Leaked documents reveal serious concerns about the quality of early batches of Pfizer’s Covid vaccine

by

Great concerns were raised about the quality of early batches of Pfizer’s coronavirus vaccine, according to leaked documents from the EU’s medical regulator.

Scientists tasked with monitoring the chemicals sent to the block for approval last year found that the doses were lower than the US drug manufacturer had promised.

In an email dated Nov. 23, a senior European Medicines Agency official warned of a “significant difference” in the quality of the vaccines compared to injections used in Pfizer’s clinical studies.

The cause of the poorer quality was unknown, and the impact on the vaccine’s safety and efficacy was “ yet to be defined, ” the email said. Pfizer claims the affected jabs have not been rolled out on the continent.

It’s unclear if similar quality issues have arisen in the UK, where the Pfizer shot is one of two vaccines already rolled out to 23 million Britons. Regulatory authorities in the EU and the UK check every batch of the vaccine before it is used.

On the back of the find, EU officials filed two “ major objections ” with Pfizer, along with a slew of other quality control questions it wanted to answer before it could approve the vaccine.

The documents were leaked to the British Medical Journal (BMJ) after a cyber attack on the EU regulator in December.

Hundreds of thousands of doses of Pfizer's Covid-19 vaccine are prepared in a factory in Belgium (image file)

Hundreds of thousands of doses of Pfizer’s Covid-19 vaccine are prepared in a factory in Belgium (image file)

While the reason behind the poorer quality of the vaccines sent to the EU is unclear, Pfizer’s shot is made from an extremely volatile genetic material known as messenger RNA (mRNA), which at the time meant it was at -70 ° C had to be kept.

If the mRNA is not stored or transported properly, it can be damaged by other molecules in the environment, including light and temperature.

The guidelines have since been updated to say the vaccine can be stored at normal freezing temperatures for two weeks. Once arrived at a clinic, it can be kept in the refrigerator for up to five days before use.

WHAT IS MRNA AND WHY IS THE PFIZER VACCINE SENSITIVE TO ‘PRINT’?

The breakthrough shot – shown to be 95 percent effective at blocking Covid-19 – was the world’s first vaccine against the virus to seal approval when Britain gave it the green light in December.

It is made of a volatile genetic material known as mRNA, which is constantly under threat from destruction by other molecules in the environment.

BioNTech packages the vaccine in dry ice-filled batches of 975 vials, each containing five doses, which must be stored at -70 ° C to avoid destruction of the mRNA during transport or storage.

Messenger RNA is used by human cells to transmit messages and give instructions. Pfizer’s jab tells the body to create the coronavirus’s unique spike protein, which trains the immune system to recognize and fight future infections.

But as a result of the natural rapid reversal of mRNA’s lifespan, it is naturally a short-lived molecule that is only meant to be a matter of hours.

This poses a significant problem when trying to get the mRNA vaccine into a human, as it will degrade and become unusable under normal conditions.

There are not many proven ways to ensure long-term survival of the vaccine. A proven method is extremely cold temperatures, which stops all movements and reactions and prevents any kind of decomposition of the mRNA. However, the vaccine must be administered at room temperature because the mRNA must be mobile.

If the vaccine is left out too long before it is injected, it will become too hot and the mRNA will start to decay naturally. If this is then injected into a person, it will not work properly, the body will not make the spike protein, and there will be no immune response. That person will still be vulnerable to Covid-19.

Light and temperature can energize the mRNA molecule, accelerating the already rapid process of decay. To conserve Pfizer’s vaccine, it must be stored at super low temperatures of approximately -70C (-94F) and stored in dark glass vials to protect from light.

These precise conditions must be maintained throughout the vaccine’s journey and, once removed from the freezer and thawed, it can only be kept in standard medical refrigerators for five days before it ‘spoils’.

Makers of the jab warn that it is only transported during transport at normal refrigerator temperatures for up to six hours, as the dreaded movement in warmer conditions breaks down the vaccine even faster.

The EMA found that only 55 percent of the mRNA in the vaccines shipped to the EU was stable and intact, compared to 78 percent in Pfizer’s studies.

