Tuesday, October 19, 2021

Moderna argues FDA should authorize half-dose of vaccine as booster

In documents released Tuesday morning, Moderna argued that the Food and Drug Administration should authorize half the dose of its coronavirus vaccine as a booster shot for recipients at least six months after the second dose, citing evidence that Giving that the vaccine’s potency against infection decreases over time. .

Moderna cited success infection rates, “real world evidence of low effectiveness against the delta variant,” and a drop in the level of neutralizing antibodies from its vaccine six to eight months after the second dose. The company said its clinical trial studies showed that a third injection raised levels of antibodies — a measure of the immune system’s response — to a second dose higher than the first.

The documents were released by the FDA ahead of a two-day meeting of the agency’s external advisory committee, scheduled for Thursday and Friday.

The committee is expected to vote on whether to recommend emergency authorization of booster shots of vaccines from both Moderna and Johnson & Johnson. While panel votes are not binding, regulators usually abide by them.

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Moderna did not try to argue that its vaccine against serious illness or hospitalization is now declining, and existing data does not support that claim. This separates Moderna’s application from the one Pfizer-BioNtech mounted last month.

The FDA said the data shows Moderna and other vaccines “still provide protection against serious COVID-19 illness and death in the United States.”

The FDA and the Centers for Disease Control and Prevention decided to authorize the emergency use of the booster for many, but not all, Pfizer-BioNTech vaccine recipients. Eligible include people who are 65 years of age or older, who live in long-term care facilities, who have underlying medical conditions or who are at higher risk of exposure to the virus because of their jobs or institutional settings. The last group includes health care workers, teachers and prisoners.

In a document released Tuesday, the FDA proposed that outside experts consider essentially the same eligibility groups for Moderna recipients.

More on the COVID-19 Pandemic

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