COVID-19 Vaccine | Johnson & Johnson has enough data to analyse jab, seek approval, says Fauci
J&J’s vaccine is a single shot one, one big reason why it has led to hawk eyes on its development.
January 22, 2021 / 04:02 PM IST
Dr Anthony Fauci (Image Source: Reuters)
Johnson & Johnson (J&J) would soon be able to seek emergency use authorisation (EUA) from drug regulators.
The United States government’s top infectious disease expert Dr Anthony Fauci at a press briefing on January 21 said the company had “sufficient data” from its last stage COVID-19 vaccine trials to begin analysis “in a week or two”, Bloomberg reported.
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J&J’s vaccine is a single shot one—a fact that has led to hawk eyes on its development. If approved, it would make vaccination drives less complicated, as all other approved vaccines follow a two-dose regimen.
Fauci’s declaration is in line with Johnson & Johnson’s earlier statement that it would review data of the 45,000 candidates from its late-stage trial by January-end or February first week.
Data analysis is likely to take one or two weeks, followed by preparation of documents for regulators in the US and globally, to consider for EUA, Chief Scientific Officer Paul Stoffels told Bloomberg.
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Stoffels added that the US Food and Drug Administration (FDA) would not authorise the vaccine candidate before March 2021, as the regulator is expected to assemble an external expert panel to review the data and make recommendations—a process that can take weeks, it added.
Pfizer and BioNTech’s vaccine was cleared on December 11–three weeks after the company’s submission for approval on November 20.Follow our full COVID-19 coverage here