Safety last: How the FDA overlooked vital Covid vaccine studies

Yes, approval of the Covid-19 vaccines was fast-tracked to counter the global pandemic, but safety tests weren’t skipped, the official narrative tells us. But new research suggests that drug regulators, such as America’s Food and Drug Administration (FDA), failed to follow up with volunteers and didn’t record adverse reactions that might have changed public health policy.

Moderna’s Spikevax and Pfizer’s BioNTech mRNA Covid vaccines are both more likely to put you in the hospital with a serious adverse event than to keep you out by protecting against a serious Covid reaction, a new study has found.

Researchers headed up by Dr Peter Doshi, editor of the British Medical Journal (BMJ), have analyzed data sets from both companies to reveal that the rate of serious adverse reactions is 10.1 per 10,000 shots (0.1 percent) for Pfizer’s vaccine and 15.1 per 10,000 shots (0.15 percent) for Moderna’s, above placebo. Together, the two vaccines caused 12.5 serious adverse reactions per 10,000 vaccines (0.12 percent).

Overall, the vaccines are more than twice as likely to put you in the hospital than to protect you from a serious Covid infection. The vaccines’ adverse events included death, hospital care, persistent and serious disability, and birth defects.

The results are far from being an outlier; Doshi’s team pointed out that a team led by Christine Benn from the University of Southern Denmark has come up with similar findings. That team’s research—which has also not been published or peer-reviewed—found no evidence that the mRNA vaccines saved lives; in their analysis, they discovered 31 deaths in vaccine groups and 30 in the placebo group, suggesting the vaccine didn’t reduce death.1

What problem?

Why didn’t the FDA and other regulators see the problems when they were assessing the vaccines for approval and subsequent mass rollout? Doshi and his team ask. The FDA’s safety analysis “included thousands of additional participants with very little follow-up, of which the large majority had only received one dose,” Doshi reports in his study, which has yet to be published and hasn’t been peer-reviewed.

The FDA also ignored worrying data that revealed that twice as many people in the vaccine group had “multiple serious adverse events” compared to those given a placebo.

The agency flagged concerns about the Pfizer vaccine—and its increased risk for pulmonary embolism (lung blockage), acute myocardial infarction (fatal or near-fatal heart attack), immune thrombocytopenia (blood not clotting) and disseminated intravascular coagulation (uncontrollable bleeding)—in July 2021. But it hasn’t reported on any progress since then.

Despite these concerns, the official line remains that the vaccines are completely safe. According to America’s Centers for Disease Control and Prevention (CDC), Covid vaccines “have undergone—and will continue to undergo—the most intensive safety monitoring in US history. Evidence from the hundreds of millions of Covid-19 vaccines already administered in the United States, and the billions of vaccines administered globally, demonstrates that they are safe and effective.”2

Sorry, wrong number

Worries about the way vaccine safety was being evaluated before approval were being raised in the autumn of 2020. Among other researchers, a whistleblower at one of the safety centers recruited by Pfizer to assess the safety of its Covid vaccine was concerned that speed was taking precedence over data integrity and patient safety. Brook Jackson, a director at Ventavia Research Group in Texas, emailed the FDA, worried that the center was falsifying data and wasn’t following up on reports of adverse events. Participants were also able to see if they were being given the vaccine or a placebo. She was fired the same day.3

In conversations she recorded with two directors, one of them admitted that the center was unable to quantify errors but that “it’s something new every day.”

When it submitted its application for “emergency use authorization” of its Covid vaccine, Pfizer didn’t mention any problems at the Ventavia site, although the FDA was aware of them and raised no concerns with the company. A day later, on December 11, 2020, Pfizer’s vaccine was approved for immediate rollout. Lax oversight of clinical trials at the FDA is a symptom of serious under-resourcing, says the US’s Citizens for Responsible Care and Research Inc. If the agency gets a complaint about a clinical trial—as happened with Ventavia—it doesn’t have the manpower to investigate.4

Citing one example, the group teamed up with consumer advocacy organization Public Citizen and public health experts to file a complaint about a clinical trial that was failing to protect its participants. The complaint was raised in July 2018, but it was nine months before an FDA inspector started investigations. A warning letter was finally sent to the pharmaceutical company in May 2021—34 months after the agency had been alerted to the problem.

