Closely following Moderna Inc, the pharmaceutical giant Pfizer announced a phase 1 trial of mRNA-based influenza vaccine candidates. The program will begin with candidates that encode individual strains of the influenza virus, leading to testing of multivalent combinations.
The trial for Pfizer’s vaccine is expected to run through June 2022
The researchers plan to enroll 615 healthy adults ages 65 to 85 at 32 U.S. locations.The trial is expected to run through June 2022 and will evaluate the safety, tolerability, and immunogenicity of monovalent and bivalent formulations in various dose levels, followed by a quadrivalent vaccine.
Participants will be randomly assigned to receive 1 of 4 dose levels of the monovalent candidate containing either strain A or B of the virus. 1 of 4 dose levels of the bivalent candidate containing strains A and B. The tetravalent candidate or a licensed tetravalent. flu shot.
The company is also exploring the vaccine platform for other respiratory viruses.
Pfizer and its partner BioNTech received full US regulatory approval for BNT162b2, its COVID-19 mRNA vaccine, in August. Work on a flu vaccine that uses mRNA technology has been underway since 2018, Kathrin U. Jansen, PhD, Pfizer senior vice president and head of vaccine research and development, said in the announcement.
The company is also exploring the vaccine platform for other respiratory viruses, cancer, and genetic diseases.
In July, Moderna announced that the first participants had been dosed in a phase 1 and 2 clinical trial of its mRNA-based quadrivalent influenza candidate, mRNA-1010.
What are mRNA vaccines and how do they work?
MRNA vaccines work by introducing a fragment of mRNA that corresponds to a viral protein. Usually a small fragment of a protein found on the outer membrane of the virus. (People who receive an mRNA vaccine are not exposed to the virus and cannot become infected with the vaccine.)
Once produced, the antibodies remain in the body, even after the body has rid itself of the pathogen, so the immune system can respond quickly if exposed again.
Like all vaccines in the United States, mRNA vaccines require clearance or approval from the Food and Drug Administration (FDA) before they can be used. Currently, vaccines for COVID-19, the disease caused by the SARS-CoV-2 coronavirus, are the only licensed or approved mRNA vaccines.
These vaccines use mRNA that directs cells to produce copies of a protein on the outside of the coronavirus known as “spike protein.” Researchers are studying how mRNA could be used to develop vaccines for additional infectious diseases; like Pfizer’s against influenza.
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