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WASHINGTON: The United States authorized the use of the country’s first COVID-19 vaccine on Friday (December 11) and inoculations could begin “in less than 24 hours,” President Donald Trump said.
The approval of the Pfizer vaccine marks a turning point in the United States, where the pandemic has killed more than 292,000 people.
The US Food and Drug Administration (FDA) said it granted an emergency use authorization for the vaccine, developed with German partner BioNTech, which was shown to be 95 percent 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 is the first nation in the world to produce a provably safe and effective vaccine. Today’s achievement is a reminder of the unlimited potential of the United States,” he said.
READ: British grandmother is the first in the world to receive the Pfizer-BioNTech COVID-19 vaccine outside the trial
US health authorities, shipping services, and hospitals were ready to immediately launch a massive inoculation campaign of an incomparable dimension.
Delivery companies United Parcel Service and FedEx plan to ship millions of doses nationwide under contract with the federal government, prioritizing vaccines in their planes and trucks.
Millions of Americans could start getting vaccinated this month, especially if a second Moderna vaccine is quickly approved.
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.
President Donald Trump speaks during an “Operation Warp Speed Vaccine Summit” at the White House compound, Tuesday, December 8, 2020, in Washington. (AP Photo / Evan Vucci)
The authorization is “of great importance,” BioNTech CEO Ugur Sahin said in an interview. “The emergency use authorization now allows us to bring the vaccine at a time that provides that extremely high medical need to the population,” Sahin said.
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 been unable to mount a coordinated effort to curb 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’m not going to feel like there is a USA tomorrow when I am caring for COVID-19 patients. Many people will become infected, many will be hospitalized, and many will die before the vaccine can.” they have a significant impact on the spread, “he added.
READ; WHO to make decisions on Pfizer, Moderna and AstraZeneca COVID-19 vaccines in weeks
COMPLEX CHALLENGES
Others with vaccines in advanced development include Moderna, which could get emergency clearance from the United States next week, AstraZeneca 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.
Britain’s health regulator has said there have been two reports of anaphylaxis and one report of a possible allergic reaction since the launch began. He advised some people with a history of anaphylaxis, an overreaction of the body’s immune system related to medicine or food, to avoid getting the vaccine.
The FDA in instructions to health care providers simply noted that “serious allergic reactions have been reported” outside of clinical trials.
READ: UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions
The vaccine presents complex distribution challenges as it must be shipped and stored at -70 degrees Celsius, 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.
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.
“SOME DEGREE OF NORMALITY”
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.
READ: Any Adverse Effects of COVID-19 Vaccine Until National Agencies Review: WHO
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.
Leading US infectious disease expert Dr. Anthony Fauci said that if distribution goes well and enough Americans agree to get vaccinated, relief for a nation weary from the pandemic 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 the 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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