Moderna Seeks Emergency Approval for COVID-19 Vaccine
2020-12-01
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1From VOA Learning English, this is the Health & Lifestyle report.
2The American drug-maker Moderna said Monday it has requested emergency use permission from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine.
3It has also asked for conditional approval from the European Medicines Agency (EMA).
4Moderna's request comes just 10 days after Pfizer and its German partner BioNTech sought emergency use approval for its vaccine in the United States and across Europe.
5In addition, Britain is looking at data from the Oxford-AstraZeneca vaccine trial for a possible emergency approval.
6Early data from the Moderna and Pfizer studies show that both vaccine candidates are nearly 95 percent effective against COVID-19.
7Britain's Oxford-AstraZeneca group says its vaccine candidate is between 62 to 90 percent effective, depending on how the vaccine is given.
8The FDA requires that a vaccine be at least 50 percent effective in order to be considered for emergency use.
9None of the three groups has published complete data from their large Phase 3 studies in scientific papers.
10On November 23, the Oxford-AstraZeneca group said its vaccine treatment of a half first dose followed by a full second dose one month later was found to be 90 percent effective.
11The treatment involving a full dose both times was found to be 62 percent effective.
12Scientists, however, remain concerned about the small number of volunteers who received the half first dose.
13AstraZeneca told the Reuters news agency that the smaller half dose treatment was at first given to volunteers by mistake.
14But it said that there should be "no concern."
15And, it added that independent scientists and regulators have studied and approved the half dose treatment.
16AstraZeneca chief Pascal Soriot said last week that the drug-maker was likely to run more trials to study the effectiveness of its vaccine treatment using the half first dose.
17A group of independent scientists known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will now study results from Moderna's and Pfizer's Phase 3 trials.
18The group will advise the FDA on the safety and effectiveness of the vaccine candidates.
19On December 10, the FDA will meet to consider Pfizer's emergency use request.
20The agency plans to look at Moderna's request one week later.
21If the FDA approves its request, Moderna expects to have 20 million treatments by the end of 2020.
22Since the treatment requires two shots, that will be enough for 10 million people.
23Pfizer says it can supply 50 million vaccine treatments by the end of 2020, enough for 25 million people.
24It hopes to produce up to 1.3 billion treatments by the end of 2021.
25Based on agreements with the U.S. government, vaccines from Moderna and Pfizer will cost between $15 and $25 a treatment.
26Oxford-AstraZeneca's vaccine will cost under $4.
27Unlike vaccine candidates from Pfizer and Moderna, the vaccine from the Oxford-AstraZeneca group does not require extreme-cold storage.
28This, along with its lower cost, makes the vaccine a good candidate for many countries around the world.
29The drug-maker added it will also seek "an Emergency Use Listing from the World Health Organization (WHO)" to make the vaccine available sooner.
30General Gustave Perna is chief operations officer for the U.S. Operation Warp Speed program.
31He said that a COVID-19 vaccine would begin to be sent out within 24 hours of FDA approval.
32Johns Hopkins University's Coronavirus Resource Center reports that nearly 63 million people have now been infected with COVID-19.
33Nearly 1.5 million have died from the disease.
34With several vaccine candidates seeking emergency use approval,
35the next step is for governments and health officials to prepare for mass vaccinations worldwide.
36That may not be easy.
37Many people do not trust the safety of COVID-19 vaccines, a June 2020 study by Nature Medicine found.
38The study collected information from more than 13,000 people in 35 countries.
39The study asked participants whether they would "accept a vaccine if it were recommended by your employer and was approved safe and effective by the government."
40Only 31.9 percent of participants answered "completely agree."
41In the United States, a USA Today/Suffolk survey from August found that two-thirds of Americans said they would not get a COVID-19 vaccine.
42And that's the Health & Lifestyle report.
43I'm Anna Matteo.
