CDC Director Dr Rochelle Walesnky has signed off on Johnson&Johnson’s vaccine. Walensky’s approval allows the federal government to begin shipping the doses to sites across the country.
Her approval comes after a CDC panel voted unanimously to recommend the shot for those 18 and older. A J&J executive told lawmakers on Tuesday that the company is prepared to ship nearly four million doses as soon as it receives emergency use authorisation.
The CDC director signed off on Johnson & Johnson’s one-shot Covid-19 vaccine on Sunday for people aged 18 years and older as the federal government prepared to ship out millions of doses this week.
“Today marks an encouraging step toward an end to the #Covid19 pandemic,” Walensky wrote on Twitter. “I have now signed CDC’s Advisory Committee on Immunisation Practices’ (ACIP) recommendation that endorsed the safety and effectiveness of Janssen’s Covid-19 vaccine for people 18 and above.”
The federal government can now begin shipping doses out to sites across the country. The advisory committee met in an emergency session to review data on the vaccine, which on Saturday became the third shot to receive an emergency use authorisation from the Food and Drug Administration.
J&J Vice President of Medical Affairs Dr Richard Nettles told lawmakers on Tuesday that the company is prepared to ship nearly four million doses as soon as it receives emergency use authorisation. He added that the company expects to be able to provide 20 million doses by the end of March.
The introduction of the J&J shot could be a boon to the US supply of vaccine. While the new vaccine showed signs of being less effective at preventing Covid-19 in clinical trials when compared with that of the Pfizer-BioNTech and Moderna vaccines, the J&J shot was 100 per cent effective at preventing death and hospitalisations caused by Covid-19 in clinical trials.
The J&J vaccine’s level of protection against the virus in trials varied by region, according to FDA documents released on Wednesday last week. About a month after the inoculation, the shot demonstrated 72 per cent efficacy in the US, 61 per cent in Latin America and 64 per cent in South Africa, where the B.1.351 variant is rapidly spreading.
The FDA review showed the vaccine was significantly less effective in people 60 and older who also have comorbidities such as diabetes or heart disease. The agency noted, though, that the data was too sparse to draw conclusions.
In contrast, Pfizer’s vaccine was found in clinical trials to be 95 per cent effective against preventing Covid, while Moderna’s was found to be about 94 per cent effective. Infectious disease experts pointed out that J&J’s numbers cannot be used as a direct comparison to the other two vaccines because it’s a single dose and the company’s trial was conducted when there were more infections as well as new, more contagious variants.
But federal health officials have pointed out that the one-shot J&J regimen comes with unique logistical advantages that could make it ideal for hard-to-reach populations.
J&J’s vaccine “makes it operationally easier in lots of contexts,” Dr Nancy Messonnier, director of the CDC’s National Center for Immunisation and Respiratory Diseases, told the Journal of the American Medical Association on Friday.
“I expect lots of considerations state health departments are having around these vaccines is more about the ease of use of the J&J vaccine and how it might be better suited for some populations.”
J&J has said it plans to ship the vaccine, which contains five doses per vial, at 36 to 46 degrees Fahrenheit.
By comparison, Pfizer’s vaccine typically needs to be stored in ultracold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit, though the FDA said recently that it can be stored at standard pharmacy freezer temperatures for up to two weeks. Moderna’s vaccine needs to be shipped at 13 below to five degrees above zero Fahrenheit.
- A Tell & Agencies report