FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected

FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected

Virus Outbreak Vaccine
This Dec 2, 2020 photo provided by Johnson & Johnson shows vials of the COVID-19 vaccine in the United States. (File photo: Johnson & Johnson via AP)

WASHINGTON: A panel of expert advisers to the United States Food and Drug Administration (FDA) began a meeting to discuss Johnson & Johnson's one-dose COVID-19 vaccine on Friday (Feb 26), setting the stage for a possible emergency use authorisation as early as this week.

After it receives the recommendation, the FDA is likely to authorise the vaccine for emergency use within a day or so, making it the third available in the United States, and the only one that requires just one shot.

READ: Johnson & Johnson's one-shot COVID-19 vaccine effective and safe: FDA staff

The panel, consisting of doctors, infectious disease experts and medical researchers, began the meeting at 9am ET (10pm Singapore time), and will vote in favour or against the vaccine's use several hours later at the end of the meeting.

The panel will consider whether the benefits of the vaccine outweigh its risk for use in people aged 18 and older.

In a 44,000-person trial, the vaccine overall was 66 per cent effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

READ: Third US COVID-19 vaccine could raise question: Which shots are best?

The effectiveness of the one-dose vaccine varied over time and location. In the United States, the effectiveness was 74 per cent at 14 days and 72 per cent two weeks later, while the shot was 64 per cent effective at stopping moderate-to-severe COVID-19 after 28 days in South Africa, where a worrying new variant has swept across the country.

The vaccine was 100 per cent effective at preventing hospitalisations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

"In the context of the pandemic, the FDA is likely to issue an emergency use authorisation (EUA) based on the data," said UBS analyst Navin Jacob ahead of the panel meeting.

READ: AstraZeneca, Sputnik vaccines face hurdles if COVID-19 shots become annual affair

The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than that of the Pfizer-BioNTech and Moderna vaccines that use mRNA technology and must be shipped and stored frozen.

J&J's vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

Between 3 and 4 million doses of the vaccine are expected to be rolled out next week.

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Source: Reuters/dv