Vaccine package insert astrazeneca
Following positive assessments by the European Medicines Agency (EMA) on safety, quality and efficacy, the Commission has so far granted conditional marketing authorization to four vaccines developed by:
The Commission is conducting intensive negotiations with the aim of building up a diversified portfolio of vaccines for EU citizens at fair prices. Contracts have been signed with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson & Johnson (400 million doses), BioNTech-Pfizer (2.4 billion doses), CureVac (405 million doses), Moderna (460 million doses), Novavax (200 million) and Valneva (60 million).
The Commission thus guarantees a portfolio of more than 4.2 billion doses. It was important for the Commission from the outset to build up a diversified portfolio of vaccines based on different technologies in order to increase the likelihood that one or more of the experimental vaccines would be approved by the EMA.
Pfizer minsal fact sheet
He reminded that “there is no 100% effective vaccine, and the (available) vaccines have very good efficacy in protecting us against severe disease,” but if many people get infected, “a few, including vaccinated ones, will end up in the hospital.”
“As we approach winter, we see the rise in infections and hospitalizations in almost all Member States. And most of the patients in intensive care are not vaccinated. We stress the need to get vaccinated and, for those eligible, to receive a booster dose,” Cavaleri warned.
The interval of at least six months has been concluded from the available data, but “it would be fully understood if countries decide to go for some flexibility in terms of the interval and consider an earlier point to administer that booster dose.”
The CHMP is already reviewing the data on the antiviral molnupiravir to “provide recommendations” to help national authorities decide on its possible early use, for example, in emergency settings, prior to its authorization. EFE
Pfizer Vaccine Fact Sheet
The EMA has analyzed “the benefits of the vaccine and the risk of unusual blood clots with low platelets in different age groups in the context of monthly infection rates: low (55 per 100,000 persons), medium (401 per 100,000 persons) and high (886 per 100,000 persons). persons).”
The benefit-risk balance analysis of the vaccine remains positive for adults of all age groups, insists the EMA: “Like all vaccines, Vaxzevria is approved because its benefits outweigh the risks for a person potentially exposed to the disease-causing agent.”
Vaccines approved by the EMA
In this way, the European health official dissociates the Commission and the regulatory body itself from the statements made by the head of the EMA vaccine strategy, Marco Cavaleri, who assured in an interview with an Italian newspaper that there is a “clear” link between this vaccine and the very rare cases of thrombi.
The EMA has so far maintained the assessments expressed since last March, in which it indicates that external experts in various medical specialties are still trying to identify risk factors and additional data to characterize the observed events of thromboembolism and, if any, to define a potential risk.
This review, which will form part of the final PRAC report, has not identified a specific risk factor, such as age, gender or a previous medical history of coagulation disorders that could explain these very rare cases of thromboembolism following vaccination, but, believing that there may be a risk, it was decided to continue with the analysis.