Johnson & Johnson is safe, FDA says, as third US Covid vaccine passes major hurdle

The Food and Drug Administration (FDA) has endorsed the Johnson & Johnson Covid-19 vaccine to receive emergency use authorisation, a critical step to bring a third Covid-19 jab to the United States.

In a staff report released on Wednesday, the federal agency found the vaccine to be safe, effective, and able to completely prevent hospitalisations and deaths when reviewing data from a large clinical trial.

A FDA independent advisory committee would now hold an all-day meeting on Friday to review the clinical data and make a determination on if the vaccine should receive emergency authorisation or not. This means the Johnson & Johnson vaccine could receive authorisation as early as Friday evening or Saturday depending on the panel’s response to the data.

Two vaccines have already received emergency use authorisation from the FDA: Pfizer and Moderna. But both of those vaccines require two doses to achieve an efficacy of about 94 per cent against the novel virus.

The Johnson & Johnson differed as it was a single-dose vaccine.

The efficacy of the Johnson & Johnson vaccine against moderate to severe Covid-19 illness across all geographical areas was 66.9 per cent after at least 14 days of receiving the dose. Vaccine efficacy stood at 66.1 per cent at least 28 days after receiving the vaccine dose, according to the new analysis.

In the United States alone, the vaccine was 72 per cent effective against moderate to severe Covid-19 illness. Vaccine efficacy diminished to 66 per cent in Latin American and 57 per cent in South Africa, likely because of the new Covid-19 variants.

Johnson & Johnson was currently researching if a second dose of its vaccine could improve efficacy against the novel virus. 

“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the FDA analysis added.

In a briefing document, the FDA said Johnson & Johnson’s vaccine data was “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorisation for Vaccines to Prevent Covid-19.”

The vaccine was already being used in South Africa, and the company has also filed for authorisation from the European Union and the World Health Organisation (WHO).

Johnson & Johnson has already committed to providing the US with 100 million vaccine doses by the end of June. Of those doses, 20 million were expected by the end of March. Those doses would add to the amount already purchased from Pfizer and Moderna in the country’s drive to give everyone access to a vaccine.

Pfizer and Moderna have committed to supplying a total of 600 million vaccine doses by the end of July.

The Biden administration has now purchased enough doses that would allow for all Americans to have access to a vaccine by the end of the summer.