Why regulators are being taken to court over Pfizer’s Covid vaccine
Both the US and SA medicines regulators have faced legal challenges over the information used to review and approve Pfizer’s Covid vaccine
People want information about Covid vaccines – which laws say they have a right to. So when word got out that it will take the US Food & Drug Administration (FDA) more than 50 years to make available the regulatory information about the BioNTech/Pfizer Covid vaccine, people were up in arms.
In the US, the Freedom of Information Act allows people to ask for any records they want from government agencies such as the FDA. SA’s Medicines Act makes a similar provision for people to object to decisions of our own medicines regulator, the SA Health Products Regulatory Authority (Sahpra). The health minister must then appoint a committee to evaluate the issue.
Both the FDA and Sahpra have been inundated with requests for information about Covid vaccines and other treatments and devices – and both have also faced legal challenges in that regard.
In the US, the FDA has received over 8,300 applications requesting information from the regulator – about various products – between October 2020 and 2021.
In one of these, on August 27, an organisation called the Public Health & Medical Professionals for Transparency asked for all the information that the regulatory body had collected on Pfizer’s jab to be released. This came four days after the FDA approved the vaccine for emergency use in the US.
Similarly, Sahpra has also been processing several requests, according to its CEO, Boitumelo Semete-Makokotlela. Semete-Makokotlela has, however, not specified how many have arrived at their offices.
Meeting these demands not only puts a heavy administrative burden on regulators – because sorting through all the information takes a lot of time and effort – but can also bring hefty legal costs should a case go to court.
A call for regulatory data in the US
In the US, requests for information from government agencies should be addressed within 20 working days. However, the law does acknowledge that more complex queries can take longer, especially if documents need to be sourced from multiple places, or be prepared according to certain rules before they can be released.
Some of these requirements relate to exceptions about what can be made public, such as trade secrets or other confidential commercial information and details that would violate someone’s privacy. This means the documents have to be sifted through carefully to redact any confidential information.
The FDA handles information requests in the order that they arrive. When the call came for details about the Pfizer vaccine, 5,592 other requests had already been submitted that year, many of them about products other than Covid vaccines.
According to the regulator, the division that would be dealing with this application already had 459 pending submissions to work through and only 10 people to do so.
A request for a faster processing time was denied by the FDA.
Three weeks after filing their initial request, the Public Health & Medical Professionals for Transparency group took the FDA to court for the documents.
The lawsuit and the document dump
The FDA argued that it was being asked to provide over 300,000 pages of documents along with 126 datasets made up of thousands of rows in spreadsheets.
Factoring in the time to process and redact the restricted information in all the required documents, the agency originally estimated that it would be able to go through 500 pages a month. At this pace, it would take 55 years to release all the documents.
In a ruling on January 6 , judge Mark Pittman noted that though providing all the requested documents would be “unduly burdensome”, fulfilling the request was “of paramount public importance” to ensure transparency in the process and dispel doubts about the vaccine’s safety.
The FDA was ordered to provide over 12,000 pages by the end of January and then from March onwards release an additional 55,000 pages each month until all the documents had been made public.
But simply making information available doesn’t mean it’s accessible.
The documents released by the FDA have been uploaded to the Public Health & Medical Professionals for Transparency website (also the pages cleared in March) — in total, there are now 150 documents available to view.
But they aren’t labelled clearly nor do they have descriptions to show what they refer to. Finding useful information in the pile of papers is therefore like looking for a needle in a haystack.
The situation in SA
In February, a nonprofit organisation called Free the Children – Save the Nation appealed Sahpra’s decision in September last year to green-light the emergency use of Pfizer’s vaccine for teenagers between 12 and 17 years old.
This self-proclaimed “children’s rights group” is headed by an engineer whose goal is to “change the perception that Covid is a deadly disease” or that the spread of the SARS-CoV-2 virus constitutes a pandemic.
At a closed meeting on the same day as the official public hearings that month, Ngcukaitobi ruled that Sahpra must hand over the documents that it used in its decision on teenage immunisations.
Because Sahpra didn’t have time to gather the documents between the closed meeting and public hearings, they weren’t handed over on that day. The proceedings have been rescheduled to May 31.
Sahpra finds itself in an unusual position because the body has to determine how much it can legally share and still protect the confidentiality of the data that Pfizer submitted as part of its application.
Though the country’s laws do allow for such information to be made available during certain legal proceedings, Sahpra cannot infringe on the rights of people whose medical information may be included in those documents, say, in results of clinical trials.
That means Sahpra’s legal team has to work through all the documents to remove any information that may get them in trouble with Pfizer.
Semete-Makokotlela says Sahpra has never been told to give information to a third party before. Usually such appeals would come from the company that applied in the first place, so sharing data would not be a problem. Because of this unfamiliar territory, the regulator has no idea how long it may take to complete this process.
“We’ve never been in a situation like this,” she says.
Misgivings and misunderstandings
As part of the approval agreement, Pfizer was required to submit regular safety updates, including any reactions people had after being vaccinated. This is so that the safety of the vaccines can continually be monitored.
Among the documents released by the FDA in March was one that tracked such reactions that had been reported within the first three months of Pfizer’s jab being used in countries’ vaccine rollouts (from December 2020 to February 2021).
The only side effect recorded at the time of the report, which was prepared in April 2021, was the risk of anaphylaxis (a severe allergic reaction that can be life-threatening because breathing becomes difficult or your blood pressure drops suddenly).
