Biden has stated that the federal government will now subsidize the unlimited distribution of Pfizer’s antiviral Paxlovid, despite there being no clinical evidence that it has any efficacy against Omicron.
Because the NIH recognizes that the drug not only has not been proven to be effective against newer strains, and that it has the potential for multiple contraindications with other medication, it is not recommended for all patients.
Still, Biden’s plan calls for pharmacies to distribute five-days worth of doses of the drugs to all patients who test positive for COVID, with the burden placed on pharmacy technicians to effectively screen for drug interactions.
This comes just months after the FDA pulled competing monoclonal antibody drugs like Regeneron off of the market for a lack of efficacy against omicron, a standard apparently not being applied uniformly.
In a move that is becoming increasingly common from the rubber stamp FDA, Paxlovid received emergency authorization just eight days after data was released from its clinical trial, and the FDA declined to convene a panel of outside advisors to review the drug, apparently deeming it unnecessary.
This incredible lifeline offered to Pfizer with a federal commitment to supply virtually unlimited doses of an unproven and potentially dangerous medication couldn’t come at a better time, as the past several weeks have seen the release of two studies which call into question the viability of the Pfizer vaccine.
A study from the New York State Department of Health showed the Pfizer BNT vaccine to have abysmally poor efficacy within children against omicron, with 12% efficacy in 5-11 year old in preventing symptomatic infection. In terms of preventing hospitalizations, effectiveness amongst this group better, but still only 48%. The study went on to highlight that because of the lack of protection offered, masking and social protections are as crucial as ever, calling into question the federal rescinding of mask mandates on regulated public transportation.
Another study though called into question the safety of the Pfizer vaccine, which as of 2022 has still not been subjected to long-term safety studies. It suggested that the genetic material from the Pfizer BNT vaccine had the capacity to enter and integrate itself in the genome of human liver cells. In vitro, the mRNA in the vaccines was reverse transcribed into DNA which then entered human cell lines and were expressed as part of the human genome. After a study last year suggested that the proteins encoded for in the Pfizer BNT vaccine may trigger vaccine-induced hepatitis, this may offer a mechanism in explanation of those cases.
It seems unlikely that the FDA will take any action in response to this data.