The US Food and Drug Administration said it approved the use of Pfizer Inc’s COVID-19 vaccine on Friday, with the first vaccinations expected in a few days, marking a turning point in the United States where the pandemic has killed more than 292,000 people.
The US Food and Drug Administration granted a permit for emergency use of the vaccine, developed with German partner BioNTech, which proved to be 95% effective in preventing the disease in a late trial.
The FDA said the vaccine can be given to people 16 years and older. Healthcare professionals and the elderly in long-term care are expected to be the main recipients of a first round of 2.9 million doses.
The US government has said it will begin distributing the vaccine around the country immediately after FDA approval, and that the first vaccinations would take place early next week.
Millions of Americans could start getting vaccinated this month, especially if a second vaccine from Moderna Incis was quickly approved.
The Pfizer / BioNTech vaccine was first approved in the UK earlier this month and UK residents began taking the shot on Tuesday. Canada also approved the vaccine and expects vaccinations to start next week.
Mexico and Bahrain have also approved the vaccine.
FDA authorization comes at a time when infections, hospital stays and deaths are rising high to record levels in the United States, which has failed to achieve a coordinated effort to slow the spread of the virus. Earlier this week, COVID-19 deaths topped a total of 3,000 in one day, while hospital-intensive care units across the country are approaching capacity, threatening to overwhelm healthcare.
Others with advanced development vaccines include Modern, which could receive an emergency from the United States as soon as next week, AstraZeneca Plc with Oxford University, 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 carrier to instruct cells to make proteins that mimic part of the new coronavirus, which the immune system learns to recognize an invader. BioNTech signed a development agreement with Pfizer inMarch.
The vaccine has complex distribution challenges as it must be transported and stored at -70 Celsius (-94 F), requiring specialized ultra-cold freezers or dry ice deliveries.
Modern vaccines use the same technology but do not need to be stored at subarctic temperatures.
The first shots
Pfizer has developed a special shipping container that is filled with dry ice to prevent the vaccine from being destroyed. Many states are concerned about whether there are enough dry ice shipments to rural areas that do not have specialized freezers, but Pfizer believes that there should be enough supply.
The US pursuit of a vaccine has been the central response to the pandemic of a Trump administration that has largely left states to fend for themselves. It has said it will have enough to supply all 330 million US residents who want to be vaccinated by mid-2021.
The government has ordered 100 million doses of Pfizervaccin – enough to inoculate 50 million people – through its Warp Speed virus development program and could not negotiate more. The status of these calls 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 the United States more doses as recently as last month but had been turned down.
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 approval of these vaccines is not imminent.
The foremost American expert on infectious diseases, dr. Anthony Fauci said that if distribution goes well and enough Americans agree to be vaccinated, relief for a tired nation in the pandemic may be on the horizon.
“If we do it effectively enough in the second quarter of 2021 and by the end of the summer or the end of the third quarter, we can actually have enough herd immunity to protect our society,” he said. “And when we get to the end of 2021, we can approach a lot of normality that is close to where we were before.”