The Food and Drug Administration’s advisory panel is holding a full-day meeting on Friday to consider whether the coronavirus vaccine made by Johnson & Johnson should be approved by federal regulators.
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Empty vials of the Johnson & Johnson vaccine in a hospital in South Africa.
The panel is expected to endorse the vaccine, meaning the United States may already have a third that may authorize Saturday.
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The panel consists of independent experts, statisticians and epidemiologists on infectious diseases and hear presentations from top scientists from Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson. Committee members will then discuss the technical components of the vaccine with them and FDA regulators.
The vote of the committee is expected to take place late Friday afternoon or early evening.
The participants in the meeting were provided with analyzes published online this week by the FDA and the company outlining how the vaccine works – its success in preventing moderate and severe cases of Covid-19, hospitalizations and deaths, as well as the side effects. effects it causes and how its effectiveness differs in different regions of the world and between different groups of people.
According to the information documents, the vaccine had an overall efficacy rate of 72 percent in the United States and 64 percent in South Africa, where a particular variant emerged in the fall and spread to the United States. The vaccine has shown 86 percent efficacy against serious forms of Covid-19 in the United States and 82 percent against serious diseases in South Africa.
None of the nearly 22,000 vaccinated in the trial died of Covid-19.
When the panel met in December to consider the two-dose coronavirus vaccines made by Pfizer-BioNTech and Moderna, the sky-high efficiency rates of the shots led to consensus and resounding voices to endorse it.
The booking on Friday can be more complicated.
The Johnson & Johnson vaccine is a single dose and uses a different type of technology than the first two authorized vaccines. And the scale and scope of the Johnson & Johnson trial was large, spanning eight states, three continents and 45,000 participants. This has led to a large data set that is likely to lead to a more complicated and potentially fragmented discussion.
According to the FDA’s analysis, the vaccine has an efficacy rate of 74 percent against asymptomatic infections, suggesting that it may help reduce the spread of the virus through vaccines. This is probably one topic of discussion during the meeting, as the public and health authorities are wrestling over how vaccination behavior should change or not change when cases remain high.
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