[ad_1]
Rome, December 1, 2020 – The race for the Covid vaccine is reaching the finish line: later Modern, which yesterday submitted the request for authorization to the US and the EU, within a week also Astrazeneca will send the Oxford vaccine approval documentation while Biontech and Pfizer have submitted the application for authorization for the anti-Covid vaccine to EMA, the European drug agency. At this point the EMA communicates the roadmap: the Pfizer vaccine will be evaluated by December 29, the modern by 12th of January and later still that of Astrazeneca. “The Agency and its scientific committees will continue to work on the evaluation during the Christmas period“, guarantees the staff.
Covid vaccines arrive, Hope: “The plan for Italy”
“It is not a race, there are no prizes to win – he stressed Francesco Vaia, director of the Spallanzani Institute – The prize is a vaccine safe, effective and for everyone“.” There has been an extraordinary effort in a very short time to be able to develop anti-Covid vaccines, but this does not mean that safety procedures are waived, so we are not talking about exceptions to the safety and effectiveness evaluation mechanisms, “he said the president of the Higher Institute of Health, Silvio Brusaferro.
Coronavirus, Brusaferro: “It will be a Covid Christmas”
Be that as it may, the Minister of Health Roberto Speranza promised that tomorrow he will present the vaccination plan for Italy. And today the general director of Prevention of the Ministry of Health, Gianni Rezza, He assured that “the vaccination plan is ready.” “So the timeframes in which the doses will arrive will depend on the regulatory agencies. Once they give the green light at that point we can have a limited number of doses first, then more and more, as established. The pharmacovigilance plan will begin after commercial authorization, and will run like the rest of vaccines, “he added at a press conference during the presentation of the data. December 1 newsletter.
Arcuri signs the agreement with Pfizer. “It will give us super-coolers for vaccines”
The times for the final ok
Between the approval of the anti-Covid vaccines by the EMA and the final approval of the EU institutions forpurchase and distribution dosage “there is a procedure that needs a couple of days“says European Commission spokesman Eric Mamer. The EU executive ensures a speedy procedure even during the Christmas holidays from the work of the Commission and the EU institutions involved in the approval process.” It is in the interest of all Member States and the European Commission that the authorization will arrive as soon as possible, ”said spokesman Stefan de Keersmaecker.
The Pfizer vaccine
L ‘European Medicines Agency (Ema) announces that the evaluation for the authorization of the vaccine developed by BioNTech and Pfizer will proceed according to an accelerated schedule: if the data presented is strong enough to draw conclusions about the quality, safety and efficacy of the vaccine, The Scientific Committee for Medicinal Products for Human Use (CHMP) of the EMA will conclude its evaluation at an extraordinary meeting scheduled to December 29, later than.
“We knew from the beginning of this journey that the patients are waiting and we are ready to send the doses of the vaccine as soon as possible authorizations allow it, “he assures. Albert bourla, president and CEO of Pfizer. “Today’s announcement marks another milestone in our efforts to deliver on our promise to do what we can to address this serious crisis, given the critical need for public health,” he says. While BionTech CEO and co-founder Ugur Sahin defines today’s step as “an important milestone for us, a company based in the heart of Europe, as we continue to strive to make global supply possible” immediately after ” Potential approval of BNT162b2 “, the candidate vaccine for mRna.
The Oxford vaccine
And therefore within a week AstraZeneca will deliver the documentation for the approval of the vaccine (Oxford) to regulatory agencies: communicate it Piero Di Lorenzo, president and managing director of Irbm Pomezia, which collaborates in the development. “The parent company AstraZeneca is preparing all the documentation, the entire package to deliver it to the regulatory agencies,” Di Lorenzo explained. I am sure that in a week this package will be ready and delivered ”.
The Modern vaccine
Always the Ema in a note communicates that, if the data presented yesterday by Modern will be sufficiently robust “, the evaluation will conclude at the latest in the extraordinary meeting of the Scientific Committee of Medicinal Products for Human Use of the EMA, scheduled for 12th of January“.
EU: out of 165 selected 10 insurances
“There are 165 vaccines that are being developed at the moment and I must say that getting to distill 10 was not difficult, because we know which are the best 10 and for us they have characteristics ofI security, which for us is the first criterion “, but also follows the” second criterion ofeffectiveness“he said Sandra Gallina, Director General of Health and Food Safety of the European Commission.
EU: out of 165 selected 10 insurances
“But there is a third criterion, the price – he continued – we paid the correct amount for our vaccines. There are some of the American vaccines, identical to ours, but we generally pay for them a third of what Americans paid. I did not have much money – he remarked – and I had to buy vaccines for everyone. A vaccine cannot cost more than 15 euros ”.
Also, on the safety of vaccines, he added: “There is one thing that says it takes 10 years to make a safe vaccine … That is not true. Professor Fauci, whose integrity I do not think there is any doubt,” said. that 10 years ago vaccines were made in one way, today they are made in another: we have ‘supercomputers’, we have many more technological possibilities to accelerate the pace ”.
CnB: do not rule out mandatory
The vaccine is a “common good” and can become mandatory in an emergency: these are some of the indications that emerged today from the National Bioethics Committee (CNB) on vaccines. “Taking note of the numerous ongoing experiments, the CNB underlines on an ethical level how the pandemic emergency should not lead to a reduction in the time of experimentation, essential at the scientific, bioethical and bio-legal level, to guarantee the quality and protection of the participants” , read the document.
In the center of the CNB reflection equity of access to vaccines. “The Committee believes that the vaccine should be considered a ‘common good’, whose production and distribution in favor of all the countries of the world is not regulated solely by the laws of the market,” writes the CNB.
The Committee also notes that every effort should be made to achieve and maintain vaccination coverage optimal “without excluding the obligation in emergencies, especially for professional groups more exposed to infection and its transmission ”, the document continues.
© All rights reserved
