The Food and Drug Administration’s vaccine advisory panel is holding a full-day meeting on Friday to consider whether the coronavirus vaccine produced by Johnson & Johnson should be authorized by federal regulators.
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Empty vials of Johnson & Johnson vaccine at a hospital in South Africa.
The panel is expected to endorse the vaccine, which means that the United States may have an authorized third party as early as Saturday.
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Comprised of independent infectious disease specialists, statisticians and epidemiologists, the panel is listening to presentations by leading scientists at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson. Committee members will discuss the technical components of the vaccine with them and FDA regulators
The committee’s vote is expected to take place late Friday afternoon or early evening.
Meeting participants are equipped with analyzes published online this week by the FDA and the company that detail how the vaccine works – its success in preventing moderate and severe cases of Covid-19, hospitalizations and death, as well as the side effects it causes and how its effectiveness varied 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 worrying variant emerged in the fall and spread to the United States. The vaccine showed 86 percent effectiveness against severe forms of Covid-19 in the United States and 82 percent against serious illnesses in South Africa.
None of the nearly 22,000 people vaccinated in the test died from Covid-19.
When the panel met in December to consider the two-dose coronavirus vaccines made by Pfizer-BioNTech and Moderna, the high efficacy rates of these vaccines led to consensus and resounding votes to endorse them.
Friday’s discussion could 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 size of the Johnson & Johnson test was vast, spanning eight countries, three continents and 45,000 participants. This has resulted in a large set of data that is likely to lead to a more complex – and potentially fragmented, discussion.
The FDA analysis estimated that the vaccine has a 74% efficacy rate against asymptomatic infections, suggesting that it may help to reduce the spread of the virus by vaccinated people. This is likely to be a topic of discussion at the meeting, as the public and health officials discuss how vaccination should – or not – change behavior when cases remain high.
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