AstraZeneca, Oxford coronavirus vaccine news, data questions

Early Monday, AstraZeneca and the University of Oxford announced preliminary results from a trial of their coronavirus vaccine.

It should have been a moment of triumph.

They said the vaccine was 70% effective, on average, in preventing COVID-19, the disease caused by the novel coronavirus that has swept the world. It exceeded the standards some regulatory bodies have set for approval, although it lags behind the results of two other investigational vaccines.

But some information, leaked in press releases, raised questions. The researchers provided little information on how they arrived at this efficacy figure, which combined data from different trials. Scientists also wondered how the company describes vaccine safety.

“Transparency and the quality of communications are probably almost as important as the results,” said Dr. Jesse Goodman, a former senior scientist with the United States Food and Drug Administration who is now a professor at the University of Georgetown.

‘Highs and lows’

“If scientific experts are bewildered by what exists, I am also concerned that the kind of ups and downs and changes in day-to-day communication will confuse the public and undermine their confidence,” he said. he adds.

AstraZeneca’s results follow announcements from Pfizer and Moderna that their coronavirus vaccines have been successful in late stage studies. Both companies said in press releases that their shots were about 95% effective in preventing COVID-19.

The three vaccine pioneers are still experimental. None of the programs published late-stage results in a medical journal, and regulators in the US, UK, and Europe have not authorized the use of any of the injections.

But Moderna and Pfizer have released more information about how their trials were going along the way, and the press releases they’ve issued so far may have been more informative. In addition, each performs a single large trial, a design less complicated than the Oxford-AstraZeneca research.

Read more: How pharmaceutical giant Pfizer teamed up with little-known biotechnology to develop an effective coronavirus vaccine in record time

To be clear, if they get the green light from regulators in the coming weeks, the three vaccines could prove to be useful tools against a pandemic that has killed more than a million people and has slammed the global economy. . And the world will need several different vaccines to immunize a significant portion of the world’s population, as each company is limited in the number it can produce.

AP Photo / Pablo Martinez Monsivais

‘A mixed bag’

Yet among outside experts, the lack of information from Oxford and AstraZeneca on their vaccine attracted skepticism almost immediately.

JPMorgan analysts called the revelations “sacred.” John LaMattina, a former Pfizer executive, called the results “strange” and said they would delay using vaccine. Geoffrey Porges, a biotechnology analyst at SVB Leerink who trained as a doctor, has issued more severe criticisms.

“We view the data disclosure as premature and insufficient, and is likely to attract a range of criticism,” he wrote. He said he doubted the vaccine would ever get approval from the United States.

The questions focused on a lack of information in two areas: How well did the vaccine work? And how safe was that?

On security, AstraZeneca’s statement raised questions saying that no security issues had been “confirmed”. AstraZeneca has also not published any new information on the side effects of the shot, although researchers have already published data from about 560 UK trial participants in the medical journal The Lancet.

There had been at least one publicly known safety issue along the way. In September, all trials were suspended due to an unexplained illness in one of the British participants. At the end of October, all trials were underway again, but Monday’s statement from AstraZeneca did not provide more information about the episode.

When it comes to efficacy, outside experts have questioned why the vaccine was 62% effective in one group and 90% in another, an unexpected finding. AstraZeneca said it averaged these numbers to arrive at an overall vaccine efficacy of 70%.

The vaccine was 90% effective in a group of people in one of the trials who were accidentally given an unusual regimen: half a dose of the vaccine, followed by a full dose a month later. Others received two full doses at once.

Photo AP / Evan Vucci

Drop of revelation raises questions

Without a peer-reviewed scientific paper explaining how the data was analyzed, it’s unclear how they calculated the numbers, Goodman said..

“You can’t do studies and then choose different outcomes or groups of studies,” Goodman said. “You sort of need to live with all of all the data.”

Soon, a disclosure about the group that received the half-dose-full-dose regimen raised eyebrows again. A senior AstraZeneca executive told Reuters that the full half-dose-dose regimen was in fact given to participants by accident. The company did not disclose this information in its press release.

The drop of information continued.

On Tuesday, Moncef Slaoui, the scientific chief of the US vaccination effort known as Operation Warp Speed, added some details confirming concerns over the Oxford-AstraZeneca data.

In a briefing to reporters, he revealed that there was a key difference between the group that received the full half-dose-dose regimen and the other trial participants: they were younger, no older than 55. . Vaccines sometimes don’t work. as well in the elderly.

“We must scientifically understand what is behind it”

Slaoui also cautioned that it was possible, but unlikely, that the difference in efficacy between the groups could be attributed to chance, as it occurred in a relatively small subset of the trial and due to other variables involved, such as age. difference.

“We have to understand scientifically what is behind this,” he said.

The news drop of the week was about Dr. Paul Offit, one of the top vaccine researchers at the University of Pennsylvania.

Paul Offit

“There may be some promising data with this vaccine, but you have to be honest with people,” he said in an interview on Friday. He also said he was concerned about how the lack of clarity could affect confidence in other vaccines, as well as AstraZeneca.

On Thursday, AstraZeneca had beaten a sort of retreat. Pascal Soriot, CEO of the company, told Bloomberg News that the company will further investigate the half-dose-full-dose regimen. He said he still expects to push ahead with requests for regulatory approval in the UK and the European Union.

US clearance will have to wait for a trial currently underway in that country, Bloomberg reported. Morgan Stanley analysts said they expected this trial to yield results later this year or early 2021.

‘There is something interesting here’

In the long term, the mistake made by workers testing the AstraZeneca-Oxford vaccine could turn out to be accidental if it reveals a better way to give the vaccination, said Deborah Fuller, a microbiologist at the University of Washington who is working on treatments. and vaccines against viruses. But there is a need to investigate more fully and understand the reasons behind this, she said.

“Let’s put the error aside and look at the data because there is something interesting here,” she said.

We should get this data soon. AstraZeneca has announced plans to publish more detailed information in a scientific journal, opening its data to public scrutiny by outside scientists.

Even if the AstraZeneca-Oxford shot proves to be 62-70% effective, it could still be an important tool in the fight against the coronavirus. This is mainly because AstraZeneca has promised to shoot a lot more shots than Pfizer or Moderna, at a significantly cheaper price, as little as $ 3 to $ 4 per shot, which could make it available to a larger party. of the world’s population.

“The vaccine’s simple supply chain and our not-for-profit commitment and commitment to broad, equitable and rapid access means it will be affordable and available worldwide, delivering hundreds of millions of doses upon approval.” Soriot said in a statement.