1From VOA Learning English, this is the Health & Lifestyle report. 2The American drug-maker Moderna said Monday it has requested emergency use permission from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine. It has also asked for conditional approval from the European Medicines Agency (EMA). 3Moderna's request comes just 10 days after Pfizer and its German partner BioNTech sought emergency use approval for its vaccine in the United States and across Europe. 4In addition, Britain is looking at data from the Oxford-AstraZeneca vaccine trial for a possible emergency approval. 5Early data from the Moderna and Pfizer studies show that both vaccine candidates are nearly 95 percent effective against COVID-19. Britain's Oxford-AstraZeneca group says its vaccine candidate is between 62 to 90 percent effective, depending on how the vaccine is given. 6The FDA requires that a vaccine be at least 50 percent effective in order to be considered for emergency use. 7None of the three groups has published complete data from their large Phase 3 studies in scientific papers. 8Question raised about AstraZeneca vaccine 9On November 23, the Oxford-AstraZeneca group said its vaccine treatment of a half first dose followed by a full second dose one month later was found to be 90 percent effective. The treatment involving a full dose both times was found to be 62 percent effective. 10Scientists, however, remain concerned about the small number of volunteers who received the half first dose. 11AstraZeneca told the Reuters news agency that the smaller half dose treatment was at first given to volunteers by mistake. But it said that there should be "no concern." And, it added that independent scientists and regulators have studied and approved the half dose treatment. 12AstraZeneca chief Pascal Soriot said last week that the drug-maker was likely to run more trials to study the effectiveness of its vaccine treatment using the half first dose. 13What's next? 14A group of independent scientists known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will now study results from Moderna's and Pfizer's Phase 3 trials. The group will advise the FDA on the safety and effectiveness of the vaccine candidates. 15On December 10, the FDA will meet to consider Pfizer's emergency use request. The agency plans to look at Moderna's request one week later. 16If the FDA approves its request, Moderna expects to have 20 million treatments by the end of 2020. Since the treatment requires two shots, that will be enough for 10 million people. 17Pfizer says it can supply 50 million vaccine treatments by the end of 2020, enough for 25 million people. It hopes to produce up to 1.3 billion treatments by the end of 2021. 18Based on agreements with the U.S. government, vaccines from Moderna and Pfizer will cost between $15 and $25 a treatment. Oxford-AstraZeneca's vaccine will cost under $4. 19Unlike vaccine candidates from Pfizer and Moderna, the vaccine from the Oxford-AstraZeneca group does not require extreme-cold storage. This, along with its lower cost, makes the vaccine a good candidate for many countries around the world. The drug-maker added it will also seek "an Emergency Use Listing from the World Health Organization (WHO)" to make the vaccine available sooner. 20General Gustave Perna is chief operations officer for the U.S. Operation Warp Speed program. He said that a COVID-19 vaccine would begin to be sent out within 24 hours of FDA approval. 21Many do not trust vaccines 22Johns Hopkins University's Coronavirus Resource Center reports that nearly 63 million people have now been infected with COVID-19. Nearly 1.5 million have died from the disease. 23With several vaccine candidates seeking emergency use approval, the next step is for governments and health officials to prepare for mass vaccinations worldwide. That may not be easy. 24Many people do not trust the safety of COVID-19 vaccines, a June 2020 study by Nature Medicine found. The study collected information from more than 13,000 people in 35 countries. 25The study asked participants whether they would "accept a vaccine if it were recommended by your employer and was approved safe and effective by the government." Only 31.9 percent of participants answered "completely agree." 26In the United States, a USA Today/Suffolk survey from August found that two-thirds of Americans said they would not get a COVID-19 vaccine. 27And that's the Health & Lifestyle report. 28I'm Anna Matteo. 29Hai Do wrote this story for Learning English with additional reporting from Reuters. Ashley Thompson was the editor. 30_____________________________________________________________ 31phase - n. a step in the process 32dose - n. the amount of medicine that is taken at one time 33regulator - n. a government official that controls a public activity by making and enforcing rules 34participant - n. a person who is involved in an activity