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COVID vaccines

Covid-19 Vaccines With ‘Minor Side Effects’ Could Still Be Pretty Bad – WIRED

More good news on progress towards an escape route from this pandemic: On Monday, vaccine researchers from Oxford University and the pharmaceutical company AstraZeneca announced results from a “Phase 1/2 trial,” suggesting their product might be able to generate immunity without causing serious harm. Similar, but smaller-scale results, were posted just last week for another candidate vaccine produced by the biotech firm Moderna, in collaboration with the U.S. National Institutes of Health.

As both these groups and others push ahead into the final phase of testing, it’s vital that the public has a clear and balanced understanding of this work—one that cuts through all the marketing and hype. But we’re not off to a good start. The evidence so far suggests that we’re getting blinkered by these groups’ PR, and so seduced by stories of their amazing speed that we’re losing track of everything else. In particular, neither the mainstream media nor the medical press has given much attention to the two vaccines’ potential downsides—in particular, their risk of nasty adverse effects, even if they’re not life-threatening. This sort of puffery doesn’t only help to build a false impression; it may also dry the tinder for the future spread of vaccine fear-mongering.

Back in May, a CNN report described the Oxford group as being “the most aggressive in painting the rosiest picture” of its product, so let’s start with them. Just how rosy is the Oxford picture really? It’s certainly true that this week’s news shows the vaccine has the potential to provide protection from Covid-19. But there are flies in the ointment. After the first clinical trial for this vaccine began in April, for example, the researchers added new study arms in which people got acetaminophen every six hours for 24 hours after the injection. That’s not featured in their marketing, of course, and I saw no discussion of this unusual step in media coverage in early summer. Newspapers only said the vaccine had been proven “safe with rhesus monkeys,” and did not cause any adverse effects in those animal tests. It was a worrying signal though: How rough a ride were people having with this vaccine? Was the acetaminophen meant to keep down fever, headaches, malaise—or all of the above?

The Oxford group is also giving acetaminophen to participants in an advanced, phase 3 trial now underway in Brazil, too. In another major study of the vaccine, involving 10,000 people in the UK, you can’t participate if you have an allergy or condition that could be made worse with acetaminophen. No mention of the extra drug, though, in the same group’s trial in South Africa.

Journalists could have pressed them on this issue months ago. The first people to get vaccines are carefully picked to be the least likely to have a negative reaction. If the Oxford vaccine is knocking them around badly, it might not bode well for the rest of us. Don’t get me wrong: a day or two of pain or illness wouldn’t deter me from getting an effective Covid-19 vaccine. But I think we need to be prepared if that’s going to be the case.

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The press release for Monday’s publication of results from the Oxford vaccine trials described an increased frequency of “minor side effects” among participants. A look at the actual paper, though, reveals this to be a marketing spin that has since been parroted in media reports. (The phrases “minor side effects” or “only minor side effects” appeared in writeups from the New York Times, the Wall Street Journal and Reuters, among other outlets.) Yes, mild reactions were far more common than worse ones. But moderate or severe harms—defined as being bad enough to interfere with daily life or needing medical care—were common, too. Around one-third of people vaccinated with the Covid-19 vaccine without acetaminophen experienced moderate or severe chills, fatigue, headache, malaise, and/or feverishness. Close to 10 percent had a fever of at least 100.4 degrees and just over one-fourth developed moderate or severe muscle aches. That’s a lot, in a young and healthy group of people—and the acetaminophen didn’t help much for most of those problems. The paper’s authors designated the vaccine as “acceptable” and “tolerated,” but we don’t yet know how acceptable this will be to most people. If journalists don’t start asking tougher questions, this will become the perfect setup for anti-vaccine messaging: Here’s what they forgot to tell you about the risks…

There is another red flag. Clinical trials for other Covid-19 vaccines have placebo groups, where participants receive saline injections. Only one of the Oxford vaccine trials is taking this approach, however; the others instead compare the experimental treatment to an injected meningococcal vaccine. There can be good reasons to do this: Non-placebo injections may mimic telltale signs that you’ve received an active vaccine, such as a skin reaction, making the trial more truly “blind.” But their use also opens the door to doubt-sowing claims that any harms of the new vaccine are getting buried among the harms already caused by the control-group, “old” vaccines.

