It lasted the space of one night, the good news of the US data AstraZeneca vaccine. Yesterday the United States had announced the good results of the trial in the USA: 79% effectiveness. This morning the American authorities question those data, the result of “outdated information”According to a statement from the Niaid led by Anthony Fauci (the National Institute of Allergy and Infectious Diseases). “The vaccine is probably very good – Fauci said in an interview with Abc – but the press release released by the company was not entirely accurate”.
“We want more precise figures”
“The Data and Safety Monitoring Board is concerned that AstraZeneca may have provided one incomplete estimate on efficacy data ”explains the press release, referring to the committee in charge of examining the data on clinical trials provided by the manufacturers. “We urge the company to work with the Board to assess the quality of the data and ensure that the most accurate, up-to-date and clearest figures possible are made public as soon as possible.” From the company came the reply: “We are analyzing the request”.
Covid, because the British are not afraid of AstraZeneca
by Enrico Franceschini
AstraZeneca said it was ready to apply for authorization from the Food and Drug Administration (Fda, the regulatory body for drugs in the USA) to the authorization of his vaccine also in the USA. Now comes yet another hitch for the Anglo-Swedish pharmaceutical company. In the fall, after an adverse event on a volunteer (a case of myelitis, a neurological disease), Europe resumed trials after a week, while the United States resumed dosing only after seven weeks of testing and testing.
While the authorization in Europe had arrived on January 29 based mainly on a trial in Great Britain with 20,000 volunteers, Washington had asked the company to complete the trial started on American soil with 32,000 volunteers, before considering the vaccine. Yesterday these results had arrived. But they weren’t enough to convince the American authorities.
EMA, the European Medicines Agency, had also been busy putting the AstraZeneca clinical trial data in order. Some of the volunteers had received a full dose, others half a dose, due to an error in the measurement of the active ingredient. An erratic supply had then forced the experimenters to delay the recall, in some cases up to three months after the first dose. In the US, however, the second doses were all inoculated later a month. The company’s production problems are also causing the delay in supplies in Europe, at the basis of the ongoing commercial dispute with the European Commission and the decision of Italian Prime Minister Mario Draghi to block the export of 250 thousand doses to Australia.
Vaccines, from Campania to Padua still waivers for AstraZeneca. And the booking case breaks out
by Alessandra Ziniti
EU accusations against the defaulting company
“This first quarter” of the vaccination campaign “was not easy,” he said Sandra Gallina, Director General of the Health Directorate of the European Commission, during a hearing in the Budget Committee on European Parliament. While “Pfizer and Moderna are respecting their commitments, except for a few short-term weekly problems” the real delay occurred “with AstraZeneca, a contract with which we have serious problems” since the pharmaceutical company “did not respect. not even a quarter of deliveries“provided for in the agreement with the EU.” We will use all the tools available to get the doses “.
“AstraZeneca – continued Gallina – had five production plants in the contract and at the moment produces from one, while another must have authorization from Ema. The company has only recently applied. from five promised plants only one works, it is impossible to fulfill a contract, or at least it is very difficult. It is a scandalous situation that is causing damage to our reputation. “The problem, underlined Gallina, is not so much the export of vials:” AstraZeneca is not currently exporting “to non-EU countries. The shortage arises precisely from a production deficit.
AstraZeneca, France bans the vaccine under 55. Italy goes on
by Elena Dusi
The director of the EMA: “Other safety studies”
Two weeks ago, the cases of one emerged rare thrombosis in people vaccinated with AstraZeneca, which had led to the precautionary stop of injections in most European countries. The European Medicines Agency Ema had recommended the resumption of vaccinations on Thursday 18 March. Some Northern European countries have not yet restarted the inoculation campaign.
In this regard, the director of the EMA took the floor again at the European Parliament Emer Cooke: “Our pharmacovigilance has realized that there is a limited group of rare thromboembolism events in which the occurrence seems to be higher. Events of this type are also found in some patients who have or have had Covid”. Cooke added: “We need additional investigations”, also “to see if there could be a correlation with, for example, the smoke or with the use of oral contraceptives, on the impact on pregnant, immunosuppressed women “.” These researches are ongoing but I cannot give you any information yet. “
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