AstraZeneca, Oxford defend vaccine trials after questions raised in US

This illustration, taken on September 9, 2020, features a test tube labeled vaccine in front of the AstraZeneca logo.

Dadu Rouvik | Reuters

AstraZeneca and the University of Oxford are defending the results and methods used in their phase three vaccine trials, based on criticism from experts in the US, that “the highest standards” were used and that “additional analysis will be done.”

AstraZeneca shares have fallen nearly 6% after the vaccine candidate was questioned this week, for which the company said the combined results showed it to be 70% effective. The figure comes from a combination of a small group of people who received unintentionally low doses of the vaccine – and what a company spokeswoman calls “serendiphyty” – leading to 90% effectiveness, and a large group that was on high doses. Receives, he is showing 62. % effect.

Monsep Saloi, head of the White House’s Operation Tana Speed, and others in the US have expressed concern over the tested age group, saying 90% of efficacy was shown only for the lowest-risk group, which was 55 years. There were 2,741 people under age. The group resulted in a 62% effectiveness of 8,895.

AstraZeneca insisted on monitoring the study by the External Data Security Monitoring Board (DSMB) against criticism and rejected the fact that the data released on Monday only constituted an interim result and more data would follow.

A spokesperson for AstraZeneca told CNBC on Thursday, “The study was conducted to the highest standards.” “An independent DSMB safety monitoring committee oversees studies to ensure safety and quality. DSMB has determined that the analysis allowed the vaccine for 14 days or longer to show its primary endpoint showing protection from COVID-19. Found after receiving the dose. “

“More data will continue to accumulate and additional analysis will be conducted to refine efficacy and establish a period of safety,” the spokesperson said.

The University of Oxford, for its part, brought about the discrepancy between dose allocation. It stated that the initial over-estimation of doses of new vaccine batches resulted in “half the dose of the vaccine being administered as the first dose” due to differences in the manufacturing process.

“Methods for measuring concentration are now established and we can ensure that all batches of vaccines are now equal,” he said.

Happy criticism

Particularly harsh criticism came from US-based health care and biotech investment bank SVB Lerink, whose analysts wrote on Monday: “We believe this product will never be licensed in the US”

“This belief is based on the company’s design of conclusive tests that do not match FDA’s requirements for the representation of minorities, serious cases, previously infected individuals, and populations of the elderly and other at-risk,” the analysis said.

In response, a spokesperson for AstraZeneca stressed that the results were interim and more data had to be accumulated and more analysis had to be done.

Defenders of the tests have reported that the criticism comes primarily from within the US, home only to other Western vaccine candidates who declare high effectiveness in the results of their vaccine trials: Pfizer-Bayonet and Modern, who launched earlier this month Declared its vaccines in 95% effectiveness has been shown.

John LaMattina, former president of Pfizer Global R & D, tweeted on Tuesday: “It’s hard to believe that the FDA will release the EUA for a vaccine whose optimal dose is only given to 2,300 people. More data for this dose Will be needed. ”Saloi was previously on the board at Modern and also worked at GlaxoSmithKline.

Cost, delivery, logistics

Outside the US, the Oxford-AstraZeneca vaccine has been particularly praised for its relative ease of manufacturing and transportation and its low cost compared to potential competitors. The vaccine will sell for between $ 3 to $ 5 per dose, while Pfizer-BioNotech and Moderna will go for $ 20 per dose and $ 32 to $ 37 per dose, respectively.

The Pfizer-BioNotech vaccine candidate, as an mRNA vaccine, requires negative 94 ° F and extremely cold storage temperatures of specialized transport equipment. Modern vaccines can be stored at minus 4 degrees F for up to six months.

The Oxford-AstraZeneca results are “very positive results when we recall that the barrier to a good enough vaccine with the flu virus was set at 50-60%,” Dr. Gillis O-Brain-Tier, Policy Chair UK-based Faculty of Pharmaceutical Medicine, said on Monday.

“The great advantage of this Oxford vaccine over mRNA vaccines is that it can be easily manufactured and delivered at an ordinary fridge (not freezer) temperature, so it can be transported and stored using the existing vaccine cold chain infrastructure May. The group has promised to provide it. The vaccine is not for the benefit of developing countries. ”

The British pharmaceutical giant has stated that its vaccines can be stored, transported and handled under normal refrigerated conditions (36–46 ° F) for at least six months and administered within existing health care settings. It has pledged to distribute the vaccine “for the duration of an epidemic” to no avail.

CNBC’s Sam Meredith contributed to this report.

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