The first known allergic reaction to the Pfizer Inc. Covid-19 vaccine in the US was reported in Alaska when some growls began to emerge in the attempt to send the shots across the country, highlighting the daunting challenges to a historic immunization push.
A health worker in Juneau, Alaska, with no history of allergies, experienced flushing and shortness of breath 10 minutes after receiving an injection, the state health department said in a statement Wednesday.
The person was admitted to the emergency room and given Pepcid, Benadryl, and epinephrine through an intravenous drip. According to the Alaska Health Department, the patient has stayed overnight and is in stable condition.
The episode follows reports of a handful of similar reactions in the UK, where health officials advised that anyone with a history of severe allergies should not use the Pfizer vaccine. US regulators last week recommended that people be monitored for allergy symptoms for 15 minutes after taking the injection, which received emergency use clearance from the Food and Drug Administration on Friday.
Pfizer, coordinating with local officials, will closely monitor any reports suggesting serious allergic reactions and will update the labeling language as needed, spokeswoman Jerica Pitts said in a statement.
The incident came to light when the first hiccups in the distribution of the vaccine in the US came to light on Wednesday, including a delay in delivering 3,900 shots to two states and the announcement that Pfizer would be delivering about 900,000 fewer doses next week. than planned. this week.
The approval of Pfizer’s shot was the start of a massive mobilization effort. Vaccines are being sent to all 50 states from two manufacturing facilities of Midwestern companies, the first wave in what is expected to be a months-long campaign to inoculate as many people as possible and end a pandemic that affects more than 300,000 in the U.S. similar shot made by Moderna Inc. expected to receive US approval in the coming days.
One challenge in moving and storing Pfizer’s shot, which it developed with the German drug manufacturer BioNTech SE, was to store it at ultra-cold temperatures in specialized freezers and containers. Four delivery bins of the shot were withdrawn from supplies to California and Alabama this week and returned to the company because they were colder than expected, according to Gustave Perna, the military general who serves as Operation Warp Speed’s chief operations officer.
Each of the bins could likely be used to vaccinate 975 people. Pfizer has said the formula should be stored at 70 degrees below zero Celsius, the equivalent of minus 94 degrees Fahrenheit. These trays turned out to be much colder, according to Perna.
“We didn’t take any chances,” he said during a newsletter on Wednesday. Pfizer and federal health agencies are in the process of determining whether the formula can still be used when it reaches such low temperatures, Perna said.
Pfizer puts the doses in temperature-controlled shipping containers developed by its own engineers. The containers are each equipped with GPS trackers “for continuous, real-time location and temperature monitoring,” said the company, which has a 24-hour control tower that monitors each shipment.
US officials also said at the briefing that about 2 million doses of the Pfizer vaccine will be allocated to the country next week, less than the 2.9 million available this week when the first shots were dispatched. They offered no explanation.
Alex Azar, the Secretary of the Department of Health and Human Services, acknowledged manufacturing challenges previously disclosed by Pfizer. “As you know, they ended up falling short of what they thought they could produce and what they announced they could produce,” Azar said in 2020.
Operation Warp Speed has said it expects to have enough vaccines between Pfizer and Moderna to inoculate 20 million Americans by December. It has contracted 100 million doses of Pfizer’s vaccine, requiring two injections per patient. Azar and other officials pushed back on recent reports that the U.S. government declined to buy more doses from Pfizer because the company couldn’t guarantee they would be ready by mid-2021.
“They are currently producing at their maximum capacity to deliver the 100 million that are in the first installment of the contract with us, and we are supporting production,” he said.
Pfizer spokeswoman Sharon Castillo said in an email that the company has not encountered any production problems.
Unlike other vaccine developers who received support from Operation Warp Speed, Pfizer did not accept research and development funding from the US government. Azar said this meant officials had less insight into the company’s production.
“The relationship Pfizer wanted with Operation Warp Speed was the guaranteed purchase of a vaccine, if approved by the FDA,” he said. Azar said the government is in talks with the company to learn more about the challenges they are facing.
Azar and other officials also said promising monoclonal antibody therapies authorized to treat Covid patients who do not require hospitalization have been used less often than they hoped.
The drugs, made by Eli Lilly and Co. and Regeneron Pharmaceuticals Inc., are available for emergency use for less severe cases. They must be administered through IVs, which has created logistical challenges for medical providers.
“We really hope to see a much, much higher use of the doses administered to healthcare facilities,” Moncef Slaoui, Operation Warp Speed’s chief advisor, said during the briefing.
The antibody drugs are intended for elderly patients and those with other diseases that put them at higher risk of hospitalization from Covid-19. They are most effective when delivered early.
“The best time to get those antibodies isn’t when you get to the emergency room, but shortly after the diagnosis is made,” Azar said. The US has allocated 300,000 doses to states, and many states have supplies available, he said.
–With the help of Riley Griffin and Jacquie Lee.
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