Coverage of the Moderna vaccine reflects a different kind of pharma spin: the drip-feeding of selective data via press release. On May 18, Moderna put out some patchy, positive findings on interim outcomes from their first-in-human trial. The company followed that up with a stock offering—and company executives sold off nearly $30 million in shares into the feeding frenzy their press release created.

Read all of our coronavirus coverage here.

With last week’s paper from Moderna, results from that same group of people finally had their formal publication. At the same time, the group registered a 30,000-person phase 3 clinical trial, specifying a pair of 100-microgram injections of the Covid-19 vaccine. According to the press release from May, there were no serious adverse events for the people in that particular dosage group. But last week’s paper shows the full results: By the time they’d had two doses, every single one was showing signs of headaches, chills or fatigue; and for at least 80 percent this could have been enough to interfere with their normal activities. A participant who had a severe reaction to a particularly high dose has talked in detail about how bad it was: If reactions even half as bad as this were to be common for some of these vaccines, they will be hard sells once they reach the community—and there could be a lot of people who are reluctant to get the second injection.

There is already a high level of misinformation and distrust about fast-tracked Covid-19 vaccines in the American community. This week, a new preprint from Kin On Kwok and colleagues found that even a sizable proportion of nurses in Hong Kong would be hesitant to take one. We may have a vaccine soon, say the authors of that paper, but “communities are not ready to accept it.” It won’t help to overcome this skepticism if notable evidence of harms keeps getting pushed off to the side. It’s much better to be straight up about what it’s really like to take one of these vaccines. Why would anyone trust the experts otherwise?


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Coronavirus vaccines

Two coronavirus vaccines ‘produce immune response’ – World – DAWN.com

Two Covid-19 vaccine candidates have proven safe for humans and produced strong immune reactions among patients involved in two separate clinical trials, doctors said on Monday.

The first trial among more than a thousand adults in Britain found that the vaccine induced ‘strong antibody and T cell immune responses’ against the novel coronavirus.

A separate trial in China involving more than 500 people showed most had developed widespread antibody immune response.

The studies, published in The Lancet medical journal, constitute a major step on the road towards a Covid-19 vaccine that is effective and safe for widespread use.

See: Coronavirus: How long before we have a vaccine?

The authors of the studies said they encountered few adverse side effects from the vaccine candidates.
They did, however, caution that more research was needed, particularly among older adults, who are disproportionately at risk of dying of Covid-19.

Co-author Sarah Gilbert from the University of Oxford said the results “hold promise”.

“If our vaccine is effective it is a promising option as these types of vaccine can be manufactured at large scale.”

The pandemic has seen an unprecedented mobilisation of funding and research to rush through a vaccine that can protect billions of people worldwide.

Both studies were phase-2 trials, which test whether the vaccine provokes an immune response and can be well tolerated by patients.

For its trial, the team at Oxford used a genetically modified strain of the common cold virus that infects chimpanzees.

They manipulated the virus to train cells to recognise the viral spike protein, which helps teach the immune system to recognise Covid-19.

As well as developing antibodies in their blood, patients given the vaccine were found to have developed a robust T cell response — helping their body identify and neutralise the virus.

“The immune system has two ways of finding and attacking pathogens — antibody and T cell responses,” said Andrew Pollard, a member of the Oxford team.

“This vaccine is intended to induce both, so it can attack the virus when it’s circulating in the body, as well as attacking infected cells.”

The Oxford team found that among the 500 or so patients given the vaccine, their immune response peaked around 14 days and decreased slightly by day 56 — the end of the study period.

The other 500 patients were instead given the meningitis vaccine as a placebo.

More than one dose?

The second trial, led by China’s Jiangsu Provincial Centre for Disease Control and Prevention, used a weakened human cold virus modified to deliver genetic material that teaches cells to recognise the novel coronavirus.

Two groups of patients were given either a high or low dose of the vaccine.

More than 90 per cent of people in both groups showed either antibody or T cell immune responses between 14-28 days post-vaccine.

Side effects in both trials were moderate but authors of the Chinese study said they needed to test the vaccine safety on older patients.

“Elderly people … are an important target population for a Covid-19 vaccine,” said Wei Chen, from the Beijing Institute of Biotechnology.

“It is possible that an additional dose may be needed in order to induce a stronger immune response in the elderly population.”

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