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FDA Scientists Are Favorable Ahead Of This Week’s Vote

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FDA officials on Wednesday set a more favorable tone for Johnson & Johnson’s Covid-19 booster shots, saying a second dose two months after the initial vaccine may be beneficial.

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

“While not independently validated by the FDA based on datasets, a summary of the data suggests that a second dose administered about 2 months after the primary dose may be beneficial compared to the efficacy seen in the pivotal COV3001 study,” they wrote in 54 -page document released Wednesday.

They also said that a single dose of J&J was consistently less effective than the mRNA vaccines made by Pfizer and Moderna in clinical trials and in real life studies.

“The highest efficacy scores (including for more severe COVID-19 disease) in clinical trials and real life studies of the Janssen COVID-19 vaccine are consistently lower than the highest efficacy scores for COVID-19 mRNA vaccines,” they said. …

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

The FDA scientists’ report is intended to inform the Agency’s Vaccines and Related Biologicals Advisory Committee, which is meeting Friday to discuss data on the safety and efficacy of a second J&J vaccine in adults. The published documents provide an insight into the agency’s point of view on additional imagery.

Unlike Pfizer and Moderna’s dual-vaccine mRNA vaccine, J&J hoped to offer a one-off solution that would protect the public and help end the pandemic. But its 72% protection in the US has been regarded by some as lower than Moderna and Pfizer’s vaccines, which are over 90% effective.

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The second dose of J&J vaccine boasts a potency similar to that of mRNA vaccines, increasing protection against symptomatic infection by up to 94% when given two months after the first dose in the United States, according to company data released September 21. J&J, which uses a modified vaccine. On October 5, the adenovirus asked the agency to approve booster vaccinations of its single-dose vaccine for people 18 and older to trigger an immune response.

An FDA advisory group plans to discuss safety and efficacy data for the Moderna booster vaccine in adults on Thursday and J&J on Friday. The agency could make a final decision within days of the meetings, handing it over to the Centers for Disease Control and Prevention and its vaccine advisory committee for their own decision, likely next week.

FDA scientists declined to comment on whether to support the Moderna Covid booster vaccines on Tuesday, saying the data shows currently sanctioned vaccines continue to protect against serious illness and death in the US.

Last month, U.S. regulators authorized the revaccination of the Pfizer and BioNTech Covid vaccines to a wide range of Americans, including the elderly, adults with underlying medical conditions, and those working or living in high-risk settings such as healthcare workers and grocery workers.

Norman Baylor, the former director of the FDA’s vaccine division, said last week that he would not advise submitting the Moderna vaccine to an advisory committee because it uses a platform similar to Pfizer’s vaccine, which has already been approved for boosters. However, J&J is a different matter.

It “gets a little tricky” because the second dose of J&J seems to be giving “a very good boost,” Baylor said. “Maybe it should have been two doses [vaccine] at the beginning.”

This is an evolving story. Please stay tuned.


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