One day of COVID-19 drug & vaccine news provides cautious reminders

Before I even turned on my computer yesterday, the BBC had blared this headline about a trial of the protein interferon beta:The sub-headline read:

The preliminary results of a clinical trial suggest a new treatment for Covid-19 reduces the number of patients needing intensive care, according to the UK company that developed it.

Eventually some caveats dribbled into the story, and some cautious independent expert quotes:

The results have not been published in a peer-reviewed journal, nor has the full data been made available; so the BBC cannot confirm the claims made for the treatment.

…

“These results are not interpretable. We need the full details and, perhaps more importantly, the trial protocol. The trial should have been registered and a protocol made available before any analysis was undertaken.”

The BBC wasn’t alone.  Yahoo News ran a French AFP story under the headline,  ‘Breakthrough’ treatment slashes virus death risk.

On Twitter, smart observers weighed in, reminding readers that:

• “Right now it looks like we just have a press release about a small trial.”
• “We’ve seen many #COVID19 clinical trial results by press release only; here’s one more.”

Mind you, many experts cheered the potential.  But it is so difficult to weigh in when so little evidence has been released to other scientists and to the public. “Breakthrough” was the biotech company’s word.

Ah, but the day was young.

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Results of two vaccine studies were published in The Lancet yesterday – something heralded by Lancet editor-in-chief Richard Horton in an unusual move a day earlier when he tweeted:

The vaccine study results came from Oxford University in a trial supported by AstraZeneca, and from a Chinese study by CanSino Biologics in Wuhan, China.

When they were published, editor Horton tweeted:

The phase 1/2 Oxford COVID-19 vaccine trial is now published. The vaccine is safe, well-tolerated, and immunogenic. Congratulations to Pedro Folegatti and colleagues. These results are extremely encouraging. https://t.co/oQp2eoZYIg

— richard horton (@richardhorton1) July 20, 2020

In response to this, former FDA commissioner Robert Califf, MD, tweeted:

I know @richardhorton1 knows this, but for lay people viewing this, “safe” in this context just means nothing bad happened that should pause larger trials. Safety of vaccines can only be determined by very large, controlled trials followed by serious post-market surveillance. https://t.co/T6ZD8TgkzK

— Robert M Califf (@califf001) July 20, 2020

Califf’s tweet was an important reminder that the words matter.  Proclaiming a vaccine as safe after early trials demands a definition of safe.

STAT News delivered a solid story, cautiously headlined, “Studies provide glimpse at efficacy of Covid-19 vaccines from Oxford-AstraZeneca and CanSino.”  Up high in its second paragraph, the story explained that 60% of patients in the Oxford trial experienced side effects, all “deemed mild or moderate.”  And the story explained “the new data represent the first glimpse researchers have gotten at its efficacy.” On the Chinese study, STAT reported: “…the vaccine induced neutralizing antibody responses — which could be vital to preventing the disease’s dangerous symptoms — in most subjects. But further study continues to show that this vaccine works better in some people than others.”

The Washington Post reported that the Oxford study was “described as promising” while the Chinese study “showed what researchers not involved in the study described as modest positive results.” The Post included a quote of concern from vaccine expert Paul Offit, MD:

His biggest concern about the Oxford study was that while the vaccine triggered the immune system best when a second shot was administered, that two-dose regimen was only tested in 10 patients. “I’d want to see, in a Phase 2 trial, two doses consistently inducing a neutralizing antibody response, and that it’s relatively long-lived — not months, not a few weeks,” Offit said.

And this from Baylor’s Peter Hotez, MD:

There’s no showstopper here…The bottom line is there’s maybe some promise, but definitely you cannot declare victory by any means on these two vaccines. There’s nothing here that would cause me to say we can now release this to the public.

Meantime, an editorial in The Lancet about the two studies offered this counsel:

…when things are urgent, we must proceed cautiously. The success of COVID-19 vaccines hinges on community trust in vaccine sciences, which requires comprehensive and transparent evaluation of risk and honest communication of potential harms.

Proceeding cautiously is not what readers got from the UK’s Daily Mail, where a vaccine news prediction shared front page space with celebrity gossip.