The EMA evaluates the booster dose of Johnson & amp; amp;  Johnson in over 18 years

The European Medicines Agency (EMA) began on Monday to evaluate a request from Janssen, the American pharmaceutical company Johnson & Johnson, to administer a booster injection of its single-dose vaccine against COVID-19 two months after the first in those over 18 years of age.

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The Committee for Medicinal Products for Human Use (CHMP) is already studied, in a process of “Accelerated assessment”, the data presented by the company to support the need for a second dose, including the results of a study of more than 14,000 adults who received a second injection or a placebo two months after the initial dose.

The EMA could announce the conclusions of its evaluation within “a few weeks”, unless additional information is needed from the pharmacist.

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Janssen’s vaccine, which is based on an adenoviral vector derived from an adenovirus that causes the common cold in humans, has already been authorized in the European Union (EU) since last March, but with a single dose, in people over 18 years of age, the scenario that was effective in clinical trials.

In addition, the agency has already endorsed the adult booster dose of the Pfizer / BioNtech and Moderna vaccines, both based on messenger RNA, six months after the second dose, although the decision to resort to this injection is the prerogative of the national authorities of each country, based on different factors, including the spread of the virus, the availability of vaccines and the capacity of the national health system.

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Last week, Marco Cavaleri, head of Vaccination Strategy at the EMA, stressed that “The booster doses are going to play an important part in the vaccination strategy” ongoing in the EU, especially given the increase in infections and hospitalizations in the region due to COVID-19.

In addition, it specified that the interval of at least six months between the second and third doses has been concluded from the available data, but “It would be fully understood if countries decide to bet on some flexibility regarding the interval and consider an earlier point to administer that booster dose ”.

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