Great concerns were raised about the quality of the first batches of Pfizer coronavirus vaccine, documents from the EU medical regulator have revealed.
The scientists in charge of checking the chemicals sent to the block for approval last year found that the doses were at a lower level than promised by the American drug maker.
In an email dated November 23, a senior European Medicines Agency official warned of a “significant difference” in the quality of vaccines compared to the punctures used in Pfizer’s clinical trials.
The cause of the poor quality and impact on the safety and efficacy of the vaccine was “unknown”, it was said in the email. Pfizer claims the affected blows did not unfold on the continent.
It is unclear whether similar quality issues were raised in the UK, where the Pfizer puncture is one of two vaccines already deployed to 23 million Britons. EU and UK regulators check each batch of the vaccine before allowing its use.
Behind the finding, EU officials presented two “big objections” to Pfizer, along with other quality control questions it wanted to address, before it could approve the vaccine.
The documents were leaked to the British Medical Journal (BMJ) following a cyberattack on the EU regulator in December.
Hundreds of thousands of doses of Pfizer’s Covf-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, the Pfizer puncture is made of extremely volatile genetic material known as messenger RNA (mRNA), which at the time meant that it had to be keep at -70C.
If not stored or transported properly, mRNA can be damaged by other molecules in the environment, including light and temperature.
Since then, guidelines have been updated to say the vaccine can be kept at the normal freezer temperature for two weeks. Once it arrives at a clinic, it can be stored in the refrigerator for five days before use.
The EMA found that only 55% of the mRNA of vaccines sent to the EU was stable and intact, compared with 78% of Pfizer studies.
It is not clear exactly what effect this has on vaccines, but intact mRNA is essential for vaccine potency, experts say.
On December 21, the EMA approved the Pfizer / BioNTech vaccine and stated that the quality of the jab was found to be “sufficiently consistent and acceptable.”
However, it is unclear how the agency’s concerns were met.
According to one of the leaked emails on November 25, an EMA official said: “The latest batches indicate that the percentage of intact RNA returns to 70-75%, which leaves us cautiously optimistic that additional data may solve the problem “.
The emails were part of more than 40 megabytes of classified information from the agency review that were posted on the dark network after the cyberattack.
Several journalists – including the 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 were unsuccessful.
None of the senders revealed their identity and the EMA says it is conducting a criminal investigation.
In a statement issued last night, the EMA said the leaked information was partially analyzed, but confirmed the emails were real.
He added: “While the individual emails are authentic, data from different users was selected and added, screenshots of various folders and mailboxes were created and the authors added additional titles.”
A Pfizer spokesman told MailOnline that quality issues were resolved with the EMA and that none of the vaccines of concern were deployed on the continent.
He added that the EMA is now twice reviewing Pfizer’s vaccine supply shipments.
They added: “Following the initial disclosure of a data breach that occurred at the EMA, some documents related to the EMA’s ongoing review of the Pfizer / BNT clinical vaccine program have been found on the Internet.
Discussions with regulatory authorities on aspects of vaccine quality, including specifications, represent a normal component of the regulatory review process.
“All issues that arose during the procedure have been discussed with the agency in a transparent manner, in accordance with normal practice, and all issues have been properly addressed during the review process.
“The positive opinion given by EMA … on 21 December … are the results of this process, which means that all the issues raised during the procedure were addressed satisfactorily and the effectiveness, the safety and quality of the vaccine in the data sent.
‘EMA is conducting comprehensive research on cyberattack on their 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 released.
As a result, the quality of all doses of vaccines marketed in Europe has been double-checked to ensure compliance with the specifications agreed with the regulatory authorities. If a batch does not meet these required specifications, the product would not be released for use in Europe.
“As with all vaccines, there are equivalent quality controls with the U.S. FDA and many other regulators around the world where the vaccine has been authorized for use.”
Leaks raise doubts about the quality of other mRNA vaccines, including the Moderna sting, which is already being rolled out in the United States and will be shipped to Britain in the coming weeks.
Pfizer and Moderna have refused to disclose what percentage of mRNA integrity they consider acceptable for Covid vaccines.
The EMA, the U.S. Food and Drug Administration (FDA) stated 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 percentage of mRNA integrity it claims nor would it say could have caused quality drops in certain batches.
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 needed because it is a new technology.
He added: “For small, low-molecular-weight products, the integrity of the active pharmaceutical ingredient is usually close to 100%.”
But for mRNA vaccines? Experience with mRNA integrity is limited. ”
Unlike traditional classics that scientists have decades of developmental experience in, this is the first time mRNA has been used in vaccinations.
Scientists say mRNA vaccines are cheaper to manufacture and modify more easily in the face of new variants or viruses.
The process of developing mRNA vaccines is also purely synthetic, meaning scientists should not rely on living animal cells.
Siu Ping Lam, MHRA’s licensing director, said: “Observations of lower levels of RNA integrity have been addressed with certain initial batches and are not a permanent concern.
“We are pleased that the RNA integrity of all batches used in the UK has so far met product requirements.”