AstraZeneca and its research partner Oxford University released the first picture of the large clinical trial they conducted in the US for their COVID-19 vaccine on Monday. It was found to be safe and prevent 79% of symptomatic diseases.
Interim results from the 32,000-person study showed the vaccine met the Food and Drug Administration’s guidelines for safety and effectiveness. The company announced that it will continue to analyze the study results and apply for approval to distribute its two-dose vaccine in the United States in the first half of April.
It would be the fourth vaccine to be approved in the US alongside Pfizer-BioNTech, Moderna and Johnson & Johnson.
Countries across Europe that had previously approved the AstraZeneca-Oxford vaccine stopped using it after some people developed blood clots or other bleeding disorders shortly after receiving the vaccine. It has already been distributed to nearly 20 million people in Europe, the UK and Asia.
Last week the European Medicines Agency – the European version of the FDA – found the vaccine was safe for general use, although it couldn’t rule out that the shot played a role in rare blood clots in the vessels draining the brain known as cerebral venous sinus thrombosis.
“It’s easy to scare people”:Europe’s decision to pull the vaccine against AstraZeneca-Oxford threatens global efforts to recover from COVID-19, according to US expertsIn the most recent study, which included volunteers from the United States, Chile and Peru, an independent review panel specifically looked for blood clots and “found that the 21,583 participants who received at least one dose of the vaccine were not at increased risk of thrombosis or events resulting from Thromboses were marked. ” , ” According to a press release from the company.
There were no cases of cerebral venous sinus thrombosis in this study.
“We’re very excited,” said Ruud Dobber, executive vice president of AstraZeneca, in an interview with reporters on Monday. “The dataset is very, very robust.”
“We had absolute confidence in the vaccine’s effectiveness, but I think when I see this data now, I hope others will have more confidence that this is a very effective and safe vaccine,” said Menelas Pangalos, executive vice president for Biopharmaceutical Research and Development at AstraZeneca.
So far, 141 people among those taking part in the new study have developed symptomatic COVID-19. None of those who received the vaccine, currently known as AZD1222, were hospitalized or died of COVID-19, which makes it 100% effective against serious illnesses, the company said.
Two-thirds of the subjects received the active vaccine and one-third a saltwater placebo.
There was no apparent difference in the vaccine’s effectiveness in terms of ethnicity or age, the company said. The vaccine was found to be 80% effective in people aged 65 and over. This was the first time it had been tested on such a large group of seniors.
The process was led by AstraZeneca and funded by the US government.
Approximately 79% of the study participants were white, 8% black, 4% Native American (mostly from Peru and Chile), and 4% Asian. About 22% were Hispanic of any race.
About 20% of the volunteers were 65 years of age and older, and about 60% had medical conditions associated with an increased risk of severe COVID-19, including diabetes, heart disease, or severe obesity.
The company will follow study participants for two years after their second injection to determine how long it has been effective and any safety concerns. However, most vaccine-related problems appear within the first six weeks.
The two doses were given four weeks apart, although in previous studies and in Europe they were given 12 weeks apart and appeared more effective with a longer gap.
The vaccine can be stored in the refrigerator and does not need to be frozen unless it is stored for more than six months.
A previous clinical study of the AstraZeneca Oxford shot raised questions about its effectiveness against a variant of the virus first seen in South Africa.
In a 17,000-person study in the UK, South Africa and Brazil, the vaccine showed 76% effectiveness in preventing symptomatic COVID-19 after just one dose. According to a study published in The Lancet this month. A second booster shot, necessary for longer term protection, was given after three months and the protection increased to 82%.
In South Africa, however, fewer than half of the participants were protected from symptomatic COVID-19 – which would bring it below the potency required for use in the United States. Still, there were no serious cases of COVID-19 or hospitalization among vaccine recipients once the vaccine was fully effective about 22 days after the first dose.
Other issues haunted this study, with some participants incorrectly receiving a lower dose of the vaccine and few people over 65 being included.
Receiving both doses of the vaccine appeared to reduce virus transmission among these study participants. Vaccines are supposed to protect against disease, but not all of them prevent an infected person from passing the virus on. This has been an open question with COVID-19 vaccines, although there is growing evidence to suggest they are slowing the spread of disease.
There were no significant safety concerns raised by this study, although it was briefly interrupted last fall to investigate a rare neurological disorder that a study participant experienced. The US trial was also canceled at this point to ensure security.
The Trump administration has pre-purchased 300 million doses of the AstraZeneca-Oxford vaccine to be made available to the American public when the vaccine is approved for use.
AstraZeneca’s Dobber said the company will make around 30 million doses available to Americans when the FDA approves the vaccine, and another 20 million within the first month of approval.
Then Abigail Bozarth, US director of external communications, wrote in a recent email: “We are planning to deliver 15 to 25 million doses per month. We are constantly looking for ways to speed it up. We are conservative with this estimate because of the variables involved in making a vaccine. “
Some have called for the US to have enough vaccines for every American adult by the end of May to distribute those AstraZeneca Oxford cans elsewhere in the world.
AstraZeneca already plans to deliver hundreds of millions of vaccine doses to 142 countries, including many considered low-income or low-income.
The AstraZeneca-Oxford vaccine is made using technology similar to the Johnson & Johnson shot. It uses a harmless virus to release a piece of the virus that causes COVID-19 into the body. While J&J uses a human cold virus as its delivery system, the vaccine developed at Oxford University and commercialized by AstraZeneca is based on a chimpanzee virus that the human immune system has never seen before.
The vaccines Pfizer-BioNTech and Moderna are based on what is known as mRNA technology, which instructs the cells to produce the virus particles.
All vaccines deliver the same piece of the coronavirus: the “spike” protein, which is outside of the SARS-CoV2 virus. As soon as the immune system sees this virus particle, if it is infected it should recognize it and attack the virus before it can establish itself.
Contact Karen Weintraub at [email protected].
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