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Green light also from the European Union to the Pfizer / Biontech vaccine. In fact, the European Commission has authorized its commercialization. This was announced by the president of the EU executive, Ursula von der Leyen. In the morning, the EMA, through the voice of Marie-Agnes Heine, communication director of the European Medicines Agency, had recommended the conditional authorization of the vaccine for Covid 19. Times faster than expected, therefore, by the EU. The first doses for Italy will begin in Belgium on December 24 and will arrive at Spallanzani in Rome from the 26th for further distribution throughout Italy. The “vaccine day” is scheduled for the 27th.
“This is the news we were waiting for,” said the Minister of Health. Roberto Speranza. “The battle against the virus remains very complex, as the latest news from London also shows, but having an effective and safe vaccine available opens a new phase and gives us more strength and confidence.”
The guarantees on the English variant
“There is currently no evidence to suggest that the new vaccine will not work in the new strain of coronavirus,” said Emer Cooke, EMA executive director. “We know a lot more about this vaccine than we did ten months and even three months ago, but there is still new information that needs to be fully evaluated, such as recent information on the new coronavirus variant that has yet to be evaluated.”
16 years and older
The authorization for the Pfizer / BioNTech vaccine came after a very large clinical study that demonstrated efficacy “in preventing Covid-19 in people 16 years of age and older.” “The trial involved about 44,000 people in total,” half of whom “received the vaccine and the other half received a sham injection.” “Effectiveness has been estimated in more than 36,000 people 16 years of age or older (including people older than 75 years) who had no previous signs of infection,” says the EMA. The study “showed a 95% reduction in the number of symptomatic Covid-19 cases in people who received the vaccine (8 of 18,198 cases had Covid-19 symptoms) compared to people who received a sham injection (162 of 18,325 cases had symptoms of Covid-19) “. This means that “the vaccine has been shown to be 95% effective in clinical trials.” The study also showed “approximately 95% efficacy in participants at risk for severe Covid-19, including those with asthma, chronic lung disease, diabetes, hypertension, or a body mass index of 30 kg / m2,” he explains. again the EU agency.
Precautions for pregnant women
“For pregnant women, we recommend a case-by-case approach based on the individual situation and considering the risk of exposure and infection,” said Harald Enzmann, chair of the EMA committee. Later, Enzmann explained that the recommendation is based on tests carried out that “did not involve enough women during pregnancy”, but, he assured, “we have also taken initiatives to fill this knowledge gap as soon as possible.”
The secundary effects
“The side effects of this vaccine are the same as those seen in other vaccines,” said Sabine Straus, chair of the EMA safety committee. The “most common” side effects found in the test phase are “injection pain, fatigue, headache, muscle and ligament pain, high fever”, but “side effects last about a day”. However, the expert recommended “an important follow-up action” to the health authorities on the observed effects.
Europe’s yes to commercialization
In the late afternoon, the president of the European Commission, Ursula von der Leyen, announced the green light for the commercialization of the Pfizer-BioNTech vaccine, following the approval of Ema. “Today we add an important chapter to a European success story. We have approved the first safe and effective vaccine against Covid-19. More vaccines are coming soon.” In fact, the EMA will issue its opinion on the second vaccine, that of Moderna, on January 6. “The doses of the vaccine approved today will be available to all EU countries at the same time, under the same conditions,” said the president, confirming the start of vaccination for December 27, 28 and 29. “This is a great way to end this difficult year and finally start moving forward,” he concluded.
