Johnson & Johnson vaccine on track for US emergency approval

Following today's positive advisory committee meeting outcome regarding the Janssen Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation

New York: US regulators are working “rapidly” to finalise emergency use authorisation for a Johnson & Johnson vaccine which is on track to become America’s third shot against the coronavirus pandemic which has killed 509,000 people in the last 12 months alone – the country’s deadliest year.

After eight hours of non-stop debate, the high powered but usually obscure Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted overwhelmingly in favour of okaying a single dose Johnson & Johnson Covid-19 vaccine for people aged 18 and older.

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“Following today’s positive advisory committee meeting outcome regarding the Janssen Biotech Inc. Covid-19 Vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation, FDA Acting Commissioner Janet Woodcock said in a statement late on Friday. The agency has already notified federal partners involved in vaccine allocation and distribution to get ready for the rollout.

Once FDA clears the J&J shot for US use, only a few million doses are expected to be ready for shipping in the first week. J&J told US Congress that it expects to deliver 20 million doses by the end of March and 100 million by June. The company aims to produce around a billion doses by the end of the year.

America, which began its historic vaccination drive on December 14 last year, has delivered a total of more than 70 million jabs in arms across first and second doses combined. More than 47 million people in the US have received at least one shot. The two vaccines currently in use – Pfizer and Moderna – are both two shot vaccines spaced about 3-4 weeks apart.

US FDA scientists have already confirmed that the Johnson & Johnson vaccine is safe and is about 66 per cent effective at preventing moderate to severe Covid-19, and about 85 per cent effective against serious illness. Similar to the other Covid-19 vaccines in the US, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache.

J&J tested its single-dose option in about 44,000 adults in the US, Latin America and South Africa with a 2-month median follow-up. “The analysis supported a favourable safety profile with no specific safety concerns identified that would preclude issuance of an EUA,” the US FDA said of the J&J vaccine.

The FDA noted that there were no Covid-19-related deaths and no Covid-19 cases requiring medical intervention 28 days or more post-vaccination among participants age 60 years or older with medical comorbidities in the vaccine group.