FDA panel The Friday meeting will also cover the boosters proposed by Johnson & Johnson.
Here are three points from the first day of the FDA Panel’s two-day meeting:
Regulators are working on incomplete data
Despite the unanimous vote, some panel members lamented the skimpy data they had to trust to make the decision. Pfizer’s case has made it difficult to move in a different direction than Moderna.
Patrick Moore, a panel member who is a professor at the University of Pittsburgh Cancer Institute, said there are some “real problems” in the voting results, based on a question about the quality of Moderna’s data.
“I just want to explain why I voted in favor. It’s more intuitive than based on really serious data,” he said. “The data itself isn’t powerful, but it’s certainly in the direction of support. It’s going on, “he added.
Moderna, like other vaccine makers, continues to refer to antibody responses as a sign that people have built levels of immunity to the coronavirus. But at the meeting, FDA regulators are still completely confident about what the best criteria for measuring how well a shot works and how long it works, the “protection correlation”. Admitted that he was not sure.
Paul Offit, a member of the University of Pennsylvania Vaccine Expert Advisory Board, uses the antibody response as a measuring rod when data appear to indicate that immunity increased over time after two doses. And lamented. He also criticized thinking of mild, asymptomatic breakthrough infections as a sign of failure or a weak vaccine.
“If the goal is to protect against the unfortunately named breakthrough infections of asymptomatic infections … then we talk about getting frequent boosters, but this is a reasonable strategy for this. I don’t think so, “said Ofit.
Another panel member, Cody Meissner of Tufts University School of Medicine, expressed concern about the wording of recommendations for people at high risk due to work and living conditions. He argued that although these people are more likely to be exposed to the virus, they are not always vulnerable to serious illness.
“If we can’t uphold these recommendations based on evidence, I think it would be even more complicated to give this vaccine to all adult Americans. That’s what we really want to do,” he said. ..
Not all vaccines are made the same
Moderna’s presentation to the Commission outlined the rationale for companies proposing half-dose booster shots, unlike the full doses approved or proposed by Pfizer and Johnson & Johnson.
“We believe we need to be vaccinated with the minimum amount of antigen needed to elicit an immune response,” said Jacqueline Miller, Senior Vice President of Infectious Diseases, Moderna.
She said low doses are sufficient to reactivate the body’s immunological memory for the first vaccination — and it may help extend the world’s supply of Moderna shots.
Moderna’s half-dose booster did not result in a four-fold increase in the antibodies that the FDA set as criteria for booster approval, but Miller said that participants in the company’s booster study had high antibody levels in the first place. Said that.
“Subjects who did not meet the definition of 4-fold elevation still benefit from a booster dose of 50 micrograms,” she said.
However, some panel members wondered if lower doses would provide as long-term protection as full-dose boosters.
Moderna’s presented data on the immune response from the full booster dose, suggesting that immune cells were able to ward off the virus even after significantly reduced antibody levels.
“I don’t know if the FDA has a sense of how it will change from 100. [micrograms] Up to 50 [micrograms]”Michael Krilla, director of clinical innovation at the National Center for Advancing Translational Sciences, said. “It can have a huge impact on durability.”
Global vaccine fairness concerns add to the booster controversy
FDA staff tried to keep the authorities’ vaccine advisors from devoting themselves to broad discussions about impartiality during the booster meeting, but the issue surfaced many times on Thursday.
Miller began his morning presentation by claiming that the company’s proposed half-dose booster would help expand its global vaccine supply.
Just under half of the world’s population receives at least one Covid-19 vaccine, but most of those shots are given in the wealthiest countries. African countries in particular are struggling to vaccinate their population.
Miller faces further questions later that day about Modana’s role in bridging the global vaccine gap from panel member Randy Hawkins, a physician specializing in lung medicine and practitioners at Charles Drew University. bottom.
He pressured Miller on criticism that Moderna is lagging behind in producing doses for low-income countries, either directly or through a global vaccine aid program known as COVAX.
“What are Moderna’s commitment to COVAX and the other steps to take to control the pandemic of countries suffering from imbalances?” He asked Miller.
She said the company would not provide intellectual property protection for generic versions of the vaccine during the pandemic, and said it had given COVAX 50 million doses as of September. Moderna also promised to build a manufacturing plant in Africa, but did not know when and where it would be opened.
“Also, there are plans to distribute 1 billion doses to low-income countries in 2022, adding to the complexity, [booster] Administer up to 50 micrograms to make more vaccines available worldwide, “says Miller.
FDA Advisors Support Moderna Booster Shots: Three Points
Source link FDA Advisors Support Moderna Booster Shots: Three Points