Wednesday, November 01, 2023

Disastrous Covid vaccination campaign in Poland

Poland’s National Audit Office known as “NIK” has identified a substantial surplus of COVID -19 vaccines due to lack of demand. The nation had contracted for a full vaccination rate multiple times over, yet the national office reports vaccination rate decline. Consequently, 13.1 million doses were allowed to expire and then exposed by the end of 2022, representing PLN 1 billion (US$237.7 million). In total, Poland spent 13.9 billion PLN (US$3.3 billion) for this nation of only 37.7 million people. TrialSite reminds that this was one of the few media to cover Poland’s attempt to renegotiate the COVID-19 vaccine contract with Pfizer due to the impact of the Russian invasion of Ukraine. Pfizer refused to budge. What follows is what in reality is a damning report from the NIK as to what appears to be an unfolding scandal in the aftermath of the COVID-19 response.

The NIK reports the effort to sell, transfer or donate the COVID-19 vaccines to mitigate the effects of the excess. By 31 December 2022, the Governmental Strategic Reserves Agency (RARS) provided to other countries over PLN 27.6 million vaccine doses with an estimated value of PLN 1.4 billion or (US$333.3 million).

A Great & Deadly ‘Health Debt’ Caused by COVID-19 Response
The NIK has gone on record that the COVID-19 response caused significant disruptions in the healthcare provision. Above all, a great part of the healthcare system resources was “relocated” to control the epidemic. That resulted in shrinking access to treatment for a broad group of patients, diagnosed with diseases other than COVID-19. Hence, the so-called health debt was growing (that was a situation where the failure to provide a medical service may lead to a disease development or its worsening).

Excess Deaths during the Pandemic—Despite the Vaccine
In 2020-2021, an increased number of deaths was reported, as compared with the average of 2015?2019. In 2020, there were over 85 thousand more of them, including about 56.5 thousand deaths for reasons other than COVID-19. And in the first half of 2021, excess deaths against the number of deaths reported a year before totaled nearly 61 thousand. But what about the COVID-19 mass vaccination response?

In fact, the COVID-19 universal vaccination countermeasure was supposed to help prevent those negative phenomena. The vaccination did not succeed despite many claims that the vaccines saved millions of lives. TrialSite has reviewed dozens of observational studies suggesting that the vaccines have reduced morbidity and mortality but the nature of these studies are such that this does not prove causation.

NIK points out in line with the assumptions the vaccines should have ensured a “return to normal.” While also serving to “unblock” the healthcare system, particularly for patients with diseases other than COVID-19. As NIK declares in a recent media entry a direct objective in the COVID-19 National Vaccination System was:

to reduce the number of deaths and complications caused by the SARS-CoV-2, particularly in elderly persons,

to reduce the population “health debt” growth.

In 2021-2023, NIK conducted a range of ad hoc audits to establish if the objectives of the COVID-10 National Vaccination Programme were achieved and how. NIK carried out five audits to look into the Programme execution which cost about PLN 17 billion (US$4.05 billion).

The NIK audit revealed that:

The Minister of Health improperly estimated needs related to the purchase of an adequate number of COVID-19 vaccine doses (meaning that the Ministry ordered more doses than they needed to, which of course meant more taxpayer dollars to the pharmaceutical companies).

Poland did not have to enter into agreements - questioned by NIK - to purchase COVID-19 vaccines. The Minister of Health did not use that right.

Estimating demand

It needs to be underlined that no documents were presented showing how the number of vaccine doses, needed to satisfy the demand of Polish citizens, were estimated. There was no basis, no rationalization used to justify the large spend.

From May 2021, subsequent vaccine doses were contracted for, although Poland was bound with contracts enabling the vaccination of the entire population several times (109 million doses were contracted for at the end of April 2021).

Even assuming that every adult person in Poland, i.e., about 31 million individuals, received the third vaccine dose, the demand would be at the level of 93 million doses, i.e., lower than the number of doses contracted for before May 2021.

What did the Health Ministry Know?

Interestingly, what did the Polish Ministry of Health know about the COVID-19 pandemic that informed them to estimate such demand?

NIK reports that the Minister of Health formulated a thesis that prior to the execution of agreements indicated as improper, there were signals that vaccine boosters every 6 months are necessary to maintain the immunological response at an adequately high level. The thesis is not only unconfirmed by the evidence gathered in the audit but also it does not reflect the opinions of specialized EU institutions taking efforts to control the COVID-19 epidemic.

