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Lasted the space of one night, the good news from the US data. AstraZeneca vaccine. Yesterday the United States had announced the good results of the trial in the United States: 79% effective. This morning the US authorities question these data, a result of “outdated information“According to a statement from Niaid directed by Anthony Fauci (the National Institute of Allergy and Infectious Diseases).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 published by the company was not entirely accurate and could be misleading.” The data provided by AstraZeneca dates back to before February 17th. They may not account for the spread of virus variants, which will likely make the vaccine less effective.
“We want more precise figures”
“The Security and Data Monitoring Board is concerned that AstraZeneca has provided a incomplete estimate on efficacy data ”explains the press release, referring to the committee charged with examining the clinical trial data 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 clear figures possible are made public as soon as possible.” The company responded: “We are analyzing the request. We will provide all the requested data within 48 hours.”
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 drug regulatory body in the US) for the authorization of your vaccine also in the USA. Now comes another problem for the Anglo-Swedish pharmaceutical company. In autumn, after an adverse event in a volunteer (a case of myelitis, a neurological disease), Europe resumed trials after one week, while the United States resumed dosing only after seven weeks of testing and analysis.
Although the authorization in Europe had arrived on January 29 Based primarily on a trial in Britain with 20,000 volunteers, Washington had asked the company to complete the trial started on US soil with 32,000 volunteers, before considering the vaccine. Yesterday these results had arrived. But they were not enough to convince the US authorities.
The EMA, the European Medicines Agency, was also busy sorting out the AstraZeneca clinical trial data. Some of the volunteers had received a full dose, others half dose, due to an error in the measurement of the active ingredient. An erratic supply had forced the experimenters to delay the memory, in some cases up to three months after the first dose. In the US, however, the second doses were inoculated later. one month. The company’s production problems are also causing delays in supplies in Europe, based on the ongoing trade dispute with the European Commission and Italian Prime Minister Mario Draghi’s decision to block the export of 250,000 doses to Australia.
Vaccines, from Campania to Padua still exempt for AstraZeneca. And the backup case explodes
by Alessandra Ziniti
EU accusations against the non-compliant company
“This first quarter” of the vaccination campaign “was not easy,” he said. Sandra Gallina, Director General of the Directorate of Health of the European Commission, during a hearing in the Committee on Budgets on European Parliament. Although “Pfizer and Moderna are fulfilling their commitments, except for some 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 it. not even a quarter of deliveriesprovided 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”. of 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 damaging our reputation. “The problem, Gallina stressed, is not so much the export of vials:” AstraZeneca does not currently export “to non-EU countries. The shortage arises precisely from a production deficit.
AstraZeneca, France prohibits the vaccine for those under 55 years of age. Italy continues
by Elena Dusi
The director of the EMA: “Other security studies”
Two weeks ago the cases of one rare thrombosis in people vaccinated with AstraZeneca, which had led to preventive interruption of injections in most European countries. The European Medicines Agency EMA had recommended the resumption of vaccinations on Thursday, March 18. Some northern European countries have not yet restarted the vaccination campaign.
In this sense, the director of the EMA took the floor again in the European Parliament Emer Cooke: “Our pharmacovigilance has realized that there is a limited group of rare thromboembolic episodes in which the incidence appears to be higher. Episodes of this type are also found in some patients who have or have had Covid.” Cooke added: “We need additional research,” too, “to see if there could be a correlation with, for example, the to smoke or with the use of oral contraceptives, on the impact on immunosuppressed pregnant women “.” These investigations are in progress but I can’t give you any indication yet. “
