European regulator raised concern over quality of early Pfizer vaccine batches, leaked emails show.

By Samuel Lovett 11th March 2021. Find Article and Video Here:-

High-ranking official flagged unexpectedly low levels of genetic molecule in November email.

Senior figures at the European Union’s medicines regulator raised concern over the quality of early supplies of the Pfizer–BioNTech vaccine, leaked documents and emails show.

Official files that have been shared globally following a cyberattack on the European Medicines Agency (EMA) show that the regulator was concerned by the molecular integrity of vaccine batches made last autumn that had been initially earmarked for commercial markets.

It is thought these supplies were never delivered to one of the many governments that pre-ordered doses of the Pfizer vaccine, or used to inoculate members of the public.

Proven to be highly effective in providing protection against Covid-19, the Pfizer jab has been authorised for use in numerous countries across the globe, with millions of doses administered to date.

The British Medical Journal (BMJ), which has reviewed the leaked EMA documents, claims that a high-ranking official within the agency outlined a series of issues with early vaccine batches made by the pharmaceutical giant in an email sent on 23 November.

The EMA highlighted that commercial manufacturing was not producing vaccine supplies to the specifications expected, with experts said to be unsure of the implications, the BMJ reports.

Specifically, the European regulator reportedly had major concerns over unexpectedly low quantities of messenger RNA (mRNA) in batches of the vaccine intended to be delivered to buying nations.

In the context of the Covid-19 vaccines, mRNA is a genetic molecule that instructs the body’s own cells to display the “spike” protein coating the outside of the virus. This prompts the immune system to produce the necessary antibodies and T-cells that then provide protection.

For early clinical batches of the Pfizer vaccine, mRNA integrity was around 78 per cent – but this figure stood at 55 per cent for certain commercial supplies, the BMJ claims.

The root cause of this disparity was unknown and the impact of this loss of mRNA integrity on the safety and efficacy of the vaccine was not defined, the email reportedly said.

Ensuring RNA integrity is one of the biggest hurdles for manufacturers developing vaccines based on this type of technology. 

These genetic molecules degrade quickly and must be kept at very low temperatures to maintain their integrity, hence the stringent cold chain requirements that surround the Pfizer and Moderna vaccines – both of which are mRNA-based.

To protect against rapid degradation, the mRNA used in the Covid-19 jabs is encapsulated in lipid nanoparticles. 

But if molecular integrity is compromised in any way – such as during the production stage – this can affect the expression of the spike protein in the body’s cells, which means the correct immune response won’t be triggered and protection may not be complete. 

The BMJ reports that is is unclear how the EMA’s concerns were satisfied. However, according to another leaked email from 25 November, the agency noted: “The latest lots indicate that % intact RNA are back at around 70-75%, which leaves us cautiously optimistic that additional data could address the issue.”

The Pfizer-BioNTech vaccine was eventually authorised for use by the EMA on 21 December. “The quality of this medicinal product, submitted in the emergency context of the current (covid-19) pandemic, is considered to be sufficiently consistent and acceptable,” the agency noted at the time.

It later acknowledged that vaccine efficacy depends on the presence of suitable amounts of intact mRNA.

However, the BMJ’s findings raise questions of what percentage of molecular integrity is considered acceptable for these types of jabs.

The Medicines and Healthcare products Regulatory Agency, which was the first regulator in the world to approve the Pfizer-BioNTech vaccine for general use, did not comment on this when approached by The Independent, and nor did Pfizer.

However, the MHRA said there were no concerns surrounding the batches of Pfizer vaccine that had been delivered to the UK.

Siu Ping Lam, MHRA director of licensing, told The Independent: “The observations of lower levels of RNA integrity with certain early batches have been addressed, and are not an ongoing concern. 

“We are satisfied that the RNA integrity of all batches used in the UK to date have met the product requirements.”

Professor Adam Finn, a member of the Joint Committee on Vaccination and Immunisation, said the BMJ report demonstrated that regulatory authorities have been monitoring vaccine quality “carefully from the outset”.

“We can also be reassured by the emerging evidence of real world effectiveness of both vaccines currently in use reported from both Scotland and England,” he added. “This would indicate that the batches used during the early part of the UK programme have been doing their job well.”

