Britain Studies Allergic Reactions Linked to Pfizer Vaccine
2020-12-10
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1Britain's health officials have advised that people with a history of serious allergies not get the Pfizer-BioNTech COVID-19 vaccine.
2The warning came after two people reported severe reactions on the first day of vaccination.
3National Health Service (NHS) medical director Stephen Powis said two NHS workers with a history of allergies were affected.
4"As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination," he said.
5Powis noted that "both are recovering well" and the Medical and Healthcare Products Regulatory Agency (MHRA) is looking to see if the reactions are linked to the vaccine.
6An allergy is a medical condition that causes someone to become sick after eating, touching, or breathing something that is harmless to most people.
7For now, MHRA said, "Any person with a history of a significant allergic reaction to a vaccine, medicine or food... should not receive the Pfizer BioNtech vaccine."
8The health agency said it would seek further information.
9Pfizer and BioNTech said they are working with investigators "to better understand each case and its causes.″
10Last week, Britain became the first nation in the world to approve the Pfizer-BioNTech vaccine for emergency use.
11It started its vaccination program yesterday (Tuesday).
12Today (Wednesday), the Canadian health agency approved the vaccine for emergency use.
13And the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are looking at the data and are expected to approve the vaccine for emergency use shortly.
14Documents published by Pfizer and BioNTech showed that people with a history of severe allergic reactions were excluded from the trials.
15The drug-makers also advised doctors to look out for such reactions in trial participants who were not previously known to have severe allergies.
16In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday.
17The documents say the Pfizer vaccine's efficacy and safety data met expectations for emergency approval and only 0.63 percent of people in the vaccine group reported possible allergic reactions in trials.
18Peter Openshaw is a professor of experimental medicine at Imperial College London.
19He said that was a very small number.
20"The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well," he added.
21For several months, Western drug-makers like Pfizer, Moderna and AstraZeneca have released and published information on the vaccine trials.
22But China and Russia have not released any information on their COVID-19 vaccine candidates.
23On Tuesday, the health ministry of the United Arab Emirates (UAE) said in a statement that it found a vaccine developed by China National Pharmaceutical Group, or Sinopharm, to have an 86 percent rate of effectiveness against COVID-19.
24UAE said it started Phase 3 trials of the Sinopharm vaccine in July.
25And the country, home to the well-known cities of Dubai and Abu Dhabi, approved emergency use of the vaccine for some groups.
26The health ministry said its study of the vaccine "shows no serious safety concerns."
27It also said that 31,000 volunteers across 125 nationalities participated in the UAE trial.
28The volunteers were between 18 and 60 years old and received two shots of the vaccine over 28 days.
29The ministry did not report how many volunteers were given the vaccine or a placebo, a shot with an inactive substance.
30It also did not say if any side effects were identified or how many volunteers became ill.
31It was unclear if the announced results included only those taking part in the UAE trials or if they also included results from China and other countries.
32Both UAE health officials and Sinopharm did not answer requests for comments from international news agencies.
33The Sinopharm vaccine uses an inactivated virus to help the body produce antibodies to fight the coronavirus.
34It is similar to how polio vaccines are made.
35The drug-maker is still conducting trials in China and countries like Egypt and Peru.
36 However, the Chinese government has approved the vaccine for emergency use.
37And almost one million government officials, health care workers and others in China have been injected with the shots.
38After the UAE vaccine announcement, city officials in Abu Dhabi said it would restart "all economic, tourism, cultural and entertainment activities in the emirate within two weeks."
39I'm Jonathan Evans.
1Britain's health officials have advised that people with a history of serious allergies not get the Pfizer-BioNTech COVID-19 vaccine. The warning came after two people reported severe reactions on the first day of vaccination. 2National Health Service (NHS) medical director Stephen Powis said two NHS workers with a history of allergies were affected. "As is common with new vaccines the MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination," he said. 3Powis noted that "both are recovering well" and the Medical and Healthcare Products Regulatory Agency (MHRA) is looking to see if the reactions are linked to the vaccine. 4An allergy is a medical condition that causes someone to become sick after eating, touching, or breathing something that is harmless to most people. 5For now, MHRA said, "Any person with a history of a significant allergic reaction to a vaccine, medicine or food... should not receive the Pfizer BioNtech vaccine." 6The health agency said it would seek further information. Pfizer and BioNTech said they are working with investigators "to better understand each case and its causes.″ 7Last week, Britain became the first nation in the world to approve the Pfizer-BioNTech vaccine for emergency use. It started its vaccination program yesterday (Tuesday). 8Today (Wednesday), the Canadian health agency approved the vaccine for emergency use. And the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are looking at the data and are expected to approve the vaccine for emergency use shortly. 9People with severe allergies excluded from trials 10Documents published by Pfizer and BioNTech showed that people with a history of severe allergic reactions were excluded from the trials. The drug-makers also advised doctors to look out for such reactions in trial participants who were not previously known to have severe allergies. 11In the United States, the FDA released documents on Tuesday in preparation for an advisory committee meeting on Thursday. The documents say the Pfizer vaccine's efficacy and safety data met expectations for emergency approval and only 0.63 percent of people in the vaccine group reported possible allergic reactions in trials. 12Peter Openshaw is a professor of experimental medicine at Imperial College London. He said that was a very small number. "The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well," he added. 13Sinopharm vaccine has 86 percent efficacy 14For several months, Western drug-makers like Pfizer, Moderna and AstraZeneca have released and published information on the vaccine trials. But China and Russia have not released any information on their COVID-19 vaccine candidates. 15On Tuesday, the health ministry of the United Arab Emirates (UAE) said in a statement that it found a vaccine developed by China National Pharmaceutical Group, or Sinopharm, to have an 86 percent rate of effectiveness against COVID-19. 16UAE said it started Phase 3 trials of the Sinopharm vaccine in July. And the country, home to the well-known cities of Dubai and Abu Dhabi, approved emergency use of the vaccine for some groups. 17The health ministry said its study of the vaccine "shows no serious safety concerns." It also said that 31,000 volunteers across 125 nationalities participated in the UAE trial. The volunteers were between 18 and 60 years old and received two shots of the vaccine over 28 days. 18The ministry did not report how many volunteers were given the vaccine or a placebo, a shot with an inactive substance. It also did not say if any side effects were identified or how many volunteers became ill. 19It was unclear if the announced results included only those taking part in the UAE trials or if they also included results from China and other countries. Both UAE health officials and Sinopharm did not answer requests for comments from international news agencies. 20The Sinopharm vaccine uses an inactivated virus to help the body produce antibodies to fight the coronavirus. It is similar to how polio vaccines are made. 21The drug-maker is still conducting trials in China and countries like Egypt and Peru. However, the Chinese government has approved the vaccine for emergency use. And almost one million government officials, health care workers and others in China have been injected with the shots. 22After the UAE vaccine announcement, city officials in Abu Dhabi said it would restart "all economic, tourism, cultural and entertainment activities in the emirate within two weeks." 23I'm Jonathan Evans. 24Hai Do adapted this story for Learning English with reporting from the Associated Press and Reuters. Susan Shand was the editor. 25___________________________________________________________ 26Words in This Story 27allergy - n. a medical condition that causes someone to become sick after eating, touching, or breathing something that is harmless to most people. 28significant - adj. large enough to have an effect or to be noticed 29participant - n. a person who is involved in an activity or event 30regulator - n. government official who controls a public activity by making and enforcing rules 31monitor - v. to watch, observe, listen to and check something for a purpose over a period of time