From the December 2, 2020 NY Times, excerpts of the discussion about unblinding. Below that, earlier remarks from the BMJ and Dr. Peter Hotez. This article preceded the FDA advisory committee meeting on authorizing the Pfizer vaccine for adults by 8 days.
Even after all this talk, and a multitude of experts asking for the trials to continue, FDA essentially ended the trials for all the vaccines after a median 2 months. But FDA spun it as if the trials continued… saying all the subjects would continue to be followed, for a couple of years. Without placebo subjects, we could still try and compare them to people of their ages, though the results would be much less accurate.
But we are still waiting to learn about the deaths and serious injuries of all those in the trials, as it is 2 years since the Phase 1 trials began and 20 months since the Phase 3 trials began. Where are those long-term data, as FDA moves next month to authorize vaccinations for the youngest kids, aged 6 months up to 5 years?
COVID vaccines are like high-jumpers: they only reach their pinnacle of performance for a brief moment before they fall. How far they fall, into negative territory perhaps, and how much damage they do along the way, remain to be seen. FDA and the manufacturers are not telling. The secrecy around the performance of these vaccine is unprecedented.
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones?
Some vaccine experts worry that “unblinding” the trials and giving all of the volunteers vaccines would tarnish the long-term results.
“But on Wednesday, 18 leading vaccine experts — including a top regulator at the Food and Drug Administration — argued that vaccinating placebo groups early would be disastrous for the integrity of the trials. If all of the volunteers who received placebo shots were to suddenly get vaccinated, scientists would no longer be able to compare the health of those who were vaccinated with those who were not.”
Placebos have been essential to clinical trials for decades. It’s vital that neither the volunteers nor the staff running the trial know who is randomly assigned to get the vaccine or the placebo. This “blinding,” as it’s called, eliminates the chance that people will behave differently depending on which treatment they get, potentially skewing the trial’s results.
The agency said in new vaccine guidelines published in October that such an authorization would not necessarily be grounds for unblinding a trial…
In their new paper in The New England Journal of Medicine, Mr. Peto and his colleagues argue that once a placebo group disappears from a clinical trial, the chance to collect rigorous data about a coronavirus vaccine will vanish.
Preliminary results don’t reveal how long a vaccine’s protection will last, for example. It’s possible that the immunity provided by a vaccine can fade over the course of months. That decline would lead to an increase in the rate of vaccinated people getting sick as compared with the placebo group. Scientists would most likely see that trend if they can keep a vaccine trial intact.
“It is clear that there is early protection, and I suspect there will be protection for quite a long time afterward,” Mr. Peto said. “But I think that we will be much better as a planet if we get clear evidence of this.”
If the companies were to encourage unblinding their trials, that could also harm their chances of receiving the F.D.A.’s full stamp of approval — a license. And allowing a trial to continue may also be good for their bottom line, because knowing when immunity from a vaccine begins to wane will dictate how frequently people will need their product…
What did the BMJ editors know and when did they know it? Remarkably perhaps, the BMJ published a short article on the vaccines, and then-editor in chief Fiona Godlee wrote the following prescient paragraphs in August 2020, only 1 month after the Phase 3 trials had begun. It seems some people knew a lot about what to expect:
“Few can doubt that we need a vaccine for covid-19 as soon as possible, and great strides are being made, including in our understanding of the immunology of SARS-CoV-2.1 But what damage may result from the race to create one? The World Health Organization has produced guidance on minimum characteristics for a vaccine, including 50% efficacy, temperature stability, potential for rapid scale-up, and proper evaluation against comparators. But, writes Els Torreele, these basic requirements are being rapidly eroded by the prevailing view that anything is better than nothing.2
So instead we are heading for vaccines that reduce severity of illness rather than protect against infection, provide only short lived immunity, and will at best have been trialled by the manufacturer against placebo. As well as damaging public confidence and wasting global resources by distributing a poorly effective vaccine, this could change what we understand a vaccine to be. Instead of long term, effective disease prevention it could become a suboptimal chronic treatment. This would be good for business but bad for global public health.”
In November 2020, before any trial data had been released,
“Peter Hotez, MD, PhD, of Baylor College of Medicine in Houston, observed that for the next few months, producing vaccines for the American population will be problematic, so it won’t be an issue in this country for a while.
“Even as the first vaccines become more widely available they may be only partially protective to reduce severity of illness and won’t stop transmission anyway so we won’t need to pay people for that purpose,” he told . “So I don’t foresee a reason to pay anyone to get vaccinated against COVID-19.”‘
So the USG must have already been talking about bribing people to get vaccinated, before the vaccine was even authorized. And vaccine mavens like Hotez knew what the vaccines’ weaknesses would be before a single vaccine was available, while the public was about to be fed a bunch of lies about 95% efficacy. Ho Hum.