FDA scientists issue a favorable tone before voting this week

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Johnson Johnson’s COVID-19 vaccine.

Allen J. Roach | Los Angeles Times | Getty Images

The staff of the US Food and Drug Administration expressed a more favorable attitude towards Johnson & Johnson’s enhanced Covid-19 injection on Wednesday, saying that it may be beneficial to inject the second dose two months after the first injection.

However, the staff admitted that the data to support the booster is limited and the agency has not yet verified all the information.

“Although the FDA has not independently confirmed from the data set, the data summary indicates that compared with the efficacy observed in the key study COV3001, giving a second dose approximately 2 months after the first dose may be beneficial,” they wrote in an article Wrote in the article. The 54-page document was released on Wednesday.

They also stated that in clinical trials and real-world studies, the effectiveness of one dose of Johnson & Johnson’s (J&J) vaccine has not been as effective as the mRNA vaccines produced by Pfizer and Moderna.

They said: “The highest estimated effectiveness of clinical trials and real-world effectiveness studies evaluating the Janssen COVID-19 vaccine (including more severe COVID-19 disease) is consistently lower than the highest estimated effectiveness of the mRNA COVID-19 vaccine. “.

Overall, the data show that a single injection of Johnson & Johnson vaccine “can still prevent severe COVID-19 illness and death in the United States.”

This report by FDA scientists aims to inform the agency’s vaccines and related biological products advisory committee, which meets on Friday to discuss data on the safety and effectiveness of the second Johnson injection for adults. The published document provides a glimpse of the agency’s view of the additional footage.

Unlike Pfizer and Moderna’s two-dose mRNA vaccine, Johnson & Johnson hopes to provide a one-time solution that can protect the public and help end the coronavirus pandemic. However, its protection rate in the United States is 72%, which is considered by some to be inferior to Moderna and Pfizer’s vaccines, both of which are more than 90% effective.

According to company data released on September 21, Johnson & Johnson’s second dose of vaccine has similar performance to the mRNA vaccine. When the first dose of vaccine in the United States is vaccinated two months later, the protection rate against symptomatic infections has increased to 94%. Adenovirus induces an immune response, requiring the agency to approve a single dose of vaccine for people aged 18 and over on October 5.

Nevertheless, in a document released on Wednesday, FDA scientists stated that there is not enough data on the elderly or rapidly changing delta variants to draw conclusions about the benefits of boosters.

They said that the sample size provided by Johnson & Johnson for people 60 years and older “limits the ability to conclude that the efficacy has increased after the second dose in this group.”

“Finally, it was confirmed that the few defendant cases caused by the Delta variant ruled out any conclusions about the efficacy of the variant,” they added.

The staff said that within two or three months after the first dose, no new safety issues were observed after the second dose, but pointed out that it is not yet known “whether the risk of these or other adverse reactions will increase” Extra dose.

The FDA advisory group plans to discuss data on the safety and effectiveness of Moderna adult booster injections on Thursday with Johnson & Johnson on Friday. The agency may make a final decision within a few days of the meeting and hand it over to the Centers for Disease Control and Prevention and its vaccine advisory committee to make its own decision next week.

Scientists from the US Food and Drug Administration refused to take a stand on whether to support Moderna’s Covid vaccine on Tuesday, saying that data shows that the currently authorized vaccine can still prevent serious illness and death in the United States

Last month, U.S. regulators authorized Pfizer and BioNTech vaccines’ Covid booster injections to a wide range of Americans, including the elderly, adults with underlying diseases, and those who work or live in high-risk environments such as health And grocery workers.

Norman Baylor, the former director of the FDA’s Office of Vaccines, said last week that he does not recommend submitting Moderna’s vaccine to an advisory committee because it uses a platform similar to Pfizer’s vaccine, which has been authorized for boosters. However, Johnson & Johnson is different.

Baylor said this “becomes a bit tricky” because Johnson & Johnson’s second dose of vaccine seems “very good.” “Maybe it should be two doses [vaccine] At the beginning. “

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