDA scientists, is intended to brief the agency’s Advisory Committee on Vaccines and Related Biological Products, which is meeting Friday to discuss data on the safety and efficacy of a second injection of Johnson & Johnson in adults. The published documents provide a glimpse into the agency’s view of the additional shots.

In contrast to the two-vaccine mRNA vaccines from Pfizer and Moderna, J&J hopes to offer a single solution that will protect the public enough to help end the pandemic. But its 72% protection in the United States is seen by some as inferior to the Moderna and Pfizer vaccines, both touting their effectiveness rates above 90%.

A second dose of J&J’s has similar performance to mRNA vaccines, boosting protection against symptomatic infection to 94% when taken two months after the first dose in the United States, according to company data released Sept. 21. To induce an immune response, it asked the agency to approve a one-dose booster dose of its vaccine for people 18 and older on October 5.

The FDA’s advisory group is scheduled to discuss data on the safety and effectiveness of Moderna’s booster shot for adults on Thursday and J&J’s on Friday. The agency can make a final decision within days of meetings, and turn it over to the Centers for Disease Control and Prevention and its Vaccine Advisory Committee for their decision, likely next week.

U.S. Food and Drug Administration (FDA) scientists declined to take a stand on whether booster shots of the Moderna Covid vaccine would be subsidized in an unusual move Tuesday, saying data shows currently authorized vaccines still protect against severe disease and death in the United States.

Last month, US regulators allowed Covid-boosted doses of the Pfizer vaccine and BioNTech to a wide range of Americans, including seniors, adults with underlying medical conditions, and those who work or live in high-risk settings such as health workers and grocers.

Norman Baylor, former director of the FDA’s Office of Vaccines, said last week that he would not have advised taking Moderna’s vaccine to an advisory panel because it uses a platform similar to Pfizer’s dose, which has already been authorized for boosters. However, J&J is different.

It “gets a little more difficult”, Baylor said, because a second dose of the J&J vaccine appears to boost “very well.” “Maybe it should have been a two-dose potion [vaccine] At first.”

This is an evolving story. . Please check back for updates

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