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FDA schedules meeting on 26 February to review J&J’s one-dose COVID-19 vaccine

Vaccine candidate demonstrated an overall efficacy of 66% in phase 3

The US Food and Drug Administration (FDA) has scheduled a meeting of an expert advisory committee to discuss the emergence use authorisation for Johnson & Johnson’s (J&J) one-dose COVID-19 vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review all available data on the efficacy and safety of J&J’s jab.

J&J’s COVID-19 vaccine candidate uses the company’s AdVac technology platform, which was also used to develop and manufacture J&J’s existing Ebola vaccine, and to construct its other investigational candidates for Zika, RSV and HIV.

In January, J&J announced that the vaccine demonstrated an overall efficacy of 66% in the phase 3 ENSEMBLE trial.

The study was conducted in eight countries across three continents, with 44% of participants enrolled in the US, 41% in Central and South America and 15% in South Africa.

Across all participants from the different geographies, the vaccine was 66% effective overall in preventing moderate-to-severe COVID-19, 28 days after vaccination.

In the US, the efficacy rate was 72% while in Latin America and South Africa the vaccine was 66% and 57% effective, respectively.

In South Africa, J&J said that 95% of the COVID-19 cases observed in the study were caused by the newly discovered B.1.351 virus variant.

Although the vaccine is less effective against the B.1.351 variant that was first discovered in South Africa, J&J said that the jab was 85% effective in preventing severe disease across all regions studied.

In an interview with Reuters, J&J’s chief scientific officer Paul Stoffels said that the company is aiming to meet a target of delivering one billion doses of its vaccine in 2021.

According to Reuters, the vaccine could become available in the EU as soon as 1 April – the vaccine is currently being assessed by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) under a rolling review.

J&J previously signed an advance purchase agreement with the European Commission (EC) for 200 million doses of its COVID-19 vaccine following regulatory approval.

The company has also reached an agreement with the US government for 100 million doses of its vaccine candidate, with the US government committing $1bn for the initial supply.

Article by
Lucy Parsons

8th February 2021

From: Regulatory

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