American drug-maker Pfizer said Friday it has requested emergency use authorization from the U.S. Food and Drug Administration (or FDA) for its COVID-19 vaccine.
Pfizer and its German partner BioNTech noted they have also started a similar process with regulatory agencies in Europe. They are also doing so in other countries, including Japan, Canada and Australia.
The action came just two days after the drug-makers announced final results of their large vaccine study.
Dr. Albert Bourla is Pfizer Chairman and chief executive. He said in a statement, “Our work to deliver a safe and effective vaccine has never been more urgent.” He noted that the company is looking “to secure authorization of our vaccine candidate as quickly as possible.”
The emergency use request comes as reported coronavirus infections have sharply increased around the world.
Health crisis spread around the world
In the U.S., the Centers for Disease Control and Prevention urged Americans to carefully consider any travel plans for the Thanksgiving holiday. It noted that travel increases the chance of getting or spreading COVID-19. About 200,000 new cases of COVID-19 infections are being reported each day. The country also recorded more than 250,000 deaths from the virus this year.
This week, India reported that it now has 9 million infections. Mexico became the fourth country to report 100,000 deaths, joining Brazil, India and the United States.
Dr. Hans Henri Kluge of the World Health Organization said Thursday that Europe now has more than 15.7 million confirmed coronavirus infections, with over 4 million new cases recorded in November. He added, “Right now, an average of 4,500 lives are lost to COVID-19 in Europe every day.”
The Japanese government placed Tokyo on its highest coronavirus warning level on Thursday. And South Korea announced new restrictions including a ban on public gatherings of more than 100 people.
Race to deliver a vaccine
Pfizer and BioNTech said final results from the large Phase 3 study show their vaccine to be 95 percent effective against COVID-19.
The results will be considered by a group of independent scientists known as the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Dr. Paul Offit of the Children’s Hospital of Philadelphia is an FDA advisor. He told the Associated Press that scientists will advise the FDA on the experimental vaccine’s safety and its effectiveness.
The FDA has the final decision on whether or not to approve or authorize emergency use of the vaccine. It requires that a vaccine be at least 50 percent effective to be considered for emergency use. The FDA says that it may approve medical products “when there are no adequate, approved, and available alternatives.”
Two other vaccine makers, Moderna and AstraZeneca, are not far behind with their own candidates to prevent the spread of COVID-19.
American drug-maker Moderna said early results showed its vaccine to be 94.5 percent effective in preventing COVID-19. And scientists at the University of Oxford, working with AstraZeneca, reported that their experimental vaccine could protect older people from getting severely ill from the new coronavirus.
Making vaccines
Drug-makers Pfizer and BioNTech said they could produce 50 million vaccine treatments this year and up to 1.3 billion treatments by the end of 2021.
The companies have developed temperature-controlled containers to transport the vaccine at minus-70 degrees Celsius. These containers can be used for storage for 15 days by refilling with frozen carbon dioxide. They also come with sensors to track location and temperature during transportation around the world.
On Thursday, General Gustave Perna, chief operations officer for the U.S. Operation Warp Speed program said that a COVID-19 vaccine would begin to be sent out within 24 hours of FDA approval.
Dr. Anthony Fauci is the country’s top infectious diseases expert. He praised the safety and effectiveness of the vaccine candidates from Pfizer and Moderna.
Fauci said, “Help is on the way!” But, he warned that people should not forget public health measures like social distancing and wearing face coverings while waiting for the vaccine.
I’m John Russell.
Hai Do wrote this story for VOA Learning English. Mario Ritter Jr. was the editor.
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Words in This Story
authorization –n. official permission to do something
regulatory –adj. concerning making officials rules about activity in a field such as medicine or business
Phase 3 –n. the third level of testing a vaccine candidate which involves thousands of people
adequate –adj. enough for some need or requirement
alternative –n. an additional choice to one that exists
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