US FDA grants emergency use approval for Pfizer COVID-19 vaccine

By Rahul Vaimal, Associate Editor
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The US Food and Drug Administration (FDA) has authorized the use of the Pfizer-BioNTech COVID-19 vaccine, which has shown 95 percent efficacy and the first inoculations is expected within days.

The US government had earlier stated that it will commence the distribution of the vaccine across the country soon after receiving the FDA approval and that the first inoculations would happen early next week.

According to the FDA’s statement, the vaccine will be given to those aged 16 and older. The healthcare workers and elderly people in long-term care facilities will be given the priority to receive the first round of 2.9 million doses. If the country approves a second vaccine from Moderna, millions of Americans will start getting vaccinated this month itself.

Earlier this month Britain had approved the Pfizer-BioNTech vaccine and become the world’s first to authorize the usage of a COVID-19 vaccine. Following this Canada, Mexico and Bahrain have also given a green signal for Pfizer’s vaccine.

The FDA approval is coming at a time when infections, hospitalizations and deaths are increasing to the highest levels in the US. Earlier this week, the one-day COVID-19 death total recorded 3,000, while hospital intensive care units across the country were nearing capacity.

BioNTech began developing the vaccine in January, using a technology called synthetic messenger RNA (mRNA), which uses a chemical messenger to instruct cells to make proteins that mimic part of the new coronavirus, which the immune system learns to recognize as an invader. BioNTech got into a development agreement with Pfizer in March.

Challenges in the path

A severe challenge related to Pfizer’s vaccine is its complex distribution requirements as it must be shipped and stored at -70 Celsius (-94 F), requiring specialized ultra-cold freezers or supplies of dry ice.

Although Pfizer has created a special shipping container that can be filled with dry ice to stop the vaccine from spoiling, many states are concerned if there would be enough dry ice for shipments to rural areas that do not have access to specialized freezers.

Other vaccine candidates that are in advanced development include Moderna, which could get an emergency authorization as soon as next week, AstraZeneca Plc with Oxford University and Johnson & Johnson (J&J).

The US quest for a vaccine has been the central response to the pandemic from a Trump administration that has mostly otherwise left states to fend for themselves. The authority has affirmed that it will have enough shots to supply all of the 330 million US residents who wish to be vaccinated by the middle of 2021.

Dr. Anthony Fauci
Dr. Anthony Fauci
American Physician & Immunologist

“If we do it efficiently enough by the second quarter of 2021 and by the end of summer or end of the third quarter, we may have enough herd immunity protecting our society. And as we get to the end of 2021, we could approach very much some degree of normality that is close to where we were before.”

The government has already ordered 100 million doses of the Pfizer vaccine which is enough to inoculate 50 million people, through its Operation Warp Speed virus development program.

The US authority have also made deals to buy 200 million doses of Moderna’s two-dose vaccine. The government had previously agreed to buy J&J and AstraZeneca vaccines but authorization of these shots has not came yet.