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BENGALURU / WASHINGTON / NEW YORK (Dec 11): The U.S. Food and Drug Administration said it authorized the use of Pfizer Inc.’s Covid-19 vaccine on Friday.The pandemic has killed more than 295,000 people.
The FDA 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. He 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.
Cases are increasing in the United States, with thousands of deaths per day, while hospital intensive care units across the country are nearing capacity, threatening to overwhelm healthcare systems.
The timing gives the authorization “great importance,” BioNTech CEO Ugur Sahin said in an interview.
US health authorities, shipping services, and hospitals were prepared to launch a nationwide vaccination campaign. State public health systems have planned to start vaccines on Monday.
Delivery companies United Parcel Service and FedEx Corp plan to ship millions of doses of Pfizer nationwide, giving the highest priority to vaccines on their planes and trucks.
Millions of Americans could start getting vaccinated this month, especially if a second vaccine from Moderna Inc. is quickly approved.
“It 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.
He added: “Many people will be infected, many will be hospitalized and many will die before the vaccine can have a significant impact on the spread.”
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 Pfizer vaccine.
US President Donald Trump, in a video posted on Twitter, hailed the achievement and blamed China for the pandemic. Critics have said his focus on China was aimed at diverting attention from his mistakes in fighting the pandemic.
“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 America’s limitless potential,” Trump said.
Complex challenges
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.
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.
US health officials have said they 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.
Scott Gottlieb, a Pfizer board member and former FDA commissioner, said in an interview with CNBC Earlier this week, the company had offered to sell more doses to the United States as recently as last month, but was 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.
“As we get closer 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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