Explained: What does the FDA advisory panel approval of the Pfizer / BioNTech vaccine mean?

By: Desk Explained | New Delhi |

Updated: December 11, 2020 4:39:51 pm





A nurse prepares an injection of the Pfizer-BioNTech Covid-19 vaccine at Guy’s Hospital in London, Tuesday, Dec. 8, 2020. (AP Photo: Frank Augstein)

An advisory panel to the U.S. Food and Drug Administration (FDA) recommended on Thursday that the regulator grant emergency use approval for the Pfizer / BioNTech COVID-19 vaccine, which manufacturers began developing ago. more than 11 months.

The move comes after a 90-year-old British woman became the first person in the world to receive a vaccine for COVID-19 outside of a testing setting on Tuesday. The UK has purchased more than 800,000 doses of the Pfizer / BioNTech vaccine and is expected to receive a total of 20 million doses of the vaccine called BNT162b2, which will be delivered until 2021 and will be enough to immunize almost a third of the population. UK population.

So what happened?

On Thursday, the FDA advisory panel called the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which has independent scientific and public health experts as members, met to discuss the request for an EUA from Pfizer / BioNTech, the first such request received by the regulator for a COVID-19 vaccine.

Pfizer submitted the application for approval to the FDA in association with BioNTech in November and has started ongoing filings in Australia, Canada, Europe and Japan. Both companies are expected to produce more than 50 million doses of the vaccine in 2020 and up to 1.3 billion doses by the end of 2021.

What does this mean for the United States?

Panel approval to the Pfizer / BioNTech vaccine means that the FDA is likely to clear its USA, after which it may begin immunizing people in the US, possibly in the next few weeks. This is significant considering that the US is the country hardest hit by the pandemic and on Wednesday recorded a grim stat of more than 3,000 deaths due to the infection.

According to The New York Times, the FDA is likely to provide an EUA for this vaccine on Saturday.

What does emergency use approval mean?

According to the FDA, emergency use authorization (USA) is a mechanism to facilitate the easy availability and use of medical countermeasures, including vaccines during public health emergencies such as the COVID-19 pandemic.

Therefore, under an EUA, the FDA may allow the use of unapproved medical products or unapproved uses of approved medical products in an emergency situation to diagnose, treat, or prevent serious or life-threatening illnesses.

How is the Pfizer / BioNTech vaccine given?

The mRNA vaccine called BNT162b2 is intended for people 16 years of age and older and is given in two doses of 30 μg each, 21 days apart. The vaccine is injected into the person’s upper arm and takes a few weeks after the second dose is completed for it to work. 📣 Follow Express explained on Telegram

How does the vaccine work?

One of the essential ingredients in this vaccine is messenger RNA, or mRNA, which carries instructions for creating the so-called spike protein of the SARS-CoV-2 virus, which makes it easier for the virus to attach itself to cells in the body.

Once the mRNA vaccine is injected into the body, it signals the cells of the body to create copies of this spike protein. The idea is to trigger a response from the body’s immune system similar to if the individual had actually been infected by the virus.

Therefore, once the vaccine can trigger this response, the immune system should be able to produce the necessary antibodies to fight the infection, thus potentially protecting the individual.

Research published in the journal Nature in 2018 noted that mRNA vaccines “represent a promising alternative to conventional vaccine approaches due to their high potency, rapid development capabilities, and potential for low-cost manufacturing and safe administration.”

How effective is the vaccine?

Data from clinical trials suggest that the vaccine is more than 94% effective in adults over 65, meaning that in one trial, if 1,000 people are given the vaccine, about 60 are likely to become infected despite of the vaccine compared to those in the placebo group.

It is significant that vaccinated people still have a small chance of becoming infected. Therefore, immunized people will need to follow social distancing guidelines and wear masks, as scientists are not yet sure whether they can transmit the virus to other people or not.

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