An evaluation by the World Health Organisation (WHO) in January this year similarly notes only two major side effects: anaphylaxis and a type of heart inflammation called myocarditis (for which younger men are at higher risk).
And a study published in the journal The Lancet Infectious Diseases on March 7 found that after close to 300-million doses of Pfizer and Moderna jabs had been administered in the US, only 0.1% of people reported having side effects within six months of getting their shots. In nine out of 10 cases the reported symptoms were mild.
But the safety document the FDA released in March caused much controversy, because of its last nine pages that listed more than 1,200 “adverse events of special interest” from facial paralysis to “foaming at the mouth”.
An adverse event is a fancy way of saying someone had a reaction after taking a medication or getting a vaccine, but this response is not necessarily caused by the product.
Only if the reported reaction is found to be linked to the product, such as a vaccine, is it officially listed as a side effect, Prof Hannelie Meyer, the chair of the health department’s independent national immunisation safety expert committee, explained in a webinar on Tuesday.
Only two of the reactions on the list of 1,291 in Pfizer’s documents have been linked to the vaccine – myocarditis and anaphylaxis.
Staying on top of special-interest reactions
Regulators and manufacturers have a watchlist of possible reactions to look out for. These are based on things they’ve seen after people received jabs that use similar ingredients or the type of technology used to make the shots. Pfizer would also have looked at the possible consequences of SARS-CoV-2 (the virus that causes Covid) infection, such as heart inflammation, and added those symptoms to the list.
Because a vaccine manufacturer doesn’t know by the time it files its application for regulatory approval if anyone will actually have this type of reaction or how often it may occur, it is listed as something to be aware of when seeing how people are faring after immunisation.
As part of the process to ensure that a product such as a vaccine is safe, regulatory bodies require manufacturers to continue providing updates about reactions people develop after getting the jab. This information has to be properly reviewed and the regulator has to remain vigilant about possible safety issues that could call for additional warnings for a product’s use.
For example, both Sahpra and the FDA were alerted to concerns that the Johnson & Johnson vaccine may be linked to blood clots through this rigorous monitoring process. The issue was then investigated and an additional side effect was listed for the jab.
“Safety is an important concern and no product, including vaccines, will be made available to the public if there are any indications that public safety will be compromised,” said Semete-Makokotlela in a statement on March 11.
How to read a safety report
At the time Pfizer submitted its report to the FDA, its vaccine had been rolled out in 56 countries and the company had received about 42,000 notifications of reactions, which included 158,893 side effects (sometimes one person may report multiple reactions, like fatigue, a headache and nausea).
Rather than just a list of the more than 1,000 special-interest effects, the report also includes a 10-page table outlining the details for each of these reactions. It concludes that the reactions will continue to be monitored but were not a safety concern at the time.
In Tuesday’s webinar, Semete-Makokotlela explained that people should think of vaccines like any drug in their medicine cabinet. Any packet of pills comes with a pamphlet that lists all the possible side effects caused by that drug — some of which are rarer than others.
Because of that small risk associated with the drug, the use of medications is monitored and the doses are controlled. In much the same way, Sahpra’s role is to stay alert about the safety of Covid vaccines, as well as their potential risks, and then let people know if there is anything new to report.
How does Sahpra keep tabs on side effects?
One of the conditions of Sahpra’s approval of Pfizer’s vaccine is that the pharmaceutical company has to continue updating information about side effects or reactions reported elsewhere in the world so that our regulator would know what to monitor, explains Florah Matlala, who oversees pharmacovigilance at Sahpra.
Pharmacovigilance is the process of monitoring a medicine’s side effects and safety after it is registered and in use by the public.
Sahpra said it had not seen exactly the same documents as the ones in the FDA’s document dump, because Pfizer sent the local regulator newer information (the company applied to have the vaccine approved in SA after it had requested authorisation in the US, so more updated information had been available).
The regulatory body doesn’t rely only on information provided by the manufacturer, and has several mechanisms in place that help it stay up to date with the safety profile of a product such as a vaccine.
These include access to a global database where multiple parties and regulatory bodies submit their data to help identify symptoms in people who have been immunised.
It also has relationships with reputable regulators, such as the FDA, to help it monitor safety updates, and partnerships with institutions elsewhere in Africa to keep an eye on any noteworthy signs or symptoms cropping up in more local settings.
One of the tools Sahpra uses involves looking at reports from the public, sent either to health-care professionals or directly to the regulator through its MedSafety App.
The app allows people to log the side effects or reactions they may experience after taking a Covid vaccine. It was launched in April 2021.
According to this data, there were 4,208 reports of side effects after 24-million Pfizer jabs had been administered in SA. These reports account for 0.02% of all shots administered.
The website doesn’t provide details on every reaction that’s monitored by the local medicines regulator, because it is worried that releasing a list of every symptom being reported “will cause unnecessary alarm,” says Semete-Makokotlela.
Reactions such as those listed in the FDA-released report have not been linked to the vaccine or are still being investigated. Semete-Makokotlela believes that publishing that data without enough context or public understanding could cause panic or lower trust in the jab’s safety. Sahpra has therefore chosen to only publicise details on side effects that have been linked to the shots.
The pandemic has helped bring safety into the spotlight and highlighted the role of the country’s medicines regulator, Matlala says. “People want to scrutinise everything and … that’s a good thing.”
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