Michael Robinson Chavez The Washington Post
LONDON — Oxford University and AstraZeneca reported on Monday that their coronavirus “vaccine for the world” was safe and 79 percent effective overall, according to data from a long-awaited clinical trial in the United States, alongside other studies in Chile and Peru. The two-shot regimen was completely effective at preventing severe cases of illness.
In a news release, the Oxford researchers, who developed the easily transported $4 shot for the British-Swedish pharmaceutical giant AstraZeneca, said their coronavirus vaccine is “safe and highly effective, adding to previous trial data from the United Kingdom, Brazil and South Africa, as well as real-world impact data from the United Kingdom.”
An independent monitoring board combed through the data to look for any cases of blood clotting events similar to those that caused the vaccination effort to be suspended in many European countries. While vaccination was started again after a pause, it undermined confidence in the vaccine. The independent board found no suggestion that the vaccine carried an increased risk of clotting.
The trials included 32,449 adult participants in all age groups, most of them in the United States. The volunteers received either two standard doses of the Oxford-AstraZeneca vaccine or a placebo, at a four-week interval, the researchers said.
[AstraZeneca, once touted as a pandemic slayer, faces challenges]
The scientists said the data show the vaccine is 79 percent effective against symptomatic covid-19, the disease caused by the coronavirus, and 100 percent effective against severe illness. There were five cases of severe illness in the trial, all of them in the group that received a placebo.
“The data look good. The numbers don’t lie,” said Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, who said he was briefed on the data on Sunday.
This is considerably higher than the Oxford-AstraZeneca trials in Britain last year, which showed 62 percent efficacy.
The company said in its release it will apply for emergency authorization from the Food and Drug Administration “in the coming weeks,” but a question that has emerged recently is whether the United States, which President Biden has promised will have enough vaccine for all adults by the end of May, will need the vaccine. Fauci said it was too soon to know how it would fit into the U.S. vaccine portfolio
“The one thing that one can say for sure, that this is good for the world, because it’s a cheap vaccine. It’s got good results. They will likely be able to produce enough for a lot of different countries,” Fauci said.
The Oxford researchers said that the Data and Safety Monitoring Board in the United States “reported no safety concerns among the participants receiving at least one dose of the vaccine.”
The results were reported in a pair of brief news releases from the pharmaceutical company and the university scientists.
The drug company said, “vaccine efficacy was consistent across ethnicity and age. Notably, in participants aged 65 years and over, vaccine efficacy was 80%.”
The U.S. government has preordered 300 million doses of the AstraZeneca vaccine.
The FDA has already given emergency authorization to vaccines from U.S. firms Pfizer, with German partner BioNTech; Moderna; and Johnson & Johnson.
Dado Ruvic
Reuters
Vials and a syringe are seen in front of an AstraZeneca logo in this photo illustration.
The Pfizer-BioNTech and Moderna vaccines, which require two doses, have shown up to 95 percent efficacy against symptomatic covid-19. The Pfizer-BioNTech vaccine requires special handling and must be kept at especially cold temperatures in special freezers.
The one-shot Johnson & Johnson efficacy rate is 66 percent overall and 72 percent in the United States in preventing moderate to severe cases of covid-19, according to data presented to the FDA.
The Oxford-AstraZeneca vaccine has advantages: It can be stored in an ordinary refrigerator — and is relatively cheap, about $4 a dose. The company has vowed to sell the vaccine at cost during the pandemic.
If the Oxford-AstraZeneca shot is approved by the FDA for emergency use, it would offer the United States a bounty of vaccines — either to administer to U.S. citizens or provide to needy countries around the world. Most nations have not administered a single dose of any vaccine.
Use of the Oxford-AstraZeneca vaccine was paused across Europe last week after reports of a handful of worrying blood clots. The European Medicines Agency, which regulates drugs in the European Union, said the vaccine was safe and effective, and was not linked with a rise in the overall risk of blood clots. But the EMA did not rule out a possible link to rare cases of clotting in the brain, known as cerebral venous sinus thrombosis, or CVST.
http://www.washingtonpost.com/video/national/tracking-where-the-astrazeneca-vaccine-is-available/2021/03/18/1db11f5c-b447-4184-a44b-362c39ff6c3d_video.html
Ann Falsey, professor of medicine at the University of Rochester School of Medicine, who was a leader of clinical trial in the United States, said: “It’s exciting to see similar efficacy results in people over 65 for the first time. This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”
Sarah Gilbert, the Oxford co-designer of the vaccine, said in a statement, “In many different countries and across age groups, the vaccine is providing a high level of protection against COVID-19 and we hope this will lead to even more widespread use of the vaccine in the global attempts to bring the pandemic to an end.”
In its first set of clinical trials in Britain, South Africa and Brazil, AstraZeneca was criticized for its failure to include enough elderly volunteers to show the vaccine works well in those most at risk of serious illness. In the current U.S. trials, about 20 percent of participants were 65 years and over, and approximately 60 percent had health conditions that can make covid more life-threatening, such as diabetes, severe obesity or cardiac disease.
The U.S. trials also sought to be representative of the population. AstraZeneca said 79 percent were White or Caucasian, 8 percent Black, 4 percent Native American and 4 percent Asian; in addition, 22 percent of participants were Hispanic.
The United States announced last year it would spend up to $1.2 billion for 300 million doses from the company. But before shots could be administered, the Oxford-AstraZeneca vaccine had to be tested in a 30,000-person trial in the United States, a choice scientists made to ensure that the multiple American vaccine trials would be roughly comparable — and large and diverse enough to adequately measure the safety and efficacy of the vaccines in many groups of people, including older adults and groups hit hardest by the pandemic.
The U.S. trial of the Oxford-AstraZeneca vaccine has taken longer than many forecast. Rare neurological symptoms occurred in three people, two of whom received doses of the study vaccine, causing trials to be suspended worldwide to explore whether those might have been caused by the vaccine. There was no evidence of a connection, but the pause went on for weeks in the United States, setting the trial back.
Johnson reported from Boulder, Colo.
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2021-03-22 07:26:00Z
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