Exactly what effect this has on the vaccines is unclear, but intact mRNA is essential for the vaccine’s potency, experts say.

The EMA approved the Pfizer / BioNTech vaccine on Dec. 21, claiming the quality of the shot was “sufficiently consistent and acceptable.”

However, it is unclear how the agency’s concerns were addressed.

According to one of the leaked emails of November 25, an EMA official said: “ The latest parties indicate that the percentage of intact RNA is back around 70-75 percent, which makes us cautiously optimistic that additional data can fix the problem . ‘

The emails were part of more than 40 megabytes of classified information from the agency’s review published on the dark web after the cyber attack.

Several journalists – including from the BMJ – and academics around the world received copies of the leaks.

They came from anonymous email accounts and most attempts to communicate with the senders were unsuccessful.

None of the senders has disclosed their identity and the EMA says it is conducting a criminal investigation.

In a statement last night, the EMA said the leaked information had been partially manipulated, but it confirmed the emails were genuine.

It added, “While individual emails are authentic, data from different users has been selected and merged, screenshots have been taken of multiple folders and mailboxes, and additional titles have been added by the perpetrators.”

A Pfizer spokesperson told MailOnline that the quality issues with the EMA had been resolved and none of the worrying vaccines were rolled out on the continent.

It added that the EMA is now double-checking Pfizer’s deliveries of vaccines.

They added: “Following the initial disclosure of a data breach that occurred at EMA, some documents were found on the Internet pertaining to the EMA’s ongoing evaluation of the Pfizer / BNT vaccine program.

Discussions with regulatory authorities on vaccine quality aspects, including specifications, are a normal part of the regulatory review process.

All issues raised during the procedure were discussed transparently with the Bureau, in accordance with normal practice, and all questions were duly addressed during the review process.

“ The EMA’s positive opinion … on December 21 … is the result of this process, which means that all questions raised during the procedure have been satisfactorily answered and that the efficacy, safety and quality of the vaccine can are demonstrated on the basis of the data submitted.

EMA is conducting a full investigation into the cyber attack on its systems.

It is important to note that each batch of vaccines is tested by the Official Medicinal Control Laboratory (OMCL) – the Paul-Ehrlich Institute in Germany – before the final product is released.

As a result, the quality of all vaccine doses marketed in Europe has been double-tested to ensure they meet the specifications agreed with the regulatory authorities. If a batch does not meet these required specifications, the product will not be released for use in Europe.

“As with all vaccines, there are equivalent quality controls at the US FDA and several other regulatory agencies around the world where the vaccine is approved for use.”

The leaks raise questions about the quality of other mRNA vaccines, including the Moderna jab, which is already being rolled out in the US and shipped to the UK sometime in the coming weeks.

Pfizer and Moderna have declined to disclose what percentage of mRNA integrity they consider acceptable for vaccines against Covid.

The EMA, the United States Food and Drug Administration (FDA) stated that specific information about criteria is confidential.

And the UK medicines and healthcare products regulator has yet to respond to MailOnline’s request for comment.

Pfizer also declined to comment on what percentage of mRNA integrity it pursues, nor would it say what could have caused the quality dips in particular batches.

The lack of transparency from regulators and vaccine manufacturers will be a concern that similar problems may arise in the future.

Professor Daan Crommelin, a pharmaceutical expert at Utrecht University in the Netherlands, said there is a lack of understanding about the percentage of intact mRNA needed because it is a completely new technology.

He added, “For low molecular weight products, the integrity of the APIs is typically close to 100 percent.”

But for mRNA vaccines? Experience with mRNA integrity is limited. ‘

Unlike traditional jabs that scientists have decades of experience with, this is the first time mRNA has ever been used in vaccinations.

Scientists say mRNA vaccines are cheaper to make and easier to modify in the face of new variants or viruses.

The process of developing mRNA vaccines is also purely synthetic, meaning scientists don’t rely on living animal cells.

Siu Ping Lam, MHRA Director of Licensing, said, “The observations of lower levels of RNA integrity in certain early batches have been addressed and are not a persistent problem.

“We are confident that the RNA integrity of all batches used in the UK to date will meet product requirements.”

Source