On 31 May 2021, the Minister of Health addressed the EU Health Commissioner concerning the vaccines purchased, pointing to the hazard of huge vaccine surplus in Europe and the need for coordinated cooperation to start talks with individual manufacturers to reduce the volumes of vaccine orders.

NIK emphasizes that the Health Ministry could have been culpable in questionably intentioned pursuits.

“It needs to be stressed that the Minister stated that the epidemiological situation is about to stabilise and pointed to the “hazard” of significant surpluses of the COVID-19 vaccines, only 11 days after signing the third agreement with Pfizer/BioNTech. It points to complete inconsistency of the Minister’s actions. According to NIK those measures were unreliable and wasteful.”

Poland’s COVID-19 Vax Contracts

As reported by the NIK, the Republic of Poland acquired the COVID-19 vaccines as part of the Agreement on the joint mechanism for the COVID-19 vaccine purchase.

The Agreement authorized the European Commission to negotiate and conclude vaccine purchase contracts, on behalf of the EU Member States. Remember, TrialSite reported on how at least part of the EC negotiation was done via private personal text between Pfizer’s CEO Albert Bourla and Commission President Ursula von der Leyen. The situation is so egregious that even the New York Times has sued the EC to get to the bottom of this possible scandal.

NIK reports that the EC as an entity took responsibility for the contracts’ content, including the principles of sharing vaccines among the EU Member States, the pool of vaccines covered by the contract, their prices and delivery dates.

The EC notified the EU member states of the former’s intention to sign the deal, and the reality that the latter had no rights to modify. NIK does inform that member states were notified that they did have the option to withdraw from the vaccine purchase contract. It was a take it or leave it deal.

NIK informs the world now that in the vaccine purchasing process two types of contracts were used: 1) contracts defining the right to purchase vaccine doses and 2) contracts defining the obligation to purchase them.

First, NIK notes that participating EU Member States were not obliged to sign that contract. With the second contractual model, the EC was obliged to inform the EU Member States about the intention to sign the contract with an obligation to purchase the vaccine doses, also defining its signing conditions. Again, Member States had not input.

NIK cites the problems with the contractual scheme as devised:

“All the contracts negatively evaluated by NIK were contracts defining the obligation to purchase COVID-19 vaccines. The states that did not agree to sign that contract or its conditions had 5 days to withdraw from the contract or declare a number of vaccines other than set out in the contract (the so-called “opt-out clause”).

NIK points out in their media entry “The opt-out clause required consent of partner states, in cooperation with the EC, to accept extra doses or to give away appurtenant doses.”

Outrageous: 117.6K Hazardous COVID-19 Vax Doses Administered to Polish Population

TrialSite also learned about this scandal in the recent NIK media piece, under the section “Supervision of the Chief Pharmaceutical Inspectorate (GIF) over the COVID-19 National Vaccination Programme.”

NIK added in its report the state’s negative evaluation supervision exercised by the Chief Pharmaceutical Inspector over the vaccine storage and distribution. The body responsible for pharmaceutical safety of the state, obliged with “special supervision”, did not know in which warehouses the vaccines were stored. This NIK reports, “The relevant information was taken from the media,” meaning the nation state had no control over the pharmaceutical product within its borders.

The Polish government found defects, yet as the government itself via the NIK reports, “GIF failed to take efforts to withdraw part of vaccines, in which some quality defects were found, also the ones posing a threat to health and life. In consequence, 117.6 thousand hazardous vaccine doses were administered to patients.”

Distribution and storage of vaccines

According to the NIK audits, 17 pharmaceutical warehouses were involved in the process of the COVID-19 vaccine distribution and storage. In the audited period, GIF carried out only two inspections in one of pharmaceutical warehouses taking part in the COVID-19 vaccine distribution.

“A lot of critical irregularities were identified, e.g., the vaccine storage conditions in special rooms or the vaccine transport from the Governmental Strategic Reserves Agency (RARS) were not registered. Also, the product safety was not provided during vaccine storage in that warehouse.”

NIK reports an alternative inspection targeting the same supply pointed to a scandalous takeaway: the “distribution process does not guarantee the safety of vaccines in terms of their quality maintenance.”

While European GIF inspectors were in fact, cognizant of the discovered irregularities adversely impacting COVID-19 vaccine safety and effectiveness, they carried out no inspections in the remaining 16 warehouses.

