Tag Archives: vaccine

The Differences Between the Vaccines Matter

Hilda Bastian, The Atlantic: March 7, 2021


Public-health officials are enthusiastic about the new, single-shot COVID-19 vaccine from Johnson & Johnson, despite its having a somewhat lower efficacy at preventing symptomatic illness than other available options. Although clinical-trial data peg that rate at 72 percent in the United States, compared with 94 and 95 percent for the Moderna and Pfizer-BioNTech vaccines, many experts say we shouldn’t fixate on those numbers. Much more germane, they say, is the fact that the Johnson & Johnson shot, like the other two, is essentially perfect when it comes to preventing the gravest outcomes. “I’m super-pumped about this,” Virginia’s vaccine coordinator told The New York Times last weekend. “A hundred percent efficacy against deaths and hospitalizations? That’s all I need to hear.”

The same glowing message—that the COVID-19 vaccines are all equivalent, at least where it really counts—has been getting public-health officials and pundits super-pumped for weeks now. Its potential value for promoting vaccination couldn’t be more clear: We’ll all be better off, and this nightmare will be over sooner, if people know that the best vaccine of all is whichever one they can get the soonest. With that in mind, Vox has urged its readers to attend to “the most important vaccine statistic”—the fact that “there have been zero cases of hospitalization or death in clinical trials for all of these vaccines.” The physician and CNN medical analyst Leana Wen also made a point of noting that “all of the vaccines are essentially a hundred percent” in this regard. And half a dozen former members of President Joe Biden’s COVID-19 Advisory Board wrote in USA Today, “Varying ‘effectiveness’ rates miss the most important point: The vaccines were all 100% effective in the vaccine trials in stopping hospitalizations and death.”

There’s a problem here. It’s certainly true that all three of the FDA-authorized vaccines are very good—amazing, even—at protecting people’s health. No one should refrain from seeking vaccination on the theory that any might be second-rate. But it’s also true that the COVID-19 vaccines aren’t all the same: Some are more effective than others at preventing illness, for example; some cause fewer adverse reactions; some are more convenient; some were made using more familiar methods and technologies. As for the claim that the vaccines have proved perfectly and equally effective at preventing hospitalization and death? It’s just not right.

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The data were indeed suggestive of an encouraging idea. Based on the numbers so far, we can expect the vaccines to provide extremely high levels of protection against the most dire outcomes. Still, we don’t know how high—and it’s clear they won’t uniformly cause hospitalizations and deaths from COVID-19 to disappear in vaccinated people.

The experts understand this, of course. Gandhi has been updating her table as more data come in, and now pegs Moderna’s efficacy on that front at 97 percent; Jha has since tweeted that “nothing is 100 percent … But these vaccines sure are close”; and Topol told The Atlantic that the numbers in his tweet are not a sufficient basis from which to draw “any determination of magnitude of effect,” though the fact that they all point in the same direction is “very encouraging.” Still, the message of perfection that their initial tables and tweets spawned—the gist, for many readers, of all those 100s and zeros—has since been picked up far and wide, and misinterpreted along the way.

For the AstraZeneca vaccine, one person in the control group had severe COVID-19, but eight people were hospitalized; for Johnson & Johnson, 34 people in the placebo group had severe COVID-19, but only five people were hospitalized. It’s true that zero vaccinated people were hospitalized in either study after the vaccines took effect. But with numbers that small, you can’t draw a reliable conclusion about how high efficacy may be for these outcomes. As Diana Zuckerman of the National Center for Health Research pointed out about the Johnson & Johnson trial, “It’s misleading to tell the public that nobody who was vaccinated was hospitalized unless you also tell them that only 5 people in the placebo group were hospitalized.” She’s right. And you can’t be confident about predicting effectiveness precisely in a wider population outside the trial, either. For example, some of the vaccine trials included relatively few people older than 60 as participants.

You can see how fragile these numbers are by looking at those compiled for severe disease. In the Pfizer trial, for example, just one vaccinated person developed severe COVID-19 versus three in the placebo group—which meant that a single bout of disease made the difference between a calculated efficacy rate of 66 percent and one of 100 percent. For the Novavax and Oxford-AstraZeneca trials, there were zero people with severe disease in the vaccinated group versus only one in the control group, so adding or subtracting one would have been even more dramatic. The problem is even greater for deaths. For that efficacy analysis, only two of the vaccine trials—for Moderna’s and Johnson & Johnson’s—reported any COVID-19 deaths at all in the control groups.

It’s also important to remember that these are early results: Some people who enrolled very late in the trials aren’t yet included in reported data, and analysis is still under way. Indeed, the FDA pointed out in December that one vaccinated person in the Moderna trial had been hospitalized with apparently severe COVID-19 two months after receiving a second dose. That person was in a group still awaiting final assessment by the researchers, and was not mentioned in Moderna’s formal readout of results.

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“The idea that people can’t handle nuance,” Jha tweeted at the end of February, “it’s paternalistic. And untrue.” I couldn’t agree more. The principle of treating people like adults is fundamental. We don’t need to exaggerate. Talking about the trade-offs between different medicines and vaccines is often complicated, but we do it all the time—and we can do it with COVID-19 vaccines too.

To read the entire article, click here

What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine

Tina Hesman Saey, ScienceNews: February 27, 2021


And then there were three: A single-shot vaccine is the latest weapon to join the battle against COVID-19 in the United States.

On February 27, the U.S. Food and Drug Administration gave emergency use authorization for Johnson & Johnson’s vaccine against SARS-CoV-2, the coronavirus that causes COVID-19. South Africa is the only other country to OK Johnson & Johnson’s vaccine so far, though other countries are poised to follow suit.

