The main concerns were raised about the quality of the first batches of Pfizer’s coronavirus vaccine, revealed documents that were leaked from the EU medical regulator.
Scientists tasked with checking the chemicals sent to the block for approval last year found that the doses were of a lower standard than the American pharmaceutical company had promised.
In an email dated 23 November, a senior official at the European Medicines Agency warned of a ‘significant difference’ in vaccine quality compared to vaccines used in Pfizer clinical trials.
The cause of the worst quality was unknown and the impact on the safety and efficacy of the vaccine “has not yet been defined,” the email said. Pfizer says the affected jabs have not been launched on the continent.
It is not clear whether similar quality problems have been raised in the UK, where the Pfizer jab is one of two vaccines that have already been launched for 23 million Britons. Regulators in the EU and the United Kingdom check each batch of the vaccine before allowing it to be used.
On the back of the discovery, EU officials filed two ‘main objections’ to Pfizer, along with a number of other quality control issues that she wanted to address before she 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 being prepared at a factory in Belgium (archive image)
Although the reason behind the poorer quality of vaccines sent to the EU is unclear, the Pfizer jab is made of extremely volatile genetic material known as messenger RNA (mRNA), which at the time meant that it had to be kept at -70 ° C.
If not stored or transported properly, mRNA can be damaged by other molecules in the environment, including light and temperature.
Since then, the guidelines have been updated to say that the vaccine can be kept at normal freezing temperatures for two weeks. Once it arrives at the clinic, it can be stored in the refrigerator for five days before use.
The EMA found that only 55 percent of the mRNA in vaccines sent to the EU was stable and intact, compared with 78 percent in Pfizer studies.
Exactly what effect this has on vaccines is unclear, but intact mRNA is essential for the vaccine’s potency, experts say.
EMA approved the Pfizer / BioNTech vaccine on December 21 and said the quality of the jab was considered ‘sufficiently consistent and acceptable’.
However, it is not clear how the agency’s concerns were addressed.
According to one of the emails that leaked on November 25, an EMA official said: ‘The last batches indicate that the% of intact RNA is around 70-75 percent, which makes us cautiously optimistic that additional data can solve the problem. ‘
The emails were part of more than 40 megabytes of confidential information from the agency’s analysis that was published on the dark web after the cyber attack.
Several journalists – including from BMJ – and academics from around the world received copies of the leaks.
They came from anonymous email accounts and most efforts to interact with senders have been unsuccessful.
None of the senders has revealed their identity and the EMA says it is conducting a criminal investigation.
In a statement released last night, the EMA said the leaked information had been partially tampered with, but confirmed that the emails were real.
He added: ‘Although individual emails are authentic, data from different users has been selected and aggregated, screenshots from various folders and mailboxes have been created and additional titles have been added by the perpetrators.’
A Pfizer spokesman told MailOnline that the quality problems have been resolved with the EMA and none of the worrying vaccines have been launched on the continent.
He added that EMA now double-checks Pfizer vaccine supply shipments.
They added: ‘After the initial disclosure of an EMA data breach, some documents related to the ongoing review of EMA’s Pfizer / BNT clinical vaccine program were found on the Internet.
‘Discussions with regulatory authorities on the quality aspects of the vaccine, including specifications, represent a normal component of the regulatory review process.
“All issues that arose during the procedure were discussed transparently with the agency, in accordance with normal practices, and all issues were properly addressed during the review process.
‘EMA’s positive opinion … on December 21st … are results of this process, which means that all issues raised during the procedure were addressed satisfactorily and the effectiveness, safety and quality of the vaccine could be proven in the data submitted.
‘EMA is conducting a thorough investigation into the cyber attack on its systems.
“It is important to note that each batch of vaccines is tested by the official drug control laboratory (OMCL) – the Paul-Ehrlich Institute in Germany – before the final product is launched.
“As a result, the quality of all doses of vaccines that are placed on the market in Europe has been doubly tested to ensure compliance with the specifications agreed with the regulatory authorities. If a batch did not meet the required specifications, the product would not be released for use in Europe.
“As with all vaccines, equivalent quality controls are in place with the US FDA and several other regulators around the world where the vaccine has been authorized for use.”
The leaks raise questions about the quality of other mRNA vaccines, including Moderna’s jab, which is already being launched in the United States and will be shipped to Britain in the coming weeks.
Pfizer and Moderna declined to disclose what percentage of mRNA integrity they consider acceptable for Covid vaccines.
The EMA, the United States Food and Drug Administration (FDA), declared that specific information about the criteria is confidential.
And the UK Medicines and Health Products Regulatory Agency has not yet responded to MailOnline’s request for comment.
Pfizer also declined to comment on the mRNA integrity percentage it aims for, nor did it say what may have caused quality declines in certain batches.
The lack of transparency by regulators and vaccine manufacturers will raise concerns that similar problems may arise in the future.
Professor Daan Crommelin, a pharmaceutical specialist at the University of Utrecht in the Netherlands, said there is a lack of understanding about the percentage of intact mRNA needed because it is an entirely new technology.
He added: ‘For small, low molecular weight products, the integrity of the active pharmaceutical ingredient is usually close to 100 percent’.
‘But for mRNA vaccines? Experience with mRNA integrity is limited. ‘
Unlike traditional jabs that scientists have decades of development experience, this is the first time that mRNA has 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, which means that scientists do not need to rely on cells from living animals.
Siu Ping Lam, Director of Licensing at MHRA, said: ‘Observations of lower levels of RNA integrity with certain initial batches have been addressed and are not an ongoing concern.
‘We are pleased that the RNA integrity of all batches used in the UK to date has met product requirements.’