Skip to content
COVID-19 |  Europe will decide in October whether to authorize Pfizer’s booster dose

COVID-19 | Europe will decide in October whether to authorize Pfizer’s booster dose

COVID-19 |  Europe will decide in October whether to authorize Pfizer’s booster dose

The European Medicines Agency reported that it will decide in early October whether or not to approve a third dose of the Pfizer / BioNTech vaccine against COVID-19 for the population over 16 years of age.

It will also decide whether or not to approve a third dose of the Pfizer and Moderna vaccines for p, the EMA added.

Protection against the COVID-19 disease at the first injection, Marco Cavaleri, the head of the European agency in charge of vaccine strategy, based in Amsterdam, said at a press conference.

“The available information indicates that the immunity acquired against COVID-19 with the first doses decreases over time from the first vaccine and protection against infection and symptoms of the disease is decreasing in various parts of the world”, Cavaleri pointed out.

As a result, the agency evaluates with Pfizer its request to apply a third dose at least six months after the second dose in

“The result of this evaluation is expected in early October, unless supplementary information is required”Cavaleri said.

The EMA is “Rigorously following the path” from “Do not rush to give booster doses if there is no clear indication that they are needed” and for the European regulator it is “important” Always base your decision on Marco Cavaleri, EMA’s Head of Vaccine Strategy, warned.

The expert pointed out that “about the need to apply a third dose shortly after the first two doses have been applied to people with fragile immune systems that“ respond little ”to the initial vaccination.

The agency “Will consider in early October whether specific recommendations can be included” on the information on Moderna and Pfizer vaccine products for those types of people, Cavaleri said. The data from these studies are already in the hands of the Committee for Human Medicines (CHMP).

“It is known that some member states are already applying a vaccine” high risk people.

Regarding the Janssen single-dose vaccine, the agency is waiting for the pharmaceutical company, a subsidiary of the American Johnson & Johnson, which has carried out a second dose, administered two months after the first injection, to “understand if a recommendation ”in this regard, although it does not yet have a date.

The EMA has also completed its analysis of the risk of developing thrombosis with thrombocytopenia with the second dose of AstraZeneca and concluded that this is and nothing indicates that a second injection increases the risk of this condition, and has not been able to conclude risk factors such as age, sex or medical history.

Agencies

Follow us on twitter:

.

Share this article:
globalhappenings news.jpg
most popular