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After the green light from Ema, the European regulatory body, for the vaccine Pfizer, now it is the turn of the Italian pharmaceutical agency. Aifa, in fact, has authorized the dissemination of the new anti-Covid formula for Italy. It was the last yes expected in Italy, in the demanding permitting process to which the documents of the manufacturing pharmaceutical company had to be submitted. Now, the next appointment is next Sunday, December 27, when the first doses will be officially inoculated.
“The Pfizer vaccine is approved for the entire population over 16 years of age and it is important to add that it has no absolute contraindications,” explained Aifa CEO Nicola Magrini. According to what was declared during the approval press conference, they will be 1 million Health workers vaccinated before January, and then passed to the RSA guests. «No special precautions will be required for the elderly or immunosuppressed. Those with bleeding disorders will have no problems, as well as pregnancy and lactation. Therefore, guarantees on all fronts of Aifa, also on the possibility of falling ill in the days immediately after the administration, considered by President Giorgio Palù “very unlikely”.
The best pharmacovigilance in Europe
Speaking of the post-vaccination period, Palù explained the work of a technical committee formed by Aifa “to monitor adverse reactions.” A work in which the Agency shows great confidence: “We have one of the best pharmacovigilance systems in Europe”, Palù continued, “specific studies will also be launched in dialysis patients, RSA patients, later in the year also the population of pregnant women. ”After the first administration, the second dose will be inoculated at 3 weeks, with an immune response from the first dose that can be visible from“ the sixth or seventh day ”.
A serial analysis capacity at 3/6/9/12 months that Aifa explained that will also include monitoring the evolution and changes of the virus. “Our platform is able to intervene with timely changes in the event of vaccine-resistant virus mutations,” explained Palù. The British are teaching us that it will also be essential to monitor the aspect of the evolutions to act immediately on new possible variants ”.
“No rejection of monoclonals”
We are interested in evaluating monoclonal antibodies and in the next few days we will evaluate if there is the possibility of experimentation ”. Aifa’s reference to the drug against Covid-19 produced in Latina was clear, underlining a total openness. As Magrini explained, the evaluation should be carried out from an experiment carried out “to confirm the results currently made available by the scientific literature.” Next, the general director continued to clarify the availability always supported by monoclonals, clarifying that “the refusal of access to Italy does not correspond to the truth.”
Regarding the events of recent months, Magrini reiterated that “Aifa has not received any donation proposal for access to monoclonals or for experimentation”, defining the future clinical study as a “primary interest to be discussed with the entire scientific community “.
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