Vaccino AstraZeneca, the case of “old and incomplete” data to the US authorities –

Fauci and the company note

After an initial fuss Antony intervened Fauci to specify that the vaccine data are probably very good, my he press release not accurate enough and said the FDA (the US regulatory body) will proceed with an independent review of the vaccine results not only related to company communications.
For its part, AstraZeneca wrote: The numbers published yesterday were based on a pre-established interim analysis with data cut-off as of February 17. We reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis. We will immediately engage with the independent data safety monitoring committee to share our primary analysis with the most up-to-date efficacy data. We intend to publish the results of the primary analysis within 48 hours.

Incomplete information

What happened? In a statement defined by the New York Times very unusual released after midnight on Monday, the National Institute of Allergy and Infectious Diseases, the body that heads Antony Fauci, had said that the data and security monitoring committee of the National Institutes of Health (NIH) had notified government agencies (and AstraZeneca) to be worried about the information that the pharmaceutical company had released on Monday morning. THE data on the efficacy of the vaccine shown on Monday were described as outdated, inappropriate and based on data not analyzed correctly. The exact written statement on the NIH (the nation’s medical research agency) website reads: The Data and Safety Monitoring Board (the oversight committee) expressed concern that AstraZeneca may have included outdated information in that trial, they may have provided one incomplete vision of efficacy data. We urge the company to work with the Board to review the efficacy data and ensure that the efficacy data more accurate and updated are made public as quickly as possible.

The data on the experimentation

The data to which the government agency refers are those that AstraZeneca made public on Monday: after a study of 32,449 volunteers recruited in the United States, Chile and Peru, the vaccine would prove to be 79 percent effective in stopping the symptoms of the Covid is 100 percent in avoiding serious complications of the infection. This is considerably higher than in the UK studies last year. The conclusion, illustrated in a company press release and not with a clinical study published in a scientific journal, had raised the morale of European governments (and the company’s actions) after the hardships of the past few weeks that had led to the vaccine being stopped ( the problems related to side effects later denied by the EMA analyzes). In the most recent study, the independent monitoring and safety committee found no increased risk of thrombosis and also recorded for the first time an efficacy of 80 percent in participants aged 65 and over. It was excellent news for the Anglo-Swedish house that is collecting the data to ask for authorization to the Food and Drug Administration Usa: the vaccine not yet authorized in the country and unlikely it will be before May.

Problem that does not affect Europe

The problem does not touch the vaccination campaign in Europe directly: in the US AstraZeneca has yet to be authorized, while we have brought the data to the regulatory agency and the vaccine has been authorized for some time by the EMA (the European medicines agency). Furthermore, with regard to safety, EMA, WHO (World Health Organization) and Aifa (Italian Medicines Agency) have just excluding the link with a generalized increase in thrombosis risk, the resumption of administration is authorized also for people over 65 years of age.

Communication problems

What leaves many scientists and analysts stupid the unusual friction between the monitoring committee and the study sponsor, which are normally in close agreement. The vaccine has already been approved in more than 70 countries, but authorization from US regulators would strengthen its global reputation, although the US may not need it, as federal officials predict in May there will be enough vaccine doses for everyone the nation’s adults from the three already licensed vaccines: Pfizer-BioNTech, Moderna, and Johnson & Johnson.

March 23, 2021 (change March 23, 2021 | 13:46)

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