en.m.wikipedia.org
AnRNA vaccine or
mRNA (messenger RNA) vaccine is a new type of
vaccine that
transfects molecules of
synthetic RNA into human cells. Once inside the cells, the RNA functions as
mRNA, reprogramming the cells to make the foreign
protein that would normally be produced by the
pathogen (e.g. a virus), or by cancer cells. These protein molecules then stimulate an
adaptive immune response that teaches the body to destroy any pathogen, or cancer cells, with the protein.
[1] The mRNA molecule is coated with a
drug delivery vehicle, usually
PEGylated lipid nanoparticles,
[2] to protect the fragile mRNA strands, and aid their absorption into the human cells.
[3][4]
An illustration of the
mechanism of action of the RNA vaccine
The advantages of RNA vaccines over traditional
protein vaccines are design and production speed, low cost of production,
[5][6] and the induction of
cellular immunity as well as
humoral immunity.
[7][8] Given the novel nature of the
mechanism of action of RNA vaccines, and their drug delivery vehicles,
[2] little is known about the medium and longer-term side effects,
[8] however,
autoimmunity, and
reactogenicity (mainly from the lipid nanoparticles), have been highlighted.
[6][9][1![0]](/styles/default/xenforo/NTemojis/alien.gif "Alien 0]")
The fragility of the mRNA molecule requires
cold chain distribution and storage, which may impair
effective efficacy due to inadequate dosage (i.e molecule degrades before injection).
[1][5][6]
Up until December 2020, no mRNA vaccine, drug, or technology platform, had ever been approved for use in humans, and before 2020, mRNA was only considered a theoretical or experimental candidate for use in humans.
[1][7][1 As of December 2020, there were two novel mRNA vaccines awaiting
emergency use authorization as
COVID-19 vaccines (having completed the required eight-week period post final human trials) –
MRNA-1273 from
Moderna, and
BNT162b2 from a
BioNTech/
Pfizer partnership.
[1][1 Global regulators had to balance a lack of medium to longer-term data on potential side-effects from the novel mechanism of the new mRNA COVID-19 vaccines,
[11][9] with the need to address the
global coronavirus pandemic,
[1[12] for which the faster production capability of mRNA vaccines is valuable.
[13][14][9]
On 2 December 2020, seven days after its eight-week post trial period, the UK's
Medicines and Healthcare products Regulatory Agency (MHRA), became the first
medicines regulator in history to approve an mRNA vaccine, granting "emergency authorization" for BioNTech/Pfizer's COVID-19 vaccine for "widespread use";
[15][16] stating: "the benefits outweigh any risk" (Phase III trials conclude in 2023
[17]).
[18][19]
There are levels to what we consider medical malpractice from gross negligence to adverse events. It's not that simple.
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