FDA scientists give a positive tone ahead of this week’s vote

Janssen Johnson & Johnson COVID-19 vaccine.

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Food and Drug Administration staff on Wednesday made a more positive tone Johnson & Johnson Covid-19 booster shot. He states that it may be beneficial to give a second dose two months after the first shot.

Staff, however, admitted that the data to support boosters was limited and the agency had not yet verified all the information.

“Although not independently confirmed by the FDA from the dataset, a summary of the data is a second dose given approximately 2 months after the first dose when compared to the efficacy seen in the critical study COV3001. It suggests that administration may be beneficial. ”A 54-page document published Wednesday.

They also stated that a single J & J dose was consistently less effective than the mRNA vaccine produced by Pfizer and Moderna in clinical trials and hands-on studies.

“The highest efficacy estimates (including the more severe COVID-19 disease) across clinical trials and actual efficacy studies evaluating the Janssen COVID-19 vaccine are the highest efficacy estimates for the mRNA COVID-19 vaccine. Consistently lower than, “they said. ..

Overall, the data show that the single-shot J & J vaccine “still provides protection against severe COVID-19 disease and death in the United States.”

A report by FDA scientists aims to outline the FDA’s Vaccine and Related Biopharmaceutical Advisory Committee on Friday to discuss data on the safety and efficacy of the second J & J shot in adults. is. The published document gives a glimpse of the agency’s views on additional shots.

Unlike Pfizer and Modana’s two-shot mRNA vaccines, J & J provides adequate protection for the population. Coronavirus pandemic.. However, its protection at 72% in the United States was seen as inferior to the Moderna and Pfizer vaccines, both of which advertised efficacy rates in excess of 90%.

The second dose of J & J’s shots performed similarly to the mRNA vaccine, according to company data released on September 21, and is symptomatic when given two months after the first dose in the United States. Increases protection from infection to 94%. Modified adenovirus To elicit an immune response, we asked the agency to approve a booster shot of the single-dose vaccine for people over the age of 18 on October 5.

Still, in a document released Wednesday, FDA scientists suggested that there wasn’t enough data on older people and fast-moving delta variants to conclude on the benefits of boosters.

They said the sample-sized J & J provided to individuals over the age of 60 “restricted their ability to conclude about increased efficacy after the second dose in this group.”

“Finally, a small number of accused cases confirmed to have been caused by the delta mutant ruled out conclusions about efficacy against the mutant,” they added.

Staff said there were no new safety issues observed after the second dose a few months after the first dose, but “whether these or other side effects increase the risk” He said it is currently unknown. Additional dose.

The FDA Advisory Group will discuss data on the safety and effectiveness of J & J booster shots with Moderna boosters taken in adults on Thursday. Authorities can make a final decision within days of the meeting and hand it over to the Centers for Disease Control and Prevention and its Vaccine Advisory Board to make their own decision, perhaps next week.

FDA scientist Refused to take a stance Regarding whether to support Moderna’s Covid vaccine booster shot in the anomalous move on Tuesday, data indicate that the currently licensed vaccine still protects against serious illness and death in the United States, he said. rice field

Last month, U.S. regulators approved Covid booster shot Pfizer When BioNTech A vaccine for a wide range of Americans, including the elderly, adults with underlying illness, and people who work or live in high-risk environments such as health and grocery workers.

Norman Baylor, a former director of the FDA’s vaccine office, did not recommend bringing Modana’s vaccine to the advisory board last week as boosters use a platform similar to Pfizer’s already licensed shots. Said that. However, J & J is different.

“A little more caution,” said Baylor, as the second dose of J & J’s vaccine seems to promote “very well.” “Maybe it should have been a double dose [vaccine] at first”

FDA scientists give a positive tone ahead of this week’s vote

Source link FDA scientists give a positive tone ahead of this week’s vote

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