Consequently, Poland’s national auditor points out how the Minister of Health was culpable in an unfolding scheme:

“The Minister of Health had a significant, adverse impact on the effectiveness of actions taken by GIF. He made the following statement which was contrary to the applicable law:

the distribution of COVID-19 vaccines is not the trade in medicinal products, in the light of the Pharmaceutical Law Act, and hence,

the trade in vaccines may not be monitored via the Integrated System for Monitoring the Trade in Medicinal Products (ZSMOPL).”

Poland’s Minister of Health essentially blocked and tackled on behalf of what appears to be some kind of cabal consisting of EC bureaucrats, industry and perhaps other high placed persons. After all, thanks to the Minister’s efforts “pharmaceutical warehouses were freed from the obligation to report vaccine stock availability on a daily basis. Hence, GIF could not monitor the trade in those vaccines. The Inspectorate drew its knowledge about the COVID-19 vaccine warehouses from the media.” This unfolding scenario could only be considered an utter and complete scandal.

Risking Patient Safety

TrialSite reminds all that national health authorities exist to ensure the safety and welfare of the population, not to further endanger them.

Yet Poland’s own auditors report that “The decision of the Minister of Health not to use the monitoring system also had a negative impact on the safety of patients.”

The NIK informs the world:

“In two cases, GIF did not decide to withdraw from the market a series of vaccines, although the Inspectorate was aware of their quality defects. GIF could not withdraw the vaccines, because their distribution was not subject to the Pharmaceutical Law Act – in line with the interpretation of the Minister of Health, and so GIF had no legal grounds to withdraw them from the market. Besides, the Inspectorate did not know in which warehouses the defective vaccines were found.”

Vaccine quality defects

GIF received eight reports of actual or alleged quality defects of the COVID-19 vaccines, of which two were of significant importance, reports the NIK media entry.

Additional Notes

On 23 April 2021, the Chief Pharmaceutical Inspectorate received information in the Rapid Alert system from the European Medicines Agency, about a possible quality defect in one of the COVID-19 vaccine series, already used in Polish patients. The report dealt with the suspicion of a 2nd class defect, that is the one that could cause an illness or improper effects. GIF failed to issue a decision to withhold or withdraw that vaccine series from the market.

Meanwhile, in April 2022 the Federal Agency for Medicinal and Health Products in Belgium informed GIF about withdrawing that series from the market. Having received the report, GIF provided the relevant information to RARS, requesting the Agency to take action to identify distribution channels and inform recipients about the situation. The efforts were pointless, though, because the entire vaccine series was already administered to patients

the quality defect of the vaccine series was reported on 7 April 2022 by the Spanish Agency of Medicines and Medical Products (AEMPS).

In the second case The vaccine quality defect could pose a threat to patients’ health and life (1st class defect), which obliged GIF to withdraw the defective product from the market.

Summary of Breaches Risking Patient Health

Summarizing this scandal, NIK reports that “In both cases, GIF not only failed to withdraw the vaccine series from the market but also did not know where they can be found.”

Having received the report, information was passed on to RARS with a request to identify distribution channels and notify recipients about the situation. The Chief Pharmaceutical Inspector explained that in the light of the Minister of Health’s interpretation, the decision to withdraw the vaccine could not be issued for the product that is not in the market. That information was also provided to RARS.

The government's vaccination commissioner

The Chancellery of the Prime Minister and the Government Commissioner for the National Vaccination Programme dealt mainly with conducting campaigns encouraging Polish people to vaccinate. Over PLN 155 million (US$36.9 million) was spent in pursuit of that aim.

In parallel, no definitions were established to determine the effects of this initiative. How could they know what success is?

While the Commissioner according to the NIK had an obligation to analyze the relevant activated legislation as well as existing solutions as they relate to prophylactic vaccinations, the office failed to do so whatsoever. The Commissioner simply deferred to analyses promulgated by the Minister of Health. This is truly problematic.

The Commissioner was also obliged to prepare proposals of new legal solutions and initiatives in terms of the COVID-10 National Vaccination Programme.

“In view of the above, according to NIK, it was unjustified to appoint a vaccination commissioner, whose tasks could be discharged by the existing state bodies.”

In performing his tasks, particularly in drafting changes to resolutions on the National Vaccination Programme, the vaccination commissioner drew on the information and knowledge of the Government Analysis Centre, the Ministry of Health, the National Health Fund, the e-Health Centre, the Government Security Centre or the Chief Sanitary Inspector.

After the vaccination commissioner’s office was lifted, the Programme supervision was entrusted to the Minister of Health, meaning a complete takeover, clearing the pathway for the exact COVID-19 countermeasure execution NIK founds so many troubles with.




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