The Therapeutic Goods Administration will publish its own findings into CSL flu shot irregularities in the wake of an investigation by US authorities in April and a follow-up letter accusing the company of failing to properly probe “dark particles” in its vials.
The US Food and Drug Administration’s two audits of CSL’s Parkville premises in April, which have been ignored by the Australian media despite stories appearing in the US business press and specialist publications this week, was followed up by a “please explain” letter sent on June 24 to CSL’s CEO Brian McNamee, the brother of tennis legend Paul McNamee. The letter was publically released this week on the FDA’s website alongside with an explanatory note on the reasons behind the probe.
It criticised the firm for not accounting for the possibility of a chemical reaction between the vaccine preservative and vials or rubber stoppers used to plug the flu shot containers, but said the vials had not endangered any patients. The investigation did not relate to the single dose syringes that were the subject of a recent seizure scare in Western Australia.
But until this morning the TGA had remained mute in line with the tight control it exercises over the information flow from Canberra. The TGA closely collaborated with the FDA during the probe and maintains strong links with the formerly government-owned manufacturer.
The TGA told Crikey it had “contributed detailed information to the public statements on the investigation of the flu vaccine issue made by the Chief Medical Officer”, and will soon publish on its website a summary of the findings:
“The TGA is aware that the US FDA’s Centre for Biologics Evaluation and Research published an Untitled letter addressed to CSL Ltd citing deviations in the facility’s compliance with current Good Manufacturing Practices. This type of letter is a standard US regulatory practice whenever matters are identified during a manufacturing inspection. It relates to products supplied to the United States.”
However, it remains unclear whether the TGA had identified the problems with the CSL vaccine before its tenacious US counterpart raised the alarm.
“Importantly,” the local regulator said, “these findings do not relate to the single dose flu vaccine vials that have been associated with febrile convulsions in Australia.” The use of seasonal influenza vaccines were suspended for children under five after troubling reports of fevers, seizures and convulsions.
The FDA’s letter demanded follow-up meetings with McNamee to ensure his product remained legit: “We would like to meet with you and other senior management at CSL Biotherapies to further discuss the issues cited in this letter and how you will address them going forward. Given the potential contributions of safe, pure, and potent vaccines to the public health, we encourage frequent interactions between your technical staff and FDA in an effort to help CSL Biotherapies move forward with corrective actions as rapidly as possible.”
The FDA also told the company to ensure containers don’t react or leach into the product, that batches of vaccines are examined each year for deterioration, and to establish tests to assure the regulator they conform to standards of strength, quality and purity.
A CSL spokesperson said this week the company was taking the issues raised by the FDA “very seriously”.
“Our investigations show that the particles are a discoloration of the vaccine, and are not foreign-contaminating matter,” they said. “CSL … will work with the regulator to resolve its concerns.”
CSL shares fell 0.68% or 32 cents to $32.51 this week, outperforming the broader market which tumbled 5.1%.
I was going on about this in February and I was accused of being a tinfoil hat guy. In fact one Catherine Scott attacked me for daring to question vaccination, the Govt. or CSL while a small university based operation that was producing single dose killed vaccine that was squalene and thimerasole free couldn’t get a gig. The NHMRC wouldn’t even grant them one million dollars in research funds but went out and splurged 120 million doses from CSL which it is still trying to jam into our arms. You see single dose packs are fine if you just want to go into the doctor and get one for yourself but if the govet ios paying, its too costly, too time consuming and too difficult to store. This is why just about everything is shipped in multi-dose vials. But to ensure multiple doses don’t spoil, they have to load them up with thimerasol (mercury) and other stabilisers. That CSL talks about single dose is a laugh. That would have been the minority of doses shipped as far as I know.
Not that I have 30 seconds for the FDA and anything they may say. That organisation to my way of thinking is no more than a revolving door through which Big Pharma appointees get to make the regulations while on sabbatical from their real jobs. A bit like the US Treasury and the Pentagon as best I can ascertain. Ditto WHO and the rest of those supposed regulators there for the safety of the public who recruit from the people they are supposed to be policing. I want to make sure this crap isn’t allowed to happen here or is it already?
After a smeer from one Catherine Scott:
15th February 2010
I said:
“I’ll take mine, single batch, squalene and thimerasol free, killed and without any live contaminants thanks! How about you?”
Immediately following this comment:
Nicolai Petrovsky from Flinders University said this:
“Having been quoted in the article I feel I should correct some misconceptions. Our Australian company Vaxine is developing a single batch, squalene, thimerosal (mercury), aluminium and egg-protein free influenza vaccine. This is very different vaccine to the inactivated egg grown virus, thiomersal containing multidose influenza vaccine produced by CSL. When we approached the NHMRC for modest funding (less than 1 million dollars) to help support the clinical trials of this vaccine this request was refused. Apart from this modest grant request which was refused we have never asked the Aust govt to buy our vaccine as suggested. We have challenged the refusal by NHMRC to provide this small funding request to development of what we would argue is a dramatically improved approach to CSL flu vaccine approach. To paraphrase the NHMRC response ‘the development of a swine vaccine was considered a low priority and of little interest to the committee assessing the swine flu research applications’. This at a time when CSL still hadn’t made an effective vaccine swine flu and these particular grants were exclusively for swine flu projects!”
Thank the lord for you, Crikey. My requests for information from the TGA have been ignored and I’ve all but given up on the media for actually following through on a story as serious as this. My only criticism of your story is that you mentioned the use of the vaccine fir under 5s was suspended “after troubling reports of fevers, seizures and convulsions” but you failed to mention two year-old Ashlee Epapara who died 9 hours after receiving the vaccine. Although a direct link has not at this time been made, it certainly has not been ruled out either.