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Explained: What does FDA advisory panel’s approval of Pfizer vaccine mean?

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 trial setting on Tuesday.

By: Explained Desk | New Delhi | December 11, 2020 4:38:25 pm
Pfizer vaccine, Pfizer vaccine allergic reactions, BioNTech vaccine, Pfizer vaccine news, Indian ExpressA nurse prepares a shot of the Pfizer-BioNTech Covid-19 vaccine at Guy's Hospital in London, Tuesday, Dec. 8, 2020. (AP Photo: Frank Augstein)

An advisory panel of the US’s Food and Drug Administration (FDA) on Thursday recommended that the regulator provide emergency use approval for Pfizer/BioNTech’s COVID-19 vaccine, which the makers started developing over 11 months ago.

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 trial setting on Tuesday. The UK has procured over 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 supplied through 2021 and will be enough to immunise nearly a third of the UK’s population.

So what has happened?

On Thursday, the FDA’s advisory panel called 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 approval request to the FDA in partnership with BioNTech in November and has initiated rolling submissions in Australia, Canada, Europe and Japan. Both companies are expected to produce over 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 US?

The panel’s nod to the Pfizer/BioNTech vaccine means that the FDA is likely to authorise its EUA after which it can begin immunising people in the US, possibly in the coming few weeks. This is significant considering that the US is the worst-hit country due to the pandemic and on Wednesday recorded a grim statistic of over 3,000 deaths due to the infection

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

What does emergency use approval mean?

Under the FDA, Emergency Use Authorisation (EUA) is a mechanism to facilitate the easy availability and use of medical countermeasures, which includes 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 diseases.

How is the Pfizer/BioNTech vaccine administered?

The mRNA vaccine called BNT162b2 is meant for individuals who are 16 years or older and is administered in two doses of 30 μg each, given 21 days apart. The vaccine is injected into the person’s upper arm and takes a few weeks after the completion of the second dose to work. 📣 Follow Express Explained on Telegram

How does the vaccine work?

One of the essential ingredients of this vaccine is the messenger RNA or mRNA, which carries instructions to create the SARS-CoV-2 virus’s so-called spike protein, which makes it easy for the virus to bind to cells in the body.

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

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

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

How effective is the vaccine?

Data from clinical trials suggest that the vaccine is over 94 per cent effective in adults over 65 years of age, which means that in a trial if 1,000 people are given the vaccine, about 60 are likely to be infected despite the vaccine compared to those in the placebo group.

Significantly, vaccinated individuals still have a small chance of getting infected. Therefore, immunised individuals will still need to follow social distancing guidelines and wear masks since scientists are not yet sure if they can still transmit the virus to others or not.

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