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LONDON – Long-awaited preliminary data from end-stage trials in the United States of a COVID-19 vaccine developed by England’s Oxford University and British-Swedish pharmaceutical giant AstraZeneca show that the two-dose injection is highly effective in all ages and ethnicities. groups, stopped hospitalization in all cases and did not increase the overall risk of blood clots.
The Oxford / AstraZeneca vaccine was 79% effective in stopping symptomatic disease and 100% effective in preventing serious illness and hospitalizations, AstraZeneca said in a statement Monday. The data was shared in anticipation of a peer-reviewed publication in the near future.
The vaccine is effective in multiple age groups, the data showed. Previous trials conducted in the UK, Brazil, and South Africa did not include a sufficient number of participants over the age of 65, so no data was available until now on how well the vaccine works for that demographic.
“It’s exciting to see similar efficacy results in people over 65 for the first time,” Ann Falsey, a professor of medicine at the University of Rochester and principal investigator of the US trial, said in a statement.
Several European countries had stopped using this vaccine in the past week due to concerns that it could be causing blood clots. However, after an investigation into a handful of deaths from thrombosis that occurred after vaccination, the World Health Organization and the European Medicines Agency (EMA) found the vaccine to be safe and effective. However, the EMA said the vaccine may be associated with certain rare types of blood clots, including those in which there are low levels of platelets in the blood, which help the blood to clot.
For the US trial, the Data Safety Monitoring Board (DSMB) “found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants who received at least one dose of the vaccine.”
“We are confident that this vaccine can play an important role in protecting millions of people around the world against this deadly virus,” said Mene Pangalos, AstraZeneca’s head of non-cancer research and development, in a statement.
The president of the company in the United States, Roud Dobber, told CNBC on Monday that the current plan is to apply for authorization in the first half of April.
“We hope to deliver 30 million doses instantly after the USA for Americans to get vaccinated, of course so it’s in the hands of the FDA,” Dobber said.
AstraZeneca will follow the same approval process and schedule as the other three vaccine producers. Once you’ve submitted your data, FDA will independently review it and hold a public hearing, followed by a non-binding vote from an independent review board. After that, the FDA will decide to authorize its use or not. Given that schedule, the most likely time this vaccine will be available in the US is May.
The US trial recruited 32,000 volunteers at 88 trial centers in the US, Peru and Chile. Participants came from all age groups and approximately 79% were Caucasian, 8% African American, 4% Native American, 4% Asian, and 22% Hispanic. Volunteers received two standard doses of the Oxford-AstraZeneca vaccine or a placebo vaccine, at an interval of four weeks.
“These new results from large phase III trials in the US, Chile, and Peru provide further confirmation of the safety and efficacy of [the AstraZeneca vaccine]”Said Sarah Gilbert, vaccination teacher and co-designer of the vaccine.
But will this data be enough to convince those who hesitate to take this vaccine?
A new survey by YouGov, which questioned about 8,000 people in seven European countries between March 12 and 18, the period in which use of the vaccine was stopped, showed that there was an increasing trend in people who thought that this vaccine is not safe and a dramatic decline. confidence in AstraZeneca vaccine compared to previous surveys conducted in February.
Experts like John Brownstein, director of innovation and professor at Harvard Medical School, hope that Monday’s results will help turn the dial for AstraZeneca’s acceptance rating.
“These data could serve to enhance the reputation of the vaccine globally and combat much of the hesitation that has arisen after the recent safety scare,” said Brownstein. “If these data can pass FDA scrutiny, the approval will likely increase confidence in the vaccine where the injection is already licensed and provide peace of mind to countries that have yet to authorize the vaccine.”
AstraZeneca’s schedule for emergency use authorization has some questioning whether there is a real need for this vaccine in the US.
“Since the supply is unlikely to be available before May, it is unclear whether this vaccine will have a measurable impact on the launch of the vaccine in the United States.” Brownstein explains: “By then, we will have enough vaccines for 260 million adults.”
The United States pre-ordered 100 million doses of the AstraZeneca vaccine, and the Biden administration is preparing to ship millions of doses to Mexico and Canada.
“I can confirm that we have 7 million releasable doses of AstraZeneca available,” White House press secretary Jen Psaki told reporters at a press conference at the White House last Thursday. “Of those 2.5 million, we are working to finalize plans to lend them to Mexico and 1.5 million to Canada.”
AstraZeneca vaccine is easy to transport and store, requiring only standard refrigeration, and because of this and its low price, it was destined for many lower-income countries. AstraZeneca’s manufacturing and distribution plan aims to manufacture the vaccines with partners around the world, keeping distribution as local as possible.
However, this vaccination process has not gone all that well: since the University of Oxford and AstraZeneca first published the data from the phase 3 trial, it has been fraught with problems. The experts were confused by the trial parameters and the way the data was presented, especially since they combined two sets of efficacy results to create an average 70% efficacy.
It was later learned that these trials had followed two different dosing regimens, after a dosing error. The first used two regular doses and was 62% effective. The second had a lower dose, followed by a regular dose, 90% effective, the researchers said.
Questions began to arise about how they collected and presented the data, including why the researchers used two dosing regimens and whether the results can be combined on an average. It was also learned that no one in the most vulnerable ages 65 and over was tested using the most effective dosing regimen.
But despite this somewhat confusing data, the UK Medicines and Health Products Regulatory Agency, the European Medicines Agency and the World Health Organization approved this vaccine for use late last year and early this year. However, some European countries were reluctant to use it in people over 65, citing insufficient data.
There have also been major disagreements between Ursula Von Der Leyen, the president of the European Commission, and AstraZeneca after problems at a factory led to a significant decrease in its supply to the continent. Compounding this mixed picture even further is the fact that this vaccine also proved to be less effective against the South African variant, with South Africa announcing last month that it would not use the vaccine at launch.
With the release of today’s data from trials in the US, Chile, and Peru, the hope is that the doubts surrounding this vaccine will be removed. “The latest data from AZD1222, also known as the Oxford / AstraZeneca vaccine, is as good as it gets.” wait, “notes Ian Jones, professor of virology at the University of Reading,” the vaccine is clearly working and misinformed suspension of use in some countries over blood clotting concerns has been shown to be unfounded. “
“The simple truth is that any gossip about the dose or lack of transparency in the data is a thing of the past … there is no risk in taking it, but there is a lot of risk from a continuously circulating SARS-CoV-2 virus. It is a classic obvious, vaccines work, take them, “he said.
