Pharmaceutical group Johnson & Johnson announced on Tuesday that it had submitted data to the United States Medicines Agency (FDA) for approval for a booster injection in adults of its single-dose vaccine against Covid-19.
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These data include the results of a clinical study in which a second dose injected approximately two months (56 days) after the first showed 94% efficacy against symptomatic (moderate to severe) cases in the United States, and 100% against severe cases 14 days after this second injection, the company said in a press release. A second dose injected six months after the first also increases
the antibody levels observed
"by nine"
, according to another
"J&J" study
, and
"by twelve"
four weeks after the booster. The vaccine, taken in single dose or as a booster dose, is generally well tolerated by patients, assured the American group.
The FDA for its part indicated that its committee of experts would meet on October 14 and 15 to study the applications for authorization from Johnson & Johnson and the company Moderna.
“We look forward to speaking with the FDA and other health authorities to support their decisions regarding booster doses
,
”
said Mathai Mammen, research and development manager at Janssen, the pharmaceutical subsidiary of Johnson & Johnson.
Single dose vaccine
“At the same time, we continue to believe that a single-dose vaccine against Covid-19, which offers strong and long-term protection, is a crucial contribution to vaccinate the world population,
” he added.
The single-dose vaccine has received emergency authorization in the United States since February 2021 and has been administered to 15 million people, far fewer than the two-dose vaccines from Pfizer / BioNTech (229.3 million) and Moderna (152 millions).
The United States has already authorized a third dose of the Pfizer / BioNTech vaccine for people 65 and over and some at
"risk"
because of their state of health or because of a job particularly exposing them to the virus.
People who are immunocompromised may also get a booster dose of Moderna's vaccine.
The subject of the third dose, at the center of the new American vaccine strategy launched in September, has revived the issue of inequalities between rich and poor countries, while access to the first dose of vaccine remains very limited in certain regions of the country. world, especially in Africa.