US FDA Authorizes Pfizer COVID-19 Vaccine for Emergency Use

A woman holds a small bottle labeled with a “COVID-19 Coronavirus Vaccine” sticker and a medical syringe in front of the Pfizer logo shown in this illustration taken on October 30, 2020. REUTERS / Dado Ruvic / Photo archive

The U.S. Food and Drug Administration said it authorized the use of the COVID-19 vaccine from Pfizer Inc. on Friday, with the first inoculations expected in a few days, marking a turning point in the states. United, where the pandemic has killed more than 295,000 people.

The US Food and Drug Administration granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95% effective in preventing the disease in a late-stage trial.

The FDA said the vaccine can be given to people over the age of 16. Healthcare workers and older people in long-term care facilities are expected to be the main recipients of a first round of 2.9 million doses.

“The first vaccine will be administered in less than 24 hours,” US President Donald Trump said in a video posted on Twitter. “I am proud to say that we have made sure this vaccine is free to all Americans.”

The United States government has said it will begin distributing the vaccine nationwide immediately after FDA clearance and that the first vaccines will be made early next week.

Millions of Americans could start getting vaccinated this month, especially if a second vaccine from Moderna Inc. is quickly approved.

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FILE PHOTO: A pharmacist receives training as he prepares for the distribution of the Pfizer coronavirus disease (COVID-19) vaccine at a Mount Sinai Health System pharmacy in the Queens borough of New York City, in this brochure photo published on December 10, 2020. Mount Sinai Health System / Brochure via REUTERS

The Pfizer / BioNTech vaccine was first approved in Britain earlier this month, and UK residents began receiving the injections on Tuesday. Canada also authorized the vaccine and expects to begin inoculations next week.

Mexico and Bahrain also approved the vaccine.

The clearance from the FDA, known as the US, comes at a time when infections, hospitalizations and deaths are skyrocketing to record levels in the United States, which has failed to mount a coordinated effort to slow the spread of the virus. Earlier this week, the total of COVID-19 deaths in one day surpassed 3,000, while hospital intensive care units across the country are approaching capacity, threatening to overwhelm healthcare systems.

“The USA was anticipated and is one step in a sequence of steps that will end this pandemic,” said Amesh Adalja, principal investigator at the Johns Hopkins Center for Health Security.

“I will not feel that there will be a USA tomorrow when I am treating patients with COVID-19. Many people will be infected, many will be hospitalized and many will die before the vaccine can have a significant impact on the spread, “he added.

Others with vaccines in advanced development include Moderna, which could get US emergency clearance next week, AstraZeneca Plc with the University of Oxford and Johnson & Johnson.

BioNTech began developing the vaccine in January, using a technology called synthetic messenger RNA (mRNA) that had not yet produced an approved product. The technology uses a chemical messenger to instruct cells to produce proteins that mimic part of the new coronavirus, which the immune system learns to recognize as an invader. BioNTech reached a development agreement with Pfizer in March.

The vaccine presents complex distribution challenges as it must be shipped and stored at -70 degrees Celsius (-94 F), requiring specialized ultra-cold freezers or supplies of dry ice.

Moderna’s vaccine uses the same technology but does not need to be stored at sub-arctic temperatures.

THE FIRST SHOTS

Pfizer has developed a special shipping container that will be filled with dry ice to prevent the vaccine from spoiling. Many states are concerned about whether there is enough dry ice for shipments to rural areas that lack specialized freezers, but Pfizer believes there should be enough supply.

The search for a vaccine by the United States has been the central response to the pandemic of a Trump administration that, for the most part, has left states to fend for themselves. It has said it will have enough to supply the 330 million US residents who want to get vaccinated by mid-2021.

The government has ordered 100 million doses of the Pfizer vaccine, enough to inoculate 50 million people, through its Operation Warp Speed ​​virus development program and could negotiate more. The status of those talks is unclear.

Pfizer board member and former FDA commissioner Scott Gottlieb said in an interview with CNBC earlier this week that the company had offered to sell more doses to the United States as recently as last month, but that they had been rejected.

The United States has agreed to buy 200 million doses of Moderna’s two-dose vaccine. The government also has supply agreements with J&J and AstraZeneca, but authorization for those vaccines is not imminent.

America’s leading infectious disease expert, Dr. Anthony Fauci, said that if distribution goes well and enough Americans agree to get vaccinated, relief for a pandemic-weary nation may be on the horizon.

“If we do it efficiently enough by the second quarter of 2021 and by the end of the summer or third quarter, we may have enough herd immunity to protect our society,” he said. “And as we get to the end of 2021, we could get closer to a certain degree of normalcy that is close to where we were before.”

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