Health & Fit The Oxford-AstraZeneca Vaccine Approval May Be the Most Globally Important Yet
Why the AstraZeneca-Oxford Covid-19 vaccine is different
AstraZeneca and the University of Oxford say their vaccine is up to 90 percent effective. But there’s a lot we still don’t know.Yet with Monday’s news from AstraZeneca and University of Oxford that early results from their phase 3 trial demonstrate their vaccine’s effectiveness, that’s exactly the scenario we’re in.
The COVID-19 vaccine developed by the University of Oxford and AstraZeneca wasn’t the first to be OK’d by regulators in the U.K.—health officialsnearly four weeks earlier. And it’s not the most effective—Stage 3 clinical trials suggest it prevents COVID-19 symptoms about 70% of the time vs. about 95% for the Pfizer vaccine and (which is authorized in the U.S., but not the U.K.).
But the greenlight from the British Medicines and Healthcare Products Regulatory Agency on Wednesday could be a big step toward bringing the.
AstraZeneca and Oxford Say Vaccine Is Up to 90 Percent Effective
AstraZeneca and the University of Oxford announced on Monday that their inexpensive, easy-to-produce coronavirus vaccine appears effective, the latest in a string of encouraging results this month from leading vaccine developers. An early analysis of data from late-stage clinical trials found that AstraZeneca’s vaccine was either 62 percent or 90 percent effective, depending on the manner in which the doses were given. While the overall efficacyAn early analysis of data from late-stage clinical trials found that AstraZeneca’s vaccine was either 62 percent or 90 percent effective, depending on the manner in which the doses were given.
It’s especially big news for the developing world because it’s cheaper and easier to handle and store. Countries from India to Brazil to South Africa have made big bets on the shot from the celebrated British university and the U.K.-Swedish drugmaker. The U.K. was the first country to allow use of the vaccine, but India is expected to follow suit within days. Trials are ongoing in the U.S. and in multiple other countries.
Questions and major hurdles remain before it will be available in the U.S. and continental Europe, where it has yet to receive regulatory approval.
However, if the vaccine is authorized for use and rolled out widely across the world, “that’s really the beginning of the end of the pandemic,” says Ben Cowling, an infectious disease epidemiologist at the University of Hong Kong.
AstraZeneca, Oxford say their vaccine is up to 90% effective
AstraZeneca and the University of Oxford announced Monday that late-stage trials show their COVID-19 vaccine was up to 90% effective in preventing the disease. © Siphiwe Sibeko/Pool via AP A volunteer receives an injection at the Chris Hani Baragwanath Hospital in Johannesburg, South Africa, on June 24, 2020, as part of Africa's first participation in the AstraZeneca/Oxford COVID-19 vaccine trial. The results are based on interim analysis of phase 3 trials in the United Kingdom and Brazil, which looked at two different dosing regimens.
Advantages of the Oxford-AstraZeneca vaccine
The first thing to know about the Oxford-AstraZeneca jab is that it’s cheap. AstraZeneca has promised it will not make a profit on the vaccine during the pandemic. As a result, it costs $3 to $4 per dose around the world. Compare that toand about $20 a dose for Pfizer’s jab, according to figures reported in Europe.
“Approval of this vaccine is a turning point for the pandemic because it has been deliberately developed to have global impact that includes people living in the most fragile and poorest regions of the world,” said Helen Fletcher, a professor of immunology at the London School of Hygiene & Tropical Medicine.
Second, it’s easier to transport and store. Unlike Pfizer’s vaccine, which must beat -70°C (-94°F), the Oxford-AstraZeneca shot requires only standard refrigeration and will remain viable for up to six months. (Morderna’s vaccine can be kept at normal freezer temperatures and stored in refrigeration for up to 30 days once thawed.)
AstraZeneca and Oxford University's vaccine is effective at preventing COVID-19, trial results suggest. Here's everything we know so far.
AstraZeneca and The University of Oxford's covid-19 vaccine is 70% effective, the groups say. Here's everything we know about the vaccine so far.The results follow months of trials of more than 20,000 volunteers in the UK, Brazil, and South Africa, and showed that the vaccine stopped people from developing any COVID-19 symptoms in 70% of the cases on average.
Additionally—there will be a lot more of it available. AstraZeneca and Oxford have worked with manufacturers across the world to produce millions of doses already, and the company says it hopes to make 3 billion more in 2021. With the current two-dose regimen, that’s enough to vaccine nearly 20% of the world’s population.
The Serum Institute of India, which was contracted to make COVID-19 vaccine for the developing world, hasand says it can make 100 million a month by March.
