Biden Says The Pandemic Is Over, So Let's Act Like It Is
Death and hospitalizations have decoupled from COVID-19 infections, natural immunity has peaked, and people have ditched their masks. Furthermore, in a recent 60 Minutes episode, Biden exclaimed the pandemic was over. Considering the President’s remark, and that life has nearly returned to normal, FDA emergency use authorization (EUA), and vaccine mandates need to end immediately.
First, FDA needs to stop fast-tracking covid vaccine, drug, and therapeutic approvals. Just so it is clear, EUA is a pathway largely utilized during times of national crisis when:
Treatments are needed to help the public, but none are available, and
Benefits of said pathway outweigh the costs.
Looking back, two and a half years of hastened FDA EUA approvals quickly brought the general public mRNA vaccines from Pfizer + Moderna, an adenovirus vector offering by J&J, Paxlovid, Remdesivir, Regeneron, molnupiravir, fluvoxamine, and monoclonal antibodies.
Understand that the EUA pathway reduces regulatory red tape that could otherwise extend the approval of a pharmaceutical years and years. The result, there is opportunity for products to reach the general public faster. Of course, a win amid a pandemic. However, with such a shortened approval track, EUA comes at a notable expense.
For instance, EUA fast-tracking lowers the bar for safety and efficacy. Such reduced standards result in lax patient follow up, questionable clinical trial structure, etc. You see, large amounts of red tape being removed result in drug companies dropping the ball during clinical trials. Sadly, that translates into population level harms like novel safety signals (vaccine adverse events), and so on.
Understand, these are for profit companies and they will cut corners to save money, even at the expense of the consumers they target. That is the grim reality of a free market, but salient to vocalize nonetheless.
On the other hand, it could be understood during a novel pandemic where no treatments exist, that rapid approval of pharmaceutical products could be life saving. Such context shifts the risk/reward analysis to favor utilizing the fast-track process.
Since the pandemic is over, it is only appropriate FDA stop speedily approving new COVID-19 pharmaceuticals and use a more traditional avenue named biological licensing for all new prospective pharmaceuticals.
To elaborate, biological licensing is one of the more traditional ways most drugs, vaccines, and therapeutics are given the green light before meeting consumers. In other words, there is more regulatory red tape, more hoops, more time applications collect dust on some bureaucrat’s desk before being examined, denied, or okayed.
Next, all vaccine mandates need to be eliminated. That simply because Moderna and Pfizer can not prevent SARS-CoV-2 transmission, severe disease and death are substantially less with Omicron BA5 compared to preceding variants, population immunity is likely over 98%, and mandates come at a cost.
Now, just so there is absolutely no confusion, a fact needs to be stated. mRNA vaccines do not meaningfully prevent viral transmission, so there is currently no benefit to any mandate. Oppositely, if Moderna and Pfizer did prevent transmission, many cases and hospitalizations could be averted. On that basis, mandates could be justified. Regardless, current mRNA vaccines do not meaningfully truncate the spread of SARS-CoV-2.
Moving on, Omicron was the best vaccine Pfizer and Moderna could not produce and nearly everyone had a run with it. Essentially, Omicron was associated with a steep reduction in mortality, and hospitalization. That means, more people who endured Omicron BA 1, or even BA 4/5 enjoyed a substantially low risk of death and hospitalization relative to Alpha and Delta variants. Vaccines could not meaningfully improve on the reduced mortality and hospital benefit conferred by Omicron.
Hopping back 1 month into the past, population immunity was already around 75% according to CDC, while BA 5 concurrently had an R0 (reproductive rate) of nearly 18. Meaning, every 1 person infected passed the virus to nearly 18 others in an environment where around 75% already had robust, and highly protective natural immunity. Considering those facts, current population immunity is likely nearing 95%+ and that trumps protection gained from vaccination.
Next, it needs to be understood that every medical intervention can yield harm. Of particular concern is myocarditis in male children and young adults aged 16-30 post 2nd, 3rd, and 4th dose of Pfizer or Moderna.
For clarity, myocarditis is inflammation of the heart muscle which can lead to lethal rhythms, heart failure, and sudden cardiac death. It is a medical emergency that needs to be treated by a physician without delay.
A great concern is that academic institutions continue to mandate COVID-19 vaccination for young, and highly immune students at nearly no risk of severe outcomes from SARS-CoV-2. Nonetheless, as most healthy students do not meaningfully benefit from a COVID vaccination, a mandate forces them to take all the risk and receive nearly no benefit. For clarity, newer data indicate mRNA vaccines (more so Moderna) are associated with myocarditis at a dose rate of around 1/5000. As one could see, the risk of academic mandates are not worth their perceived reward.
Considering the facts, Biden hit the nail on the head. The pandemic is over, so it is time we start acting like it. That means ending FDA EUA fast tracked approvals, and ineffective vaccine mandates.
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