A Johnson & Johnson announced on Tuesday that it has delivered data to the US regulatory agency Food and Drug Administration (FDA) for emergency use authorization for a booster dose of your covid-19 vaccine in people over 18 years of age.
J&J said the application includes data from an advanced-stage study that concluded that a booster dose given 56 days after the initial dose provides 94% protection against symptomatic cases of Covid in the United States and 100% against severe disease. , at least 14 days after application of the booster dose.
Although scientists are divided over the need for booster doses against Covid at a time when many people in the US and other countries have yet to receive vaccines, the government of US President Joe Biden has announced the initiative to apply a extra dose in August to boost protection against the highly transmissible Delta variant of the coronavirus.
J&J’s request comes after the FDA last week scheduled an Oct. 15 meeting of its expert committee to discuss whether to authorize a second dose of the company’s single-dose vaccine.
The FDA has already authorized a booster dose of the covid-19 vaccine developed by Pfizer in partnership with BioNTech for people over 65, people at high risk for severe forms of the disease, and those who are regularly exposed to the virus.
Pfizer has also asked the FDA to extend this authorization to all people over the age of 16, but the regulatory agency has decided to limit the scope of the authorization on the grounds that evidence has shown the enhancement is beneficial to older people and people exposed to greater risk.
J&J said it intends to hand over the data to other regulatory bodies, the World Health Organization (WHO) and the National Immunization Technical Advisory Groups.
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