But there could be a more sinister reason for drug regulator tardiness. Regulators rely on the drug industry for their funding. Essentially, this means regulators are given the job of policing their paymasters—and this compromises the relationship.

It goes back years. The US Congress passed the Prescription Drug User Act in 1992, which allowed the drug industry to directly fund the FDA through “user fees,” in exchange for which the agency is supposed to swiftly review drug applications and get them to market. With the Act, the FDA ceased to be a taxpayer-funded agency and became one paid for by the industry it regulates. The drug industry has shown its gratitude: in 1993, the FDA received $29 million from Big Pharma, and this had risen to $884 million by 2016.

It’s a similar pattern across Europe. In 1995, Big Pharma funded just 20 percent of the then-new EU regulator, the European Medicines Agency, and today it contributes 89 percent of total revenues.

Politicians in the UK’s House of Commons raised concerns about the cozy relationship in 2005. A health committee was worried that industry funding would “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” But nearly two decades on, nothing has changed.

Medical writer Maryanne Demasi has spoken to six drug regulators around the world—in Australia, Canada, Europe, Japan, the UK and the US—and discovered an uneasy relationship. Regulators are not transparent about their funding, the influence it has on their decision-making and how it affects the speed at which drugs are approved.

They also protect the drug companies by not releasing the original safety data on which they based their decision—a problem Peter Doshi discovered when he was trying to discern the true safety profile of the Covid vaccines.

Drug company money “permeates the globe’s leading regulators,” she has found, and it raises the question: are drug regulators for hire?5

No award for you

It doesn’t end with the regulators. Drug companies sponsor academia and “independent” researchers, and their money even seeps into august bodies such as the UK’s British Medical Association (BMA), as leading cardiologist Aseem Malhotra discovered to his cost.

Dr Malhotra had presented a talk—”Advocating for Real Evidence-Based Medicine”—to a group at the BMA. Guests at the talk included the BMA’s chairperson, Dr Chaand Nagpaul, and president, Prof. Nina Modi.

He touched on Peter Doshi’s research into the mRNA Covid vaccines in his talk, and it was well received, with Dr Nagpaul afterward presenting Malhotra with the award “Champion of Preventative Medicine.” A day later, Nagpaul was in frantic contact with Malhotra, telling him to remove any reference to the BMA.

Author and speaker Dr Malcolm Kendrick investigated the strange about-turn and discovered an individual high up in the BMA “had close connections with Moderna.” Kendrick and Malhotra suspect the reference to the Doshi study was enough to prod Moderna to militate and force the BMA to distance itself from the speech and subsequent award.6

Despite referencing the Doshi study, Malhotra isn’t an “anti-vaxxer.” In 2021, he participated in a campaign to promote the Covid vaccines to the BAME (Black, Asian, minority, ethnic) community.

Not telling

There are concerns that the Doshi paper will never be published. But Doshi has greater fears—that the safety data guarded by the drug companies, and possibly the regulators, will never be released even though it is in the public interest to do so.

The public has the right to know the real safety of the Covid vaccines—any medication, come to that—even while it may accept that they have been a good thing that have stemmed the Covid tide.

Nonetheless, it’s a sign of an adult society that it can hold several views at the same time, that it can recognize the overall good of the vaccines while accepting their safety profile may mean they are not appropriate for everyone to take, such as the low-risk groups of children, teenagers and people under the age of 60 or so.

Exploring the data and raising concerns about the risk/reward profile for the young doesn’t make you an “anti-vaxxer” or a spreader of “fake news,” nor does it mean that your Twitter or Facebook account should be expunged.

Instead, it’s part of being a grown-up— only through criticism do things improve.