Maybe because I’m 70 years old, I jumped at the first chance I had to receive the Covid-19 vaccine. Even better, I received the version from Johnson and Johnson, not only a trusted brand for floor wax (actually that’s SC Johnson – not the same), but also a vaccine that needed only one shot. I came back from France (where at the time I was neither old enough nor sick enough to receive the vaccine) to the US so that I could receive this injection at a Rite-aide Pharmacy in Spokane, WA. The experience for me was painless and incident free, no discomfort, no swelling, no side effects.
That was in April. Since then, I’ve come back to France, where, because of fear of spread of the new delta variant, the government has mandated that, as of August 9th, each person present a verification, a digital code sent from the state in the form of a QR Code, that they have received the vaccine or can otherwise prove via the code presented, that they do not have Covid-19. This is a coercive effort by the government to get more people vaccinated.
Though my vaccine, recognized in both the EU and the US as safe and effective, allows me to cross the border into the EU using the shot card that I was provided by Rite-aide, it doesn’t meet the French government’s new rules for controlling access to public places. For this, the record of your vaccination has to originate in Europe and be trackable in a way that lets the French government issue an easily scannable QR code (printed or on your cell phone app) so that guardians at the entry to bars, restaurants, museums, or concert halls can quickly grant or deny access to these spaces based on your vaccine status. For Americans, this means that your record of covid vaccination is inadequate to gain access to most of the tourist activities in France, including trains and aircraft within the country. If you do not have the vaccine credential, you can present the results of a Covid PCR test or antibody test taken within the prescribed time limits. This applies to outdoor venues as well as indoors. My last covid PCR test, good for 72 hours, cost me 53€. I can’t imagine why any American would want to visit France under those circumstances.
It is authorized for you to cross the border into France based upon your US record of vaccination, but it is not authorized for you to use that record to sit outside for lunch at a café. This might have something to do with the US precaution to not yet allow EU tourists across our borders.
One can see that the public health record of vaccinations in the US was neither conceived nor intended as certified record that could be linked to our national ID card. Oh yeah, we don’t actually have a national ID card.
Both in France and in the United States, I think a majority of people disdain the vocal minority who refuse to get the vaccination. It seems contrary to “science”, many would say. Yet the fact is, the US government (through the US Food and Drug Administration), while encouraging and mandating that certain groups get vaccinated, as well as supporting state and private efforts to do the same, refuses to certify that the vaccine is safe, except for emergency use.
In the August 5th edition of the Wall Street Journal, a letter to the editor included the following commentary, rebutting an editorial that criticized the FDA position:
The history of drug and vaccine development illustrates possible pitfalls of post-approval drug manufacturing, some of which have had dire consequences. The most notorious was the 1955 “Cutter incident,” in which more than 200,000 American children received a polio vaccine in which the process of inactivating the live virus was defective. The vaccine, manufactured by Cutter Laboratories, eventually caused 40,000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10.
The Pfizer -BioNTech and Moderna vaccines are not killed-virus vaccines, so faulty inactivation is not a possibility, but the manufacture is highly complex. Emergent BioSolutions, designated by the U.S. government as the sole domestic manufacturer of the Johnson & Johnson and AstraZeneca vaccines, had to discard 75 million vaccine doses because of possible contamination. Earlier this year, the Food and Drug Administration recalled certain batches of a commonly prescribed diabetes drug, metformin, because it contained unacceptably high levels of a cancer-causing chemical contaminant.
Applications for approval are extraordinarily complex and sometimes contain shortcomings or inconsistencies. The medical and public-health experts who are, with the best of intentions, demanding immediate full approval of the Covid-19 vaccines, have not actually reviewed all the data documenting that the manufacturers can produce batch after batch of vaccine with the necessary purity, potency and sterility.
There is also the big-picture issue: If the FDA were to grant full approval to a product that caused a debacle similar to the Cutter incident, or even a problem like the metformin contamination, it would not only injure patients but also provide fodder for anti-vaccine activists and make the public skeptical of vaccines for years, or even decades. We can’t afford a misstep.
Henry I. Miller, M.D.
It would seem that Dr Miller, a founding director of the FDA’s Office of Biotechnology, has already provided sufficient cause (if not verified, the future manufacturing of these vaccines could go awry) for anti-vaccine activists to make the public skeptical. Though about 400 million doses of the various types of vaccines have already been administered in the US, who is to say that future doses won’t be ill-manufactured and cause some sort of catastrophe (though having Covid-19 when you are young seems nothing like contracting polio)?
Perhaps the FDA should perform a cost benefit analysis of protecting their administrative integrity.