..
Hacked emails allegedly detail how EU drug regulator was pressured to approve Pfizer jab despite ‘problems’ with the vaccine
18 Jan 2021 12:54
An alleged cache of email exchanges between EU officials and the European Medicines Agency show that the drug regulator was uncomfortable about fast-tracking approval for the Pfizer and Moderna Covid jabs, Le Monde has reported.
The EMA has claimed that the contents of the messages, which were obtained by hackers and published on the dark web, were tampered with in order to undermine confidence in the drugs, without providing further details. However, the agency acknowledged to the French newspaper that the correspondences reflect “issues and discussions” that took place in the lead-up to the decision to grant approval to the vaccines. The agency said it can’t specify which documents are genuine.
Some of the “discussions” appear to have been less than congenial. For example, in a document dated November 19, a senior EMA official described a “rather tense, sometimes even a little unpleasant” conference call with the European Commission regarding the review process for the drugs. The official said he felt there was a clear “expectation” that the vaccines would be approved. A day later, the same individual had an exchange with the Danish Medicines Agency in which he expressed surprise that Ursula von der Leyen, the president of the European Commission, had announced that the Moderna and Pfizer jabs could receive the green light before the end of the year.
“There are still problems with both,” the unnamed EMA official noted in the leaked correspondence.
According to Le Monde, the hacked documents primarily detail issues that the EMA had with the Pfizer/BioNTech drug. The regulator apparently had three “major issues” with the vaccine:
certain manufacturing sites used for its production had not yet been inspected,
data on batches produced for commercial use were still missing, and, most importantly,
available data revealed qualitative differences between the commercial batches and those used during clinical trials.
The EMA expressed particular concern about the last point, noting that mass production had decreased the purity of the RNA contained in the vaccine. The Pfizer jab uses a mRNA strand, a sequence of molecules that tell cells what to ‘build’ in order to produce a disease-specific antigen.
The EU drug regulator signaled that it was worried that less rigorous manufacturing methods would make the vaccine less effective and safe. However, Pfizer appears to have agreed to make necessary adjustments in order to meet the EMA’s standards.
Which is possibly what they are doing now, now that horror stories are beginning to emerge. They could be making up for batches of vaccine that had to be thrown out because of quality issues.
Despite its hesitancy, it appears the EMA understood that it was under a clear deadline. In an email exchange between colleagues at the agency, one employee said the EMA needs to “accelerate the process to align [with other agencies],” and risks facing “questions and criticisms” from Brussels, the media and the general public if it did not fast-track approval.
The Pfizer jab was granted approval by the EU on December 21, while the Moderna variant was given the go-ahead earlier this month. Since then, numerous reports have emerged of both drugs being linked to adverse effects in countries around the world, prompting investigations by health authorities.
California halts injections of Moderna Covid vaccine batch
due to ‘higher-than-usual number of adverse events’
18 Jan 2021 07:03
California health officials are asking vaccine providers to stop administering a batch of Moderna’s Covid-19 jab, after an unusually high number of adverse reactions were linked to the drug.
Doses from Moderna Lot 041L20A are suspected of causing a “higher-than-usual number of adverse events” and should be shelved until a proper investigation can be conducted, the California Department of Public Health said on Sunday.
State epidemiologist Dr. Erica S. Pan said in a statement that “fewer than 10 individuals” suffered “a possible severe allergic reaction” and required medical attention over the past 24 hours after being injected with the specific batch of vaccine. All of the incidents appear to have occurred at a single community clinic that was administering the lot. The site reportedly closed for several hours after the string of adverse reactions occurred, before switching to a different batch of the drug.
It seems quality control issues are not restricted to Pfizer.
“Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory,” the health official said.
More than 330,000 doses from the same Moderna vaccine batch have been distributed to 287 providers across the state, but this is the first time that health authorities have received reports detailing adverse reactions associated with the lot, according to Pan.
While acknowledging that “less data exists on adverse reactions related to the Moderna vaccine,” the state epidemiologist said that it’s rare for vaccines to trigger serious side effects.
Moderna, the Centers for Disease Control and Prevention (CDC), and the US Food and Drug Administration (FDA) are reviewing the batch and all relevant medical data.
The Covid-19 jab has been linked to other cases of serious medical emergencies. In December, a physician in Boston said he suffered one of the worst allergic reactions he’s ever experienced after receiving Moderna’s vaccine, describing the episode as potentially life-threatening.
Similar cases linked to the Pfizer/BioNTech vaccine have been referred to the CDC and FDA for review.
No comments:
Post a Comment