How Does Pfizer-BioNTech Vaccine work?

The Conversation reports that vaccines train the immune system to identify the disease-causing part of a virus. They added that traditionally, vaccines contain either weakened viruses or purified signatures proteins of the virus.

How do mRNA vaccines work?

(Photo : WPA Pool)
Staff At Royal Free Hospital Simulate The Preparation Of The Pfizer Vaccine

According to The New York Times, both Pfizer and Moderna vaccines are based on SARS-CoV-2's genetic instruction for building the spike protein.

They added that the vaccine utilizes messenger mRNA genetic material that is read by our cells in making proteins. The Conversation added that these genetic instructions are injected in the upper arms; the muscle cells will translate them in order to make the viral protein directly into the body.

The New York Times added that the vaccinated cell dies, leaving the spikes and will be detected by helper T-cells and alarm the immune response to fight the infection. They stress that the antigen-presenting cells can also activate another type of immune cell called killer T-cell to eradicate any coronavirus infected cells that display the spike protein fragments on their surfaces.

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Vaccine Summit

Vaccine Summit invitation by the White House, brushed off by two medical giants, Pfizer and Moderna.

It is remembered that the two companies have shown the promising results of their final clinical trial and is currently waiting for the United States Food and Drug Administration's (FDA) issuance of Emergency Use Authorization (EUA).

Stat News reports that the authorities' event aims to pressure the Food and Drug Administration to move quickly in an authorization.

Forbes added that Pfizer and Moderna confirmed with them their absence in the said event. They noted that Moderna notes their invitation by the White House but basing on the agenda, the company said that their participation would not be required.

FDA on slow approval

According to the US Food and Drug Administration, the approval of a drug by the agency means that the data on the drug's side effects should undergo a review by the FDA's Center for Drug Evaluation and Research (CDER), where the drug will be determined to provide benefits that overwhelm the potential risks and side effects for the intended populace.

From there, FDA reports that the agency will analyze and review the clinical benefits and risks information submitted by the drug maker, alongside any uncertainties that may result from incomplete data.

They added that the risk management label's approval shows the benefits and risks of the drug; and how an individual can detect and manage the risks since they note in their release that all medicines have accompanying risks and sometimes, more effort is required to manage the risks.

FDA's release furthers that the agency and the drug maker may come up with a different inference basing on the same data, or there may be a different opinion among the members of the FDA review team, making the process extend and deliberate further.

FDA Advisory Panel

According to Bloomberg, an FDA advisory panel is scheduled on December 10, two days after the vaccine summit. They added in their report that the board would discuss Pfizer's clinical trial results and recommend whether the vaccine should be cleared for use. They also emphasized in the article that FDA authorization is expected after the clearance of the agency.

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