Pfizer coordinates with officials and will closely monitor all reports suggesting allergic reactions.
The first known allergic reaction to the Pfizer Inc. vaccine. Covid-19 in the United States was reported in Alaska as some rudeness began to emerge in the effort to send shots across the country, highlighting daunting challenges for a historic vaccination boost.
A health worker from Juneau, Alaska, who had no history of allergies, experienced redness and shortness of breath 10 minutes after receiving a shot, the state health department reported Wednesday.
The person was admitted to the emergency room and given Pepcid, Benadryl and epinephrine by intravenous drip. The patient spent the night and is in stable condition, according to the Alaska Department of Health.
One bottle of Pfizer-BioNTech Covid-19 vaccine.
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 take the Pfizer vaccine. U.S. regulators last week recommended that people be monitored for allergy symptoms for 15 minutes after receiving the shot, which obtained an emergency use permit from the Food and Drug Administration on Friday. Drug Administration.
Pfizer is coordinating with local officials, closely monitoring all reports suggesting serious allergic reactions and updating the language of labeling if necessary, spokeswoman Jerica Pitts said in a statement.
The incident came to light when the first hiccups in the distribution of the vaccine in the United States emerged on Wednesday, including a suspension to deliver 3,900 shots to two states and the announcement that Pfizer would deliver about 900,000 fewer doses next week of those scheduled to ship this week.
Authorization to fire Pfizer began a major mobilization effort. Vaccines are being sent from two Midwestern business production facilities in the 50 states, the first wave expected to be a months-long campaign to inoculate as many people as possible and end a pandemic that has killed more than 300,000 in the United States. A similar feature is expected to be made by Moderna Inc. get permission from the United States in the next few days.
A challenge in moving and storing the Pfizer feature, which it developed with German drug manufacturer BioNTech SE, has been that it must be stored at ultra-cold temperatures in specialized freezers and containers. Four gun delivery trays were withdrawn from delivery in California and Alabama this week and sent to the company because they were colder than expected, according to Gustave Perna, the Army general who acts as chief of operations for Operation Warp Speed.
Each of the trays can be used to vaccinate 975 people. Pfizer has said its formula should be stored at 70 degrees below zero Celsius, the equivalent of minus 94 degrees Fahrenheit. According to Perna, these trays were found to be much colder.
“We were not taking any risks,” he said during a briefing on Wednesday. Pfizer and federal health agencies are working to determine if the formula can still be used when it reaches such low temperatures, according to Perna.
Pfizer deploys doses in temperature-controlled shipping containers developed by its own engineers. The containers are equipped with GPS trackers “for continuous real-time location and temperature tracking,” according to the company, which has a control tower open 24 hours a day that monitors each shipment.
Smaller allocation
U.S. officials also said in the briefing that approximately 2 million doses of the Pfizer vaccine will be allocated for the country next week, less than the 2.9 million available this week when the first shots were sent. They offered no explanation.
Alex Azar, secretary of the Department of Health and Human Services, acknowledged the production challenges Pfizer had previously revealed. “As you know, they ended up being left with half of what they thought they could produce and what they had announced they could produce” by 2020, Azar said.
Operation Warp Speed has said it expects to have enough vaccines between Pfizer and Moderna to inoculate 20 million Americans in December. 100 million doses of Pfizer vaccine have been contracted, requiring two shots per patient. Azar and other officials backed up recent reports that the U.S. government refused to buy more doses of Pfizer, saying the company could not guarantee they were ready by mid-2021.
“Right now they are producing at their maximum capacity to deliver the 100 million that is in the first tranche of the contract with us, and we are providing manufacturing support,” he said.
Pfizer spokeswoman Sharon Castillo said in an email that the company has not experienced any production issues.
Unlike other vaccine developers who received support from Operation Warp Speed, Pfizer did not receive money for development and research from the U.S. government. Azar said this meant officials had less information about the company’s production.
“The relationship Pfizer wanted with Operation Warp Speed was the guaranteed purchase of vaccine if approved by the FDA,” he said. Azar said the government is talking to the company to learn more about the challenges they face.
Unused antibodies
Azar and other officials also said that promising therapies with monoclonal antibodies authorized to treat Covid patients who do not need hospitalization have been used less frequently than expected.
The drugs, manufactured by Eli Lilly and Co. and Regeneron Pharmaceuticals Inc., are available for emergency use in less severe cases. They need to be managed through infusions, which has created logistical challenges for medical providers.
“We really expect to see a much higher level of use of the doses delivered to the sanitary facilities,” Moncef Slaoui, chief adviser to Operation Warp Speed, said in the briefing.
Antibody drugs are intended for elderly patients and people with other diseases that pose a higher risk of hospitalization for Covid-19. They are most effective when delivered earlier.
“The best time to get these antibodies is not when they show up in the emergency room, but shortly after they are diagnosed,” Azar said. The United States has allocated 300,000 doses to states and many states have supply available, he said.
With the help of Riley Griffin and Jacquie Lee.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)