FDA set to approve J&J’s single-dose Covid vaccine, the third for US

The US drugs regulator is set to grant emergency use authorisation to Johnson & Johnson’s Covid-19 vaccine as public health officials warned of a “very concerning” upward shift in new infections and deaths and said “now is not the time to relax restrictions”.

After a “positive” outcome of a meeting of an advisory committee of independent experts on the Johnson & Johnson’s vaccine on Friday, the US Food and Drug Administration said it had told the company it will “rapidly work toward finalisation and issuance of an emergency use authorisation.”

The authorisation, expected over the weekend, will add a third vaccine to the US fight against the Covid-19 epidemic, which has killed more than 510,000 Americans and infected nearly 28.5 million, according to the Johns Hopkins University tracker. The US is by far the worst hit by the pandemic.

Pfizer-BioNTech and Moderna’s are the other two vaccines, which have been in use since December. But they are both two-dose vaccines, requiring primer and booster shots. Johnson & Johnson’s, on the other hand, is a single-dose vaccine, and is easier to store and transport.

According to papers submitted by Johnson & Johnson earlier this month for emergency use authorisation, its vaccine has demonstrated an efficacy level of 66% overall; 72% in the United States and 57% in South Africa, which is dealing with a highly contagious strain of the virus. It has been more effective — 86% — against severe forms of Covid-19 in the US, and 82% against severe disease in South Africa, reducing the risk of hospitalisation and death.

The third vaccine comes amid warnings by public health officials of an upward shift in the pandemic. After consistent decline in infections and cases since early January, “the latest data suggests that these declines may be stalling, potentially levelling off at, still, a very high number”, said Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC), at a White House briefing on Covid-19 on Friday.

“We at CDC consider this a very concerning shift in the trajectory. The most recent seven-day average of cases -- approximately 66,350 -- is higher than the average I shared with you on Wednesday. In fact, cases have been increasing for the past three days compared to the prior week,” she said, adding, “Now is not the time to relax restrictions.”

Walensky also said the impact of the new variants of the virus are beginning to be seen now. And she warned: “We may be done with the virus, but clearly, the virus is not done with us. We cannot get comfortable or give in to a false sense of security that the worst of the pandemic is behind us -- not now; not when mass vaccination is so very close -- when what we need to prevent this is truly imminent.”