The FDA determined that Johnson & Johnson’s vaccine meets the criteria for safety and effectiveness and that there is clear evidence that it may prevent COVID-19, the agency said in a statement.

“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus,” said Peter Marks,  director of the FDA’s Center for Biologics Evaluation and Research.

Its authorization for emergency use in the United States – for people age 18 and older – follows similar authorizations in December for vaccines made by Moderna and by Pfizer and its German partner BioNTech.

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As of February 25, more than 52,000 people were hospitalized in the United States fighting COVID-19, according to the COVID Tracking Project. That’s down from the record-setting daily peaks of more than 130,000 in early January and the lowest since early to mid-November. More than half a million people in the United States have now died from COVID-19.

In Johnson & Johnson’s clinical trial, two of the 19,514 people in the vaccine group were hospitalized with COVID-19 starting 14 days after vaccination. That compares with 29 hospitalizations among the 19,544 people in the placebo group. None of the vaccinated people died, but there were seven deaths related to COVID-19 in the placebo group. Those numbers are small and some researchers say the data aren’t clear-cut on the benefits.

“The data indicate that the vaccine is effective, but doesn’t prove that the vaccine is especially effective against moderate to severe COVID,” said Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C.–based think tank that analyzes health research.

The data were also collected after only two months of follow-up. Normally, the FDA requires a year or more of data to fully approve a vaccine. Some questions about the vaccine can’t be answered with less than six months of data, Zuckerman said during a public comment period in the Feb. 26 advisory board hearing.  “Let’s be very honest with the public about what we do know and what we won’t know” for some time to come.

For all the vaccines, no one knows how long immunity will last. And what’s already authorized might need to be tweaked if resistant variants become widespread. Booster shots may be needed, Benjamin says.

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To read the entire article, click here.

FDA Panel Reviewing Pfizer Vaccine Leaves Out Some Experts Who Raised Concerns

David Hilzenrath, Project on Government Oversight: December 9, 2020.


When an FDA advisory committee meets tomorrow to review Pfizer’s coronavirus vaccine, the lineup of committee members will look different from the group that met in October to begin the committee’s discussion of coronavirus vaccines.

Four people who participated in the earlier meeting as temporary committee members, including experts who raised questions and expressed concerns about the testing process, do not appear on the “draft roster” of panelists the FDA has posted for tomorrow’s meeting.

Meanwhile, there will be new faces. The FDA has added 10 temporary committee members who did not participate in the earlier meeting.

The changes in the lineup raise concerns, Diana Zuckerman, president of the National Center for Health Research, said in answer to questions from the Project On Government Oversight (POGO).

Zuckerman said experts might have been excluded to avoid tough questions about Pfizer’s data.

“It is not unusual for temporary members of FDA Advisory Committees to change, but seems surprising since the issues they are considering at the Oct meeting and tomorrow are so similar,” Zuckerman said by email.

Zuckerman’s organization analyzes the safety and effectiveness of pharmaceuticals and other medical products.

POGO asked the FDA whether the disappearance of some people from the advisory committee lineup had anything to do with any questions, concerns, or opinions they have expressed. In response, an FDA spokesperson did not directly answer.

The FDA routinely supplements advisory committees with temporary voting members, including “scientists or medical personnel whose expertise may not be represented by the fixed voting membership,” the FDA spokesperson said by email. “Many times, committees need to invite experts who are unrelated to the knowledge and expertise spelled out in the committee charter if a medical product or topic for discussion calls for a specific need for a particular expert,” the spokesperson added.

That does not seem to explain why the FDA would drop temporary voting members it selected to participate in the October meeting. At that meeting, without evaluating any particular vaccine, the committee advised the FDA on how in general it should approach experimental coronavirus vaccines.

Dr. Luigi Notarangelo, an expert on clinical immunology at the National Institute of Allergy and Infectious Diseases, was not invited to participate in the December 10 FDA advisory committee meeting on Pfizer’s coronavirus vaccine. He served as a temporary committee member when the panel met in October and minced no words then as he expressed general concerns about the testing of coronavirus vaccines.

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POGO recapped his commentary at the October meeting in a November 2 story, “FDA Whitewashes Warnings About Coronavirus Vaccine Trials.”

As POGO reported:

Dr. Luigi Notarangelo, a committee member who is a chief researcher at the National Institutes of Health, minced no words as he articulated several of the critiques.

Notarangelo said measures of vaccine effectiveness included in an FDA document the committee was asked to review have two problems.
“First of all, they really are biased—skewed towards mild disease,” he said. “Mild disease may not mean very much.”
“The other problem with those efficacy measures is that most of them are really subjective,” he said. “And I think that’s a major concern. I mean, we’re relying basically upon reporting from the subjects without any objective validation of what they’re reporting.”

At the time, Notarangelo was not commenting specifically on Pfizer’s data.

Another person who served as a temporary member on October 22 but does not appear on the roster for tomorrow is Kathryn Holmes, a professor emerita in the Department of Immunology & Microbiology at the University of Colorado School of Medicine.

“One of the things I have not heard much about during this conversation is infection,” Holmes said at the October meeting. “I’d like to see how we could actually be measuring infection rather than just mild disease. … We should be looking to see what can prevent infection because that is the rubric which would prevent spread through the community most effectively and that is what would protect our elderly as well.”

Holmes could not be reached for comment for this story.

Another person who participated in the October meeting but is not slated to participate tomorrow is Dr. Michael Nelson, president of the American Board of Allergy and Immunology and a physician at Walter Reed Army National Military Medical Center.

At the October meeting, Nelson said “more real-time data might be needed.”

Nelson also noted that, when the acting chair of the committee summarized members’ comments, he omitted “a lot of concern” about an aspect of how vaccine effectiveness was being measured—whether it was focused inordinately on preventing milder cases.

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