Pfizer, one of the world’s largest drug companies, has set a target of. Moderna, an upstart pharmaceutical company, says it hopes to . However, rich countries have already claimed much of the expected supply of the Pfizer and Moderna vaccine. “Those vaccines are already committed, so they are not available for most middle income and low income countries,” says Dr. Chandrakant Lahariya, a Delhi-based epidemiologist and author of a book on India’s COVID-19 fight.
Covid-19 vaccine efficacy results are not enough
What the latest Covid-19 vaccine announcements from AstraZeneca-Oxford, Pfizer-BioNTech, and Moderna can and can’t tell us.All three vaccine candidates appear to be highly effective against Covid-19, the research teams say. Pfizer and BioNTech say their vaccine had an efficacy of 95 percent against Covid-19, meaning 95 percent of people who received the vaccine were protected against the disease. Moderna reported that its product was 94.5 percent effective. Oxford and AstraZeneca reported that theirs was 62 percent effective in one dosing regimen and 90 percent effective in another, averaging to 70 percent.
The Oxford-AstraZeneca vaccine, on the other hand,secured by COVAX, a consortium of 190 world governments formed to help ensure COVID-19 vaccines were distributed fairly around the world—including to developing countries.
How is the Oxford-AstraZeneca vaccine different?
The Oxford-AstraZeneca uses different technology from the Pfizer and Moderna vaccines that are approved for use in the U.S.
While those two vaccines useof the coronavirus to train the body’s defenses, the Oxford-AstraZeneca vaccine uses a “viral vector,” introducing a harmless virus—in this case a virus that causes the common cold in chimpanzees—modified with the SARS-CoV-2 virus spike protein to stimulate an immune response.
Other COVID-19 vaccines in the pipeline also use the viral vector method—including one from Johnson & Johnson and Russia’s Sputnik V. This technique has already proved successful in the past, including with the Ebola vaccine. The mRNA vaccines, on the other hand, are the first using that approach to receive authorization.
While the U.K.’s decision to use the vaccine is significant, Cowling, the HKU epidemiologist, says other countries may wait to begin administering it until after the European Medical Authority (EMA) or the U.S. Food and Drug Administration (FDA) grant authorization—both of which are.
AstraZeneca admits the best results in its COVID-19 vaccine study came from a dosing error, and experts are raising new questions about the shot
AstraZeneca described the error as "serendipity": The company mistakenly gave some patients a half-dose of the vaccine, leading to better results.The COVID-19 vaccine is on average 70% effective, according to the latest large-scale trial results announced Monday. The vaccine was found to be 62% effective in those who had two full doses, but rose to 90% effective in those who had a half-dosage in their first shot.
that AstraZeneca has not even submitted its vaccine for a regulatory consideration yet, adding that approval in January wasn’t likely.
There also remain questions surrounding late-stage trials for the Oxford-AstraZeneca vaccine.
In September, AstraZeneca and Oxford halted trials in the U.K. after a volunteer experienced an unexplained illness—but did not announce the pause until it. U.K. regulators gave the OK to continue trials days later.
However,that U.S. regulators at the FDA were not notified of the pause and taken aback by the news. It took almost seven weeks before regulators allowed trials to resume in the U.S.
Then, in November, clinical trial data raised questions about dosing. The results showed that the vaccine was 62% effective for subjects given two full doses, and 90% effective for those who were mistakenly given a half dose first, and then a full dose. There were.
The company said it maintained the highest standards during clinical trials and reported the dosing issue to authorities when it was discovered. U.K. regulators signed off on a plan to continue the trial with the half-dose participants. However, the group that received the half dose was too small and included no patients over age 55—meaning no firm conclusions could be drawn. On Wednesday, British regulators authorized the use of two full doses, administered four to 12 weeks apart.
Despite these questions, Fletcher at the London School of Hygiene & Tropical Medicine says the dosing question should not delay approval by the FDA and EMA—both regulators were only considering authorization for two full doses.
Additionally, there are very little data on how long protection for the Oxford-AstraZeneca vaccine—or any other COVID-19 vaccine—will last.
Regardless, the Oxford-AstraZeneca jab will almost surely help turn the tide against the pandemic. “With more than 30 supply agreements and partner networks established globally, the Oxford-AstraZeneca vaccine could slow the pandemic,” she says, “and should save many lives within the next year.”
The U.S. Is Sitting on Tens of Millions of Vaccine Doses the World Needs .
WASHINGTON — Tens of millions of doses of the coronavirus vaccine made by the British-Swedish company AstraZeneca are sitting idly in American manufacturing facilities, awaiting results from its U.S. clinical trial while countries that have authorized its use beg for access. The fate of those doses of AstraZeneca’s vaccine is the subject of an intense debate among White House and federal health officials, with some arguing the administration should let them go abroad where they are desperately needed while others are not ready to relinquish them, according to senior administration officials. AstraZeneca is involved in those conversations.