AstraZeneca May Expand US Trial to Get 90% Effective Vaccine



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AstraZeneca’s (AZN) positive interim results for its COVID-19 vaccine on Monday were met with some confusion as health and Wall Street experts attempted to analyze claims of vaccine effectiveness “up to 90% ”and“ average 70% ”of the company.

The vaccine candidate was tested in two different ways, resulting in two different efficacy rates – 62% and 90% – which the company was achieving on average at 70%. The lowest efficacy came from two full doses given one month apart, the greatest efficacy came from halving the first dose followed by a full booster.

But it confused health experts and angered some analysts.

“I am completely surprised. I don’t understand, ”said Dr. Arthur Caplan, a prominent bioethicist and professor at Langone Medical Center at New York University, explaining why the company chose to test both diets so late in the game and why the diet weaker provided a stronger diet. protection.

He was not alone. Other vaccine experts like Dr Peter Hotez of Baylor College of Medicine and Dr Paul Offit of Pennsylvania Children’s Hospital made similar statements in interviews with Yahoo Finance on Monday.

“It’s science by press release and it’s really hard to know what’s going on,” Offit said.

What do the numbers mean?

The 62% effectiveness of a full-dose regimen was intriguing to many, with some wondering if previous concerns about an adenovirus vector platform – which both AstraZeneca and some Chinese vaccine candidates use – were at stake. Johnson & Johnson also use a similar platform, but the same problem is unlikely to occur, some experts have said.

Unlike Pfizer (PFE) / BioNTech (BNTX) and Moderna (MRNA), which use a new synthetic technology called messenger RNA, AstraZeneca uses a weakened strain of adenovirus to deliver the vaccine.

Hotez speculated that the first hit induced more antibodies that inhibited a second dose. Adenovirus vaccines can sometimes make the body immune to a second injection of the same vaccine.

But even with lower efficiency than Pfizer and Moderna, both of which hit around 95%, Hotez noted that real-world efficiency is still unknown.

“These efficacy figures can fluctuate as we immunize the entire American population,” he said.

SVB Leerink analysts were less indulgent, saying AstraZeneca and its partner at the University of Oxford embellished the results to show superior efficiency.

“The suggestion by the inventors that the small sample given the lower priming dose was evidence of superior efficacy only discredits the program,” said analyst Geoffrey Porges.

He added, “It appears that the occurrence of pre-existing or post-vaccine immunity to the vector has a significant attenuating effect on vaccine efficacy.”

NYU’s Caplan noted that even with published data from any vaccine trial, much remains unknown about vaccines.

Age group, ethnicity or disease state works or does not work best with a specific vaccine, as well as the durability of protection and the ability to block transmission all remain unknown, he said. .

Which means that while regulators globally prepare to assess the data, there is still a lot to be seen.

Porges said: “We consider the disclosure of the data to be premature and insufficient.”

The company will submit for emergency use to the World Health Organization, which will allow low- and middle-income countries to have a vaccine candidate that does not require special shipping and handling.

Other SVB Leerink analysts said so on Monday.

“Despite the apparent inferiority to mRNA drugs, we believe that some attributes of the program are important, particularly during the first wave of vaccines at the height of the pandemic, where demand will significantly exceed supply,” said they declared.

FILE - In this Thursday April 23, 2020, screenshot of a file taken from a video posted by the UK University of Oxford, showing a person being injected as part of the UK's first human trials. United to test a potential vaccine against the coronavirus, not taken by the University of Oxford in England.  AstraZeneca says late-stage trials of its COVID-19 vaccine were
AstraZeneca says late-stage trials of its COVID-19 vaccine were “very effective” in preventing the disease. A vaccine developed by AstraZeneca and the University of Oxford has prevented 70% of people from developing the coronavirus in late stage trials, the team reported Monday, November 23, 2020 (Oxford University Pool via AP, File)

Double the dose reduction in half

AstraZeneca US Director Ruud Dobber told Yahoo Finance the company will engage with the US Food and Drug Administration (FDA) to discuss the US trial and possibly add a new arm in the stage trial advanced to include the half-dose primer.

“Overall, I think the data set is very comprehensive and very positive,” Dobber said.

When asked about the reason for the dosage change and why the higher dose was not as effective, AstraZeneca declined to comment. An executive told The Guardian the half-dose was an accident. But why this resulted in higher efficiency remains unknown.

But it’s clear the company is excited about the discovery and intends to continue the half-dose and full-dose booster regimen in ongoing trials.

In an emailed statement on Tuesday, a spokesperson said, “We see a lot of merit in this regimen and we will now begin discussions with regulators to incorporate this combination of doses for further clinical investigation. We will continue to follow the science to better understand this data and share it in a peer-reviewed journal in due course. “

Meanwhile, Dobber said data for trials in the UK and Brazil will be released by the end of this week and have been submitted to a peer-reviewed journal.

Among the main candidates, the company is the only one to date not to promise any profit from its vaccine amid the pandemic. The price is around $ 3 per dose, compared to around $ 20 and up for mRNA candidates.

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