Pfizer meanwhile said that all questions surrounding the efficacy, safety and quality of the vaccine were “addressed satisfactorily” and could by “demonstrated on the data submitted” to the EMA.

“It’s important to note that each batch of vaccines is tested by the official medicinal control laboratory (OMCL) – the Paul-Ehrlich Institute in Germany – before final product release,” a spokesperson added.

“As a result, the quality of all vaccine doses that are placed on the market in Europe has been double tested to ensure compliance with the specifications agreed upon with the regulatory authorities. 

“Should a batch not meet these required specifications, the product wouldn’t be released for use in Europe.”

EMA has said it is conducting a full investigation into the cyberattack on its systems. 

No Safety Data? No Problem!

By Rosemary Frei, via her website 10th March 2021. Find Full Article and 8min Video Here:-

Video also available on Vimeo Here:-

US, UK, Canada, Australia, Switzerland and Singapore Will Let New-Variant Vaccines Onto the Market Without Safety or Efficacy Testing.

On March 4 and 5, Canada, the United Kingdom, Australia, Switzerland and Singapore released identical guidelines for fast-tracking release onto the market of vaccines for the new variants.

The countries issued the recommendations under the banner of the ‘ACCESS Consortium.’ ACCESS is an acronym based on the first letters of the five countries’ names.

A few days earlier, on February 22, the US Food and Drug Administration (FDA) released a similar set of recommendations. They allow Emergency Use Authorizations (EUAs) for “investigational” vaccines for new variants, letting them be used on the general public without first showing evidence of safety or effectiveness.

The recommendations all state that companies don’t need to conduct new clinical trials before putting the new-variant vaccines onto the market and potentially into millions of people’s arms. Requiring new trials, the ACCESS document asserts, would cause “considerable delay” and “bears the risk that the virus is evolving even further, potentially making a new vaccine version outdated at the time of approval again.”

Instead, the safety record of the currently used Covid vaccines can be used to judge the safety of the new ones, the countries’ regulatory agencies declare.

And they claim that the currently used vaccines are safe and effective: “[T]here is considerable safety experience accumulating as the pandemic progresses and vaccines are rolled out, and [in any case] efficacy has been established for the initial vaccine candidate [i.e., the original Covid vaccines] via large clinical Phase 3 studies,” the ACCESS document states.

This is despite the fact that many observers have documented significant safety problems associated with the Covid vaccines, including high death rates.

That helps explain why public-health officials and politicians around the world are bending over backwards to assert that Covid vaccines are very safe and effective. This gives the green light for all future forms of these vaccines to be used without safety testing.

(The regulatory authorities also say these new guidelines can only be used for vaccines that are modifications of the Covid vaccines already in use. But there’s enough wiggle room in the new recommendations that I believe they also will be used for new entrants into the Covid-vaccine race.)

Rather than full clinical trials, only a small amount of data needs to be put together by the manufacturers prior to seeking an EUA. Then after the EUA is granted further data can then be gathered from people in the general population who are given the vaccines.

This approach apparently is modeled on the approval of new flu vaccines every year. The flu-vaccine regulations were in turn, “developed based on ample experience gained through years of seasonal vaccinations, and the 2009 H1N1 pandemic,” the ACCESS guidelines state.

The latter claim is particularly alarming. The H1N1 swine-flu ‘pandemic’ never materialized. Hundreds of people were needlessly severely injured by the main vaccine for it, GlaxoSmithKline’s Pandemrix. Furthermore, Glaxo was not required to compensate victims; instead, the UK government paid tens of millions of pounds to people who were brain injured by Pandemrix.

Sweden is a success story and the rest of the world should emulate it. (Video)

By HECTOR DRUMMOND 11th March 2021. Watch 18min Video Here:-

The 2020 all-cause death rate for Sweden is now in and it shows unambiguously that Covid-19 is nowhere near as dangerous a disease as the lockdown fanatics are making out. The evidence is now clear: lockdowns are a pointless infringement upon our liberties.

Watch also on YouTube Here:-

Steve Bell on Prince William leading the defence of the royal family – cartoon.

By Steve Bell 11th March 2021 Find Cartoon Here:-