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 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 prevent hospitalisations and deaths when reviewing data from a large clinical trial.

An FDA independent advisory committee will now hold an all-day meeting on Friday to review the clinical data and decide whether the vaccine should receive emergency authorisation or not.

The Pfizer and Moderna vaccines have already received emergency use authorisation from the FDA, but both require two doses to achieve an efficacy of around 94 per cent against the virus. Johnson & Johnson is a single-dose vaccine.

The efficacy of the Johnson & Johnson vaccine against moderate to severe Covid-19 illness was around 66 per cent, according to the analysis.

In the US alone, the vaccine was 72 per cent effective against moderate to severe Covid-19. Efficacy dropped to 66 per cent in Latin American and 57 per cent in South Africa – likely because of the new coronavirus variants.

Johnson & Johnson was currently researching whether a second dose of its vaccine could improve efficacy. 

“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 would be added 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.