EMA does not publish vaccine data from January 2021: “Covered by military Secrecy’

Originally published in Byoblu.

What is the real effectiveness of vaccines against Covid?

All the backtracks on vaccine efficacy

The vaccine efficacy numbers provided by pharmaceutical companies and regulators in recent months have looked more like lottery draws than in-depth analyses. Why has the vaccine gone from an alleged efficacy of 95% in December 2020 to 47% in November 2021, and finally to a paltry 12%, as the latest Pfizer documents published in the US seem to show?

The answer may lie in the often flawed procedures adopted by multinational drug companies in testing these vaccines, as emerged in other documents also signed by Pfizer and publicised at the request of the Public Health and Medical Professionals for Transparency. However, Big Pharma can only do as it pleases if regulatory agencies such as the FDA and EMA do not do their job, i.e. do not monitor.

Where are the EMA reports on Covid vaccines?

Well, this inexplicably lax attitude seems to be confirmed by the EMA’s monitoring of Covid vaccines. According to the European Agency itself, the marketing authorisation of a drug is subject to the submission of what are identified as Periodic Safety Update Reports (PSURs).

The EMA writes that: “The objective of these documents is to present a critical and comprehensive analysis of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative risk-benefit information.” These documents are therefore necessary to trace the profile of the drug used and become even more important if the product has received conditional authorisation, as is the case for Covid vaccines.

So far, a year and a half after the first vaccine was administered, the EMA has only published one such report, and that was dated 29 January 2021. What is surprising is that in that document, only 2 pages long, there was a clear reference to future update reports: “The EMA will publish monthly safety updates for all authorised COVID-19 vaccines, in line with the exceptional transparency measures for COVID-19”. None of this has been done and since then more than 24 update reports on Covid vaccines are missing. Why?

Lawyers in Italy have decided to investigate

A group of Italian lawyers, on behalf of two associations of social promotion IDU (Human Rights Petitions, of Novara) and DUS (Human Rights and Health, of Rome) is trying to get to the bottom of this matter and has filed a complaint with the Public Prosecutor’s Office of Rome against AIFA, precisely for the failure to publish these documents.

According to a decision of the Italian Medicines Agency, the marketing of Covid vaccines is in fact conditional on AIFA obtaining the reports. However, AIFA diverted the lawyers to the EMA, which gave a very strange answer: ‘The reports are covered by military secrecy’.

Is the double-blind breakdown at the root of it all?

Why should reports on the safety of a vaccine administered to millions of people, even by force, be subject to military secrecy? We are talking about public health, people’s lives, and the EMA’s motivation seems so meaningless and logical. Unless you think that the regulatory body is trying to cover up the product’s defects and the manufacturer’s shortcomings.

On the other hand, it was the drug companies themselves who admitted that they had interrupted the double-blind procedure by administering the vaccine to the placebo group at a later date. So how could these multinationals monitor the safety and efficacy of a drug without having the initial reference points? They would have to go by feel, as may have been happening for months. This is why grassroots action to try to restore a minimum of legality seems to be increasingly necessary.

In the meantime, the EMA has announced that it has begun the assessment procedure for authorising the administration of the Moderna vaccine to children aged between 6 months and 6 years: ‘We have just started the assessment of the Moderna application, this is the first for this age group,’ said Marco Cavaleri, head of the vaccines task force. Are we sure we want to inoculate children with a product whose safety data are covered by military secrecy?

Originally published in Byoblu.

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