A vaccine to prevent Lyme disease is being fast-tracked for approval by the U.S. Food and Drug Administration to address what public health officials say is the most rapidly growing vector-borne disease in the United States.
Currently, there is no Lyme vaccine for humans, although one is available for dogs. The human vaccine being expedited for approval by the FDA is known in its preapproval phase as VLA15, a product of French vaccine-maker Valneva. Only 180 participants in a preliminary clinical trial have received the inoculation so far.
Valneva has been authorized to move its research into the FDA’s program called Fast Track. Designated products are aimed at unmet medical needs, agency officials said.
“The incidence of Lyme disease has increased dramatically,” said Dr. Benjamin Luft, the Edmund D. Pellegrino Professor of Medicine at Stony Brook University and a specialist in infectious diseases. He said the number of people who have contracted Lyme disease and other tick-related illnesses has risen as the bugs have expanded their range.The Borrelia burgdorferi bacterium, which causes Lyme disease, is shown in this electron micrograph image. Photo Credit: Alamy Stock Photo / RGB Ventures
Luft, who himself has developed a Lyme vaccine, said that any inoculation aimed at Borrelia burgdorferi — the bacterium that causes Lyme disease — must address the variations seen in the organism. Otherwise, he said, the vaccine is of no benefit to those who receive it.
( See Antigenic Variation below )
Luft’s vaccine was licensed to the Illinois-based Baxter pharmaceutical company, but the license now is held by Shire Plc, he said.
Shire, with headquarters in Dublin, Ireland, acquired Baxter’s biopharmaceutical division last year.
Valneva officials, meanwhile, said their vaccine appears to be effective against the six most common types of B. burgdorferi that are prevalent in the United States and Europe. Under the fast-track designation, the company will advance to a larger clinical study of the vaccine early next year.
Lipids: The Essential Metabolites
Lipids are hydrophobic or amphipathic small molecules which include fats, waxes, sterols, fat-soluble vitamins (such as vitamins A, D, E and K), monoglycerides, diglycerides and phospholipids. The crucial role of lipids in a cell, tissue and organ physiology is evident by their unique membrane organizing properties that provide cells with functionally distinct subcellular membrane compartments.
The main biological functions of lipids include:
- Energy storage and structural components of cellular membranes.
- Cell signaling (e.g. phospholipase C and phospholipase A2 in modulating immunological responses).
- Endocrine actions (e.g. steroid hormones)
- Essential role in signal transduction, membrane trafficking and morphogenesis.
Classification of Lipids
Lipids can be classified into 8 classes based on their chemical structure:
|1.||Fatty Acyls [FA]|
|The fatty acyls are a diverse group of molecules synthesized by chain elongation of an acetyl-CoA primer with malonyl-CoA (or methylmalonyl-CoA) groups that may contain a cyclic functionality and/or are substituted with heteroatoms.
Ex: Palmitic Acid
Did you figure it out yet?
Yup, they both have Triacyl (meanining 3) fatty acids or lipoproteins, Pam3cys, fungal antigen, immunosuppresive, TLR2/1 agonists attached to the N-terminals.
Did you know;
CDC officers falsified research to fraudulently qualify the LYMErix vaccine. They used high-passage, plasmid-dropping strains (leaving out antigens OspA and B) and knowingly raised the cutoff for the ELISA, leaving out all the neurological cases. This effectively changed the definition of the disease, from relapsing fever Borreliosis to Steere’s Knees, a purely arthritic knee outcome. The sickest people cannot get a diagnosis, and the arthritis cases likely are not looking for one! This is proven by publicly available information from the 1994 Dearborn conference along with a parallel, secret report that illustrates how the research fraud was perpetrated. We want nothing less than USDOJ prosecution of these heinous acts.
As the saying goes, “Those who fail history are destined to repeat it”. I say those who repeat it are destined to fail.
I don’t know about you but I’m not getting in line.