Pfizer is coordinating with officials and will closely monitor all reports that suggest allergic reactions.
The first known allergic reaction to Pfizer Inc.’s Covid-19 vaccine in the US was reported in Alaska as some grunts began to emerge in the effort to ship the vaccines nationwide, highlighting the huge challenges that lie ahead. for a historic immunization campaign.
A health worker in Juneau, Alaska, with no history of allergies, experienced redness 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 was administered Pepcid, Benadryl and epinephrine through an intravenous drip. The patient stayed overnight and is in stable condition, according to the Alaska Department of Health.
A vial 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. US regulators recommended last week that people should be monitored for allergy symptoms for 15 minutes after receiving the injection, which obtained an emergency use authorization from the Food and Drug Administration on Friday.
Pfizer is coordinating with local officials, will closely monitor all reports suggesting serious allergic reactions and will update label language if necessary, spokeswoman Jerica Pitts said in a statement.
The incident came to light when the first setbacks in the distribution of the vaccine in the US emerged on Wednesday, including a delay in the delivery of 3,900 injections in two states and the announcement that Pfizer would administer around 900,000 fewer doses. next week of those that are scheduled to ship. this week.
The authorization of the Pfizer shooting started a massive mobilization effort. Vaccines are being shipped from two company production facilities in the Midwest to all 50 states, the first wave of what is 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 US A similar shot by Moderna Inc. is expected to gain US clearance.
One challenge in moving and storing Pfizer’s injection, which it developed with German drugmaker BioNTech SE, has been that it must be kept at ultra-cold temperatures in specialized freezers and containers. Four injection delivery trays were removed from delivery to California and Alabama this week and shipped back to the company because they were colder than anticipated, according to Gustave Perna, the Army general who serves as director of operations for Operation Warp Speed.
Each of the trays can likely be used to vaccinate 975 people. Pfizer has said its formula should be stored at minus 70 degrees Celsius, the equivalent of minus 94 degrees Fahrenheit. These trays were found to be much colder, according to Perna.
“We are not taking chances,” he said during a news conference 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 implements the doses in temperature controlled shipping containers that its own engineers developed. Each of the containers is equipped with GPS trackers “for continuous monitoring of location and temperature in real time,” according to the company, which has a control tower that monitors each shipment 24 hours a day.
Smaller allocation
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 injections were shipped. They offered no explanation.
Alex Azar, Secretary of the Department of Health and Human Services, acknowledged the production challenges that Pfizer had previously disclosed. “As you know, they ended up falling short of half what they thought they could produce and what they had announced they could produce” in 2020, Azar said.
Operation Warp Speed has said it hopes to have enough vaccines between Pfizer and Moderna to inoculate 20 million Americans in December. It has contracted 100 million doses of the Pfizer vaccine, which requires two injections per patient. Azar and other officials rejected recent reports that the US government refused to buy more doses of Pfizer, saying the company could not guarantee they would be ready by mid-2021.
“Right now they are producing at their maximum capacity to meet the 100 million that are 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 problems.
Unlike other vaccine developers who received support from Operation Warp Speed, Pfizer did not receive research and development money from the US government, Azar said that meant officials had less knowledge of the company’s production.
“The relationship that Pfizer wanted with Operation Warp Speed was the guaranteed purchase of the vaccine if the FDA approved it,” he said. Azar said the government is speaking with the company to learn more about the challenges they face.
Unused antibodies
Azar and other officials also said that promising monoclonal antibody therapies licensed to treat Covid patients who do not need hospitalization have been used less frequently than expected.
The drugs, made by Eli Lilly and Co. and Regeneron Pharmaceuticals Inc., are available for emergency use in less severe cases. They must be administered via infusions, which has created logistical challenges for medical providers.
“We really expect to see a much, much higher level of use of the doses being delivered to healthcare facilities,” Moncef Slaoui, Senior Advisor for Operation Warp Speed, said at the briefing.
The antibody drugs are intended for older patients and people with other illnesses 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 is not when you show up to the emergency room, but shortly after being diagnosed,” Azar said. The United States has assigned 300,000 doses to states and many states have supplies available, he said.
–With help from Riley Griffin and Jacquie Lee.
(Except for the headline, this story has not been edited by NDTV staff and is posted from a syndicated feed.)
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