The US Food and Drug Administration (FDA, in English) confirmed this Tuesday the security and efficacy of the covid-19 injection from Pfizer and BioNTech in a very first analysis prior to authorization, with which he pointed out that Vaccination may begin in the country in the next few days.
In its analysis, the FDA known that the vaccine, the first to be considered intended for distribution in typically the US, met “with the prescribed success criteria” andn the clinical study.
The report says that the vaccine, which need a couple doses, guarantees “confirmed COVID-19 danger reduction at least seven days after serving 2” and “confirmed severe COVID-19 risk reduction at any time after serving 1”.
The side effects Most frequent among the 43,252 contributors in the clinical trial, including little ones and adolescents aged 12 years and also were: reactions around the injection web site on the arm (84,1%), fatigue (62,9%), Headaches (55.1%), soreness (38.3%), chills (31.9%), joint pain (23.6%) together with fever (14.2%).
They registered strong reactions between 0 together with 4.6% of participants, these types of were less frequent in folks over 55 years old (2.8%) than in young people (4.6%).
Serious undesirable effects, that is, for example necessitating hospitalization, affected very few participants (less than 0.5%) and there was as many in the placebo group such as the vaccinated group, suggesting the vaccine it was not his problem.
With the exception of non-serious side effects in those under 5 decades old, probably due to the fact that the immune system in the youngest is usually more active, typically the FDA indicates that the vaccine is secure regardless of age, sex, ethnicity nor the first presence of pathologies.
Regarding efficaciousness, the FDA confirms the very dangerous of the vaccine (95%), which acquired already been announced by Pfizer together with BioNTech.
The analysis by the US ALL agency showed a new aspect of typically the vaccine: not only does it seem quite effective in preventing severe forms of COVID-19 after two doses, it is also really effective to prevent contagion after the very first dose, “although the data available for these results do not allow definitive conclusions.”
Meeting on Thursday
This Thursday, a private body scientist will review these types of results, and if agreed with the FEDERAL DRUG ADMINISTRATION, would open the possibility of start supply this weekenda.
The calculations in the US authorities suggest that before the stop of the year 20 million may be vaccinated of people in the country.
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The United Kingdom commenced this Tuesday to supply the first doasage amounts of the vaccine from Pfizer together with BioNTech for the immunization of the human population.
United States is the most difficult hit country in typically the world by the pandemic, with more than 15 million afflicted and 280,000 dead, in accordance with the independent count of Johns Hopkins University.