Great concern has been raised about the quality of early groups of Pfizer’s coronavirus vaccine, leaked documents from the EU’s medical regulator revealed.
Scientists sent to the block last year for approval of the chemicals found that doses were of a lower standard than the U.S. drugmaker promised.
In a November 23 email, a senior European Medicines Agency official warned of a ‘significant difference’ in the quality of the vaccines compared to samples used in Pfizer’s clinical trials.
The cause of the poorer quality was unknown and the impact on the safety and efficacy of the vaccine has not yet been defined, the email reads. Pfizer claims that the jabs in question were not rolled out on the mainland.
It is unclear whether similar quality issues have been raised in the UK, where the Pfizer stab point is one of two vaccines already rolled out to 23 million Britons. Regulators in the EU and the UK check each range of vaccines before they are approved.
At the back of the finding, EU officials addressed two ‘major objections’ to Pfizer, along with a number of other quality control questions they wanted to answer, before approving the vaccine.
The documents were leaked to the British Medical Journal (BMJ) following a cyber attack on the EU regulator in December.
Hundreds of thousands of doses of Pfizer’s Covid-19 vaccine are being prepared in a factory in Belgium (file image)
Although the reason for the poor quality of vaccines sent to the EU is unclear, Pfizer’s sticking point from extremely volatile genetic material is known as messenger RNA (mRNA), which at the time meant it had to be kept at -70 ° C. .
If not stored or transported properly, the mRNA can be damaged by other molecules in the environment, including light and temperature.
Guidance has since been updated to say that the vaccine can be kept at normal freezer temperatures for two weeks. Once it arrives at a clinic, it can be stored in a refrigerator for five days before use.
According to the EMA, only 55 percent of the mRNA in vaccines sent to the EU was stable and intact, compared to 78 percent in Pfizer’s studies.
Exactly what effect it has on the vaccines is unclear, but intact mRNA is essential for the potency of the vaccine, experts say.
The EMA approved Pfizer / BioNTech’s vaccine on 21 December, claiming that the quality of the jab was ‘sufficiently consistent and acceptable’.
However, it is unclear how the agency’s concerns were met.
According to one of the leaked emails of November 25, an EMA official said: ‘The latest lots indicate that% of intact RNA is about 70-75 percent back, leaving us cautiously optimistic that additional data could handle 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 the BMJ, and academics worldwide have received copies of the leaks.
It comes from anonymous email accounts and most attempts to communicate with the senders were unsuccessful.
None of the senders disclosed their identities, and the EMA says it is launching a criminal investigation.
In a statement issued last night, the EMA said the leaked information was partially doctored, but it confirmed that the email was true.
It adds: ‘Although individual emails were authentic, data from different users were selected and merged, screenshots were created from multiple folders and mailboxes, and additional titles were added by the offenders.’
A Pfizer spokesman told MailOnline that issues with the EMA had been ironed out and that none of the concerned vaccines had been rolled out on the continent.
It added that the EMA is now monitoring Pfizer’s shipments of vaccines.
They added: ‘Following the initial disclosure of a data breach that occurred at EMA, some documents related to the EMA’s ongoing review of the clinical program Pfizer / BNT vaccine were found on the Internet.
Discussions with regulators on aspects of vaccine quality, including specifications, are a normal part of the review process.
‘All the issues raised during the procedure were discussed transparently with the agency, in accordance with normal practice, and all the issues were properly addressed during the review process.
The positive opinion given by the EMA on 21 December … is the results of this process, which means that all the questions raised during the procedure have been satisfactorily addressed and that the efficacy, safety and quality of the vaccine have been the data can be shown. submitted.
‘EMA is conducting a full investigation into the cyber attack on its systems.
‘It is important to note that each group of vaccines is tested by the official Medical Control Laboratory (OMCL) – the Paul-Ehrlich Institute in Germany – before the final product is released.
‘As a result, the quality of all vaccine doses placed on the market in Europe has been double-tested to ensure compliance with the specifications agreed by the regulatory authorities. If a group does not meet the required specifications, the product will not be released for use in Europe.
“As with all vaccines, equivalent quality controls apply to the US FDA and several other regulators around the world where the vaccine has been authorized to be used.”
The leaks raise questions about the quality of other mRNA vaccines, including the modern jab that is already being rolled out in the US and will be sent to Britain somewhere in the coming weeks.
Pfizer and Moderna declined to say what percentage of mRNA integrity they consider acceptable for vaccines against Covid.
The EMA, the U.S. Food and Drug Administration (FDA), said specific information about criteria is confidential.
And the UK Regulatory Agency for Medicines and Healthcare Products has not yet responded to MailOnline’s request for comment.
Pfizer also declined to comment on what percentage of mRNA integrity it envisages, nor would it say what could have caused quality decline in certain groups.
The lack of transparency of regulators and vaccine manufacturers will raise concerns 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 required because it is a brand new technology.
He added: “For small products with a low molecular weight, the integrity of the active pharmaceutical ingredient is usually almost 100 percent.”
‘But for mRNA vaccines? Experience with mRNA integrity is limited. ‘
In contrast to the traditional samples that scientists have decades of experience in development, this is the first time that mRNA has ever been used in vaccinations.
According to scientists, mRNA vaccines are cheaper to apply and easier to adapt to new variants or viruses.
The process of developing mRNA vaccines is also purely synthetic, meaning that scientists do not have to rely on living animal cells.
Siu Ping Lam, MHRA Director of Licensing, said: ‘The observations of lower levels of RNA integrity with certain early groups have been addressed and are not an ongoing concern.
“We are pleased that the RNA integrity of all groups used in the UK so far has met the product requirements.”